Amalgamation of QbD and Alcohol Induced Dose Dumping Studies on Diltiazem Hydrochloride Modified Release Tablets
PH Viramgama1, CD Modi2★, DJ Patel1, AB Chaudhary3★ Corresponding author
- 1Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
- 2Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, INDIA.
- 3Department of Pharmaceutical Chemistry, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
CORRESPONDENCE
CD Modi
Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, INDIA.
Received: 17-06-2022; Revised: 09-07-2022; Accepted: 12-08-2022.
Volume 12, Issue 4 · pp. 462–469 · PUBLISHED · DOI: 10.5530/ijpi.2022.4.79
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.
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Viramgama, P., Modi, C., Patel, D., & Chaudhary, A. (). Amalgamation of QbD and Alcohol Induced Dose Dumping Studies on Diltiazem Hydrochloride Modified Release Tablets. International Journal of Pharmaceutical Investigation, 12(4), 462–469. https://doi.org/10.5530/ijpi.2022.4.79