In vitro dissolution kinetics of amlodipine tablets marketed in russia under biowaiver conditions

Dissolution Technologies

Volumn 17, Issue 3, 2010, Pages 20-22

  Shohin, I E ^a,b   Ramenskaya, G V ^a,b   Vasilenko, G F ^b   Malashenko, E A ^a  

^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

AMLODIPINE;

ARTICLE; BIOEQUIVALENCE; DRUG SOLUBILITY; KINETICS; RUSSIAN FEDERATION; TABLET DISINTEGRATION; WORLD HEALTH ORGANIZATION;

EID: 78649709849     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT170310P20     Document Type: Article

References (7)

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. Amlodipine besylate prescribing information, Pfizer, 2006.
3. United States Pharmacopeia and National Formulary USP 29-NF 24; The United Pharmacopeial Convention, Inc.: Rockville, MD, 2006.
4. European Pharmacopoeia, 6th ed.; European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France, 2007.
5. Drug Bank database. Drug card for Amlodipine. http://www.drugbank.ca/drugs/DB00381 (accessed Jul 7, 2010).
6. WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Model List of Essential Medicines, 15th list; World Health Organization: Geneva, Switzerland, 2007.
7. FGU NCESMP Roszdravnadzor database. http://www.regmed.ru (accessed Jul 12, 2010).