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CapsulesJ E Newberynj01@gre.ac.uk Capsules - CapsulaeEP 5.01‘Capsules are solid preparations with hardor soft shells of various shapes andcapacities, usually containing a single doseof active substance. They are intended fororal administration’. The capsule shells are made of gelatin…..Hard Capsules Relatively easy production. Capsule shells available from many manufacturers.Often filled in Dispensary/HospitalSoft Capsules Specific rooms (humidity temperature) and equipment necessary for productionOnly very few Contract Manufacturers Gelatin manufacturegelatin-gmia/html/rawmaterials.html Gelatin manufacture Result:Different iso-electrical pointType A rather alkaline (pH 6.0 – 9.5)Type B rather acidic (pH 4.7 – 5.6)Reason:Hydrolysis of glutamine/asparagine occurs only during the alkaline process Properties of GelatinAppearance Faintly yellow or light yellowish-brown, solid, usually occurring as translucent sheets, shreds, granules or powder.Solubility – Swells in cold water and gives on heating a colloidal solution – Good solubility in glycerol, propylene glycol, sorbitol solution and acetic acid – Partially soluble in EtOH-water-mixtures – Insoluble in ethanol, ether and other organic solvents Soft Capsules? Multi purpose dosageform: eg, oral, rectal,vaginal? Swallow, break with theteeth, suck on (Gelsolets)? Filling volume from 0.1 -20 ml Soft Gelatin Capsules The thick shell contains glycerol and/or sorbitol as plasticiserWater content 7-8%Higher hygroscopicity than hard gelatin capsules (plasticiser)Huge diversity in forms and coloursUsed for non aqueous solutions and suspensions Size/shape manufacture1. Swelling of the gelatin2. Addition of plasticisers,antimicrobial preservatives,sweeteners, colouring matter3. Casting of gelatin ribbons4. Shaping to the dimension ofthe die5. Filling from dosing pumpdirectly before sealing Rotary-Die Method (Scherer, 1933)A Continuous process…/Rotary-Die method1 Gelatin ribbons2 Rotary dies3 V-notch filler4 Finished cap