CAPSULES 

Manufacture of Gelatin 

The manufacturing process of gelatin involves several main stages:

  1. Pretreatments: This step prepares the raw materials for the main extraction step and removes impurities that may negatively affect the physicochemical properties of the final gelatin product. 

  2. Hydrolysis of Collagen: Collagen, a natural protein present in the tendons, ligaments, and tissues of animals, is hydrolyzed to form gelatin. This process involves boiling the connective tissues, bones, and skins of animals.

  3. Extraction: Gelatin is extracted from the hydrolysis mixture. The gelatin can be ground into a fine powder or cut into sheets for use.

  4. Freeze drying: Solution is freeze dried and gelatin is prepared. 

Contents of capsules 

HARD GELATIN CAPSULE

SOFT GELATIN CAPSULE

Gelatin

Gelatin

Water

Plasticizer: Glycerine

Sulfer Dioxide: Prevents Decomposition

Water

Preservatives: Methyl/ ethyl paraben

Preservatives: Methyl/ ethyl paraben

Die/pigment: Erythrosine

Die/pigment: Erythrosine

Diluents: Lactose, Mannitol

Opacifying Agent: TiO2

Lubricants: Talc, Calcium stearate

Flavouring agent: Vanillin

Disintegration Agent: Calcium carboxymethyl cellulose

Wetting agent: SLS

MANUFACTURE OF HARD GELATIN CAPSULE 

The manufacturing process of hard gelatin capsules involves several steps:

  1. Gelatin Solution Preparation: Gelatin is dissolved in demineralized water heated to about 60 to 70 degree Celsius to prepare a concentrated gelatin solution. This highly viscous solution comprises about 30 to 40 percent w/w gelatin.

  2. Dip-coating of Gelatin Solution onto Metal Pins (DIPPING): Once the targeted level of viscosity is attained, proceed to the dipping process. The processed gelatin solution is required to be moved to the capsule manufacturing machine at this stage.

  3. Rotation of The Dip-coated Pins (SPINNING): Coated pins are made to pass through the furnace for setting and drying purposes. They are spined in a defined manner to avoid any point formation at the top of the shell. It is important to control the temperature and humidity in the process to successfully remove the moisture from the capsule.

  4. Drying of The Gelatin-coated Pins: The drying process is carried out in a controlled environment.

  5. Stripping (removal from pins) and Trimming: The pin plate now enters the table section of the machine. Capsules are divided into 2 equal or roughly equal sizes.

  6. Joining The Trimmed Capsule Shell: During the capsule filling unit operation, the body is filled with the drug substances and the shell is closed by bringing the body and the cap together.

  7. Polishing: Polished using dry cloths. 

  8. Printing: This is an optional step where details like product name, brand name or logos can be printed on the capsules.

SOFT GELATIN CAPSULE 


Soft gelatin capsules are prepared using only one sheet of gelatin and do not have any body or cap part as hard gelatin capsule. soft gelatin capsule contains liquid or semisolid medicament inside it. 

Manufacture Process:

Plate Process: 

            - Place gelatin sheet over a die plate containing die pockets.
            - Vacuum is applied to draw the gelatin sheet into the pocket
            - Filling the pocket with liquid containing medicament
            - Place another gelatin sheet aver the filled pocket 
            - Pressure applied to combine both the sheets together
            - Soft gelatin capsule is prepared  

rotary dye Process 

            - In this process, the soft gelatin capsules are prepared and filled immediately 
            - It consists of 2 hoppers and 2 rotating dies. 
            - Liquid mixture of gelatin is placed in one hopper and liquid medicament in other hopper 
            - 2 dyes are rotated in opposite direction when the fluid gelatin mixture enters the machine from the hopper and forms 2 ribbons 
            - Half shell of the capsule is formed 
            - Measured quantity of medicament is filled by the help of a pump and other half of the capsule is formed by subsequent movement of dyes 
            - 2 halves of the capsule is sealed together by application of heat and pressure 
            - as the dye rolls rotate, cuts out the filled capsule. 
        

Accogel Process: 

            - It consist 3 parts: Measuring roll, Die roll, Sealing roll.
            - As measurung roll and dye roll rotates, the measured doses are transferred to the gelatin linked dye roll 
            - then sealing roll seals the another sheet of gelatin with the dye roll gelatin sheet by the pressure between dye roll and sealing roll and cuts out the capsules. 

Characteristic

Hard gelatin capsule

Soft gelatin capsule

Appearance

Two-piece capsule with a cylindrical body and cap

One-piece capsule

Texture

Hard and brittle

Soft and flexible

Fill

Dry powders, granules, or pellets

Liquids, semisolid, or suspensions

Dissolution rate

Dissolves more slowly than soft gelatin capsules

Dissolves more quickly than hard gelatin capsules

Bioavailability

May be lower than soft gelatin capsules for some substances

May be higher than hard gelatin capsules for some substances

Production process

Two separate machines are used to produce the body and cap of the capsule, and then the capsule is filled with the active ingredient.

A single machine is used to produce and fill the capsule in one step.

Common uses

Pain relievers, antibiotics, vitamins, and minerals

Omega-3 fatty acids, fish oil, and herbal supplements


Quality Control Tests 


PHYSICAL TEST 

(a) Disintegration time test 
Place Capsules in basket 
Set temperature of water 37+_ 2 
if capsule floats, use Disk 
operate for 30 m for HGC, and 1h for SGC
Passed, if no residue is left in the screen of Apparatus 
Repeat for 12 capsules, if more than 1 or 2 are failed, 
Test passed if 16 out of 18 are disintegrated. 

(b) Weight Variation test 


CHEMICAL TEST

(a) Dissolution test 
(b) Content uniformity 
(c) stability Test 
(d) Moisture Permeation Test

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