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Development and validation of dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data.
J Pharm Biomed Anal. 2008 Jul 15; 47(3):547-52.JP

Abstract

The objective of the present study was to develop and validate a dissolution test for lopinavir soft gel capsules (Kaletra), using a simulated absorption profile based on in vivo data. Different conditions such as surfactant concentration, apparatus and rotation speed were evaluated. In vivo release profiles were obtained from the literature. The fraction (and percentage) of dose absorbed (FA) was calculated by using Wagner-Nelson method. The best in vitro dissolution profile was obtained using Apparatus 2 (paddle) at 25 rpm, 1000 ml of medium with 2.3% of sodium lauryl sulfate and pH 6.0. Under these conditions a level-A in vitro-in vivo correlation (IVIVC) was obtained (r = 0.997). 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. Both the HPLC method and the in vitro dissolution method were validated and could be used to evaluate the release profile of lopinavir soft gel capsules.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

18403160

Citation

Donato, Eliane Maria, et al. "Development and Validation of Dissolution Test for Lopinavir, a Poorly Water-soluble Drug, in Soft Gel Capsules, Based On in Vivo Data." Journal of Pharmaceutical and Biomedical Analysis, vol. 47, no. 3, 2008, pp. 547-52.
Donato EM, Martins LA, Fröehlich PE, et al. Development and validation of dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data. J Pharm Biomed Anal. 2008;47(3):547-52.
Donato, E. M., Martins, L. A., Fröehlich, P. E., & Bergold, A. M. (2008). Development and validation of dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data. Journal of Pharmaceutical and Biomedical Analysis, 47(3), 547-52. https://doi.org/10.1016/j.jpba.2008.02.014
Donato EM, et al. Development and Validation of Dissolution Test for Lopinavir, a Poorly Water-soluble Drug, in Soft Gel Capsules, Based On in Vivo Data. J Pharm Biomed Anal. 2008 Jul 15;47(3):547-52. PubMed PMID: 18403160.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data. AU - Donato,Eliane Maria, AU - Martins,Laura Alegria, AU - Fröehlich,Pedro Eduardo, AU - Bergold,Ana Maria, Y1 - 2008/02/26/ PY - 2007/10/26/received PY - 2008/02/12/revised PY - 2008/02/18/accepted PY - 2008/4/12/pubmed PY - 2008/9/10/medline PY - 2008/4/12/entrez SP - 547 EP - 52 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 47 IS - 3 N2 - The objective of the present study was to develop and validate a dissolution test for lopinavir soft gel capsules (Kaletra), using a simulated absorption profile based on in vivo data. Different conditions such as surfactant concentration, apparatus and rotation speed were evaluated. In vivo release profiles were obtained from the literature. The fraction (and percentage) of dose absorbed (FA) was calculated by using Wagner-Nelson method. The best in vitro dissolution profile was obtained using Apparatus 2 (paddle) at 25 rpm, 1000 ml of medium with 2.3% of sodium lauryl sulfate and pH 6.0. Under these conditions a level-A in vitro-in vivo correlation (IVIVC) was obtained (r = 0.997). 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. Both the HPLC method and the in vitro dissolution method were validated and could be used to evaluate the release profile of lopinavir soft gel capsules. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/18403160/Development_and_validation_of_dissolution_test_for_lopinavir_a_poorly_water_soluble_drug_in_soft_gel_capsules_based_on_in_vivo_data_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(08)00112-X DB - PRIME DP - Unbound Medicine ER -