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Capsules outline-2010 - Capsules (titaniumdioxide...

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1 Capsules Can be colored with dyes or opaque (titanium dioxide) Moisture – 13 16% Higher moisture: absorbed by caps – become distorted and lose rigid shape Very low humidity (high dryness): moisture lost – become brittle and crumble Package with desiccant to avoid excess or to lower the humidity Gelatin Insoluble in cold water Soluble in hot water and in warm gastric fluid Protein, so digested by proteolytic enzymes and absorbed Manufacturing of shells Two sections – body and cap: overlap when joined with cap fitting snugly over the open end of the body Taper ends to avoid splitting Pegs made of manganese bronze Capsule sizes Determined by the amount of fill material to be encapsulated *density and compressibility of fill will largely determine to what extent it may be packed into capsule shell initial judgment to approximate size Final determination: use of trial and error Human sizes range from Size 000 (largest) to 5 (smallest) Can have a single medicinal agent or a combo of stuff Preparation of filled hard gelatin capsules: large or small scale 1. Developing and preparing the formulation and selecting the size capsule 2. Filling the capsule shells 3. Capsule sealing (optional) 4. Cleaning and polishing the filled capsules. Developing the formulation and selection of capsule size Goal: prepare a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and elegance Dry formulations: powders mix thoroughly – uniform powder mix especially important in low dose drugs Diluents/fillers: lactose, microcrystalline cellulose, & starch Æ for bulk and cohesion to the powders
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