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Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data.
Int J Pharm. 2007 Jun 29; 338(1-2):119-24.IJ

Abstract

The purpose of the study was to develop and validate a dissolution procedure for ritonavir soft gelatin capsules (Norvir) based on in vivo data. Several conditions such as medium composition, pH, surfactant concentration and rotation speed were evaluated. The method was carried out using the same batch of Norvir used in a bioequivalence study and the in vivo data were used to select the best dissolution test conditions based on in vitro-in vivo correlation (IVIVC). The dissolution test was validated using a high-performance liquid chromatographic method (HPLC). For this formulation, the best dissolution conditions were achieved using paddle, 900ml of medium containing water with 0.7% (w/v) of sodium lauryl sulfate at a rotation speed of 25rpm. Under these conditions a significant linear relationship between fraction of ritonavir absorbed and dissolved was obtained (R(2)=0.993) and a level A IVIVC was established. In the HPLC method a relative standard deviation for intra-day precision was <1.6% and for inter-day precision was <1.4%. Accuracy was from 98.5% to 101.6% over the concentration range required for the dissolution test (4.0-124.0microg/ml). Both the HPLC method and the dissolution test are validated and could be used to evaluate the dissolution profile of ritonavir soft gelatin 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 availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17343999

Citation

Rossi, Rochele C., et al. "Development and Validation of Dissolution Test for Ritonavir Soft Gelatin Capsules Based On in Vivo Data." International Journal of Pharmaceutics, vol. 338, no. 1-2, 2007, pp. 119-24.
Rossi RC, Dias CL, Donato EM, et al. Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data. Int J Pharm. 2007;338(1-2):119-24.
Rossi, R. C., Dias, C. L., Donato, E. M., Martins, L. A., Bergold, A. M., & Fröehlich, P. E. (2007). Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data. International Journal of Pharmaceutics, 338(1-2), 119-24.
Rossi RC, et al. Development and Validation of Dissolution Test for Ritonavir Soft Gelatin Capsules Based On in Vivo Data. Int J Pharm. 2007 Jun 29;338(1-2):119-24. PubMed PMID: 17343999.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of dissolution test for ritonavir soft gelatin capsules based on in vivo data. AU - Rossi,Rochele C, AU - Dias,Carolina L, AU - Donato,Eliane M, AU - Martins,Laura A, AU - Bergold,Ana M, AU - Fröehlich,Pedro E, Y1 - 2007/01/31/ PY - 2006/10/18/received PY - 2007/01/24/revised PY - 2007/01/24/accepted PY - 2007/3/9/pubmed PY - 2007/7/20/medline PY - 2007/3/9/entrez SP - 119 EP - 24 JF - International journal of pharmaceutics JO - Int J Pharm VL - 338 IS - 1-2 N2 - The purpose of the study was to develop and validate a dissolution procedure for ritonavir soft gelatin capsules (Norvir) based on in vivo data. Several conditions such as medium composition, pH, surfactant concentration and rotation speed were evaluated. The method was carried out using the same batch of Norvir used in a bioequivalence study and the in vivo data were used to select the best dissolution test conditions based on in vitro-in vivo correlation (IVIVC). The dissolution test was validated using a high-performance liquid chromatographic method (HPLC). For this formulation, the best dissolution conditions were achieved using paddle, 900ml of medium containing water with 0.7% (w/v) of sodium lauryl sulfate at a rotation speed of 25rpm. Under these conditions a significant linear relationship between fraction of ritonavir absorbed and dissolved was obtained (R(2)=0.993) and a level A IVIVC was established. In the HPLC method a relative standard deviation for intra-day precision was <1.6% and for inter-day precision was <1.4%. Accuracy was from 98.5% to 101.6% over the concentration range required for the dissolution test (4.0-124.0microg/ml). Both the HPLC method and the dissolution test are validated and could be used to evaluate the dissolution profile of ritonavir soft gelatin capsules. SN - 0378-5173 UR - https://www.unboundmedicine.com/medline/citation/17343999/Development_and_validation_of_dissolution_test_for_ritonavir_soft_gelatin_capsules_based_on_in_vivo_data_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(07)00089-0 DB - PRIME DP - Unbound Medicine ER -