Capsules -Pharmaceutics
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Jun 06, 2016
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About This Presentation
Capsules -Pharmaceutics
Slide Content
Capsules are solid dosage forms in which one or
more medicinal and/or inert substances are enclosed
within a small shell or container generally prepared
from a suitable form of gelatin.
Depending upon their formulation, the gelatin
capsule shells may be hard or soft.
more medicinal and/or inert substances are enclosed
within a small shell or container generally prepared
from a suitable form of gelatin.
Depending upon their formulation, the gelatin
capsule shells may be hard or soft.
Hard Gelatin CapsulesHard Gelatin Capsules
The hard gelatin capsule The hard gelatin capsule
consists of a base or consists of a base or
body and a shorter cap, body and a shorter cap,
which fits firmly over the which fits firmly over the
base of the capsulebase of the capsule. .
The hard gelatin capsule The hard gelatin capsule
consists of a base or consists of a base or
body and a shorter cap, body and a shorter cap,
which fits firmly over the which fits firmly over the
base of the capsulebase of the capsule. .
Hard Gelatin CapsulesHard Gelatin Capsules
1. Mask the unpleasant tastes of a drug. 1. Mask the unpleasant tastes of a drug.
2. Allow powders to be dispensed in an uncompressed 2. Allow powders to be dispensed in an uncompressed
form, thus allowing for quicker dissolution and form, thus allowing for quicker dissolution and
absorption of the drug following oral dosingabsorption of the drug following oral dosing
3. Have the flexibility which permit a wide prescribing 3. Have the flexibility which permit a wide prescribing
opportunity by the physician in that the pharmacist may opportunity by the physician in that the pharmacist may
prepare capsules containing a single chemical prepare capsules containing a single chemical
substance or a combination of drugs at the accurate substance or a combination of drugs at the accurate
dosage level for the individual patient. dosage level for the individual patient.
4. Be easier than tablets for some people to swallow.4. Be easier than tablets for some people to swallow.
5. Can alter the release rate of the drug. 5. Can alter the release rate of the drug.
Advantage of Hard gelatin capsulesAdvantage of Hard gelatin capsules
1. Mask the unpleasant tastes of a drug. 1. Mask the unpleasant tastes of a drug.
2. Allow powders to be dispensed in an uncompressed 2. Allow powders to be dispensed in an uncompressed
form, thus allowing for quicker dissolution and form, thus allowing for quicker dissolution and
absorption of the drug following oral dosingabsorption of the drug following oral dosing
3. Have the flexibility which permit a wide prescribing 3. Have the flexibility which permit a wide prescribing
opportunity by the physician in that the pharmacist may opportunity by the physician in that the pharmacist may
prepare capsules containing a single chemical prepare capsules containing a single chemical
substance or a combination of drugs at the accurate substance or a combination of drugs at the accurate
dosage level for the individual patient. dosage level for the individual patient.
4. Be easier than tablets for some people to swallow.4. Be easier than tablets for some people to swallow.
5. Can alter the release rate of the drug. 5. Can alter the release rate of the drug.
Advantage of Hard gelatin capsulesAdvantage of Hard gelatin capsules
DisadvantagesDisadvantages or limitations include the followingor limitations include the following: :
1.1.They are subject to the effects of relative humidity and They are subject to the effects of relative humidity and
to microbial contaminationto microbial contamination. .
2. They may be difficult for some people to swallow2. They may be difficult for some people to swallow. .
3. More expensive (commercially)3. More expensive (commercially). .
1.1.They are subject to the effects of relative humidity and They are subject to the effects of relative humidity and
to microbial contaminationto microbial contamination. .
2. They may be difficult for some people to swallow2. They may be difficult for some people to swallow. .
3. More expensive (commercially)3. More expensive (commercially). .
Opaque capsules may be prepared by adding an Opaque capsules may be prepared by adding an
insoluble substance as titanium dioxide to the gelatin insoluble substance as titanium dioxide to the gelatin
mixture. Colored, opaque capsules may be prepared by mixture. Colored, opaque capsules may be prepared by
using both a colorant and the opaque-producing using both a colorant and the opaque-producing
substance.substance.
Gelatin, NF, is a product obtained by partial hydrolysis of Gelatin, NF, is a product obtained by partial hydrolysis of
collagen obtained from the skin, white connective tissue, collagen obtained from the skin, white connective tissue,
and bones of animals.and bones of animals.
It is found in commerce in the form of a fine powder, a It is found in commerce in the form of a fine powder, a
coarse powder, shreds, flakes, or sheets coarse powder, shreds, flakes, or sheets
The basic empty capsule shells The basic empty capsule shells
are made from a mixture of gelatin, are made from a mixture of gelatin,
sugar, and water and are clear, sugar, and water and are clear,
colorless, and essentially tasteless.colorless, and essentially tasteless.
Colorants may be used to prepare Colorants may be used to prepare
distinctive capsules.distinctive capsules.
insoluble substance as titanium dioxide to the gelatin insoluble substance as titanium dioxide to the gelatin
mixture. Colored, opaque capsules may be prepared by mixture. Colored, opaque capsules may be prepared by
using both a colorant and the opaque-producing using both a colorant and the opaque-producing
substance.substance.
Gelatin, NF, is a product obtained by partial hydrolysis of Gelatin, NF, is a product obtained by partial hydrolysis of
collagen obtained from the skin, white connective tissue, collagen obtained from the skin, white connective tissue,
and bones of animals.and bones of animals.
It is found in commerce in the form of a fine powder, a It is found in commerce in the form of a fine powder, a
coarse powder, shreds, flakes, or sheets coarse powder, shreds, flakes, or sheets
The basic empty capsule shells The basic empty capsule shells
are made from a mixture of gelatin, are made from a mixture of gelatin,
sugar, and water and are clear, sugar, and water and are clear,
colorless, and essentially tasteless.colorless, and essentially tasteless.
Colorants may be used to prepare Colorants may be used to prepare
distinctive capsules.distinctive capsules.
depending upon the environmental conditions, in depending upon the environmental conditions, in
high humidity, capsules absorb moisture and become high humidity, capsules absorb moisture and become
distorted and lose their rigid shape. distorted and lose their rigid shape.
but in extreme dryness, some of the moisture but in extreme dryness, some of the moisture
normally present in the gelatin capsules may be lost, normally present in the gelatin capsules may be lost,
and the capsules become brittle and crumble.and the capsules become brittle and crumble.
Thus capsules should be stored in areas of low Thus capsules should be stored in areas of low
humidity.humidity.
Normally, hard gelatin capsules Normally, hard gelatin capsules
contain between 13 and 16% of contain between 13 and 16% of
moisture.moisture.
moisture may be absorbed or moisture may be absorbed or
released by gelatin capsules, released by gelatin capsules,
high humidity, capsules absorb moisture and become high humidity, capsules absorb moisture and become
distorted and lose their rigid shape. distorted and lose their rigid shape.
but in extreme dryness, some of the moisture but in extreme dryness, some of the moisture
normally present in the gelatin capsules may be lost, normally present in the gelatin capsules may be lost,
and the capsules become brittle and crumble.and the capsules become brittle and crumble.
Thus capsules should be stored in areas of low Thus capsules should be stored in areas of low
humidity.humidity.
Normally, hard gelatin capsules Normally, hard gelatin capsules
contain between 13 and 16% of contain between 13 and 16% of
moisture.moisture.
moisture may be absorbed or moisture may be absorbed or
released by gelatin capsules, released by gelatin capsules,
Gelatin is insoluble in cold water but soluble in hot Gelatin is insoluble in cold water but soluble in hot
water, and in gastric fluid where a gelatin capsule water, and in gastric fluid where a gelatin capsule
rapidly releases its contents. rapidly releases its contents.
Gelatin, being a protein, is digested and absorbed.Gelatin, being a protein, is digested and absorbed.
water, and in gastric fluid where a gelatin capsule water, and in gastric fluid where a gelatin capsule
rapidly releases its contents. rapidly releases its contents.
Gelatin, being a protein, is digested and absorbed.Gelatin, being a protein, is digested and absorbed.
Hard gelatin capsule shells are manufactured mechanical
dipping of manganese bronze pins of the desired shape
and diameter to the desired depth and time into a
reservoir of the melted gelatin mixture, maintained at a
constant temperature to achieve the desired degree of
fluidity.
Then the plate and the pins slowly lifted from the gelatin
bath and gently dried by a flow of temperature and
humidity controlled air
dipping of manganese bronze pins of the desired shape
and diameter to the desired depth and time into a
reservoir of the melted gelatin mixture, maintained at a
constant temperature to achieve the desired degree of
fluidity.
Then the plate and the pins slowly lifted from the gelatin
bath and gently dried by a flow of temperature and
humidity controlled air
Capsule SizesCapsule Sizes
Empty gelatin capsules are manufactured in various Empty gelatin capsules are manufactured in various
sizes, varying in length, in diameter, and capacity.sizes, varying in length, in diameter, and capacity.
For human use, empty capsules ranging in size from For human use, empty capsules ranging in size from
000 the largest, to 5 the smallest are commercially 000 the largest, to 5 the smallest are commercially
available.available.
Empty gelatin capsules are manufactured in various Empty gelatin capsules are manufactured in various
sizes, varying in length, in diameter, and capacity.sizes, varying in length, in diameter, and capacity.
For human use, empty capsules ranging in size from For human use, empty capsules ranging in size from
000 the largest, to 5 the smallest are commercially 000 the largest, to 5 the smallest are commercially
available.available.
preparation of filled Hard Gelatin Capsules preparation of filled Hard Gelatin Capsules
The preparation of filled hard gelatin capsules may be The preparation of filled hard gelatin capsules may be
divided into the following steps:divided into the following steps:
1.1. Preparing the formulation Preparing the formulation
2.2. Selecting the capsule size.Selecting the capsule size.
3. Filling the capsule shells.3. Filling the capsule shells.
4. Cleaning and polishing the filled capsules.4. Cleaning and polishing the filled capsules.
The preparation of filled hard gelatin capsules may be The preparation of filled hard gelatin capsules may be
divided into the following steps:divided into the following steps:
1.1. Preparing the formulation Preparing the formulation
2.2. Selecting the capsule size.Selecting the capsule size.
3. Filling the capsule shells.3. Filling the capsule shells.
4. Cleaning and polishing the filled capsules.4. Cleaning and polishing the filled capsules.
Preformulation studies are used to determine if the bulk Preformulation studies are used to determine if the bulk
powders may be blended together as such, or if they powders may be blended together as such, or if they
require reduction of particle size or processing into require reduction of particle size or processing into
formed granules.formed granules.
i. preparinG tHe formulationi. preparinG tHe formulation
MillingMilling
To achieve uniform drug distribution through out a To achieve uniform drug distribution through out a
powder mix, it is advantageous that the density and powder mix, it is advantageous that the density and
particle size of the drug and non-drug components are particle size of the drug and non-drug components are
similar. This is achieved by particle size reduction similar. This is achieved by particle size reduction
(milling).(milling).
Dry PowderDry Powder
powders may be blended together as such, or if they powders may be blended together as such, or if they
require reduction of particle size or processing into require reduction of particle size or processing into
formed granules.formed granules.
i. preparinG tHe formulationi. preparinG tHe formulation
MillingMilling
To achieve uniform drug distribution through out a To achieve uniform drug distribution through out a
powder mix, it is advantageous that the density and powder mix, it is advantageous that the density and
particle size of the drug and non-drug components are particle size of the drug and non-drug components are
similar. This is achieved by particle size reduction similar. This is achieved by particle size reduction
(milling).(milling).
Dry PowderDry Powder
DiluentDiluent
Generally, hard gelatin capsules are used to encapsulate Generally, hard gelatin capsules are used to encapsulate
between about 65 mg and 1 g of powdered material, between about 65 mg and 1 g of powdered material,
including drug and any diluent required. including drug and any diluent required.
If the dose of the drug to be placed in a single capsule is If the dose of the drug to be placed in a single capsule is
smaller than 65 mg to produce the proper fill, lactose, smaller than 65 mg to produce the proper fill, lactose,
microcrystalline cellulose, and pregelatinized starch are microcrystalline cellulose, and pregelatinized starch are
common diluents used in capsule filling. But when the common diluents used in capsule filling. But when the
amount of drug is large enough to fill a capsule amount of drug is large enough to fill a capsule
completely, a diluent may not be required.completely, a diluent may not be required.
Generally, hard gelatin capsules are used to encapsulate Generally, hard gelatin capsules are used to encapsulate
between about 65 mg and 1 g of powdered material, between about 65 mg and 1 g of powdered material,
including drug and any diluent required. including drug and any diluent required.
If the dose of the drug to be placed in a single capsule is If the dose of the drug to be placed in a single capsule is
smaller than 65 mg to produce the proper fill, lactose, smaller than 65 mg to produce the proper fill, lactose,
microcrystalline cellulose, and pregelatinized starch are microcrystalline cellulose, and pregelatinized starch are
common diluents used in capsule filling. But when the common diluents used in capsule filling. But when the
amount of drug is large enough to fill a capsule amount of drug is large enough to fill a capsule
completely, a diluent may not be required.completely, a diluent may not be required.
LubricantLubricant
a lubricant as 1% Magnesium stearate is utilized to a lubricant as 1% Magnesium stearate is utilized to
prevent adhesion and facilitate the flow of the powder in prevent adhesion and facilitate the flow of the powder in
capsule filling machine.capsule filling machine.
GlidantGlidant
The powder mixture or granules must be free-flowing to The powder mixture or granules must be free-flowing to
allow passage from the hopper by the addition of a allow passage from the hopper by the addition of a
glidant such as 1% silicon dioxide.glidant such as 1% silicon dioxide.
Lubricant and Glidant are used to improve filling Lubricant and Glidant are used to improve filling
properties. properties.
a lubricant as 1% Magnesium stearate is utilized to a lubricant as 1% Magnesium stearate is utilized to
prevent adhesion and facilitate the flow of the powder in prevent adhesion and facilitate the flow of the powder in
capsule filling machine.capsule filling machine.
GlidantGlidant
The powder mixture or granules must be free-flowing to The powder mixture or granules must be free-flowing to
allow passage from the hopper by the addition of a allow passage from the hopper by the addition of a
glidant such as 1% silicon dioxide.glidant such as 1% silicon dioxide.
Lubricant and Glidant are used to improve filling Lubricant and Glidant are used to improve filling
properties. properties.
Wetting agentWetting agent
Addition wetting agents, as sodium lauryl Addition wetting agents, as sodium lauryl
sulfate, in capsule facilitate the wetting sulfate, in capsule facilitate the wetting
of the drug substance by gastrointestinal fluids to of the drug substance by gastrointestinal fluids to
enhance dissolution, and overcome the problem enhance dissolution, and overcome the problem
associated with water-insoluble lubricant as associated with water-insoluble lubricant as
magnesium stearate which can delay the dissolution magnesium stearate which can delay the dissolution
of the drug and its absorption.of the drug and its absorption.
Addition wetting agents, as sodium lauryl Addition wetting agents, as sodium lauryl
sulfate, in capsule facilitate the wetting sulfate, in capsule facilitate the wetting
of the drug substance by gastrointestinal fluids to of the drug substance by gastrointestinal fluids to
enhance dissolution, and overcome the problem enhance dissolution, and overcome the problem
associated with water-insoluble lubricant as associated with water-insoluble lubricant as
magnesium stearate which can delay the dissolution magnesium stearate which can delay the dissolution
of the drug and its absorption.of the drug and its absorption.
Eutectic mixtures Eutectic mixtures or mixtures that tend to liquefy, may or mixtures that tend to liquefy, may
require a diluent or absorbant such as magnesium require a diluent or absorbant such as magnesium
carbonate, kaolin, or light magnesium oxide to separate carbonate, kaolin, or light magnesium oxide to separate
physically the interacting agents and to absorb any physically the interacting agents and to absorb any
liquefied material. liquefied material.
euteCtiC mixtureseuteCtiC mixtures
require a diluent or absorbant such as magnesium require a diluent or absorbant such as magnesium
carbonate, kaolin, or light magnesium oxide to separate carbonate, kaolin, or light magnesium oxide to separate
physically the interacting agents and to absorb any physically the interacting agents and to absorb any
liquefied material. liquefied material.
euteCtiC mixtureseuteCtiC mixtures
However, some liquids such as fixed or volatile oils that However, some liquids such as fixed or volatile oils that
do not interfere with the stability of the gelatin shells may do not interfere with the stability of the gelatin shells may
be placed in gelatin capsules which then may be sealed be placed in gelatin capsules which then may be sealed
to ensure the retention of the liquid (to ensure the retention of the liquid ( soft gelatin soft gelatin
capsules)capsules)
Gelatin capsules are Gelatin capsules are
unsuitable for the unsuitable for the
encapsulation of aqueous encapsulation of aqueous
liquids, because water liquids, because water
softens the gelatin to softens the gelatin to
produce distortion of the produce distortion of the
capsules. capsules.
LiquidsLiquids
do not interfere with the stability of the gelatin shells may do not interfere with the stability of the gelatin shells may
be placed in gelatin capsules which then may be sealed be placed in gelatin capsules which then may be sealed
to ensure the retention of the liquid (to ensure the retention of the liquid ( soft gelatin soft gelatin
capsules)capsules)
Gelatin capsules are Gelatin capsules are
unsuitable for the unsuitable for the
encapsulation of aqueous encapsulation of aqueous
liquids, because water liquids, because water
softens the gelatin to softens the gelatin to
produce distortion of the produce distortion of the
capsules. capsules.
LiquidsLiquids
SemisolidsSemisolids
This system can be used for both This system can be used for both
liquid and solid active ingredients.liquid and solid active ingredients.
Mixtures for filling need only beMixtures for filling need only be
liquid when filled and should be liquid when filled and should be
semisolid after being inside the capsules.semisolid after being inside the capsules.
The materials to be filled must be either thermosoftening The materials to be filled must be either thermosoftening
or thixotropic in nature to be liquefied by heating or or thixotropic in nature to be liquefied by heating or
shearing forces using heated hopper with a stirrer and shearing forces using heated hopper with a stirrer and
revert to the solid state within the capsule shell. revert to the solid state within the capsule shell.
Used for potent drugs to improve uniformity of filling.Used for potent drugs to improve uniformity of filling.
Used for safely handling toxic drugs to reduce Used for safely handling toxic drugs to reduce
contamination with filling of powders. contamination with filling of powders.
This system can be used for both This system can be used for both
liquid and solid active ingredients.liquid and solid active ingredients.
Mixtures for filling need only beMixtures for filling need only be
liquid when filled and should be liquid when filled and should be
semisolid after being inside the capsules.semisolid after being inside the capsules.
The materials to be filled must be either thermosoftening The materials to be filled must be either thermosoftening
or thixotropic in nature to be liquefied by heating or or thixotropic in nature to be liquefied by heating or
shearing forces using heated hopper with a stirrer and shearing forces using heated hopper with a stirrer and
revert to the solid state within the capsule shell. revert to the solid state within the capsule shell.
Used for potent drugs to improve uniformity of filling.Used for potent drugs to improve uniformity of filling.
Used for safely handling toxic drugs to reduce Used for safely handling toxic drugs to reduce
contamination with filling of powders. contamination with filling of powders.
Granules and PelletsGranules and Pellets
Granules are produced by Granules are produced by
granulation and are more granulation and are more
irregular than pellets which irregular than pellets which
are spherical and are spherical and
produced by produced by
microencapsulation microencapsulation
techniquetechnique
Granules and Pellets are Granules and Pellets are
packed in capsules instead packed in capsules instead
of powder to produce of powder to produce
modified release patterns.modified release patterns.
Granules are produced by Granules are produced by
granulation and are more granulation and are more
irregular than pellets which irregular than pellets which
are spherical and are spherical and
produced by produced by
microencapsulation microencapsulation
techniquetechnique
Granules and Pellets are Granules and Pellets are
packed in capsules instead packed in capsules instead
of powder to produce of powder to produce
modified release patterns.modified release patterns.
Capsules within capsules:Capsules within capsules:
Tablets within capsules:Tablets within capsules:
This small tablet can be placed inside the capsule following This small tablet can be placed inside the capsule following
the addition of a small quantity of the powder and the filling the addition of a small quantity of the powder and the filling
completed.completed.
Small tablets are filled into capsules to Small tablets are filled into capsules to
produce special release forms or to produce special release forms or to
separate incompatible ingredients.separate incompatible ingredients.
If one ingredient must be separated from If one ingredient must be separated from
others in the formulation, a small capsule, others in the formulation, a small capsule,
such as a No. 5, may be filled with one such as a No. 5, may be filled with one
powder and placed into a larger capsule powder and placed into a larger capsule
with the remaining ingredients in the with the remaining ingredients in the
formulation. formulation.
Tablets within capsules:Tablets within capsules:
This small tablet can be placed inside the capsule following This small tablet can be placed inside the capsule following
the addition of a small quantity of the powder and the filling the addition of a small quantity of the powder and the filling
completed.completed.
Small tablets are filled into capsules to Small tablets are filled into capsules to
produce special release forms or to produce special release forms or to
separate incompatible ingredients.separate incompatible ingredients.
If one ingredient must be separated from If one ingredient must be separated from
others in the formulation, a small capsule, others in the formulation, a small capsule,
such as a No. 5, may be filled with one such as a No. 5, may be filled with one
powder and placed into a larger capsule powder and placed into a larger capsule
with the remaining ingredients in the with the remaining ingredients in the
formulation. formulation.
PowdersPowders
GranulesGranules
BeadsBeads
TaBleTsTaBleTs
CaPsulesCaPsules
PasTesPasTes
liquidsliquids
GranulesGranules
BeadsBeads
TaBleTsTaBleTs
CaPsulesCaPsules
PasTesPasTes
liquidsliquids
The selection of capsule size is best done during the The selection of capsule size is best done during the
development of the formulation, because the amount of development of the formulation, because the amount of
inert materials to be employed is dependent upon the size inert materials to be employed is dependent upon the size
or capacity of the capsule to be selected. or capacity of the capsule to be selected.
ii. seleCTion oF CaPsule siZeii. seleCTion oF CaPsule siZe
The density and compressibility of a powder or a powder The density and compressibility of a powder or a powder
mixture will largely determine to what extent it can be mixture will largely determine to what extent it can be
packed into a capsule shell.packed into a capsule shell.
The amount may vary according to the degree of pressure The amount may vary according to the degree of pressure
used in filling the capsules.used in filling the capsules.
development of the formulation, because the amount of development of the formulation, because the amount of
inert materials to be employed is dependent upon the size inert materials to be employed is dependent upon the size
or capacity of the capsule to be selected. or capacity of the capsule to be selected.
ii. seleCTion oF CaPsule siZeii. seleCTion oF CaPsule siZe
The density and compressibility of a powder or a powder The density and compressibility of a powder or a powder
mixture will largely determine to what extent it can be mixture will largely determine to what extent it can be
packed into a capsule shell.packed into a capsule shell.
The amount may vary according to the degree of pressure The amount may vary according to the degree of pressure
used in filling the capsules.used in filling the capsules.
Determination of capsule fill weightDetermination of capsule fill weight
To determine the size of capsule to be used or the To determine the size of capsule to be used or the
fill weight for a formulation the following relationship fill weight for a formulation the following relationship
is used:is used:
Capsule fill weight =Capsule fill weight =
Tapped Bulk Density of Formulation X Capsule Tapped Bulk Density of Formulation X Capsule
VolumeVolume
To determine the size of capsule to be used or the To determine the size of capsule to be used or the
fill weight for a formulation the following relationship fill weight for a formulation the following relationship
is used:is used:
Capsule fill weight =Capsule fill weight =
Tapped Bulk Density of Formulation X Capsule Tapped Bulk Density of Formulation X Capsule
VolumeVolume
iii. FillinG The CaPsule shellsiii. FillinG The CaPsule shells
1.1."Punch" Method "Punch" Method
2.2. Hand-Operated Capsule Filling MachinesHand-Operated Capsule Filling Machines
3.3. Automatic-Operated Capsule Filling Automatic-Operated Capsule Filling
Machines Machines
1.1."Punch" Method "Punch" Method
2.2. Hand-Operated Capsule Filling MachinesHand-Operated Capsule Filling Machines
3.3. Automatic-Operated Capsule Filling Automatic-Operated Capsule Filling
Machines Machines
Used for filling a small number of capsules in the Used for filling a small number of capsules in the
pharmacy, at the prescription counter.pharmacy, at the prescription counter.
The ingredients are triturated to the same particle size The ingredients are triturated to the same particle size
and then mixed by geometric dilution. and then mixed by geometric dilution.
The powder is placed on a powder paper or ointment The powder is placed on a powder paper or ointment
slab and smoothed with a spatula to a height slab and smoothed with a spatula to a height
approximately half the length of the capsule body. approximately half the length of the capsule body.
"PunCh" MeThod "PunCh" MeThod
pharmacy, at the prescription counter.pharmacy, at the prescription counter.
The ingredients are triturated to the same particle size The ingredients are triturated to the same particle size
and then mixed by geometric dilution. and then mixed by geometric dilution.
The powder is placed on a powder paper or ointment The powder is placed on a powder paper or ointment
slab and smoothed with a spatula to a height slab and smoothed with a spatula to a height
approximately half the length of the capsule body. approximately half the length of the capsule body.
"PunCh" MeThod "PunCh" MeThod
The base of the capsule is held vertically and the open The base of the capsule is held vertically and the open
end is repeatedly pushed or "punched" into the powder end is repeatedly pushed or "punched" into the powder
until the capsule is filled; until the capsule is filled;
The cap is then replaced to close the capsule. Each The cap is then replaced to close the capsule. Each
filled capsule is weighed using an empty capsule as a filled capsule is weighed using an empty capsule as a
counterweight. counterweight.
Powder is added or removed until the correct weight has Powder is added or removed until the correct weight has
been placed in the capsule. been placed in the capsule.
The filled capsule is tapped so that no air spaces are The filled capsule is tapped so that no air spaces are
visible within the contents. visible within the contents.
end is repeatedly pushed or "punched" into the powder end is repeatedly pushed or "punched" into the powder
until the capsule is filled; until the capsule is filled;
The cap is then replaced to close the capsule. Each The cap is then replaced to close the capsule. Each
filled capsule is weighed using an empty capsule as a filled capsule is weighed using an empty capsule as a
counterweight. counterweight.
Powder is added or removed until the correct weight has Powder is added or removed until the correct weight has
been placed in the capsule. been placed in the capsule.
The filled capsule is tapped so that no air spaces are The filled capsule is tapped so that no air spaces are
visible within the contents. visible within the contents.
Cappunch.rm
Pharmacists that prepare capsules on a regular or Pharmacists that prepare capsules on a regular or
extensive basis may use hand-operated capsule extensive basis may use hand-operated capsule
machines. machines.
These machines are available in capacities of 24, 96, These machines are available in capacities of 24, 96,
100, and 144 capsules. 100, and 144 capsules.
First, the plates are adjusted to hold the capsule bodies First, the plates are adjusted to hold the capsule bodies
in place while the caps are removed all at one time. in place while the caps are removed all at one time.
The caps remain in place in the top of the machine for The caps remain in place in the top of the machine for
later use. later use.
hand-oPeraTed CaPsule MaChineshand-oPeraTed CaPsule MaChines
extensive basis may use hand-operated capsule extensive basis may use hand-operated capsule
machines. machines.
These machines are available in capacities of 24, 96, These machines are available in capacities of 24, 96,
100, and 144 capsules. 100, and 144 capsules.
First, the plates are adjusted to hold the capsule bodies First, the plates are adjusted to hold the capsule bodies
in place while the caps are removed all at one time. in place while the caps are removed all at one time.
The caps remain in place in the top of the machine for The caps remain in place in the top of the machine for
later use. later use.
hand-oPeraTed CaPsule MaChineshand-oPeraTed CaPsule MaChines
Then the plates are adjusted again so that the capsule Then the plates are adjusted again so that the capsule
bodies will "drop" into place so that the tops are flush bodies will "drop" into place so that the tops are flush
with the working surface of the plate. with the working surface of the plate.
The formulation powder is poured onto the plate and The formulation powder is poured onto the plate and
special spreaders are used to fill the individual special spreaders are used to fill the individual
capsules. capsules.
The combs are used to tamp (compress) and pack the The combs are used to tamp (compress) and pack the
powder into the capsules. powder into the capsules.
All of the caps are then returned to the capsule bodies, All of the caps are then returned to the capsule bodies,
and the closed capsules are removed from the and the closed capsules are removed from the
machine. machine.
bodies will "drop" into place so that the tops are flush bodies will "drop" into place so that the tops are flush
with the working surface of the plate. with the working surface of the plate.
The formulation powder is poured onto the plate and The formulation powder is poured onto the plate and
special spreaders are used to fill the individual special spreaders are used to fill the individual
capsules. capsules.
The combs are used to tamp (compress) and pack the The combs are used to tamp (compress) and pack the
powder into the capsules. powder into the capsules.
All of the caps are then returned to the capsule bodies, All of the caps are then returned to the capsule bodies,
and the closed capsules are removed from the and the closed capsules are removed from the
machine. machine.
auToMaTiC-oPeraTed CaPsule FillinG MaChinesauToMaTiC-oPeraTed CaPsule FillinG MaChines
Machines developed for industrial use can automatically Machines developed for industrial use can automatically
remove the caps from empty capsules, fill the capsules, remove the caps from empty capsules, fill the capsules,
replace the caps, and clean the outside of the capsules replace the caps, and clean the outside of the capsules
at a rate of up to 165,000 capsules and greater per hour.at a rate of up to 165,000 capsules and greater per hour.
Machines developed for industrial use can automatically Machines developed for industrial use can automatically
remove the caps from empty capsules, fill the capsules, remove the caps from empty capsules, fill the capsules,
replace the caps, and clean the outside of the capsules replace the caps, and clean the outside of the capsules
at a rate of up to 165,000 capsules and greater per hour.at a rate of up to 165,000 capsules and greater per hour.
In this process, the two capsule parts are sealed with a In this process, the two capsule parts are sealed with a
gelatin or polymer band at the joint of the cap and body. gelatin or polymer band at the joint of the cap and body.
A tamper-resistant seal on hard gelatin capsules wasA tamper-resistant seal on hard gelatin capsules was
SEALING of GELAtIN cApSuLESSEALING of GELAtIN cApSuLES
developed in which the developed in which the
contact areas of the contact areas of the
cap and body are cap and body are
wetted with a mixture wetted with a mixture
of water and ethanol to of water and ethanol to
soften the gelatin and soften the gelatin and
then thermally bonded then thermally bonded
at 104° to 113at 104° to 113
oo
F to F to
form the seal. form the seal.
gelatin or polymer band at the joint of the cap and body. gelatin or polymer band at the joint of the cap and body.
A tamper-resistant seal on hard gelatin capsules wasA tamper-resistant seal on hard gelatin capsules was
SEALING of GELAtIN cApSuLESSEALING of GELAtIN cApSuLES
developed in which the developed in which the
contact areas of the contact areas of the
cap and body are cap and body are
wetted with a mixture wetted with a mixture
of water and ethanol to of water and ethanol to
soften the gelatin and soften the gelatin and
then thermally bonded then thermally bonded
at 104° to 113at 104° to 113
oo
F to F to
form the seal. form the seal.
coNI-SNAp HArd GELAtIN cApSuLEcoNI-SNAp HArd GELAtIN cApSuLE
A recent innovation in capsule A recent innovation in capsule
shell shell
design, where the two halves of design, where the two halves of
the the
capsule shells are enable to be capsule shells are enable to be
positively joined through locking positively joined through locking
grooves in the shell walls.grooves in the shell walls.
The two grooves fit into each The two grooves fit into each
other other
and ensure reliable closing of the and ensure reliable closing of the
filled capsule.filled capsule.
Opening of such capsule is Opening of such capsule is
difficult difficult
with increasing security of the with increasing security of the
contents of the capsule.contents of the capsule.
A recent innovation in capsule A recent innovation in capsule
shell shell
design, where the two halves of design, where the two halves of
the the
capsule shells are enable to be capsule shells are enable to be
positively joined through locking positively joined through locking
grooves in the shell walls.grooves in the shell walls.
The two grooves fit into each The two grooves fit into each
other other
and ensure reliable closing of the and ensure reliable closing of the
filled capsule.filled capsule.
Opening of such capsule is Opening of such capsule is
difficult difficult
with increasing security of the with increasing security of the
contents of the capsule.contents of the capsule.
IV. cLEANING ANd poLISHING tHE fILLEd cApSuLESIV. cLEANING ANd poLISHING tHE fILLEd cApSuLES
Capsules prepared on a small scale or on a large scale Capsules prepared on a small scale or on a large scale
may have small amounts of the powder adhering to the may have small amounts of the powder adhering to the
outside of the capsules. outside of the capsules.
This powder should be removed before packaging or This powder should be removed before packaging or
dispensing to improve the appearance of the capsules and dispensing to improve the appearance of the capsules and
to preserve their quality of being tasteless on to preserve their quality of being tasteless on
administration. On a large scale, many capsule-filling administration. On a large scale, many capsule-filling
machines are affixed with a cleaning vacuum that removes machines are affixed with a cleaning vacuum that removes
any extraneous material from the capsules.any extraneous material from the capsules.
Capsules prepared on a small scale or on a large scale Capsules prepared on a small scale or on a large scale
may have small amounts of the powder adhering to the may have small amounts of the powder adhering to the
outside of the capsules. outside of the capsules.
This powder should be removed before packaging or This powder should be removed before packaging or
dispensing to improve the appearance of the capsules and dispensing to improve the appearance of the capsules and
to preserve their quality of being tasteless on to preserve their quality of being tasteless on
administration. On a large scale, many capsule-filling administration. On a large scale, many capsule-filling
machines are affixed with a cleaning vacuum that removes machines are affixed with a cleaning vacuum that removes
any extraneous material from the capsules.any extraneous material from the capsules.
Another proposed cleaning method is to put the capsules Another proposed cleaning method is to put the capsules
in a container filled with sodium bicarbonate, sugar, or in a container filled with sodium bicarbonate, sugar, or
sodium chloride, and gently roll the container. sodium chloride, and gently roll the container.
Then the container contents can be poured into a ten-Then the container contents can be poured into a ten-
mesh sieve where the "cleaning salt" will pass through the mesh sieve where the "cleaning salt" will pass through the
sieve. sieve.
in a container filled with sodium bicarbonate, sugar, or in a container filled with sodium bicarbonate, sugar, or
sodium chloride, and gently roll the container. sodium chloride, and gently roll the container.
Then the container contents can be poured into a ten-Then the container contents can be poured into a ten-
mesh sieve where the "cleaning salt" will pass through the mesh sieve where the "cleaning salt" will pass through the
sieve. sieve.
Soft GELAtIN cApSuLESSoft GELAtIN cApSuLES
Soft gelatin capsules (soft elastic gelatin capsules) or (softgels) Soft gelatin capsules (soft elastic gelatin capsules) or (softgels)
are prepared from continuous gelatin shells to which glycerin or are prepared from continuous gelatin shells to which glycerin or
a polyhydric alcohols such as sorbitol has been added to render a polyhydric alcohols such as sorbitol has been added to render
gelatin elastic or plastic-like. gelatin elastic or plastic-like.
Soft gelatin capsules may be oblong, elliptical (oval), or Soft gelatin capsules may be oblong, elliptical (oval), or
sphericalspherical round, oval, oblong, tube in shape., They may also be round, oval, oblong, tube in shape., They may also be
prepared of single or two-tone color, prepared of single or two-tone color,
Soft gelatin capsules (soft elastic gelatin capsules) or (softgels) Soft gelatin capsules (soft elastic gelatin capsules) or (softgels)
are prepared from continuous gelatin shells to which glycerin or are prepared from continuous gelatin shells to which glycerin or
a polyhydric alcohols such as sorbitol has been added to render a polyhydric alcohols such as sorbitol has been added to render
gelatin elastic or plastic-like. gelatin elastic or plastic-like.
Soft gelatin capsules may be oblong, elliptical (oval), or Soft gelatin capsules may be oblong, elliptical (oval), or
sphericalspherical round, oval, oblong, tube in shape., They may also be round, oval, oblong, tube in shape., They may also be
prepared of single or two-tone color, prepared of single or two-tone color,
Application of Soft Gelatin CapsulesApplication of Soft Gelatin Capsules
1. Water immiscible, volatile and nonvolatile liquids such 1. Water immiscible, volatile and nonvolatile liquids such
as vegetable and aromatic oils, aromatic and aliphatic as vegetable and aromatic oils, aromatic and aliphatic
hydrocarbons, chlorinated hydrocarbons, ethers, esters, hydrocarbons, chlorinated hydrocarbons, ethers, esters,
alcohols, and organic acids.alcohols, and organic acids.
2. Water miscible, nonvolatile liquids such as 2. Water miscible, nonvolatile liquids such as
polyethylene glycols, and nonionic surface active polyethylene glycols, and nonionic surface active
agents as tween 80.agents as tween 80.
3. Solids may be encapsulated into soft gelatin capsules 3. Solids may be encapsulated into soft gelatin capsules
as as
solutions in one of the suitable liquid solvents, as solutions in one of the suitable liquid solvents, as
suspensions, or as dry powders, granules, or suspensions, or as dry powders, granules, or
pelletized pelletized
materials.materials.
1. Water immiscible, volatile and nonvolatile liquids such 1. Water immiscible, volatile and nonvolatile liquids such
as vegetable and aromatic oils, aromatic and aliphatic as vegetable and aromatic oils, aromatic and aliphatic
hydrocarbons, chlorinated hydrocarbons, ethers, esters, hydrocarbons, chlorinated hydrocarbons, ethers, esters,
alcohols, and organic acids.alcohols, and organic acids.
2. Water miscible, nonvolatile liquids such as 2. Water miscible, nonvolatile liquids such as
polyethylene glycols, and nonionic surface active polyethylene glycols, and nonionic surface active
agents as tween 80.agents as tween 80.
3. Solids may be encapsulated into soft gelatin capsules 3. Solids may be encapsulated into soft gelatin capsules
as as
solutions in one of the suitable liquid solvents, as solutions in one of the suitable liquid solvents, as
suspensions, or as dry powders, granules, or suspensions, or as dry powders, granules, or
pelletized pelletized
materials.materials.
Liquids which can easily migrate through the
capsule shell cannot be encapsulated into soft
gelatin capsules.
These materials include:
Water, above 5%, and low molecular weight water
soluble and volatile organic compounds such as
alcohols, ketones, acids, amines, and esters.
capsule shell cannot be encapsulated into soft
gelatin capsules.
These materials include:
Water, above 5%, and low molecular weight water
soluble and volatile organic compounds such as
alcohols, ketones, acids, amines, and esters.
1.1.They permit liquid medications to become easily They permit liquid medications to become easily
portable.portable.
2.2.Comparing the degree of irritation or ulcerogenic Comparing the degree of irritation or ulcerogenic
potential of soft gelatin capsule formulations with a potential of soft gelatin capsule formulations with a
tablet formulation, Capsule formulations had a reduced tablet formulation, Capsule formulations had a reduced
ulcerogenic potential when compared to the tablet ulcerogenic potential when compared to the tablet
formulation.formulation.
3. Dose uniformity is optimized, because the drug is 3. Dose uniformity is optimized, because the drug is
dissolved or dispersed in a liquid which is then dosed dissolved or dispersed in a liquid which is then dosed
volumetrically into the capsule accurately.volumetrically into the capsule accurately.
Advantages of Soft Gelatin Capsules Advantages of Soft Gelatin Capsules
portable.portable.
2.2.Comparing the degree of irritation or ulcerogenic Comparing the degree of irritation or ulcerogenic
potential of soft gelatin capsule formulations with a potential of soft gelatin capsule formulations with a
tablet formulation, Capsule formulations had a reduced tablet formulation, Capsule formulations had a reduced
ulcerogenic potential when compared to the tablet ulcerogenic potential when compared to the tablet
formulation.formulation.
3. Dose uniformity is optimized, because the drug is 3. Dose uniformity is optimized, because the drug is
dissolved or dispersed in a liquid which is then dosed dissolved or dispersed in a liquid which is then dosed
volumetrically into the capsule accurately.volumetrically into the capsule accurately.
Advantages of Soft Gelatin Capsules Advantages of Soft Gelatin Capsules
4. Improve drug stability by resist gaseous diffusion and 4. Improve drug stability by resist gaseous diffusion and
contain no water, thus protect drugs sensitive to contain no water, thus protect drugs sensitive to
oxidation or hydrolysis on long term storage.oxidation or hydrolysis on long term storage.
5. Good bioavailability of drugs than from the commercial 5. Good bioavailability of drugs than from the commercial
tablets or capsules, that dissolved or dispersed in a tablets or capsules, that dissolved or dispersed in a
water miscible or oily liquids, thus when the capsule water miscible or oily liquids, thus when the capsule
ingested, the drug dispersed as solution or emulsion to ingested, the drug dispersed as solution or emulsion to
give a drug dispersion of high surface area give a drug dispersion of high surface area
contain no water, thus protect drugs sensitive to contain no water, thus protect drugs sensitive to
oxidation or hydrolysis on long term storage.oxidation or hydrolysis on long term storage.
5. Good bioavailability of drugs than from the commercial 5. Good bioavailability of drugs than from the commercial
tablets or capsules, that dissolved or dispersed in a tablets or capsules, that dissolved or dispersed in a
water miscible or oily liquids, thus when the capsule water miscible or oily liquids, thus when the capsule
ingested, the drug dispersed as solution or emulsion to ingested, the drug dispersed as solution or emulsion to
give a drug dispersion of high surface area give a drug dispersion of high surface area
prEpArAtIoN of Soft GELAtIN cApSuLESprEpArAtIoN of Soft GELAtIN cApSuLES
In a soft gelatin capsule formulation the medicament is in In a soft gelatin capsule formulation the medicament is in
solution or is dispersed as a fine suspension in either a solution or is dispersed as a fine suspension in either a
hydrophilic vehicle or a hydrophobic base. hydrophilic vehicle or a hydrophobic base.
Formulation of soft gelatin capsulesFormulation of soft gelatin capsules
There are two main aspects to be considered during the There are two main aspects to be considered during the
formulation of soft gelatin capsules:formulation of soft gelatin capsules:
The composition of the gelatin shell and the composition The composition of the gelatin shell and the composition
of the fill material.of the fill material.
In a soft gelatin capsule formulation the medicament is in In a soft gelatin capsule formulation the medicament is in
solution or is dispersed as a fine suspension in either a solution or is dispersed as a fine suspension in either a
hydrophilic vehicle or a hydrophobic base. hydrophilic vehicle or a hydrophobic base.
Formulation of soft gelatin capsulesFormulation of soft gelatin capsules
There are two main aspects to be considered during the There are two main aspects to be considered during the
formulation of soft gelatin capsules:formulation of soft gelatin capsules:
The composition of the gelatin shell and the composition The composition of the gelatin shell and the composition
of the fill material.of the fill material.
The composition of the soft capsule shell consists of two The composition of the soft capsule shell consists of two
main ingredients: gelatin and a plasticize (e.g. glycerol). main ingredients: gelatin and a plasticize (e.g. glycerol).
Water is used to form the capsule and it may be desirable Water is used to form the capsule and it may be desirable
or even necessary to add other additives such as or even necessary to add other additives such as
preservatives, dyes, opacifiers and, rarely, flavours and preservatives, dyes, opacifiers and, rarely, flavours and
drugs.drugs.
Formulation of the gelatin shellFormulation of the gelatin shell
main ingredients: gelatin and a plasticize (e.g. glycerol). main ingredients: gelatin and a plasticize (e.g. glycerol).
Water is used to form the capsule and it may be desirable Water is used to form the capsule and it may be desirable
or even necessary to add other additives such as or even necessary to add other additives such as
preservatives, dyes, opacifiers and, rarely, flavours and preservatives, dyes, opacifiers and, rarely, flavours and
drugs.drugs.
Formulation of the gelatin shellFormulation of the gelatin shell
To produce shells with a greater flexibility than hard gelatin To produce shells with a greater flexibility than hard gelatin
capsules it is necessary to control carefully the viscosity and capsules it is necessary to control carefully the viscosity and
strength of the gelatin used in production.strength of the gelatin used in production.
The mechanical properties of the gelatin shells are The mechanical properties of the gelatin shells are
controlled by choice of gelatin grade and by adjusting the controlled by choice of gelatin grade and by adjusting the
concentration of plasticizer in the shell.concentration of plasticizer in the shell.
GelatinGelatin
If the viscosity of aqueous gelatin solution is too low, a If the viscosity of aqueous gelatin solution is too low, a
thin, thin,
low strength shell is produced which has the disadvantage low strength shell is produced which has the disadvantage
of of
requiring prolonged drying. requiring prolonged drying.
If the viscosity of the gelatin solution is too high, a thick If the viscosity of the gelatin solution is too high, a thick
film is produced which may be too hard and brittle. also film is produced which may be too hard and brittle. also
require higher sealing temperatures during manufacture.require higher sealing temperatures during manufacture.
capsules it is necessary to control carefully the viscosity and capsules it is necessary to control carefully the viscosity and
strength of the gelatin used in production.strength of the gelatin used in production.
The mechanical properties of the gelatin shells are The mechanical properties of the gelatin shells are
controlled by choice of gelatin grade and by adjusting the controlled by choice of gelatin grade and by adjusting the
concentration of plasticizer in the shell.concentration of plasticizer in the shell.
GelatinGelatin
If the viscosity of aqueous gelatin solution is too low, a If the viscosity of aqueous gelatin solution is too low, a
thin, thin,
low strength shell is produced which has the disadvantage low strength shell is produced which has the disadvantage
of of
requiring prolonged drying. requiring prolonged drying.
If the viscosity of the gelatin solution is too high, a thick If the viscosity of the gelatin solution is too high, a thick
film is produced which may be too hard and brittle. also film is produced which may be too hard and brittle. also
require higher sealing temperatures during manufacture.require higher sealing temperatures during manufacture.
The main plasticizer used for soft gelatin capsules is The main plasticizer used for soft gelatin capsules is
glycerol.glycerol.
Sorbitol and propylene glycol have also been used but Sorbitol and propylene glycol have also been used but
they are normally added in combination with glycerol. they are normally added in combination with glycerol.
Plasticizers are added in relatively large concentrations. Plasticizers are added in relatively large concentrations.
The greater the plasticizer content the greater the The greater the plasticizer content the greater the
flexibility of the shell. (0.3-1.0 parts of dry plasticizer to flexibility of the shell. (0.3-1.0 parts of dry plasticizer to
1 part of dry gelatin). 1 part of dry gelatin).
Low ratios 0.3-0.5 are used for oily liquid fills, Low ratios 0.3-0.5 are used for oily liquid fills,
(0.4-0.6) for oily fills with added surfactant,(0.4-0.6) for oily fills with added surfactant,
(0.6-1.0) for water-miscible fills and chewable capsules.(0.6-1.0) for water-miscible fills and chewable capsules.
PlasticizersPlasticizers
glycerol.glycerol.
Sorbitol and propylene glycol have also been used but Sorbitol and propylene glycol have also been used but
they are normally added in combination with glycerol. they are normally added in combination with glycerol.
Plasticizers are added in relatively large concentrations. Plasticizers are added in relatively large concentrations.
The greater the plasticizer content the greater the The greater the plasticizer content the greater the
flexibility of the shell. (0.3-1.0 parts of dry plasticizer to flexibility of the shell. (0.3-1.0 parts of dry plasticizer to
1 part of dry gelatin). 1 part of dry gelatin).
Low ratios 0.3-0.5 are used for oily liquid fills, Low ratios 0.3-0.5 are used for oily liquid fills,
(0.4-0.6) for oily fills with added surfactant,(0.4-0.6) for oily fills with added surfactant,
(0.6-1.0) for water-miscible fills and chewable capsules.(0.6-1.0) for water-miscible fills and chewable capsules.
PlasticizersPlasticizers
WaterWater
The demineralized water content of gelatin solution used The demineralized water content of gelatin solution used
to produce a soft gelatin capsule shell depends on the to produce a soft gelatin capsule shell depends on the
viscosity of gelatin used (0.7-1.3 parts of water to each viscosity of gelatin used (0.7-1.3 parts of water to each
part of dry gelatin), 1: 1 ratio being typical. part of dry gelatin), 1: 1 ratio being typical.
PreservativesPreservatives
Preservatives are added to prevent mould growth in the Preservatives are added to prevent mould growth in the
gelatin shell. Potassium sorbitate and methyl, ethyl and gelatin shell. Potassium sorbitate and methyl, ethyl and
propyl hydroxybenzoate (methyl-, ethyl- and propyl hydroxybenzoate (methyl-, ethyl- and
propylparaben) are common additives. propylparaben) are common additives.
The demineralized water content of gelatin solution used The demineralized water content of gelatin solution used
to produce a soft gelatin capsule shell depends on the to produce a soft gelatin capsule shell depends on the
viscosity of gelatin used (0.7-1.3 parts of water to each viscosity of gelatin used (0.7-1.3 parts of water to each
part of dry gelatin), 1: 1 ratio being typical. part of dry gelatin), 1: 1 ratio being typical.
PreservativesPreservatives
Preservatives are added to prevent mould growth in the Preservatives are added to prevent mould growth in the
gelatin shell. Potassium sorbitate and methyl, ethyl and gelatin shell. Potassium sorbitate and methyl, ethyl and
propyl hydroxybenzoate (methyl-, ethyl- and propyl hydroxybenzoate (methyl-, ethyl- and
propylparaben) are common additives. propylparaben) are common additives.
ColoursColours
A wide range of colours can be incorporated into soft A wide range of colours can be incorporated into soft
gelatin shells gelatin shells
Water-soluble dyes (synthetic and vegetable), insoluble Water-soluble dyes (synthetic and vegetable), insoluble
inorganic and organic pigments and lakes.inorganic and organic pigments and lakes.
OpacifiersOpacifiers
Titanium dioxide is the most common. It is added in Titanium dioxide is the most common. It is added in
concentrations of about 0-0.5%.concentrations of about 0-0.5%.
Enteric treatmentEnteric treatment
Enteric properties can be imparted to soft gelatin shells Enteric properties can be imparted to soft gelatin shells
by coating with 4% cellulose acetate phthalate.by coating with 4% cellulose acetate phthalate.
A wide range of colours can be incorporated into soft A wide range of colours can be incorporated into soft
gelatin shells gelatin shells
Water-soluble dyes (synthetic and vegetable), insoluble Water-soluble dyes (synthetic and vegetable), insoluble
inorganic and organic pigments and lakes.inorganic and organic pigments and lakes.
OpacifiersOpacifiers
Titanium dioxide is the most common. It is added in Titanium dioxide is the most common. It is added in
concentrations of about 0-0.5%.concentrations of about 0-0.5%.
Enteric treatmentEnteric treatment
Enteric properties can be imparted to soft gelatin shells Enteric properties can be imparted to soft gelatin shells
by coating with 4% cellulose acetate phthalate.by coating with 4% cellulose acetate phthalate.
Any non-aqueous liquid or powdered solid in suspension Any non-aqueous liquid or powdered solid in suspension
can be filled into soft gelatin capsules.can be filled into soft gelatin capsules.
It is possible to fill soft gelatin capsules with a very wide It is possible to fill soft gelatin capsules with a very wide
range of materials. range of materials.
Suspensions, pastes, drugs in solution in either oils, Suspensions, pastes, drugs in solution in either oils,
self-emulsifying oils or water-miscible liquids. self-emulsifying oils or water-miscible liquids.
Formulation of the capsule contentsFormulation of the capsule contents
can be filled into soft gelatin capsules.can be filled into soft gelatin capsules.
It is possible to fill soft gelatin capsules with a very wide It is possible to fill soft gelatin capsules with a very wide
range of materials. range of materials.
Suspensions, pastes, drugs in solution in either oils, Suspensions, pastes, drugs in solution in either oils,
self-emulsifying oils or water-miscible liquids. self-emulsifying oils or water-miscible liquids.
Formulation of the capsule contentsFormulation of the capsule contents
Limitations for fill materialsLimitations for fill materials
Drugs or excipients containing large amounts of water or Drugs or excipients containing large amounts of water or
other gelatin solvents cannot be incorporated. other gelatin solvents cannot be incorporated.
It is not recommended to fill emulsions (whether they be It is not recommended to fill emulsions (whether they be
o/w or w/o) since they are unstable and will crack as the o/w or w/o) since they are unstable and will crack as the
water is lost from the shell in the manufacturing process. water is lost from the shell in the manufacturing process.
Surfactants may have a deleterious effect on the capsule Surfactants may have a deleterious effect on the capsule
seal. seal.
Extremes of pH must be avoided. pHs below about 2.5 Extremes of pH must be avoided. pHs below about 2.5
attack the gelatin leading to hydrolysis and leakage and attack the gelatin leading to hydrolysis and leakage and
pHs above about 7.5 have a tanning effect on the gelatin, pHs above about 7.5 have a tanning effect on the gelatin,
and affecting the solubility of the shell.and affecting the solubility of the shell.
Aldehydes must also be avoided since these have a Aldehydes must also be avoided since these have a
tanning action on the proteins of the gelatin shell.tanning action on the proteins of the gelatin shell.
Drugs or excipients containing large amounts of water or Drugs or excipients containing large amounts of water or
other gelatin solvents cannot be incorporated. other gelatin solvents cannot be incorporated.
It is not recommended to fill emulsions (whether they be It is not recommended to fill emulsions (whether they be
o/w or w/o) since they are unstable and will crack as the o/w or w/o) since they are unstable and will crack as the
water is lost from the shell in the manufacturing process. water is lost from the shell in the manufacturing process.
Surfactants may have a deleterious effect on the capsule Surfactants may have a deleterious effect on the capsule
seal. seal.
Extremes of pH must be avoided. pHs below about 2.5 Extremes of pH must be avoided. pHs below about 2.5
attack the gelatin leading to hydrolysis and leakage and attack the gelatin leading to hydrolysis and leakage and
pHs above about 7.5 have a tanning effect on the gelatin, pHs above about 7.5 have a tanning effect on the gelatin,
and affecting the solubility of the shell.and affecting the solubility of the shell.
Aldehydes must also be avoided since these have a Aldehydes must also be avoided since these have a
tanning action on the proteins of the gelatin shell.tanning action on the proteins of the gelatin shell.
Liquid vehiclesLiquid vehicles
Water-immiscible oils or water-miscible liquids.Water-immiscible oils or water-miscible liquids.
Water-immiscible oils:Water-immiscible oils:
Either volatile or non-volatile oils,Either volatile or non-volatile oils,
Fixed aromatic vegetable oils, Fixed aromatic vegetable oils,
Aliphatic, aromatic and chlorinated hydrocarbons, Aliphatic, aromatic and chlorinated hydrocarbons,
Liquid ethers and esters.Liquid ethers and esters.
Water-immiscible oils or water-miscible liquids.Water-immiscible oils or water-miscible liquids.
Water-immiscible oils:Water-immiscible oils:
Either volatile or non-volatile oils,Either volatile or non-volatile oils,
Fixed aromatic vegetable oils, Fixed aromatic vegetable oils,
Aliphatic, aromatic and chlorinated hydrocarbons, Aliphatic, aromatic and chlorinated hydrocarbons,
Liquid ethers and esters.Liquid ethers and esters.
Water-miscible liquids (hydrophilic)Water-miscible liquids (hydrophilic)
Polyols as Polyethylene glycols with low molecular Polyols as Polyethylene glycols with low molecular
weight (400-600) since they are liquid at ambient weight (400-600) since they are liquid at ambient
temperatures. Alcohols as isopropyl alcohol, temperatures. Alcohols as isopropyl alcohol,
polyglycerols, triacetin, glyceryl esters, sorbitan esters, polyglycerols, triacetin, glyceryl esters, sorbitan esters,
sugar esters and polyglyceryl esters.sugar esters and polyglyceryl esters.
Propylene glycol and glycerol can be used, but the Propylene glycol and glycerol can be used, but the
concentration must be low, (5-10%), in order to prevent concentration must be low, (5-10%), in order to prevent
migration into the gelatin and softening of the shell.migration into the gelatin and softening of the shell.
Polyols as Polyethylene glycols with low molecular Polyols as Polyethylene glycols with low molecular
weight (400-600) since they are liquid at ambient weight (400-600) since they are liquid at ambient
temperatures. Alcohols as isopropyl alcohol, temperatures. Alcohols as isopropyl alcohol,
polyglycerols, triacetin, glyceryl esters, sorbitan esters, polyglycerols, triacetin, glyceryl esters, sorbitan esters,
sugar esters and polyglyceryl esters.sugar esters and polyglyceryl esters.
Propylene glycol and glycerol can be used, but the Propylene glycol and glycerol can be used, but the
concentration must be low, (5-10%), in order to prevent concentration must be low, (5-10%), in order to prevent
migration into the gelatin and softening of the shell.migration into the gelatin and softening of the shell.
SuspensionsSuspensions
The particle size of the solid should be reduced to less The particle size of the solid should be reduced to less
than 180 µm to pass through the filling head. than 180 µm to pass through the filling head.
Insoluble drugs can be dispersed (with suspending Insoluble drugs can be dispersed (with suspending
agents and surfactants) in the above vehicles or agents and surfactants) in the above vehicles or
combinations of vehicles. combinations of vehicles.
Suspending agentsSuspending agents are added to prevent settling and are added to prevent settling and
maintain homogeneitymaintain homogeneity
•
For oily bases (beeswax, paraffin wax, ethylcellulose For oily bases (beeswax, paraffin wax, ethylcellulose
and hydrogenated vegetable oil)and hydrogenated vegetable oil)
•
For non-oily bases (solid glycol esters as PEG 4000 For non-oily bases (solid glycol esters as PEG 4000
and and
PEG 6000).PEG 6000).
The particle size of the solid should be reduced to less The particle size of the solid should be reduced to less
than 180 µm to pass through the filling head. than 180 µm to pass through the filling head.
Insoluble drugs can be dispersed (with suspending Insoluble drugs can be dispersed (with suspending
agents and surfactants) in the above vehicles or agents and surfactants) in the above vehicles or
combinations of vehicles. combinations of vehicles.
Suspending agentsSuspending agents are added to prevent settling and are added to prevent settling and
maintain homogeneitymaintain homogeneity
•
For oily bases (beeswax, paraffin wax, ethylcellulose For oily bases (beeswax, paraffin wax, ethylcellulose
and hydrogenated vegetable oil)and hydrogenated vegetable oil)
•
For non-oily bases (solid glycol esters as PEG 4000 For non-oily bases (solid glycol esters as PEG 4000
and and
PEG 6000).PEG 6000).
Surfactants Surfactants as polysorbate 80 (Tween 80) are often as polysorbate 80 (Tween 80) are often
added as wetting agent. added as wetting agent.
Caking of suspensions in soft gelatin capsules can be Caking of suspensions in soft gelatin capsules can be
avoided by rheological control of the vehicle.avoided by rheological control of the vehicle.
added as wetting agent. added as wetting agent.
Caking of suspensions in soft gelatin capsules can be Caking of suspensions in soft gelatin capsules can be
avoided by rheological control of the vehicle.avoided by rheological control of the vehicle.
PreParation of Soft Gelatin CaPSuleSPreParation of Soft Gelatin CaPSuleS
PreParation of Soft Gelatin CaPSuleSPreParation of Soft Gelatin CaPSuleS
Soft gelatin capsules may be prepared by:Soft gelatin capsules may be prepared by:
The plate process, using a set of molds to form the The plate process, using a set of molds to form the
capsules.capsules.
The die processes (rotary or reciprocating processes) The die processes (rotary or reciprocating processes)
more efficient and productive processes more efficient and productive processes
Soft gelatin capsules may be prepared by:Soft gelatin capsules may be prepared by:
The plate process, using a set of molds to form the The plate process, using a set of molds to form the
capsules.capsules.
The die processes (rotary or reciprocating processes) The die processes (rotary or reciprocating processes)
more efficient and productive processes more efficient and productive processes
A warm sheet of gelatin (plain or colored) is placed on A warm sheet of gelatin (plain or colored) is placed on
the bottom plate of the mold.the bottom plate of the mold.
The liquid medication is poured on it. The liquid medication is poured on it.
Then a second sheet of the prepared gelatin is Then a second sheet of the prepared gelatin is
carefully carefully
laid in place on top of the medication, and the top laid in place on top of the medication, and the top
plate plate
of the mold is put in place.of the mold is put in place.
The entire mold is then subjected to a press where The entire mold is then subjected to a press where
pressure is applied to form, fill, and seal the capsules pressure is applied to form, fill, and seal the capsules
simultaneously. simultaneously.
The capsules are then removed and washed with a The capsules are then removed and washed with a
solvent harmless to the capsules. solvent harmless to the capsules.
the plate processthe plate process
the bottom plate of the mold.the bottom plate of the mold.
The liquid medication is poured on it. The liquid medication is poured on it.
Then a second sheet of the prepared gelatin is Then a second sheet of the prepared gelatin is
carefully carefully
laid in place on top of the medication, and the top laid in place on top of the medication, and the top
plate plate
of the mold is put in place.of the mold is put in place.
The entire mold is then subjected to a press where The entire mold is then subjected to a press where
pressure is applied to form, fill, and seal the capsules pressure is applied to form, fill, and seal the capsules
simultaneously. simultaneously.
The capsules are then removed and washed with a The capsules are then removed and washed with a
solvent harmless to the capsules. solvent harmless to the capsules.
the plate processthe plate process
Liquid gelatin flowing from an Liquid gelatin flowing from an
overhead tank is formed into two overhead tank is formed into two
continuous ribbons by the rotary continuous ribbons by the rotary
die machine and brought die machine and brought
together between twin rotating together between twin rotating
dies.dies.
the rotary die processthe rotary die process
At the same time, metered fill material is injected At the same time, metered fill material is injected
between the ribbons at the moment that the dies form between the ribbons at the moment that the dies form
pockets of the gelatin ribbons.pockets of the gelatin ribbons.
These pockets of fill-containing gelatin are then These pockets of fill-containing gelatin are then
sealed by pressure and heat.sealed by pressure and heat.
The soft gelatin capsules may be prepared of single The soft gelatin capsules may be prepared of single
or two-tone color, the latter resulting from the or two-tone color, the latter resulting from the
employment of two different colored ribbons of gelatin employment of two different colored ribbons of gelatin
to form the sides of the capsule. to form the sides of the capsule.
overhead tank is formed into two overhead tank is formed into two
continuous ribbons by the rotary continuous ribbons by the rotary
die machine and brought die machine and brought
together between twin rotating together between twin rotating
dies.dies.
the rotary die processthe rotary die process
At the same time, metered fill material is injected At the same time, metered fill material is injected
between the ribbons at the moment that the dies form between the ribbons at the moment that the dies form
pockets of the gelatin ribbons.pockets of the gelatin ribbons.
These pockets of fill-containing gelatin are then These pockets of fill-containing gelatin are then
sealed by pressure and heat.sealed by pressure and heat.
The soft gelatin capsules may be prepared of single The soft gelatin capsules may be prepared of single
or two-tone color, the latter resulting from the or two-tone color, the latter resulting from the
employment of two different colored ribbons of gelatin employment of two different colored ribbons of gelatin
to form the sides of the capsule. to form the sides of the capsule.
ManufaCturinG ProCeSSManufaCturinG ProCeSS
•
The reciprocating die process is similar to the rotary The reciprocating die process is similar to the rotary
process in that ribbons of gelatin are formed and used process in that ribbons of gelatin are formed and used
to to
encapsulate the fill,encapsulate the fill,
•
But it differs in that the gelatin ribbons are fed between a But it differs in that the gelatin ribbons are fed between a
set of vertical dies that continually open and close to set of vertical dies that continually open and close to
form form
rows of pockets in the gelatin ribbons. rows of pockets in the gelatin ribbons.
•
These pockets are filled with the medication and are These pockets are filled with the medication and are
sealed, shaped, and cut out of the film as they progresssealed, shaped, and cut out of the film as they progress
through the machinery.through the machinery.
•
As the capsules are cut from the ribbons, they fall into As the capsules are cut from the ribbons, they fall into
refrigerated tanks which prevent the capsules from refrigerated tanks which prevent the capsules from
adhering to one another. adhering to one another.
The reciprocating die processThe reciprocating die process
The reciprocating die process is similar to the rotary The reciprocating die process is similar to the rotary
process in that ribbons of gelatin are formed and used process in that ribbons of gelatin are formed and used
to to
encapsulate the fill,encapsulate the fill,
•
But it differs in that the gelatin ribbons are fed between a But it differs in that the gelatin ribbons are fed between a
set of vertical dies that continually open and close to set of vertical dies that continually open and close to
form form
rows of pockets in the gelatin ribbons. rows of pockets in the gelatin ribbons.
•
These pockets are filled with the medication and are These pockets are filled with the medication and are
sealed, shaped, and cut out of the film as they progresssealed, shaped, and cut out of the film as they progress
through the machinery.through the machinery.
•
As the capsules are cut from the ribbons, they fall into As the capsules are cut from the ribbons, they fall into
refrigerated tanks which prevent the capsules from refrigerated tanks which prevent the capsules from
adhering to one another. adhering to one another.
The reciprocating die processThe reciprocating die process
•
Capsules are usually packaged in glass or in plastic Capsules are usually packaged in glass or in plastic
containerscontainers
•
Some containing packets of a desiccant to prevent the Some containing packets of a desiccant to prevent the
absorption of excessive moisture by the capsules. absorption of excessive moisture by the capsules.
•
Soft capsules have a greater tendency than do hard Soft capsules have a greater tendency than do hard
capsules to soften and adhere to one another, and capsules to soften and adhere to one another, and
they they
must be maintained in a cool, dry place. must be maintained in a cool, dry place.
Capsules are usually packaged in glass or in plastic Capsules are usually packaged in glass or in plastic
containerscontainers
•
Some containing packets of a desiccant to prevent the Some containing packets of a desiccant to prevent the
absorption of excessive moisture by the capsules. absorption of excessive moisture by the capsules.
•
Soft capsules have a greater tendency than do hard Soft capsules have a greater tendency than do hard
capsules to soften and adhere to one another, and capsules to soften and adhere to one another, and
they they
must be maintained in a cool, dry place. must be maintained in a cool, dry place.
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