Amalgamation of QbD and Alcohol Induced Dose Dumping Studies on Diltiazem Hydrochloride Modified Release Tablets

Background: Alcohol induced dose dumping is a noteworthy question in designing of modified release dosage forms and it led the marketed products withdrawal by regulatory agencies. Diltiazem HCl highly watersoluble drug may undergo faster dissolution presence alcohol. The purpose present study was to develop extended-release tablets direct compression method having robustness hydro-alcoholic media. Materials Methods: Using QbD approach, lubricants polymer as CMAs CQAs were identified further optimization done employing 32 factorial design. evaluated for hardness, friability, weight variation performed 40% Alcoholic Phosphate buffer pH 5.8. Results: scientific finding reveals that concentration HPMC K-100M DC (12%) xanthan gums are capable providing extended till end 12 hr 5.8 phosphate well Conclusion: These results showed robust in-vitro profile when exposed media hr. Formulation subjected accelerated condition stability testing found satisfactory.