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Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets.
J Pharm Pharm Sci. 2005 Aug 11; 8(2):289-98.JP

Abstract

PURPOSE

This study describes the development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets using an HPLC method.

METHOD

The appropriate conditions were determinate after testing sink conditions, dissolution medium, and agitation intensity. The apparatus, paddle and basket, were applied to tablets and capsules, respectively. Fexofenadine hydrochloride capsules, products A and B, and coated tablets, products A, B and C were evaluated. The best dissolution conditions tested, for the products in each respective pharmaceutical dosage form were applied to evaluate the dissolution profiles. The parameters of difference factor, similar factor, and dissolution efficacy were employed.

RESULTS

Optimal conditions to carry out the dissolution tests were 900 ml of 0.01 M hydrochloric acid as dissolution medium, basket at 100 rotation per minute (rpm) stirring speed for capsules and paddle at 75 rpm for tablets. The dissolution profiles for tablets products A, B, and C and for capsules products A and B were not similar.

CONCLUSION

The developed and validated dissolution tests satisfactorily describes the time-course of the drug release. The obtained results provided adequate dissolution profiles. The HPLC method was validated to quantify fexofenadine capsules and coated tablets from the dissolution tests.

Authors+Show Affiliations

Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, CEP 90610-000, Brazil. anarita_breier@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16124939

Citation

Breier, Ana R., et al. "Development and Validation of Dissolution Tests for Fexofenadine Hydrochloride Capsules and Coated Tablets." Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques, vol. 8, no. 2, 2005, pp. 289-98.
Breier AR, Paim CS, Steppe M, et al. Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets. J Pharm Pharm Sci. 2005;8(2):289-98.
Breier, A. R., Paim, C. S., Steppe, M., & Schapoval, E. E. (2005). Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets. Journal of Pharmacy & Pharmaceutical Sciences : a Publication of the Canadian Society for Pharmaceutical Sciences, Societe Canadienne Des Sciences Pharmaceutiques, 8(2), 289-98.
Breier AR, et al. Development and Validation of Dissolution Tests for Fexofenadine Hydrochloride Capsules and Coated Tablets. J Pharm Pharm Sci. 2005 Aug 11;8(2):289-98. PubMed PMID: 16124939.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets. AU - Breier,Ana R, AU - Paim,Clésio S, AU - Steppe,Martin, AU - Schapoval,Elfrides E S, Y1 - 2005/08/11/ PY - 2005/8/30/pubmed PY - 2006/4/7/medline PY - 2005/8/30/entrez SP - 289 EP - 98 JF - Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques JO - J Pharm Pharm Sci VL - 8 IS - 2 N2 - PURPOSE: This study describes the development and validation of dissolution tests for fexofenadine hydrochloride capsules and coated tablets using an HPLC method. METHOD: The appropriate conditions were determinate after testing sink conditions, dissolution medium, and agitation intensity. The apparatus, paddle and basket, were applied to tablets and capsules, respectively. Fexofenadine hydrochloride capsules, products A and B, and coated tablets, products A, B and C were evaluated. The best dissolution conditions tested, for the products in each respective pharmaceutical dosage form were applied to evaluate the dissolution profiles. The parameters of difference factor, similar factor, and dissolution efficacy were employed. RESULTS: Optimal conditions to carry out the dissolution tests were 900 ml of 0.01 M hydrochloric acid as dissolution medium, basket at 100 rotation per minute (rpm) stirring speed for capsules and paddle at 75 rpm for tablets. The dissolution profiles for tablets products A, B, and C and for capsules products A and B were not similar. CONCLUSION: The developed and validated dissolution tests satisfactorily describes the time-course of the drug release. The obtained results provided adequate dissolution profiles. The HPLC method was validated to quantify fexofenadine capsules and coated tablets from the dissolution tests. SN - 1482-1826 UR - https://www.unboundmedicine.com/medline/citation/16124939/Development_and_validation_of_dissolution_tests_for_fexofenadine_hydrochloride_capsules_and_coated_tablets_ L2 - http://www.ualberta.ca/~csps/JPPS8(2)/A.Breier/fexofenadine.htm DB - PRIME DP - Unbound Medicine ER -