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

  • C D Modi Department of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, INDIA.
  • D J Patel Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
  • A B Chaudhary Department of Pharmaceutical Chemistry, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
  • P H Viramgama Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat Technological University, Ahmedabad, Gujarat, INDIA.
Keywords: Diltiazem Hydrochloride, Extended release, Hydroalcoholic dissolution media, Dose dumping, Factorial Design

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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Published
2022-08-12
How to Cite
1.
Modi C, Patel D, Chaudhary A, Viramgama P. Amalgamation of QbD and Alcohol Induced Dose Dumping Studies on Diltiazem Hydrochloride Modified Release Tablets. ijpi [Internet]. 12Aug.2022 [cited 6Dec.2022];12(4):462-9. Available from: https://jpionline.org/index.php/ijpi/article/view/1591