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Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets.
AAPS PharmSciTech. 2010 Jun; 11(2):637-44.AP

Abstract

A dissolution test for tablets containing 40 mg of olmesartan medoxomil (OLM) was developed and validated using both LC-UV and UV methods. After evaluation of the sink condition, dissolution medium, and stability of the drug, the method was validated using USP apparatus 2, 50 rpm rotation speed, and 900 ml of deaerated H(2)O + 0.5% sodium lauryl sulfate (w/v) at pH 6.8 (adjusted with 18% phosphoric acid) as the dissolution medium. The model-independent method using difference factor (f(1)) and similarity factor (f(2)), model-dependent method, and dissolution efficiency were employed to compare dissolution profiles. The kinetic parameters of drug release were also investigated. The obtained results provided adequate dissolution profiles. The developed dissolution test was validated according to international guidelines. Since there is no monograph for this drug in tablets, the dissolution method presented here can be used as a quality control test for OLM in this dosage form, especially in a batch to batch evaluation.

Authors+Show Affiliations

Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Av. Ipiranga, 2752, CEP 90610-000, Porto Alegre, RS, Brazil. lisianebajerski@yahoo.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

20373150

Citation

Bajerski, Lisiane, et al. "Development and Validation of a Discriminating in Vitro Dissolution Method for a Poorly Soluble Drug, Olmesartan Medoxomil: Comparison Between Commercial Tablets." AAPS PharmSciTech, vol. 11, no. 2, 2010, pp. 637-44.
Bajerski L, Rossi RC, Dias CL, et al. Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets. AAPS PharmSciTech. 2010;11(2):637-44.
Bajerski, L., Rossi, R. C., Dias, C. L., Bergold, A. M., & Fröehlich, P. E. (2010). Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets. AAPS PharmSciTech, 11(2), 637-44. https://doi.org/10.1208/s12249-010-9421-0
Bajerski L, et al. Development and Validation of a Discriminating in Vitro Dissolution Method for a Poorly Soluble Drug, Olmesartan Medoxomil: Comparison Between Commercial Tablets. AAPS PharmSciTech. 2010;11(2):637-44. PubMed PMID: 20373150.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets. AU - Bajerski,Lisiane, AU - Rossi,Rochele Cassanta, AU - Dias,Carolina Lupi, AU - Bergold,Ana Maria, AU - Fröehlich,Pedro Eduardo, Y1 - 2010/04/07/ PY - 2009/08/05/received PY - 2010/03/09/accepted PY - 2010/4/8/entrez PY - 2010/4/8/pubmed PY - 2010/10/12/medline SP - 637 EP - 44 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 11 IS - 2 N2 - A dissolution test for tablets containing 40 mg of olmesartan medoxomil (OLM) was developed and validated using both LC-UV and UV methods. After evaluation of the sink condition, dissolution medium, and stability of the drug, the method was validated using USP apparatus 2, 50 rpm rotation speed, and 900 ml of deaerated H(2)O + 0.5% sodium lauryl sulfate (w/v) at pH 6.8 (adjusted with 18% phosphoric acid) as the dissolution medium. The model-independent method using difference factor (f(1)) and similarity factor (f(2)), model-dependent method, and dissolution efficiency were employed to compare dissolution profiles. The kinetic parameters of drug release were also investigated. The obtained results provided adequate dissolution profiles. The developed dissolution test was validated according to international guidelines. Since there is no monograph for this drug in tablets, the dissolution method presented here can be used as a quality control test for OLM in this dosage form, especially in a batch to batch evaluation. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/20373150/Development_and_validation_of_a_discriminating_in_vitro_dissolution_method_for_a_poorly_soluble_drug_olmesartan_medoxomil:_comparison_between_commercial_tablets_ L2 - https://dx.doi.org/10.1208/s12249-010-9421-0 DB - PRIME DP - Unbound Medicine ER -