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

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Article · Volume 12, Issue 4 · pp. 462–469

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

PH Viramgama1, CD Modi2, DJ Patel1, AB Chaudhary3

  1. 1Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
  2. 2Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, INDIA.
  3. 3Department of Pharmaceutical Chemistry, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.

Abstract

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

Keywords: Diltiazem Hydrochloride; Extended release; Hydroalcoholic dissolution media; Dose dumping; Factorial Design

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