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Quality by design (QbD) approach to match tablet glossiness
Niyaz Mansuri1, Karishma Patel1, Munjal Mehta1
1Formulation Development, Piramal Pharma Solutions, Ahmedabad, India.
Pharmaceutical Development and Technology
|May 21, 2020
Summary
A quality by design approach successfully developed a polyvinyl alcohol (PVA)-based placebo tablet matching innovator glossiness. Key parameters like solid concentration and drying capacity were identified for optimal tablet surface shine.
Area of Science:
- Pharmaceutical Technology
- Coating Science
- Quality by Design
Background:
- Developing placebo tablets that mimic the appearance of innovator products is crucial for clinical trials.
- Achieving consistent surface glossiness in tablet coatings presents a significant formulation challenge.
Purpose of the Study:
- To develop a polyvinyl alcohol (PVA)-based 'look-alike' placebo tablet with comparable glossiness to an innovator tablet using a Quality by Design (QbD) approach.
- To identify critical coating parameters influencing tablet surface shine.
Main Methods:
- A full factorial design of experiments (DoE) was employed to study critical coating parameters.
- Pilot-scale coating runs were performed using a perforated pan coater.
- Tablet appearance, including surface shine, roughness, and logo bridging, was evaluated by a panel of volunteers.
Main Results:
- Solid concentration in the coating dispersion and drying capacity were identified as key parameters affecting tablet surface shine.
- Human visual evaluation proved more sensitive to subtle appearance differences than Munsell evaluation.
- A look-alike placebo tablet was successfully developed by optimizing solid concentration and drying conditions.
Conclusions:
- The QbD approach enabled the successful development of a PVA-based look-alike placebo tablet with desired glossiness.
- Optimizing coating dispersion solid concentration and drying conditions are critical for achieving tablet surface shine.
- Hydroxypropyl methylcellulose (HPMC)-based coatings resulted in reduced shine compared to PVA-based coatings.
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