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QbD-based optimisation and level A IVIVC of gliclazide sustained-release matrix tablets using Pectin and HPMC
Santhosh Kumar Chinnaiyan1, Anjana Thekke Veedu1, Arya Rathnakaran1
1Department of Pharmaceutics, Rajiv Gandhi Institute of Pharmaceutical Sciences and Research (RIPSAR), Trikaripur, 671310, Kasargod, Kerala, India.
This study developed optimized sustained-release gliclazide matrix tablets using a Quality by Design approach. The new formulation improves blood glucose control and patient compliance for type 2 diabetes mellitus management.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Diabetes Mellitus Management
Background:
- Conventional oral gliclazide therapy causes fluctuating blood glucose levels and poor patient compliance.
- Sustained-release matrix tablets (SRMT) offer improved plasma concentration stability, reduced hypoglycemia, and better patient adherence.
Purpose of the Study:
- To optimize gliclazide sustained-release matrix tablets (GSRMT) using a Quality by Design (QbD) approach.
- To achieve predictable in vitro-in vivo performance for enhanced type 2 diabetes mellitus management.
Main Methods:
- A QbD approach with Pectin and HPMC as formulation variables.
- Central composite design (CCD) to evaluate tablet hardness and drug release (CQAs).
- Response surface methodology (RSM) and convolution for in vivo performance prediction and validation.
Main Results:
- Optimized formulation (OPF) showed desired hardness, controlled burst release, and extended drug release (93.22% at 12h).
- Exhibits good excipient compatibility and sustained release via erosion and diffusion.
- In vivo pharmacokinetic predictions closely matched marketed formulations with <10% prediction error.
Conclusions:
- QbD approach successfully developed a robust GSRMT with predictable in vitro-in vivo performance.
- Offers a cost-effective and clinically relevant alternative to conventional gliclazide formulations.
- Enhances therapeutic outcomes for type 2 diabetes mellitus patients.
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