Formulation & Evaluation of Fast Dissolving Tablets of Amlodipine Besylate by Using Co- Processed Superdisintegrants.
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Date
2013-10
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Abstract
Aims: To formulate fast dissolving tablets of amlodipine besylate using co-processed
superdisintigrant and evaluate the properties of fast dissolving tablets.
Study Design: Formulation, evaluation of fast dissolving tablets of amlodipine besylate.
Place and Duration of Study: Department of Quality Assurance S. N. D. College of
Pharmacy Babhulgoan Yeola Dist Nashik 423401, between July 2012 to February 2013.
Methodology: In the present study, novel co-processed superdisintegrants were
developed by solvent evaporation method using crospovidone and sodium starch
glycolate in different ratios (1:1, 1:2 1:3 2:1, 3:1) in the fast dissolving tablet formulations.
Drug and the developed excipients were characterized for compatibility studies with FTIR
and DSC. The co-processed superdisintigrant mixture was evaluated for angle of repose,
Carr’s index and Hausner’s ratio in comparison with physical mixture of superdisintegrants. Fast dissolving tablets of Amlodipine Besylate were prepared using
co-processed superdisintegrants and evaluated for pre-compression and postcompression
parameters. Effect of co-processed superdisintegrants (crospovidone and
sodium starch glycolate) on wetting time, disintegrating time, drug content, in-vitro
release, and stability parameters have been studied.
Results: The angle of repose of the developed excipients was found to be < 300
Compressibility (%) index in the range of 13.14 to 14.63 % and Hausner’s ratio in the
range of 1.15-1.19. The prepared tablets were characterized by FTIR and DSC Studies
there was no change in the result. Based on in-vitro dispersion time (approximately 40
sec), promising formulation CP5 was tested for in-vitro drug release pattern in phosphate
buffer pH 6.8.
Conclusion: Among the designed formulations, the formulation (CP5) containing coprocessed
superdisintegrant (3:1 mixture of crospovidone and sodium starch glycolate)
emerged as the overall best formulation based on drug release characteristics in
phosphate buffer pH 6.8. From this study, it can be concluded that dissolution rate of
amlodipine besylate could be enhanced by tablets containing co-processed
superdisintegrant.
Description
Keywords
Co-processed mixture, sodium starch glycolate, crospovidone, amlodipin besylate, FDT
Citation
Naikwade Jeevan T, Patil Vikas V, Katkade Mayur H, Thorat Vaibhav D, Ansari Tahir, Vaidya Chetan R. Formulation & Evaluation of Fast Dissolving Tablets of Amlodipine Besylate by Using Co- Processed Superdisintegrants. British Journal of Pharmaceutical Research. 2013 Oct; 3(4): 865-879.