Torsemide Fast Dissolving Tablets: Development, Optimization Using Box–Bhenken Design and Response Surface Methodology, In Vitro Characterization, and Pharmacokinetic Assessment View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-08

AUTHORS

Ahmed A. El-Shenawy, Mahmoud M. Ahmed, Heba F. Mansour, Saleh Abd El Rasoul

ABSTRACT

The present study planed to develop new fast dissolving tablets (FDTs) of torsemide. Solid dispersions (SDs) of torsemide and sorbitol (3:1) or polyvinylpyrrolidone (PVP) k25 were prepared. The prepared SDs were evaluated for in-vitro dissolution. Fourier transform infrared spectroscopy and differential scanning calorimetry for SDs revealed no drug/excipient interactions and transformation of torsemide to the amorphous form. Torsemide/sorbitol SD was selected for formulation of torsemide FDTs by direct compression method. Box-Bhenken factorial design was employed to design 15 formulations using croscarmellose sodium and crospovidone at different concentrations. The response surface methodology was used to analyze the effect of changing these concentrations (independent variables) on disintegration time (Y1), percentage friability (Y2), and amount torsemide released at 10 min. The physical mixtures of torsemide and the used excipients were evaluated for angle of repose, Hausner's ratio, and Carr's index. The prepared FDTs tablets were evaluated for wetting and disintegration time, weight variation, drug content, percentage friability, thickness, hardness, and in vitro release. Based on the in-vitro results and factorial design characterization, F10 and F7 were selected for bioavailability studies following administration to Albino New Zealand rabbits. They showed significantly higher C max and (AUC0-12) and shorter T max than those obtained after administration of the corresponding ordinary commercial Torseretic ® tablets. Stability study was conducted for F10 that showed good stability upon storage at 30°C/75% RH and 40°C/75% RH for 3 months. More... »

PAGES

2168-2179

Identifiers

URI

http://scigraph.springernature.com/pub.10.1208/s12249-016-0697-6

DOI

http://dx.doi.org/10.1208/s12249-016-0697-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1001551151

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28050711


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