Shehla Khan*, Sadhana Shahi, Santosh Borde, Saliya Shaikh
Department of Pharmaceutics, Government College of Pharmacy, Aurangabad - 431005, Maharashtra, India
*Address for Corresponding Author
Department of Pharmaceutics,
Government College of Pharmacy, Aurangabad, (MH), India- 431005
Objective: The aim of the proposed work was to apply quality by design (QbD) in the formulation and evaluation of methylphenidate HCl fast dissolving tablet using superdisintegrants for rapid dissolution of drug and absorption, which may produce rapid onset of action in the management of Attention deficit hyperactivity disorder (ADHD) with better patient compliance. Method: QbD assures pharmaceutical quality by understanding and controlling formulation and manufacturing variables ensuing as an advanced approach towards drug development. The study discusses elements of the QbD for development of methylphenidate HCl fast dissolving tablet via identifying quality target product profile, critical quality attributes, defining risk assessments, establishing design space, control strategy and product life cycle management &continuous improvement. FDT’s were prepared by direct compression method using Avicel PH 102 and Indion 234 as superdisintegrants to enhance its disintegration. A 32 full factorial design was applied to inspect the effect of two independent variables i.e., concentration of Avicel PH 102 and concentration of Indion 234 on disintegration time (DT) and percentage drug release as dependent parameter. The compressed tablets were evaluated for hardness (kg/cm2), thickness (mm), friability (%), weight variation (mg), drug content (%), wetting time (s), disintegration time (s), and in-vitro drug release (%). Furthermore, analysis of variance (ANOVA), multiple regression analysis, 3D response graph and Overlay plot were successfully implemented to understand significant effects of both the variables on the selected responses. Result: All the FDT’s of all the formulation had drug content, weight variation, hardness and friability within USP limits. The optimized formulation showed percentage drug content of 98.88± 0.25%, wetting time of 23 ± 0.61 s, disintegration time of 14± 0.92 s and In-vitro drug release was found to be 98.14 ± 0.65 %. Conclusion: Thus, it can be conclude that formulation of Methylphenidate HCl FDT with increased dissolution rate and decreased disintegration time that dissolves rapidly in the mouth were prepared via implementation of QbD that could increase efficiencies and provide regulatory support.
Keywords: Methylphenidate HCl, quality by design (QbD), fast dissolving tablet (FDT), 32 factorial design, Attention deficit hyperactivity disorder (ADHD)