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Dissolution parameters for sodium diclofenac-containing hypromellose matrix tablet.
Int J Pharm. 2010 Feb 15; 386(1-2):201-7.IJ

Abstract

Sodium diclofenac (SD) release from dosage forms has been studied under different conditions. However, no dissolution method that is discriminatory enough to reflect slight changes in formulation or manufacturing process, and which could be effectively correlated with the biological properties of the dosage form, has been reported. This study sought to develop three different formulae of SD-containing matrix tablets and to determine the effect of agitation speed in its dissolution profiles. F1, F2 and F3 formulations were developed using hypromellose (10, 20 and 30%, respectively for F1, F2 and F3) and other conventional excipients. Dissolution tests were carried out in phosphate buffer pH 6.8 at 37 degrees C using apparatus II at 50, 75 or 100 rpm. Dissolution efficiency (DE), T(50) and T(90) were determined and plotted as functions of the variables agitation speed and hypromellose concentration. Regarding DE, F2 showed more sensitivity to variations in agitation speed than F1 and F3. Increasing hypromellose concentration reduced DE values, independent of agitation speed. Analysis of T(50) and T(90) suggests that F1 is less sensitive to variations in agitation speed than F2 and F3. Most discriminatory dissolution conditions were observed at 50 rpm. Results suggest that the comparison of dissolution performance of SD matrix tablets should take into account polymer concentration and agitation conditions.

Authors+Show Affiliations

Núcleo de Investigações Químico-Farmacêuticas, Curso de Farmácia, Universidade do Vale do Itajaí, Rua Uruguai, 358, Centro, CEP 88302-202 Itajaí-SC, Brazil. smourao@univali.brNo 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

19941944

Citation

Mourão, Samanta C., et al. "Dissolution Parameters for Sodium Diclofenac-containing Hypromellose Matrix Tablet." International Journal of Pharmaceutics, vol. 386, no. 1-2, 2010, pp. 201-7.
Mourão SC, da Silva C, Bresolin TM, et al. Dissolution parameters for sodium diclofenac-containing hypromellose matrix tablet. Int J Pharm. 2010;386(1-2):201-7.
Mourão, S. C., da Silva, C., Bresolin, T. M., Serra, C. H., & Porta, V. (2010). Dissolution parameters for sodium diclofenac-containing hypromellose matrix tablet. International Journal of Pharmaceutics, 386(1-2), 201-7. https://doi.org/10.1016/j.ijpharm.2009.11.022
Mourão SC, et al. Dissolution Parameters for Sodium Diclofenac-containing Hypromellose Matrix Tablet. Int J Pharm. 2010 Feb 15;386(1-2):201-7. PubMed PMID: 19941944.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dissolution parameters for sodium diclofenac-containing hypromellose matrix tablet. AU - Mourão,Samanta C, AU - da Silva,Cristiane, AU - Bresolin,Tania M B, AU - Serra,Cristina H R, AU - Porta,Valentina, Y1 - 2009/11/24/ PY - 2009/05/29/received PY - 2009/11/12/revised PY - 2009/11/18/accepted PY - 2009/11/28/entrez PY - 2009/11/28/pubmed PY - 2010/4/9/medline SP - 201 EP - 7 JF - International journal of pharmaceutics JO - Int J Pharm VL - 386 IS - 1-2 N2 - Sodium diclofenac (SD) release from dosage forms has been studied under different conditions. However, no dissolution method that is discriminatory enough to reflect slight changes in formulation or manufacturing process, and which could be effectively correlated with the biological properties of the dosage form, has been reported. This study sought to develop three different formulae of SD-containing matrix tablets and to determine the effect of agitation speed in its dissolution profiles. F1, F2 and F3 formulations were developed using hypromellose (10, 20 and 30%, respectively for F1, F2 and F3) and other conventional excipients. Dissolution tests were carried out in phosphate buffer pH 6.8 at 37 degrees C using apparatus II at 50, 75 or 100 rpm. Dissolution efficiency (DE), T(50) and T(90) were determined and plotted as functions of the variables agitation speed and hypromellose concentration. Regarding DE, F2 showed more sensitivity to variations in agitation speed than F1 and F3. Increasing hypromellose concentration reduced DE values, independent of agitation speed. Analysis of T(50) and T(90) suggests that F1 is less sensitive to variations in agitation speed than F2 and F3. Most discriminatory dissolution conditions were observed at 50 rpm. Results suggest that the comparison of dissolution performance of SD matrix tablets should take into account polymer concentration and agitation conditions. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/19941944/Dissolution_parameters_for_sodium_diclofenac_containing_hypromellose_matrix_tablet_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(09)00824-2 DB - PRIME DP - Unbound Medicine ER -