An optimisation of critical quality attributes for acyclovir dispersible tablets: a quality by design approach. (26th February 2021)

• Record Type: Journal Article
• Authors: Nandedkar, Janhavi; Masane, Manish; Mali, Ashwin J.
• Is Part Of: International journal of experimental design and process optimisation. Volume 6:Number 3(2020)
• Page Start: 253
• Page End: 274
• Publication Date: 2021-02-26
• Subjects: acyclovir -- quality by design -- QbD -- design of experiment -- DoE -- superdisintegrants -- 23 factorial design; Experimental design -- Periodicals; Process control -- Statistical methods -- Periodicals; 620.0072
• Languages: English
• ISSNs: 2040-2252

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 ( X 1 ), sodium starch glycolate ( X 2 ) and magnesium stearate ( X 3 ) as a critical quality attributes (CQA's). The design of experiment (DoE) comprising two levels, three factors (2 3 ) is applied to optimise the combined effect of CQA's on the dependent variables such as disintegration time ( Y 1 ), hardness ( Y 2 ) and drug release ( Y 3, Y 4 and Y 5 ). The centre point batch F5 has depicted the excellent properties comprising 1.20% of X 1, 4.89% of X 2 and 1% of X 3 with better Y 1 (48 ± 1.62 sec), Y 2 (138 ± 1.7 N) and Y 4 (101 ± 1.32%) as compared to the commercial formulation Zovirax©. The key effects of CQA's are observed on the Y 1 and Y 4 (p < 0.05) as compared to the Y 2 of DTs.