Dissolution

SPECIFICATIONS FOR DISSOLUTION TESTING OF ORAL DOSAGE FORMS:

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The dissolution specification is defined by the amount (Q) of active substance that dissolves within a designated time frame, represented as a percentage of the content indicated on the product label. According to the Indian Pharmacopoeia, the dissolution specification is articulated in terms of the amount (D) of active substance that dissolves in a specified … Read more

BIOPHARMACEUTICS CLASSIFICATION SYSTEM

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According to the solubility and permeability of drugs, the following Biopharmaceutics Classification System (BCS) is suggested in the literature (Amidon 1995) This classification serves as a foundation for establishing in vitro dissolution specifications and also aids in predicting the probability of achieving a successful in vivo-in vitro correlation (IVIVC). The solubility of a drug is … Read more