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RegisterFDA: Diss. and Spec’s for BCS Classes 1 and 3 [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2015-09-14 13:52 (3939 d 17:59 ago) – Posting: # 15395
Views: 5,780
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the FDA published a new Draft Guidance “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3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:
the FDA published a new Draft Guidance “Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3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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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- FDA: Diss. and Spec’s for BCS Classes 1 and 3Helmut 2015-09-14 11:52 [Dissolution / BCS / IVIVC]
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Ing. Helmut Schütz