Title: An optimisation of critical quality attributes for acyclovir dispersible tablets: a quality by design approach

Authors: Janhavi Nandedkar; Manish Masane; Ashwin J. Mali

Addresses: Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, India ' Global Technical Services, Wockhardt Research Center, D4, Chikalthana, Aurangabad 431006, Maharashtra, India ' Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune 411038, Maharashtra, India

Abstract: The objective of the present study is the development of dispersible tablets (DTs) of an acyclovir (ACV) by quality by design (QbD) approach using maize starch (X1), sodium starch glycolate (X2) and magnesium stearate (X3) as a critical quality attributes (CQA's). The design of experiment (DoE) comprising two levels, three factors (23) is applied to optimise the combined effect of CQA's on the dependent variables such as disintegration time (Y1), hardness (Y2) and drug release (Y3, Y4 and Y5). The centre point batch F5 has depicted the excellent properties comprising 1.20% of X1, 4.89% of X2 and 1% of X3 with better Y1 (48 ± 1.62 sec), Y2 (138 ± 1.7 N) and Y4 (101 ± 1.32%) as compared to the commercial formulation Zovirax©. The key effects of CQA's are observed on the Y1 and Y4 (p < 0.05) as compared to the Y2 of DTs.

Keywords: acyclovir; quality by design; QbD; design of experiment; DoE; superdisintegrants; 23 factorial design.

DOI: 10.1504/IJEDPO.2020.113560

International Journal of Experimental Design and Process Optimisation, 2020 Vol.6 No.3, pp.253 - 274

Received: 16 Nov 2019
Accepted: 13 Apr 2020

Published online: 26 Feb 2021 *

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