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Softgel Formulation & Analytical Development
One of the most frequent issues in product development of soft gelatin capsules is dissolution performance. Gelatin is a protein containing terminal reactive amino o carboxylic groups which proceed to crosslinking reactions, leading to the formation of insoluble high molecular weight chains that decrease or limit the release of the fill content of the capsules to the dissolution media. The progress of this reaction will depend on the content of high molecular weight chains, the content of free groups to react in gelatin or the reactive impurities in excipients. In product formulation, some properties of the gelatin such as the gelatin type and the molecular weight have been identified to determine the dissolution of the product. In regards to the gelatin formulation, some relevant variables are the type and content of plasticizer.