Capsule

Define :-
is solid dosage form in which the drug (usually a single dose) is enclosed in either a hard or soft shell
(mainly gelatin,cellulose derivatives or modified starch).
Gelatin nature
Define
Is a mixture of water soluble proteins (Mw ranges from 20-250)
Preparation method
Prepared by the hydrolysis of collagen (protein of the connective tissues ) followed by
purification ,concentration and drying .
Sources collagen Main sources of collagen : animal bones and skin
Types
According to the hydrolysis processing:
Type A: produced by acid hydrolysis
Type B: produced by basic (alkaline ) hydrolysis.
Important properties
-Bloom strength (a measure of gel rigidity )
-Viscosity
Advantage of gelatin cap
-Non toxic , FDA approved in food stuff!!
-Soluble in biological fluids at body temperature
-Good film-producing material .
-Displays thixotropic properties.

Types of capsules
1-Hard gelatin capsule

Shell Contain Materials (filled)
Gelatin Various material can be filled into hard gelatin capsules
1-Dry solids: powders, pellets, granules & tablets
2-Semisolids
3-Non-aqueous liquids and suspensions

Properties of filled must not :
-not react with gelatin
-not contain a high level of free moisture
-not exceed the volume size of the selected capsules
(Raw materials density?!)

Selection of different excipiets dependis on:
-drug properties : dose,solubility,particle size & shape .
-the filling machines to be used.
-the size of the capsules to be used .

Types of excipients used in powder filled cap
-Diluents : lactose
-Glidants: Aerosil, improve powder flow
-Lubricants: Mg stearate, reduce powder adhesion to
metal parts.
-Wetting agents: improve water penetration
-Disintegrate: may or may not be added
Water
Content
-12-16% : acts as a plasticizer
-Very critical during manufacturing and storage.

Problems :
%softening and deformation, microbial
contamination
%brittle , breakdown upon use.
Colourint
-Mainly synthetic
-Water-soluble or water insoluble.
-Azo or non-azo dyes.
-Usually , a mixture is used.
-Examples: erythrosine , indigocarmine
Opecifing
Uses : to make the capsule opaque.
E.g; Titanium dioxide (white)
Composed
Composed of 2 pieces :
1- body : is longer and slightly smaller in diameter
than the cap.
2-Cap :
Shape Mainly oblong
Size
Different sizes : from 000 (biggest) to 5 (smallest )
, different filling capacity (60mg to 1g) depending
on the density .
Preservative
Wetting
agent




2- Soft gelatin capsules
Steps of formed
Capsules are formed ,filled and sealed in one operation
Shape Available in various shapes (round , oval , oblong,)
Size In terms of number of drops :4,5 ( volume of fill= number x 0.06 ml)
Shell composition
-Gelatin
-Water 30-40% in the wet gel
-Plasticizer 20-30% of the wet gel
-Opacifiers
-Colorants
-Preservatives
Capsule content
-Non aqueous liquids ( oils)
-Oily suspensions
Applications
(uses of soft gel cap)
-Oral capsules
-Rectal and vaginal suppositories
-Single-dose eye ointment
Advantage of soft gelatin
capsules
Improved
-Drug absorption (biavailability )
-Patient compliance
-Safety for potent and cytotoxic drugs
-Dose uniformity for low dose drugs
-Product stability