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: 11 Mar 2021 *

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