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Summary

Summary Capsules

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Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images

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  • June 8, 2023
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  • 2019/2020
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Capsules

Gelatin Capsules

 Edible composed of gelatin or starch
 Consists of cap and body
 Filled with powder or liquid
 Sizes:
 5=0.13mL
 4=0.20mL
 3=0.27mL
 2=0.37mL
 1=0.48mL
 0=0.67mL
 00=0.95mL
 000=1.36mL
 Use capsules instead of tablets when the drug: changes polymorph on compression,
degrades on compression or is water sensitive and not easily dry granulated

Hard Gelatin Capsules

 Prepared by hydrolysis of collagen from an animal source
 Non-toxic, good film former and readily disperses in body fluids
 Characterised by viscosity of solution or gel- bloom strength
 Based on force required to force a plunger a set distance into a 6.66% solution at 10 oC
 High bloom is used for hard gelatin and lower for soft

Colourants

 Soluble dyes or insoluble pigments
 Pigments- titanium dioxide (white opacifying agent) or iron oxides (black, red or yellow)
 Dyes- azo and non-azo or erythrosine (pink)

Manufacture of HGCs

 Gelatin solution prepared in hot demineralised water
 Moulds (pins) mounted on metal bars and are dipped in the solution
 Removed with film of gelatin and rotated for uniform thickness
 Passed through series of drying kilns
 Stripped off pins and cut to size and 2 halves

Powder Filling of HGCs (Bench Scale)

 Either bench or industrial scale
 Halves separated and powder spread to fill them

Powder Filling of HGCs (Industrial Scale)

 Dependant- uses capsule body to measure the powder, it slow and depends on operators
skill and uniformity of dosing is dependant on powder flow

,  Independent- powder hopper feeds it and a dosator is used to fill
the capsules
 Formation of the powder plug:
 Dosing tube in which there’s a spring loaded piston
 Volume of the dosing tube is a measure of the chamber between
the tip of the tube and the bottom of the piston
 Volume can be adjusted by moving the position of the piston

Filling Using Dosage Tubes

1. Dose tube plunged into powder bed- powder rises to form a powder plug
2. Dosing tube ruses out of bed
3. Moves over to capsule body and plunger moves down depositing the powder in a shell
4. Dose is determined by the volume of the plug in dosator

Excipients for HGCs

 Diluents- starch or lactose (for low dose drugs to aid flow and compression)
 Glidants- fumed silicon dioxide (reduced inter-particulate adhesion to improve powder flow)
 Lubricants- magnesium sterates (recues adhesion to metals

Drug Release from HGCs

 Dissolution of capsule shell
 Readily soluble at 37oC but solubility dramatically decreases as temperature drops (insoluble
at 30oC)
 (dm/dt)=DA(Cs-C)/h
 (dm/dt)-drug dissolution rate
 D- diffusion coefficient
 Cs- solubility of drug
 C- concentration of drug
 h- diffusion layer thickness
 A- effective surface area
 A can be changed by changing the particles size of the powder (larger=dissolve faster)
 Same quantity of powder should contain more particles when you reduce the particle size
 Potential cause of slow drug release- particle aggregation as decreases A
 Tightly packed particles hinders water penetration so slows down wetting of particles
 Hydrophobic powders, lubricants and glidants reduce wetting

Unconventional Capsules

 Multi-particulate system (via granulation)- for controlled release purpose
 Beneficial dissolution properties
 Pellets may be used
 Liquid or semi-solid filled HGCs
 Molten liquid sets

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