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Pharmaceutical Manufacturing and Packing Sourcer
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Gelatine capsules are a sophisticated and widespread pharmaceutical dosage form, specially designed for the application of light- and oxygen-sensitive pharmaceutical ingredients coupled with a high level of patient compliance (1). There are two types of gelatine capsules on the market: soft gelatine capsule that are manufactured and filled in a simultaneous process, and hard gelatine capsules.
Hard gelatine capsules (HC) are produced as two separate halves - known as bodies and caps - by dipping stainless steel pins into pre-heated concentrated gelatine solutions which may contain colouring agents, pigments and processing aids. Dried and pre-locked hard capsules are supplied to pharmaceutical companies or contract manufacturers where they are filled with powdered, granulated or even liquid ingredients. For the production of hard gelatine capsules several quality parameters of the used gelatine are of great importance.
These are for example Bloom, viscosity, viscosity breakdown and setting properties (having an impact on brittleness, drying, gliding and dissolution properties of finished capsules). According to the USP/EP there are two different systems to determine the release and bioavailibility of a drug filled into hard gelatine capsules: the dissolution and the disintegration test. The release of a drug is not only influenced by the solubility of the drug itself but also by the dissolution properties of the gelatine shell.
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