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Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data.
J Pharm Biomed Anal. 2011 Feb 20; 54(3):439-44.JP

Abstract

The aim of this work is to develop and validate a dissolution test for fosamprenavir tablets (Telzir(®)) based on in vivo data. The appropriate conditions were determined after testing sink conditions in dissolution medium, rotation speed and stability of the drug. In vivo release profiles were obtained from the literature. The fraction (and percentage) of dose absorbed (FA) was calculated by deconvolution, using the Wagner-Nelson method. For this formulation, the best dissolution conditions were achieved using a USP apparatus 1 900 ml of medium containing HCl 0.01 M at a rotation speed of 75 rpm. Under these conditions a significant linear relationship between fraction of drug absorbed versus dissolved was obtained (R(2)=0.984) and a level-A IVIVC was established. The in vitro dissolution samples were analyzed using a HPLC method and the validation was performed according to USP protocol. The method showed accuracy, precision, linearity and specificity within the acceptable range. The discriminatory power of the dissolution method was challenged. The kinetics of dissolution was determined using model-dependent methods. The dissolution profiles were best described by the Hixson-Crowell model. The dissolution test was validated and could be applied to evaluate the dissolution profile of fosamprenavir tablets.

Authors+Show Affiliations

Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Av. Ipiranga, 2752, Porto Alegre, RS 90610-000, Brazil.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

20943342

Citation

Rossi, Rochele C., et al. "Development and Validation of Discriminating Method of Dissolution for Fosamprenavir Tablets Based On in Vivo Data." Journal of Pharmaceutical and Biomedical Analysis, vol. 54, no. 3, 2011, pp. 439-44.
Rossi RC, Dias CL, Bajerski L, et al. Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data. J Pharm Biomed Anal. 2011;54(3):439-44.
Rossi, R. C., Dias, C. L., Bajerski, L., Bergold, A. M., & Fröehlich, P. E. (2011). Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data. Journal of Pharmaceutical and Biomedical Analysis, 54(3), 439-44. https://doi.org/10.1016/j.jpba.2010.09.004
Rossi RC, et al. Development and Validation of Discriminating Method of Dissolution for Fosamprenavir Tablets Based On in Vivo Data. J Pharm Biomed Anal. 2011 Feb 20;54(3):439-44. PubMed PMID: 20943342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data. AU - Rossi,Rochele C, AU - Dias,Carolina L, AU - Bajerski,Lisiane, AU - Bergold,Ana Maria, AU - Fröehlich,Pedro E, Y1 - 2010/09/15/ PY - 2010/06/10/received PY - 2010/08/31/revised PY - 2010/09/07/accepted PY - 2010/10/15/entrez PY - 2010/10/15/pubmed PY - 2011/5/21/medline SP - 439 EP - 44 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 54 IS - 3 N2 - The aim of this work is to develop and validate a dissolution test for fosamprenavir tablets (Telzir(®)) based on in vivo data. The appropriate conditions were determined after testing sink conditions in dissolution medium, rotation speed and stability of the drug. In vivo release profiles were obtained from the literature. The fraction (and percentage) of dose absorbed (FA) was calculated by deconvolution, using the Wagner-Nelson method. For this formulation, the best dissolution conditions were achieved using a USP apparatus 1 900 ml of medium containing HCl 0.01 M at a rotation speed of 75 rpm. Under these conditions a significant linear relationship between fraction of drug absorbed versus dissolved was obtained (R(2)=0.984) and a level-A IVIVC was established. The in vitro dissolution samples were analyzed using a HPLC method and the validation was performed according to USP protocol. The method showed accuracy, precision, linearity and specificity within the acceptable range. The discriminatory power of the dissolution method was challenged. The kinetics of dissolution was determined using model-dependent methods. The dissolution profiles were best described by the Hixson-Crowell model. The dissolution test was validated and could be applied to evaluate the dissolution profile of fosamprenavir tablets. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/20943342/Development_and_validation_of_discriminating_method_of_dissolution_for_fosamprenavir_tablets_based_on_in_vivo_data_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(10)00516-9 DB - PRIME DP - Unbound Medicine ER -