Abstract
ABSTRACT The present investigation was computational predictability of Polyethylene Glycol (PEG) encapsulated modified release multiple unit pellets system (MUPS) tablet of Metoprolol succinate by quality by design (QbD). Quality target product profile (QTPP) and critical quality attributes (CQAs) of MUPS tablets were defined. Risk assessment was done using Ishikawa diagram and failure mode effect analysis (FMEA) as per ICH Q8 guidelines. Formulation was screened and optimized using Plackett–Burman and Box– Behnken design. Pellets were prepared by wruster coating system-using polymers such as hydroxypropyl methylcellulose (HPMC), Ethyl cellulose (EC) with other excipients. Formulation variables X1: HPMC and X2: EC have affected the drug release (Y1). PEG capsulation ensures the intactness of film after compression. ANOVA results confirm the selected model was statistically significant. This investigation demonstrated the PEG encapsulated HPMC and EC polymer coated with optimised curing time will achieve a single dose of metoprolol succinate applying QbD.
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