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Optimization of empagliflozin immediate release tablets (10 mg) using central composite rotatable design with
Anas M Hanif1, Rabia Bushra2, Wajiha Iffat2
1Department of Pharmaceutics, Institute of Pharmaceutical Sciences, Jinnah Sindh Medical University, Karachi, Pakistan.
This study optimized 10mg empagliflozin immediate-release tablets using direct compression. The developed formulations demonstrated acceptable tablet attributes and stability, suitable for type 2 diabetes management.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Empagliflozin is a sodium-glucose co-transporter II inhibitor used for type 2 diabetes.
- Effective oral dosage forms are crucial for patient adherence and therapeutic outcomes.
Purpose of the Study:
- To design, formulate, and optimize 10mg empagliflozin immediate-release tablets.
- To evaluate the impact of excipient variations on tablet properties and drug release.
Main Methods:
- Direct compression technique was employed for tablet preparation.
- Central composite rotatable design (CCRD) and response surface methodology (RSM) were used for optimization.
- Physico-chemical properties, in vitro drug release, and stability were assessed.
Main Results:
- Four formulations (EF2, EF7, EF8, EF9) showed acceptable tablet attributes.
- Drug release followed Weibull kinetics with high regression coefficients (0.983-0.992).
- Optimized tablets exhibited a projected shelf life of 22-25 months under accelerated conditions.
Conclusions:
- Direct compression is an effective method for developing empagliflozin immediate-release tablets.
- The optimized formulations meet quality standards for pharmaceutical use.
- The study provides a robust approach for developing similar oral dosage forms.
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