Abstract

AbstractThe effectiveness of disintegrants (Starch, Sodium Starch Glycolate, Microcrystalline Cell u lose, cross-linked cellulose, cross-linked Polyvinylpyrollidone) and the influence of excipients such as the lubricant (Magnesium Stearate), glidant (Talc), insoluble and soluble compressible fillers (Calcium Phosphate, Dextrose), as well as processing factors such as the blending sequence of additives, and effects of light compaction (powder-slugs) on the disintegration of hard shell gelatin capsules were examined. It was found generally that wicking and swelling type disintegrants were most effective at de-aggregating the encapsulated powder mass especially when Magnesium Stearate was present. The incorporation of Talc to the premix (filler, disintegrant, lubricant) appeared to reduce disintegration times due to abrasion of the hydrophobic lubricant film. Tamped powder fills (slugs) took twice as long to disintegrate as loosely filled capsules, but differences became negligible when disintegrants were in...

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