Soft and hard gelatin capsules

Capsules are tasteless, odorless and can easily be
administered.
Combination of powders we can use
There are attractive in appearance.
The drugs having un-pleasant odor and taste are
enclosed in a tasteless shell.
They can be filled quickly and conveniently.
Physician can change the dose and combination of drug
according to patient requirement.
They are economical.
They are easy to handle and carry.

1. Capsule
Manufacturing
ShmmonAhmad,
Asst. Professor,
(Faculty of Pharmaceutics)
GlocalUniversity, Saharanpur
Former Q.A Officer Ind-Swift Ltd.
(WHO, GMP, MHRA-UK, EME-
Europe)

2. INTRODUCTION
Capsules are solid dosage forms in which drug substance is
enclosed within hard or softsoluble shell.The shells are
generally formed fromgelatin.
Capsules are of twotypes
1.Hard gelatin capsules
2.Soft gelatincapsules

3. Capsules are tasteless, odorless and can easily be
administered.
Combination of powders we can use
There are attractive inappearance.
The drugs having un-pleasant odor and taste are
enclosed in a tastelessshell.
They can be filled quickly and conveniently.
Physician can change the dose and combination of drug
according to patientrequirement.
They areeconomical.
They are easy to handle and carry.
Advantages

4. Hygroscopic drugs are not suitable for filling into
capsules, because they absorb water present in
capsule shell makes shell very brittle and ultimately
lead to crumble intopieces.
The concentrated solutions which require previous
dilution are unsuitable for capsules because if
administered as such lead to irritation intostomach
Disadvantages

5. Forhumanuse,emptycapsulesranginginsize
from000thelargestto5thesmallest.
Generally,hardgelatincapsuleareusedtoencapsulate
between65mgto1gram.
Capsulesize

6. GELATIN
Gelatin is heterogeneous product derived by hydrolytic
extraction of animal'scollagen.
The sources of gelatins including animal bones, hide
portions and frozen porkskin.
TYPES OFGELATIN
TypeA
TypeB

7. Therearetwobasictypesof
gelatin
TYPEA
Derived from acid treated precursor that exhibits an iso electric
point at pH-9. It is manufactured mainly from porkskin.
TYPEB
Derived from alkali treated precursor that exhibits an iso electric
point at pH-4.7.Itismanufactured mainly from animal bones

8. PreparationOfGelatin

9. Steps involved in making emptygelatin capsules…
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming andJoining
6.Polishing
Manufacturing of hard gelatincapsules

10. Dipping:
Pairs of the stainless steel pins are dipped into the dipping
solution to simultaneously form the caps andbodies.
The dipping solution is maintained at a temperature of about
50
0
C in a heated, jacketed dippingpan.
Spinning :
The pins are rotated to distribute the gelatin over the pins
uniformly and to avoid the formation of a bead at the capsule
ends.
Drying:
The gelatin is dried by a blast of cool air to form a hardshells.
The pins are moved through a series of air drying kilns to remove
water
Stripping:
A series of bronze jaws strip the cap and body portions of the
capsules from thepins.

11. Trimming andjoining
The stripped cap and body portions are trimmed to the required
length by stationaryknives.
After trimming to the right length, the cap and body portion are
joined and ejected from themachine.
Polishing
Pan Polishing : Acela-cota pan is used to dust andpolish.
Cloth Dusting : Capsule are rubbed withcloth.
Brushing : Capsule are feed under soft rotatingbrush.

12. Preparationoffilledhardgelatincapsules:
In large scale or small preparations of filled hard
gelatin capsules divided into the following general
steps:
Developing and preparing formulation.
Filling the capsuleshell
Capsulesealing
Cleaning and polishing the filledcapsules.

13. Developing and preparing theformulation
•Diluents and fillers: lactose, microcrystaline
cellulose, starch.
•Disintegrants: sodium starch glicolate
,pregelatinised starch
•Gligants and lubricants: silicon
dioxide,magnesium stearte,calciumstearate
•Wetting agents:SLS

14. 14
FILLINGOFHARDGELATIN
CAPSULES
•
•
•
Hand Operatedmethods.
ex: feton capsule fillingmachine
Semi Automatic Capsules Devices.
Automatic fillingmachine.
ex: osaka capsule filling machine ,macofar capsule fillingmachine

15. HANDOPERATED CAPSULEFILLING
MACHINE
Itis having following p arts:-
a)Bed having 200-300holes.
b)Loading tray having 200 -300holes.
c)Powdertray.
d)Pin Plate having 200-300pins.
e)Sealing plate having rubber top.
f)Lever
g)Camhandel

16. JAANSUN CAPSULE FILLING MACHINE

17. SEMI AUTOMATICMACHINE

18. MG2 MODEL60

19. Filling ofCapsules
POWDERS w/capseal GRANULES
BEADS TABLETS

20. 1.Tamper evident capsules by sealing the joint between the 2 capsule
parts
2.Distinctive looking capsules by sealing them with colored band of
gelatin(Kapseals).Ifremoved, the band cannot be restored without
expert sealing withgelatin
3.Through a heat welding process that fuses the capsule cap to the ring
around the capsule where heatwelded
Example:Weld’s gelatinseal

21. 4.Capsule may also be sealed through a heat
welding process that fuse capsule cap to
the body.
5.Lightly coating the inner surface of the cap
with a warmgelatinsolutionimmediately
priortoplacementon thefilled capsule
body.

23. Soft Gelatin capsules are one piece, hermetically sealed, soft
gelatin shells containing a liquid, a suspension, or asemisolid.
Soft gelatin is mainly composed of gelatin, plasticizers,
preservative, colouring and opacifying agents, flavoring agents
and sugars.

24. 24
Theshapeofsoftgelatincapsuleareround,oval,
oblong,tube.

25. 1.Composition of theshell
Thebasic component of soft gelatin shell is gelatin; however,
the shell has beenplasticize
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 softshell
Up to 5% sugar may be included to give a “chewable” quality
to theshell
The residual shell moisture content of finished capsules will be
in the range of6-10%.

26. II.Formulation:
Formulationforsoftgelatincapsulesinvolvesliquid,rather
thanpowdertechnology.
Materialsaregenerallyformulatedtoproducethesmallest
possiblecapsuleconsistentwithmaximumstability,
therapeuticeffectivenessandmanufactureefficiency.
The liquids are limited to those that do not have an adverse
effect on gelatinwalls.
Emulsion can not be filled because water will be released
that will affect the shell
The pH of the liquid can be between 2.5 and7.5.

27. 27
Is manufactured by fourmethods
1)Plateprocess
2)Rotary dieprocess
3)Reciprocatingdie
4)Accogelmachine

29. 1) In this machine the soft gelatin capsules are prepared &
thenfilledimmediately with liquid medicaments it is having
two hoppers & two rotatingdies
2)Liquid mixture is placed in one hopper & the liquid
medicament in other Hooper.
3)Thetwo rotating dies rotatein oppositedirections when
the fluid gelatin mixture enters the machine from the hopper it
produces two continuous ribbons .
4)These half shell ofthecapsuleisformed.

30. 5) Atthisstagethe measured quantity of the medicament
is filledin to it with the stroke of a pump with the
subsequent movement of the dies the other half capsule is
formed.
6)Thetwohalves' ofthecapsulesaresealedtogetherby
the heat & pressure of the rotatingdies.
7) As the die rolls rotate, the convergence of the matching
die pockets seals and cuts out the filledcapsules

31. HARD GELATIN
CAPSULES
HARDGELATIN
CAPSULES
1)Two piece (large body &short
cap)
2) Cylindricalshape.
3)Powder drug or palletscoated
with drug areencapsulated.
4)Gelatin in Hard form isused.
5) Capsules are sealed afterthey
are filled to ensure thatthe
medicaments may notcome
out of the capsule due torough
handling.
6)8 different type of sizesare
available
SOFT GELATIN
CAPSULES
SOFTGELATIN
CAPSULES
1) One piece & hermetically
sealed.
2) Available in round , oval&
tube likeshapes.
3) Liquid & Semi liquid fill&
unstable substances are
encapsulated.
4) Molten gelatin areused.
5) Filling & sealing of softgelatin
capsules are done ina
combined operation on
machine.
6) No specific sizes areavailable.

32. EVALUTION OFCAPSULES
WEIGHT VARIATIONTEST
CONTENT UNIFORMITYTEST
DISSOLUTIONTEST
DISINTEGRSTIONTEST

33. Weight variationtest:
Inwhich20capsulesareindividuallyweighed
andstandarddeviationfrommeanweightwas
measuredthatshouldnotbe<90%or>110%.

34. Contentuniformity
The amount of active ingredient should be
within the range of 85% to 115% of the label
amount for 9 of 10 capsules, with no unit
outside the range of 70% to 125% of label
amount.