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Indian Journal of Pharmaceutical Education and ResearchNOW IN
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Design, Optimization, and in vitro Evaluation of Orally Disintegrating Tablets Containing Amlodipine Besylate

Sevinç Şahbaz1, Setenay Özer-Önder1,2, Timuçin Uğurlu1★★ Corresponding author

  1. 1Department of Pharmaceutical Technology, Marmara University, İstanbul, TURKEY.
  2. 2Institute of Health Sciences, Marmara University, İstanbul, TURKEY.

CORRESPONDENCE

Timuçin Uğurlu

Prof. Dr. Timuçin Uğurlu Faculty of Pharmacy, Department of Pharmaceutical Technology, Marmara University, Başıbüyük Health Campus, 4/A, Maltepe, İstanbul, TURKEY.

tugurlu@marmara.edu.tr

ORCID: 0000-0002-8874-5941

Received: 14-07-2023; Revised: 27-11-2023; Accepted: 23-08-2024.

Volume 58, Issue 4 · pp. 1205–1214 · PUBLISHED Oct-Dec 2024 · DOI: 10.5530/ijper.58.4.133

View on IJPER original site ↗

ABSTRACT

Background: In this study, it was aimed to prepare orally disintegrating tablet formulations of amlodipine besylate by applying the experimental design. Materials and Methods: A face-centered, central composite 32 full factorial design was applied to evaluate the effects of filler ratio (MAN: MCC; X1) and super disintegrant percentage (SSG; X2) on the critical tablet characteristics such as tensile strength (Y1), disintegration time (Y2) and dissolution rate (5th min) (Y3). Results: The Quadratic model showed good predictability (p<0.0001) on tablet tensile strength and the linear model was found to be suitable for disintegration time and dissolution time profiles (p<0.001 and p>0.05 respectively). In addition to the compendial quality control tests for tablet formulations, a texture analyzer with the tablet disintegration rig fixture was also used for the disintegration test and onset of disintegration (s), end of disintegration (s), disintegration rate (mm/s), duration of swelling (s), swelling distance (mm), residual height (mm) values were obtained. Conclusion: It was determined that F9, with the highest MAN: MCC (75:25) and SSG (10%) ratios, met all pharmacopeia standards and gave the best disintegration time results (18.55±1.28 s), which is a very crucial factor for orally disintegrating tablet characterization, compared to other formulations.

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    Şahbaz, S., Özer-Önder, S., & Uğurlu, T. (2024). Design, Optimization, and in vitro Evaluation of Orally Disintegrating Tablets Containing Amlodipine Besylate. Indian Journal of Pharmaceutical Education and Research, 58(4), 1205–1214. https://doi.org/10.5530/ijper.58.4.133