All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Abstract

Scalable Design and Development of Modified Release Hydrochlorothiazide Formulation Employing Quality by Design Approach

Author(s): V. D. Singhai, S. Sharma, S. Paliwal, R. Tekade and R. Maheshwari*
Department of Pharmacy, Banasthali Vidyapith, Banasthali 304022, Rajasthan, 1National Institute of Pharmaceutical Education and Research, Ahmedabad 380054, Gujarat, 2School of Pharmacy and Technology Management, Shri Vile Parle Kelavani Mandals Narsee Monjee Institute of Management Studies (SVKM’S NMIMS), Jadcherla, Hyderabad, Telangana 509301, India

Correspondence Address:
R. Maheshwari, School of Pharmacy and Technology Management, Shri Vile Parle Kelavani Mandals Narsee Monjee Institute of Management Studies (SVKM’S NMIMS), Jadcherla, Hyderabad, Telangana 509301, India, E-mail: [email protected]


Myocardial infarction, generally known as ‘heart attack’ occurs predominantly during the early morning hours and a cause of millions of death worldwide. Hydrochlorothiazide is the recommended drug for the prevention of heart disease, but the commercial market lacks its long action (>4 h) formulation. The endeavor of the present research was to develop a quality product profile of hydrochlorothiazide modified release tablets (~14 h release) by applying computational quality by design approach. Three independent factors were identified by qualitative and quantitative risk assessment. Selected dependent variables were cumulative percent of dissolved hydrochlorothiazide in 2, 5, 8 and 12 h. Graphical tools like half normal, normal and Pareto charts were used to manage model selection. The graphical relationship among the critical, independent variables was represented using contour plot and three-dimensional surface plot. Design space was identified by plotting overlay plot using three factors, two-level full factorial design. Outstanding correlation was observed between predicted and actual values. Similarity factor (F2) of reproducible trials was 78 and 79, and content uniformity was 100.9 % and 100.4 %. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Quality by design approach, along with quality risk management tool furnished an efficient and effective paradigm to structure quality modified release tablets of hydrochlorothiazide.

Full-Text | PDF

 
 
Google scholar citation report
Citations : 53647

Indian Journal of Pharmaceutical Sciences received 53647 citations as per google scholar report