Capsules

B. Pharm. - III, (Sem-VI)

Sant Gajanan Maharaj College of

Pharmacy,Mahagaon

Contents…

Introduction Hard capsules• Raw materials• Shell manufacturing• Capsule size• Properties of filled material and formulation• Capsule filling equipments•Evaluation of finished capsules and official standards

Introduction

The word “ Capsule” is derived from latin Capsula meaning small box.These are solid unit dosage forms intended for oral use.

Capsule are solid dosage form usually containing one dose of drug enclosed within a small, water –soluble shell of a suitable form of gelatin.Gelatin capsules were first prepared in france by Mothes and Dublanc, a french pharmacist in 1834.

Types of capsules: 1.Hard Gelatin capsules 2.Soft Gelatin Capsules

Advantages of Capsules

1.Capsules are tasteless, odorless and can be easily

administered.

2.They are attractive in appearance.

3.The drugs having unpleasant odor and taste are

enclosed in a tasteless shell.

4.They are economical.

5.They are easy to handle and carry.

Disadvantages of Capsules

1.The drugs which are hygroscopic are not suitable for filling into capsules.The y will absorb the water present in capsule shell rendering the shell very brittle and lead to crumble into pieces.2.The concentrated solutions which require previous dilution are unsuitable for capsules because if administered as such lead to irritation in the stomach.

HARD CAPSULES

Solid substances are enclosed in hard capsules is called as hard gelatin capsule. The hard capsule consists of 2 pieces in form of cylinders closed at one end,the shorter piece, called the “ Cap” fits over the open end of longer piece called the body.

Hard capsules….Raw material

Hard capsules are made up of base containing plasticizers and water. The base may also contain preservatives,colors,flavors and sugars. Raw materials have been used in manufacturing of both types of capsule both contain gelatin, water ,colourants and preservatives. Soft capsules contain various plasticizers such as glycerin and sorbitol.

GelatinIt is the major component used for capsules.Gelatin is a protein substances derived from collagen, a natural protein present in ligaments and tissues of mammals. It is produced by boiling the connective tissues ,bones and skin of animals usually cows and pigs. Gelatin is a translucent, colorless brittle (when dry) solid substances prepared by hydrolysis of collagen which is a main protein constituent of connective tissues.Gelatin possesses basic properties that make suitable for mfg of capsule.1.It is non-toxic2.It is readily soluble in biological fluids at body temperature.3.It is a good film-forming material producing a strong flexible film.

Gelatin is derived from pork skin, bones etc.The raw materials are prepared by different acid and alkali process.Acid and alkali such as lime or sodium carbonate are used to extract minerals and bacteria from animal parts.There are 2 main types of gelatin.1.Type A: which is produced by acid hydrolysis from skin.2.Type B: which is produced by basic hydrolysis from bones.

Shell Manufacturing

Metal moulds at room temperature are dipped into a hot gelatin

solution which gels to form a film. This dried,cut to length,removed

from the moulds and 2 parts are joined together.

Steps invovled are as follows:

Dipping : A pairs of stainless steel pins are dipped into dipping

solution to forms caps and bodies.

Drying: The gelatin is dried by a blast of cool air to form a hard

shells.The pins are removed through a series of air drying kilns to

remove water.

Stripping:A series of bronze jaws strip the cap and body portions of the capsule from pins.

Trimming and joining: The stripped cap and body portions are trimmed to the required length by stationary knives. After trimming to right length the cap and body portion are joined

and ejected from machine.

Polishing: Acela cota pan is used to polish the capsules shell.

Shell Manufacturing

Shell Manufacturing

Dipped into gelatin solution Dried Stripped off Combined

Filling is a separate process

For human use, capsules ranging in size from

000 (the largest) to 5 (the smallest) are

commercially available.

- Larger capsules are used in veterinary

applications.

Capsule size

Properties of filled material and formulation

1. Lubricant - A lubricant is added to facilitate the flow of the drug-fill into the machinery which reduce powder to metal adhesion. E.g. Magnessium Stearate2. Wetting Agent - Wetting agents are used to enhance the dissolution of solid particles. Lithium carbonate is a commonly used wetting agent. -Wetting agent pre-vents agglomeration of particles and accelerates the dissolution of particles by allowing water to penetrate.

-

Properties of filled material and formulation

3.Fillers include lactose, starch, dicalcium phosphate.

4.Glidants: which improve powder flow.E.g:Talc

5.Disintegrants: which produce disruption of the powder

mass. Promoting liquid penetration (wicking) and Promoting

deaggregation

E.g: Sodium starch glycolate

6.Stabilizers:Which improve product stability.Eg:Benzoic acid

Hard capsules… Capsule filling Equipments

For filling of small no of capsules. 1.The proper size of capsule shell is selected which depends upon the quantity and density of the powder to be filled in.2.Each ingredient is weighed and finely powdered if already not in a fine powder. They are mixed together by triturating so that a uniform powder is obtained.3. The mixed powder is placed on the paper and spread with a spatula so as to make a small pile .4.Remove the cap from the capsule and hold it in the left hand, press the body repeatedly into the powder until it is filled.5.Insert the cap on the body and weigh the capsule.

Hand operated Hard Gelatin Capsule Filling Machine

Hand operated Hard Gelatin Capsule Filling Machine consists of following parts:1. A bed with 200 or 300 holes2. A capsule loading tray3. A powder tray4. A pin plate having 200 or 300 pins corresponding to the no of

holes in the bed and capsule loading tray5. A lever6. A handle7. A plate fitted with rubber top

Hand operated Hard Gelatin Capsule Filling Machine

Filling equipments

1.Rotosort- for filled capsule machine .2. Rotofill- to fill pellets in hard gelatin capsule3. Rotoweigh- A high speed capsule weighing machine.4. Accogel- filling of dry powder in soft gelatin capsule.5. Accofill- fill exact powder dose in hard gelatin capsule

6.Osaka- capsule filling machine (powder, granules)7. Zanasi- capsule filling (powder,pellets,tablets)8. Lily/parke-davis- capsule filling (powder)

Filling equipments

11. Erweka- De-dusting and polishing capsule

machine.

12. Seidender- Uses a Belt for visual

inspection.

13. Vericap 1200- capsule weighing

machine.

14.Wurster- for coating.

Evaluation of finished capsules and official standards

1. Containers for dispensing

Tight, well closed and light resistant containers .

2. Disintegration Test for Capsules

Introduce one capsule into each tube and suspend the apparatus in beaker containing 900 ml of water at 37.If hard capsules float on the surface of water,the discs may be added.Operate the apparatus for 30 min,,remove the assembly from the liquid.The capsules pass the test if no residue remains on the screen of the apparatus.

Evaluation of finished capsules and official standards

3.Weight Variation

4. Content Uniformity

This test is applicable to all capsules which are meant for oral administration. For this test a sample of the contents is assayed as described in individual monographs and the values calculated which must comply with the prescribed standards.

Evaluation of finished capsules and official standards

5. Dissolution test

The capsule is placed in a basket formed from stainless steel.A stirrer shaft is attached to the basket and the basket is immersed in the dissolution medium.The dissolution medium is held in a 1000 ml glass vessel and maintained at 37 by means of constant temperature water bath.

Soft Gelatin Capsule Will continue next time…

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