Evaluation of in vitro equivalence for drugs containing BCS class II compound ketoprofen

Dissolution Technologies

Volumn 18, Issue 1, 2011, Pages 26-29

  Shohin, I E ^a,b   Kulinich, J I ^a,b   Ramenskaya, G V ^a,b   Vasilenko, G F ^b  

^a I M SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY   (Russian Federation)

^b Scientific Centre for Expert Evaluation of Medicinal Products   (Russian Federation)

Author keywords

[No Author keywords available]

Indexed keywords

DODECYL SULFATE SODIUM; EXCIPIENT; KETOPROFEN;

ANALYTIC METHOD; ARTICLE; DISSOLUTION; DRUG CAPSULE; DRUG SCREENING; IN VITRO STUDY; PERMEABILITY; PH;

EID: 79953022197     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT180111P26     Document Type: Article

References (13)

1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, No. 937, Annex 8. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; World Health Organization: Geneva, Switzerland, 2006.
2. WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, No. 937, Annex 7. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; World Health Organization: Geneva, Switzerland, 2006.
3. Ketoprofen prescribing information, Lek Pharmaceuticals d. d., Slovenia, 2007.
4. United States Pharmacopeia and National Formulary USP 29-NF 24; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2006.
5. European Pharmacopoeia, 6th ed.; European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France, 2007.
6. Tubic-Grozdanis, M.; Bolger, M.; Langguth, P. Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds. AAPS J. 2008, 10 (1), 213-226.
7. Therapeutic Systems Research Laboratories; Biopharmaceutics Classification System (BCS) search engine. http://69.20.123.154/services/bcs/search.cfm (accessed Jan 19, 2011).
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9. Sheng, J.; Kasim, N. A.; Chandrasekharan, R.; Amidon, G. L. Solubilization and dissolution of insoluble weak acid, ketoprofen: Effects of pH combined with surfactant. Eur. J. Pharm. Sci. 2006, 29, 306-314.
10. FGU NCESMP Roszdravnadzor database. http://www.regmed.ru (accessed Jan 13, 2011).
11. Hilfinger, J. Permeability Classification... In vitro and in situ methodology. Presented at the AAPS Workshop on BE, BCS and Beyond, Bethesda, MD, May 21, 2007. http://www.aapspharmaceutica.com/meetings/files/90/13Hilfinger.pdf (accessed Jan 18, 2011).
12. WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Model List of Essential Medicines, 15th list; World Health Organization: Geneva, Switzerland, 2007.
13. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evolution and Research (CDER). U.S. Government Printing Office: Washington, DC, August 2000.