SEMINAR ON MANUFACTURE AND EVALUATION OF CAPSULES…

PRESENTED BY

M.G.P.LAKSHMI Y12MPH413

I/IIM.PHARM CEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

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CONTENTS

* Hard gelatin capsule.

* Types of gelatin.

* Parts of capsule.

* Manufacture of empty gelatin capsules.

* Filling of gelatin capsules.

* Soft gelatin capsules.

* Application of soft gelatin capsules.

* Manufacture of soft gelatin capsules .

* Important specification of gelatin.

* Evaluvation of capsules.

* Bibliography.2

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• DEFINITION:- These are solid dosage form of medicaments, in which

drug is enclosed within the shells made up of gelatin.

These capsules are made up of gelatin blends, small amount of certified dyes, opaquants, plasticizers and preservatives.

HARD GELATIN CAPSULE

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Certified DyesColour approved by D & C act.

OpacifiersTitanium dioxide.

PlasticizersSorbitol, Glycerin.

PreservativesPropyl and Methyl Parabens.

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GELATIN

• Gelatin is heterogeneous product derived by hydrolytic extraction of animal's collagen.

• The sources of gelatins including animal bones, hide portions and frozen pork skin.

TYPES OF GELATINType AType B

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There are two basic types of gelatin

TYPE A Derived from acid treated precursor that exhibits an iso electric point at pH-9. It is manufactured mainly from pork skin.

TYPE B Derived from alkali treated precursor that exhibits an iso electric point at pH-4.7. It is manufactured mainly from animal bones

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PARTS OF CAPSULE

CAPCAP

BODYBODY

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MANUFACTURE OF EMPTY GELATIN CAPSULES

Steps involved in making empty gelatincapsules…

• Dipping• Spinning• Drying• Stripping• Trimming and Joining• Polishing.

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Dipping :Pairs of the stainless steel pins are dipped into the dipping solution to simultaneously form the caps and bodies.The dipping solution is maintained at a temperature of about 500C in a heated, jacketed dipping pan.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.

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Drying :The gelatin is dried by a blast of cool air to form a hard shells.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 the pins.

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Trimming and joining

The stripped cap and body portions are trimmed to the required length by stationary knives.

After trimming to the right length, the cap and body portion are joined and ejected from the machine.

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SIZE OF CAPSULES

SizeSize Volume in mlVolume in ml Size in mmSize in mm

000000 1.371.37 26.326.3

0000 0.950.95 23.723.7

00 0.680.68 21.821.8

11 0.500.50 19.219.2

22 0.370.37 18.318.3

33 0.300.30 15.315.3

44 0.210.21 14.714.7

55 0.150.15 11.911.9

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SHAPES OF CAPLUSE

*The largest size of the capsule is No: 000.*The smallest size is No: 5.*The standard shape of capsules is traditional, symmetrical bullet shape.

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FILLING OF HARD GELATIN CAPSULES

Various Filling Machine Available…• Eli-lily and Co.• Farmatic.• Hofliger and Karg.• Zanasi.• Parke-Davis.

• These machine differ in there design and output

ZANASI AUTOMATICCAPSULE FILLING MACHINE

HOFLIGER KARG AUTOMATICCAPSULE FILLING MACHINE

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PolishingPan 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.

StorageFinished capsules normally contain an equilibrium

moisture content of 13-16%.

To maintain a relative humidity of 40-60% when handling and storing capsules

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SOFT GELATIN CAPSULE

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SOFT GELATIN CAPSULE

Definition:-Soft Gelatin capsules are one piece, hermetically

sealed, soft gelatin shells containing a liquid, a suspension, or a semisolid.

Soft gelatin is mainly composed of gelatin, plasticizers, preservative, colouring and opacifying agents, flavoring agents and sugars.

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APPLICATION OF SOFT GELATIN CAPSULE

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.

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Plasticizer and Gelatin ratio

In soft gelatin capsule the amount of plasticizers used is more

In soft gelatin capsule the plasticizer and gelatin ratio is0.8 : 1

In hard gelatin capsule the plasticizer and gelatin ratio is

0.4 : 1

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SHAPE OF CAPSULE

The shape of soft gelatin capsule are round, oval, oblong, tube.

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MANUFACTURE OF SOFT GELATIN CAPSULES

Is manufactured by four methods

• Plate process.• Rotary die process.• Reciprocating die.• Accogel machine.

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Plate process:•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.

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Rotary die process: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.

The rotary die process

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IMPORTANT SPECIFICATIONS OF GELATIN

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

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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 milli 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.

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EVALUVATION OF CAPSULES

1. STABILITY TESTS.

a) Shell integrity test

b) Determination of shelf life

2.INVARIABILITY TESTS. a ) Weight variation

b) Content uniformity

3. DISINTEGRATION TEST.

4. DISSOLUTION TEST.

5. MOISTURE PERMEATION TEST.

1.STABILITY TESTS

• Stability tests for capsules are performed to know the integrity of gelatin capsule shell ( but not to know the stability of therapeuticallay active agent ) and for determining the shelf life of capsules.

• The tests helps in improving the quality of contents of capsule shell and for choosing the appropriate retail package.

BEFORE ACTUALLY PERFORMING THE TESTS FOLLOWING FACT:(i).the capsule shell are to be stabilized to know atmospheric

condition with relative humidity about 20-30 % and temperature about 21-24⁰c .

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A ) SHELL INTEGRITY TEST : ▪ This test is performed to find out the integrity of

capsule shell.The standard capsule shells kept at the room

temperature 40 ⁰c and 80% RH becomes more soft ,sticky and swollen .

B) DETERMINATION OF SHELF LIFE : Shelf life or the expiry date of packed capsules is determined under normal storage conditions.

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INVARIABILITY TESTS

The invariabilty in the medicaments packed in thecapsule shells can be determined by performing the following tests :

a)Weight variation test

b) Content uniformity test

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DISINTEGRATION TEST

• Disintegration test is a method to evaluate the rate of disintegration of solid dosage forms .

disintegration is defined as the breakdown of solid dosage form into small particles after it is ingested .

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DISSOLUTION TEST

▪ Dissolution test is an official method todetermine the dissolution rate of a solid dosageform .▪ Dissolution rate is defined as the rate at which

the drug is released into the systemic circulation from the dosage from .

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DISSOLUTION TEST APPARATUS

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a) . Apparatus -1 ( rotating basket dissolution apparatus ) :-

▪Small wire mesh size basket – 22 ▪Temperature – 37 +/- 5⁰c ▪Rotated speed – 25 -150 rpm ▪Dissolution medium hight from the bottam of the vessel :- 23-27 mm

b) Apparatus -2 ( rotating paddle dissolution apparatus) :-

Small wire mesh size :- 22Dissolution medium hight from the bottam of the vessel :- 23-27 mm▪Temperature – 37 +/- 5⁰c ▪Rotated speed – 25 -150 rpm ▪Dissolution medium hight from the

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MOISTURE PERMEATION TEST

To assure the suitability of containers forpackaging capsules .The moisture permeating feature of capsules packaged in ▪ single unit containers – blister pack or strip

pack ▪ unit dose containers – glass or plastic bottlesAre to be determined .

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BIBLIOGRAPHY

◊The science and practice of pharmacy by Remington

-P.G . NO- 918.

◊ The theory and practice of industrial pharmacy by

Leon Lachman ,Herbert A.Lieberman – P.G . NO -374.

◊ Pharmaceutics the design and manufacture of medicines by E. Aulton – P.G .NO – 515.

◊ Practical pharmaceutics by Dr.G.D. Gupta , R.S .Gaud – P.G . NO – 14.◊ Dispensing pharmacy by R.M.Mehta - P.G . NO – 134 .

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