A risk based approach to in vitro performance testing: A case study on the use of dissolution vs. disintegration for liquid filled soft gelatin capsules

American Pharmaceutical Review

Volumn 9, Issue 5, 2006, Pages

  Han, Jian Hwa ^a   Gallery, Jean ^a  

^a ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GELATIN;

ARTICLE; DECISION TREE; DRUG CAPSULE; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; PH MEASUREMENT; PRACTICE GUIDELINE; RISK MANAGEMENT;

EID: 55749085125     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Q6A, October 1999. (Federal Register, Vol.65, No. 251, Pages 83041-83063, December 29, 2000).
2. FDA Guidance for Industry "Dissolution Testing of Immediate Release Solid Oral Dosage Forms", August 1997.
3. Umesh V. Banakar, "Pharmaceutical Dissolution Testing", Drugs and the Pharmaceutical Sciences, Vol. 49, CRC Press, ISBN: 0824785673, Marcel Dekker, New York, NY (1991).
4. Qiu, Yihong; Cheskin, Howard S.; Engh, Kevin R.; Poska, Richard P. "Once-a Day Controlled -Released Dosage Form of Divalproex Sodium I: Formulation Design and In Vitro/In Vivo Investigation", J. of Pharmarceutical Sciences, Vol. 92(6), Pages 1166-1173, (2003).
5. Qiu, Yihong; Garren, J.; Samara, E.; Cao, G.; Abraham, C. Cheskin, H. S.; Engh, K. R. "Once-a Day Controlled -Released Dosage Form of Divalproex Sodium II: Development of a Predictive In Vitro Drug Release Method ", J. of Pharmarceutical Sciences, Vol. 92(11), Pages 2317-2325, (2003).
6. Iain J. McGilveray, "Overview of Workshop: In Vitro Dissolution of Immediate Release Dosage Forms: Development of In Vivo Relevance and Quality Control Issues", Drug Information Journal, Vol. 30, Pages 1029-1037, (1996).
7. ICH Guidance on Quality Risk Management Q9, November 2005. (Federal Register, Vol. 70, No. 151; pages 45722-45723, August 8, 2005).
8. Jean Gallery, Jian-Hwa Han, and Chiramel Abraham "Pepsin and Pancreatin Performance in the Dissolution of Crosslinked Gelatin Capsules from pH 1 to 8", Pharmacopeial Forum, Vol. 30(3), Pages 1084-1089, (2004).
9. USP 29-NF 24, 〈711〉 Dissolution, (2006).
10. Gelatin Capsule Working Group, Stimuli to the Revision Process: "Collaborative Development of Two-Tiered Dissolution Testing for Gelatin Capsules and Gelatin-Coated Tablets using Enzyme- Containing Media", Pharmacopeial Forum 24 (5): 7045-7050 (1998).