Abstract
The aim of the study was to optimize compression process variables of Pantoprazole oro-dispersible (Multiunit particulate system) MUPS tablet. Enteric coated Pantoprazole pellets were compressed to oro-dispersible tablet for geriatric and pediatric patients for easy administration. The risk related to compression process variables was identify, assessed and mitigated using Failure Mode and Effect Analysis (FMEA). A full factorial design was applied to develop design space and determine control strategy for compression process, which were developed, have promising chemical and physical results. The compression process variables studied were pre-compression force (X1), main compression force (X2) and turret speed (X3), versus affecting hardness (Y1), disintegration time (Y2), friability (Y3), weight variation (Y4), content uniformity (Y5), drug release in 0.1N HCl (Y6) and assay (Y7) as responses/Critical quality attributes (CQAs). Response surface graphs depicted that X2 had more impact on CQAs than X1. Design space plot revealed that tablet CQAs were within limit when X3 maximum 44 rpm and X2 in the range of 10 to 12.5 kN. Scale up performed on commercial scale compression machine of same make that of lab scale showed reproducible physical and chemical parameters. It could be concluded that a quality Pantoprazole oro-dispersible MUPS tablet was successfully designed using QbD approach to compression process variables.
Highlights
Nowadays, there has been an increasing interest in the development of multiparticulate dosage form in the form of tablets rather than hard gelatin capsules
This study indicated that multiunit particulate system (MUPS) tablets hardness governed by main compression as same case of convectional tablets
In the given study Pantoprazole enteric coated pellets mixed with cushioning agent and taste enhancers to compressed in oro-dispersible MUPS tablet
Summary
There has been an increasing interest in the development of multiparticulate dosage form in the form of tablets rather than hard gelatin capsules. There are some advantages of multiunit particulate system (MUPS) tablets over capsule form like tamper-proof dosage form, better microbiological and physicochemical stability, prepared at low cost & more output (Celik, 1994; Sirisha et al, 2012), reduction of irritation of the gastric mucosa due to drug degradation of simple units (Abdul et al, 2010; Bhad et al, 2010) and divided in to desired dose strengths without formulation changes (Deb et al, 2013). The compression of MUPS tablet is a challenging. Maintain the oro-dispersible properties of tablets like disintegration time less than 30 sec, gritty free mouth feel and pleasant taste were the challenges. The systematic study of compression process parameter were performed based on Quality by Design (QbD) for ideal orodispersible MUPS tablet. Risk management performed using Failure Mode and Effect Analysis (FMEA) tool for compression process
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