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SOFT GELATIN CAPSULE

►Capsules areCapsules are solid dosage forms with solid dosage forms with hard or soft shells. They are of various hard or soft shells. They are of various shapes and sizes, and contain a single shapes and sizes, and contain a single dose of one or more active dose of one or more active ingredients. They are intended for oral ingredients. They are intended for oral administration.administration.

► In capsules the drug is enclosed within In capsules the drug is enclosed within hard or soft shell.hard or soft shell.

Capsule shells are made of gelatin or other Capsule shells are made of gelatin or other substances, the consistency of which may substances, the consistency of which may be modified by the addition of substances be modified by the addition of substances such as glycerol or sorbitol. such as glycerol or sorbitol.

The shell should disintegrate in the The shell should disintegrate in the presence of digestive fluids so that the presence of digestive fluids so that the contents are released. contents are released. The contents should not cause The contents should not cause deterioration of the shell.deterioration of the shell.

Excipients for production Excipients for production of the Capsule shells :of the Capsule shells :

diluents, diluents, solvents, solvents, surface-active substances, surface-active substances, opaque fillers, opaque fillers, antimicrobial agents, antimicrobial agents, sweeteners, sweeteners, colouring matter, colouring matter, flavouring substances, flavouring substances, disintegrating agents, disintegrating agents, glidants, glidants, lubricants, lubricants, substances capable of modifying the behaviour of the active substances capable of modifying the behaviour of the active ingredient(s) in the gastrointestinal tract. ingredient(s) in the gastrointestinal tract.

Categories of capsules hard capsules; soft capsules (softgels); modified-release capsules:1. delayed-release capsules

(gastroresistant / enteric capsules)2. sustained-release capsules (extended-/prolonged release capsules).

Type of capsules depend on Type of capsules depend on plasticizer content plasticizer content

and technological principleand technological principle

1. Hard-Shell Gelatin Capsules;1. Hard-Shell Gelatin Capsules;

2. Soft- Gelatin Capsules 2. Soft- Gelatin Capsules ((softgelssoftgels););

Soft gelatin capsules (softgels) are hermetically sealed one-piece capsules containing a liquid or a semisolid fill.Soft capsules are usually formed, filled, and sealed in one operation.

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SOFT GELATIN CAPSULEDefinition:-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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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 is0.4 : 1

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SHAPE OF CAPSULEThe shape of soft gelatin

capsule are round, oval, oblong, tube.

Advantages of soft-gelatin capsules1. Improved bioavailability, as the drug is presented in a

solubilized form. 2. Enhanced drug stability. 3. Consumer preference regarding ease of swallowing,

convenience, and taste can improve compliance. 4. Offer opportunities for product differentiation via colour,

shape, and size and product line extension. 5. The softgels can be enteric coated for delayed release.

They are popular for pharmaceuticals, cosmetics, andnutritional products.

Hard capsules have shells consisting of two prefabricated cylindrical sections that fit together.

One end of each section is rounded and closed, and the other is open. The contents of hard capsules are usually in solid form (powder or granules).

In the manufacture of capsules, measures are taken to: ensure that the active ingredient(s) when

present in solid state form have appropriate solid-state properties such as particle-size distribution and polymorphic form;

ensure that mixing with excipients is carried out in a manner that ensures homogeneity;

minimize the degradation of the active ingredient(s);

minimize the risk of microbial contamination; minimize the risk of cross contamination.

Stage of capsules production:

1. Preparing of gelatin solutions.

2. Preparing of gelatin shells.

3. Hard-gelatin capsule filling.

4. Packing and labeling.

1. Preparing of gelatin solutions.

2. Preparing and filling of soft-gelatin capsules.

3. Packing and labeling.

Methods of softgels production

Droplet method Pressing method

Droplet method1. Container with

medicines substance 2. Hoper with

medicines substance 3. Container with

gelatin solution4. Conical nozzle 5. Pulsater6. Cooler 7. Container with

Vaseline oil

Characteristic of Droplet method

It is based on formation of spherical gelatinous drop filled with a solution or suspension of medicinal substance at simultaneous drop dosage of medicinal substance solution followed by subsequent cooling of heated gelatinous mass in cool liquid petrolatum. As the result joinless spherical gelatious capsule with elastic shell is formed.

Droplet method

1. Container with medicines substance

2. Hoper with medicines substance

3. Container with gelatin solution

4. Conical nozzle 5. Pulsater6. Cooler 7. Container with

Vaseline oil

Pressing methodPreparing of an initial gelatinous tape, placing it into metal plates and rolls having deepening holes resembling half of the capsules.While heating gelatin fills this mould. Drug is fed into a hollow in a gelatinous tape, then this half of a capsule is joined with another one formed and filled in the same way. Obtained capsules have a horizontal weld.

Pressing (rotate die) method

The glycerol – gelatin solution is heated and pumped onto two chilled drums-1 to form two separate ribbons-2, which form each half of the softgel.

The ribbons are lubricated and fed into the filling machine, forcing the gelatin to adopt the contours of the die.

The fill-4 is manufactured in a separate process and pumped in, and the softgels are sealed by the application of heat and pressure.

Once cut from the ribbon (5), they are tumble - dried and conditioned at

20 % relative humidity.

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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Difference between Hard and Soft Gelatin Capsule

Features Hard Gelatin Capsule Soft Gelatin Capsule

Structure Composed of two parts-1) Body, 2) Cap

Composed of a Single part.

Composition of Shell

Composed of gelatin blends, dyes , plasticizers and water.

Gelatin, plasticizers and water

State of Medicaments

Only solid medicaments are enclosed

Solid, semi-solid medicaments are enclosed

Shape and Size

Capsule shell is cylindrical

Capsule shell may be round, oblong, oval

Difference between Hard and Soft Gelatin Capsule

Features Hard Gelatin Capsule Soft Gelatin Capsule

Thickness Less thicker Thicker

Routes of administration

Only orally Oral, Opthalmic, Suppository

Sealing Not completed sealed Completely sealed

Manufacturing Can be made by hand, semiautomatic or automatic machine.

Not by hand.