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Quality by Design Empowered Development and Optimisation of Time-Controlled Pulsatile Release Platform Formulation
Riddhish Patadia1, Chintan Vora1, Karan Mittal1
1Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, 390001, Gujarat, India.
AAPS Pharmscitech
|July 28, 2016
Summary
This study developed a novel time-controlled pulsatile release (PR) platform for managing early morning symptoms. The optimized formulation demonstrated a robust lag time and burst release, adaptable for various drugs and dissolution conditions.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Early morning symptom exacerbations pose clinical challenges.
- Time-controlled pulsatile release (PR) formulations offer a strategy for targeted drug delivery.
Purpose of the Study:
- To develop a versatile pulsatile release (PR) platform formulation for managing early morning chronological attacks.
- To establish a robust formulation adaptable to diverse drug molecules and varying dissolution conditions.
Main Methods:
- Utilized prednisone as a model drug for developing compression-coated tablets (CCTs) via direct compression.
- Employed ethylcellulose (EC)-hydroxypropyl methylcellulose (HPMC) for compression coating.
- Applied central composite design (DoE) for optimization and failure mode and effect analysis (FMEA) for risk assessment.
- Incorporated five different drugs into the optimized formulation, addressing solubility and flow issues with solid dispersion and API granulation.
Main Results:
- Optimized CCTs exhibited a 4-6 hour lag time followed by a burst release profile.
- The formulation demonstrated consistent performance across various dissolution conditions, including multi-media, altered apparatus/agitation, and biorelevant media.
- Successfully adapted the formulation for methylprednisolone, diclofenac sodium, diltiazem hydrochloride, nifedipine, and lornoxicam, maintaining the desired pulsatile release characteristics.
Conclusions:
- The developed PR platform is a robust and versatile system for delivering diverse drug molecules with controlled pulsatile release.
- This formulation strategy effectively manages early morning symptom attacks and shows promise for various therapeutic applications.
- The platform's adaptability to different drugs and dissolution conditions highlights its potential for broad pharmaceutical development.
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