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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Optimization of Fast-dissolving Tablets of Ledipasvir-sofosbuvir Inclusion Complexes by Design of Experiments

Uday Kumar Thummala1,2★, Eswar Gupta Maddi3, Prameela Rani Avula4★ Corresponding author

  1. 1Department of Pharmaceutics, Aditya College of Pharmacy, Surampalem, Kakinada, Andhra Pradesh, INDIA.
  2. 2School of Pharmacy, JNT University, Kakinada, Andhra Pradesh, INDIA.
  3. 3Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bengaluru, Karnataka, INDIA.
  4. 4University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, INDIA.

CORRESPONDENCE

Uday Kumar Thummala

Associate Professor, Aditya College of Pharmacy, Surampalem, Kakinada-533001, Andhra Pradesh, INDIA.

udaykumar.apc@gmail.com

Received: 21-02-2022; Revised: 24-06-2022; Accepted: 08-08-2022.

Volume 57, Issue 1 · pp. 33–44 · PUBLISHED 2023 · DOI: 10.5530/001954641530

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ABSTRACT

Background: Fast-dissolving tablets (FDTs) were aimed to be developed for the latest approved combination drugs for Hepatitis-C treatment, Ledipasvir (LDV) and sofosbuvir (SBV) which suffered with poor water solubility. Materials and Methods: Cyclodextrin (CD) complexation was done for the drugs to improve their solubility. The optimized CD complexes were taken for developing FDTs to improve dissolution limited bioavailability of these drugs. FDTs were developed by adopting design of experiments approach using Design Expert software. Type of β-CD, type of disintegrant and concentration of disintegrant were taken as the factors. Disintegration time, time for 90% dissolution of LDV and SBV were taken as the responses. The prepared tablets as per the selected experimental design were evaluated for the responses and also other characteristics like tensile strength, packing fraction, wettability. The results were analyzed by ANOVA and numerical optimization was performed with the desirability of minimizing all the responses. Results: All the selected factors were found to influence disintegration and dissolution times significantly. Dimethyl β-CD, croscarmellose sodium at 8% w/w was obtained as the optimized combination of the factors for the FDTs. The FTDs at this optimized combination of the factors were found to have 79.6 sec of DT, 17.72 and 13.68 min. of time for 90% dissolution of LDV and SBV respectively. Conclusion: These results which were significantly much better than those of the marketed tablets indicated that the FTDs were successfully developed using Design of experiments.

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    Thummala, U. K., Maddi, E. G., & Avula, P. R. (2023). Optimization of Fast-dissolving Tablets of Ledipasvir-sofosbuvir Inclusion Complexes by Design of Experiments. Indian Journal of Pharmaceutical Education and Research, 57(1), 33–44. https://doi.org/10.5530/001954641530