Is FDA dissolution database more preferable to product specific FDA BE guidance? [Dissolution / BCS / IVIVC]

posted by Vineeth KE – India, 2019-04-25 15:15 (1884 d 10:16 ago) – Posting: # 20229
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❝ For a Oral solid dosage form [tablet and suspension], FDA dissolution database is recommending dissolution to be done at 25 degrees whereas, product specific FDA guidance for the same product is mentioning 37 degrees.


❝ Which temperature should i need to adapt and follow for generic development ?


For development purpose, it is advisable to follow 37 degrees, as it mimics in-vivo condition (For oral solid dosage form).

If the drug release is affected by temperature (due to API solubility/Surfactant Solubility in dissolution media/API degradation/gelling of excipients or any other reasons), it is better to consider the worst case scenario (25 or 37degrees).

For submission purpose, we need to evaluate in both the conditions as mentioned in FDA-Dissolution database & FDA-Product specific guidance.

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