Formulation of semi solid dosage forms for topical application utilizing quality by design (QbD) approach.
Eni Bushi1,2, Ledjan Malaj1, Piera Di Martino3
1Department of Pharmacy, University of Medicine Tirana, Tirana, Albania.
Drug Development and Industrial Pharmacy
|April 26, 2025
Summary
This study introduces a Quality by Design (QbD) framework for developing topical semisolid formulations, moving beyond empirical methods. Implementing this framework enhances the development of stable and effective topical products.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Topical semisolid formulation development traditionally relies on empirical approaches.
- Despite advancements, a systematic framework for topical semisolid design is lacking.
Purpose of the Study:
- To establish a Quality by Design (QbD) framework for the rational design and development of topical semisolid products.
- To transition topical formulation development from empirical methods to a science- and risk-based approach.
Main Methods:
- A comprehensive literature review was performed to identify key factors in topical semisolid formulation development using QbD.
- A QbD framework was constructed based on defining the Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs).
Main Results:
- The QTPP for topical products typically includes dosage form, administration route, and shelf life.
- Key CMAs (API and excipient characteristics) and CPPs (temperature, mixing speed) were identified for their impact on CQAs.
- The framework outlines understanding the influence of CMAs and CPPs on CQAs and establishing a control strategy.
Conclusions:
- A QbD framework provides a structured approach to topical semisolid formulation development.
- Thorough characterization of the API and drug delivery system is crucial for successful formulation.
- This systematic approach minimizes development risks and enhances product stability, acceptability, and tolerability.
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