Optimization of thermoreversible poloxamer gel system using QbD principle
Eunmi Ban1, Dong-Jin Jang2, Su-Jin Kim1
1a College of Pharmacy , CHA University , Seongnam , Korea.
Pharmaceutical Development and Technology
|August 3, 2016
Summary
Quality by Design (QbD) and Design of Experiments (DoE) optimized thermoreversible poloxamer gels for improved gelation temperature and emodin solubility, establishing a manufacturing control strategy.
Area of Science:
- Pharmaceutical Sciences
- Formulation Development
- Drug Delivery Systems
Background:
- Optimizing thermoreversible gel formulations is crucial for drug delivery.
- Poloxamers (P407, P188) and polyethylene glycol 400 are key components.
- Emodin, a poorly water-soluble drug, presents formulation challenges.
Purpose of the Study:
- To optimize thermoreversible poloxamer gel formulations using Quality by Design (QbD).
- To enhance gelation temperature and solubilizing capacity for emodin.
- To establish a design space and manufacturing control strategy.
Main Methods:
- Applied Design of Experiments (DoE) with an extreme vertices mixture design.
- Investigated weight percentages of poloxamer 407 (X1), poloxamer 188 (X2), and polyethylene glycol 400 (X3).
- Measured gelation temperature (Y1) and emodin solubility (Y2) for 15 formulations.
Main Results:
- Gelation temperature and emodin solubility were adequately described by cubic and quadratic models, respectively.
- High linearity observed between theoretical and experimental responses (R²=0.9943 for gelation temp., R²=0.9629 for solubility).
- Established a design space with high prediction accuracy (104.5% for gelation temp., 96.6% for solubility).
Conclusions:
- Successful application of DoE for predicting thermoreversible poloxamer gel properties.
- The developed models enable precise control over gelation temperature and drug solubility.
- The study provides a robust framework for manufacturing control strategies in gel formulation.
