Capsules

Chapter 7: Capsules
Capsule Sizes	000à largest 5à smallest ; 65 mg :Human use Larger: vet use Hard Gelatin: 65 mg to 1 g capacity
Hard capsule	Titanium dioxide: makes them opaque
Soft capsule

CAPSULES

-          Solid dosage forms in which the drug substance is enclosed in either a hard or soft soluble container or shell of a suitable form of gelatin.

-          CAPSULES ARE POPULAR FOR THE FOLLOWING REASONS:

1.       They are tasteless and are easily administered.

2.       They are easily either extemporaneously or in large quantity commercially

3.       They permit flexibility and exact dosage level

HARD GELATIN CAPSULES

• Also referred to as dry-filled capsules (DFC)
• Consists of two sections, one slipping over the other thus completely surrounding the drug formulation in an oblong shell.
• Supplied in a variety of size numbering from 000-5.
• Composed of:

-          Gelatin

-          FD and colorant

-          Opacifying agent (titanium dioxide)

-          0.15% sulfur dioxide

-          Water (water content: 12-16% but may vary depending on storage conditions)

 

 

PRINCIPLES AND METHODS FOR THE UNFORM DISTRIBUTION

Of a n active medicinal agent in a powder mixture are similar to those of pwders

-          Filling into hard gelatin capsules with the use of hand operated or autonomic filling machine includes:

-          1. Separation of cap from the body

-          2. Filling the body half

-          3. Rejoing the cap and and the body halves

-          Cleaning of the filled capsules

-           

SOFT GELATIN  CAPSULE

-          Soft globular gelatin shell somewhat thicker than the hard gelatin capsules

-          It has a seam of the point of the closure of the 2 halves and the contents can be liquid paste or powder

-          Oblong, oval, spherical, tube, pearl, suppository type

-          - 6-10%

-          Rendered plastic-like with addition of plasticizers

-          Materials for capsule shell making

o   Gelatin

o   Plasticizers- for elasticity and flexibility (glycerin and sorbitol)

o   COLORANTS

o   Preservatives

o   Opacifying agent

+for large scale : glidants, lubricants and surfactants may also be employed

-          There are also many recognized methods for soft gelatin such as:

1.       Plate process

Ø  A warm sheet of prepared gelatin is laid over the lower plate and the liquid is poured into it

Ø  A second sheet of  gelatin is carefully put in place and this is followed by top plate of the mold

Ø  The set is placed under the press where  the pressure is applied to form and capsule which are washed off with a volatile solventto remove any trace of all from the exterior

 

2.       Rotary Die Process

Ø  Rotary die machine is a self contained unit capable of continuously and automatically producing finished capsules from a supply of gelatin mass and filling material or paste that will not dissolve again

Ø  Two continuous gelatin ribbons which machine form are brought into convergence between a pair of revolving dies and an injection wedge

Ø  Accurate filling under the pressure and sealing of the capsule will occur as dual and coincidence operation

3.       Norton Capsule Machine

Ø  This machine produces capsules completely automatically by leading two films of gelatin

In a set of vertical dies

Ø  These are dies as they close , open and close, are in effect  of continual vertical plate forming row  fter row of pockets across gelatin film

Ø  These are filled with medicament and as they progress through the dies are sealed shaped and cut of the film as capsules which drop into a cooled solvent bath

4.       Accogel Capsule machine

Ø  Stern machine which uses system of rotary dies but in that it is the only machine that can be successfully fill dry powder into a soft gelatin capsule

Ø  Extremely versatile not only producing capsules with dry powder but also encapsulating liquids and combination of liquids and powders

Ø  By means of an attachment slugs or compressed tablet may be enclosed in a gelatin film

Ø  Capsule can be made with variety of colors and shapes and sizes

USP STANDARDS for Capsule

1.       Content uniformity = 85- 115% active ingr. Same as label claim; 9 out of 10 capsule