Capsules hard gelatin and soft gelatin.ppt

capsules soft gelatin and hard gelatin capsules

2. These are solid dosage form of medicaments, in which
drug is enclosed within the shells made up of gelatin.

3. Structure of hard gelatin capsule shell

5. 1.Shell composition :
Gelatin :
Gelatin is heterogeneous product derived by hydrolytic
extraction of animal's collagen.
The sources of gelatins including animal bones, calf skin
and frozen pork skin.
Possesses 4 essential properties
Stable when dry
Subject to microbial degradation when moist
Digested and
Absorbed
Gelatin in its chemical and physical properties, depending
upon the source of the collagen and extraction.

6. There are two basic types of gelatin:
Type – A and Type – B.
The two types can be differentiated by their
isoelectric points (7.0 – 9.0 for type A and 4.8 –
5.0 for type B) and by their viscosity and film
forming characteristics.
Combination of pork skin and bone gelatin are
often used to optimize shell characteristics.
The physicochemical properties of gelatin of
most interest to shell manufactures are the
bloom strength and viscosity.

7. Colorants :
Various soluble synthetic dyes (“coal tar dyes”) and insoluble
pigments are used.
Not only play a role in identifying the product, but also may play a
role in improving patient compliance.
E.g., white, analgesia; lavender, hallucinogenic effects; orange or
yellow, stimulants and antidepressants.
Opaquing agents :
Titanium dioxide may be included to render the shell opaque.
Opaque capsules may be employed to provide protection against
light or to conceal the contents.
Preservatives :
When preservatives are employed, parabens are often selected.

8. 2)Shell manufacture :

9. I.Dipping :
Pairs of the stainless steel pins are dipped into the dipping
solution to simultaneously form the caps and bodies.
The pins are at ambient temperature; whereas the dipping
solution is maintained at a temperature of about 50
0
C in a
heated, jacketed dipping pan.
The length of time to cast the film has been reported to be
about 12 sec.
II.Rotation :
After dipping, pins are elevated and rotated 2-1/2 times
until they are facing upward.
This rotation helps to distribute the gelatin over the pins
uniformly and to avoid the formation of a bead at the
capsule ends.

10. III.Drying :
The racks of gelatin coated pins then pass into
a series of four drying oven.
Drying is mainly done by dehumidification.
A temperature elevation of only a less degrees
is permissible to prevent film melting.
Under drying will leave the films too sticky
for subsequent operation.
IV.Stripping :
A series of bronze jaws strip the cap and body
portions of the capsules from the pins.

11. V.Trimming :
The stripped cap and body portions are
delivered to collects in which they are firmly
held.
As the collects rotate, knives are brought
against the shells to trim them to the required
length.
VI.Joining :
The cap and body portions are aligned
concentrically in channels and the two
portions are slowly pushed together.

12. 3)Sorting :
The moisture content of the capsules as they are from the
machine will be in the range of 15 – 18% w/w.
During sorting, the capsules passing on a lighted moving
conveyor are examined visually by inspectors.
Defects are generally classified according to their nature
and potential to cause problems in use.
4)Printing :
In general, capsules are printed before filling.
Generally, printing is done on offset rotary presses having
throughput capabilities as high as three-quarter million
capsules per hour.

13. Size Volume Fill weight(g) at 0.8
g/cm
3
powder density
000 1.37 1.096
00 0.95 0.760
0 0.68 0.544
1 0.50 0.400
2 0.37 0.296
3 0.30 0.240
4 0.21 0.168
5 0.15 0.104
5)Sizes and shapes :
For human use, empty gelatin capsules are
manufactured in eight sizes, ranging from 000 to 5.
Capsule capacities in table:

14. SHAPES OF CAPSULE
*The largest size of the capsule is No: 000.
*The smallest size is No: 5.
*The largest size normally acceptable to patient is a No: 0.
*The standard shape of capsules is traditional, symmetrical
bullet shape.

Some manufactures have employed distinctive shapes.

15. 6)Sealing :
Capsules are sealed and somewhat reshaped in the Etaseal
process.
This thermal welding process forms an indented ring around the
waist of the capsule where the cap overlaps the body.
7) Polishing :
Pan Polishing : Acela-cota pan is used to dust and polish.
Cloth Dusting : capsule are rubbed with cloth.
Brushing : Capsule are feed under soft rotating brush.
8) Storage :
Finished capsules normally contain an equilibrium moisture
content of 13-16%.
To maintain a relative humidity of 40-60% when handling and
storing capsules.

16. operations involved
Rectification of empty capsules
Separation of caps from bodies
Filling capsule bodies
Replacing caps and ejecting filled capsules
3 basic methods for powder filling
Auger fill
Vibratory fill
Piston tamp principle
1. Dosator machine
2. Dosing disc machine

17. Equipment used in capsule filling operations
involves one often of two types of filling systems.
Zanasi or Martelli encapsulator:
Forms slugs in a dosatar which is a hollow tube
with a plunger to eject capsule plug.
Hofliger-Karg machine:
Formation of compacts in a die plate using
tamping pins to form a compact.

18. HOFLIGER KARG AUTOMATIC
CAPSULE FILLING MACHINE
ZANASI AUTOMATIC
CAPSULE FILLING MACHINE

19. In this both system, the scale-up process
involve bulk density, powder flow,
compressibility, and lubricant distribution.
Lubricated granules are responsible for
delaying capsule disintegration and
dissolution.

20. OSAKA MODEL R-180
SEMI AUTOMATIC CAPSULE
FILLING MACHINE

21. Advantages
–Tasteless and odourless
–Swallowing is easy
–Flexibility in formulating
–Uniquely suitable for blinded clinical trials
–Useful for extemporaneous compounding by pharmacist
Disadvantages
–Tend to be more expensive to produce than tablets
–Not suitable for highly soluble salts

23. Soft gelatin capsules are one piece, hermetically
sealed, soft gelatin shells containing a liquid, a
suspension or a semisolid.
Soft gelatin mainly composed of gelatin,
plasticizers, preservative, coloring agents,
flavoring agents and sugars.
Oblong, spherical, elliptical in shape
Shells are softened by addition of glycerin or
polyhydric alcohol (ex. sorbitol)

24. Plasticizer and Gelatin ratio In soft gelatin capsule
the amount of plasticizers used is more
In soft gelatin capsule the plasticizer and gelatin
ratio is
0.8 : 1
 In hard gelatin capsule the plasticizer and gelatin
ratio is
0.4 : 1

25. Composition of the shell
Similar to hard gelatin shells, the basic
component of soft gelatin shell is gelatin;
however, the shell has been plasticized.
The ratio of dry plasticizer to dry gelatin
determines the “hardness” of the shell and can
vary from 0.3-1.0 for very hard shell to 1.0-1.8
for very soft shell.
Up to 5% sugar may be included to give a
“chewable” quality to the shell.
The residual shell moisture content of finished
capsules will be in the range of 6-10 %.

26. Formulation
Formulation for soft gelatin capsules involves
liquid, rather than powder technology.
Materials are generally formulated to produce the
smallest possible capsule consistent with
maximum stability, therapeutic effectiveness and
manufacture efficiency.
The liquids are limited to those that do not have
an adverse effect on gelatin walls.
The pH of the lipid can be between 2.5 and 7.5.
Emulsion can not be filled because water will be
released that will affect the shell.

27. The types of vehicles used in soft gelatin capsules fall in
to two main groups:
1.Water immiscible, volatile or more likely more
volatile liquids such as vegetable oils, mineral
oils, medium-chain triglycerides and acetylated
glycerides.
2.Water miscible, nonvolatile liquids such as low
molecular weight PEG have come in to use more
recently because of their ability to mix with water
readily and accelerate dissolution of dissolved or
suspended drugs.
All liquids used for filling must flow by gravity at a
temperature of 35
0
c or less.
The sealing temperature of gelatin films is 37-40
0
C.

28. Is manufactured by four methods
 Plate process
 Rotary die process
 Accogel process
 Bubble process

29. Place the gelatin sheet over a die plate containing
numerous die pockets,
Application of vacuum to draw the sheet in to the die
pockets,
Fill the pockets with liquid or paste,
Place another gelatin sheet over the filled pockets, and
Sandwich under a die press where the capsules are
formed and cut out.

30. The material to be encapsulated flows by gravity. the
gelatin sheets are feed on rolls contain small orifice lined
up with the die pocket of the die roll.
Two plasticized gelatin ribbons are continuously and
simultaneously fed with the liquid or paste fill between
the rollers of the rotary die mechanism where the
capsule are simultaneously filled, shaped, hermetically
sealed and cut from the gelatin ribbon.
The sealing of the capsule is achieved by mechanical
pressure on the die rolls and the heating(37-40°C) of the
ribbons by the wedge.

32. Accogel process
In general, this is another rotary process involving
A measuring roll,
A die roll, and
A sealing roll.
As the measuring roll and die rolls rotate, the measured
doses are transferred to the gelatin-linked pockets of the
die roll.
The continued rotation of the filled die converges with the
rotating sealing roll where a second gelatin sheet is
applied to form the other half of the capsule.
Pressure developed between the die roll and sealing roll
seals and cuts out the capsules.

33. Bubble process
The Globex Mark II capsulator produces truly
seamless, one-piece soft gelatin capsules by a “bubble
method”.

34. A concentric tube dispenser simultaneously
discharges the molten gelatin from the outer annulus
and the liquid content from the tube.
By means of a pulsating pump mechanism, the
liquids are discharged from the concentric tube
orifice into a chilled-oil column as droplets that
consists of a liquid medicament core within a molten
gelatin envelop.
The droplets assume a spherical shape under surface
tension forces and the gelatin congeals on cooling.
The finished capsules must be degreased and dried.

35. Bloom or gel strength: It is a measure of cohesive
strength of cross-linkage that occurs between
molecules and is proportion to the molecular weight
of gelatin.
Bloom is determined by measuring the weight in grams
required to move a plastic plunger of 0.5inches in
diameter, 4mm into a 62/3% gelatin that has held at
10°C for 17 hrs.
The unit of bloom is grams and it is between 150-250g

36. Viscosity:
Is determined on a 62/3% gelatin of water at
60°C and it is a measure of the molecular
chain length. Standard used: 25-45 mill poise.
Iron content:
Iron is always present in raw gelatin, and its
concentration usually depends on the iron
content of the large quantities of water used in
its manufacture . amount should not exceed
15ppm.

37. ADVANTAGES
May contain liquids, suspensions, pastes
Rapid release of contents
Useful for drugs prone to oxidation
DISADVANTAGES
Have a greater tendency to adhere to each other
More expensive
Increased possibility of interactions between drug
and shell

38. The pharmaceutical applications of soft gelatin
capsules are:
As an oral dosage form
As a suppository dosage form
As a specialty package in tube form, for human
and veterinary use,
Single dose application for topical, ophthalmic,
and rectal ointments.

39. Weight variation
Content uniformity
Dissolution test
Disintegration test