Helmut
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Vienna, Austria,
2015-09-14 13:52
(3469 d 22:44 ago)

Posting: # 15395
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 FDA: Diss. and Spec’s for BCS Classes 1 and 3 [Dissolution / BCS / IVIVC]

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Dear all,

the FDA published a new Draft Guidance “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs”. In a nut­shell:
  • Highly soluble in ≤250 mL over a pH range of 1 to 6.8. The API has to be stable for 24 hours [sic] in this pH range.
  • Not applicable to NTIDs or if tmax is critical to the intended use (e.g., analgetics).
  • Contact the review staff if large quantities of excipients (seweeteners, surfactants) are chosen for the product.
  • Diss. spec’s (≥80% dissolved): 30 minutes (Class 1) and 15 minutes (Class 3).
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