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Comparative static curing versus dynamic curing on tablet coating structures.
Claire Gendre1, Muriel Genty, Barbara Fayard
1Univ Paris-Sud, EA 4041, Groupe de Chimie Analytique de Paris-Sud, IFR 141-IPSIT, Faculty of Pharmacy, 92296 Châtenay-Malabry, France. claire.gendre@gmail.com
International Journal of Pharmaceutics
|June 25, 2013
Summary
Dynamic curing of film coatings in pharmaceutical manufacturing offers an efficient alternative to static oven drying. This study confirms dynamic curing yields comparable film properties and drug release to traditional methods, optimizing production.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Polymer Chemistry
Background:
- Film coating stabilization of solid dosage forms typically requires post-coating drying under static conditions.
- Traditional curing methods involve transferring coated products to ovens, increasing processing time and complexity.
- Performing curing directly within coating equipment offers significant industrial advantages.
Purpose of the Study:
- To investigate the influence of curing conditions on the structural properties of pharmaceutical film coatings.
- To compare the outcomes of dynamic curing within coating equipment versus traditional static curing.
- To elucidate the film-coating structure and potential aging mechanisms after curing.
Main Methods:
- Utilized advanced characterization techniques: X-ray micro-computed tomography, vibrational spectroscopies (NIR, Raman), and X-ray microdiffraction.
- Determined the dynamic curing end-point.
- Analyzed coating layers for drug release, porosity, water content, polymer chain rearrangement, and crystalline distribution.
Main Results:
- Dynamic curing for 4 hours at 60°C achieved comparable film coating properties (drug release, porosity, water content, structure) to static curing for 24 hours under identical conditions.
- X-ray microdiffraction revealed distinct crystalline compositions in coatings based on storage time, suggesting an aging mechanism.
- Observed migration of cetyl alcohol and sodium lauryl sulfate within the coating layer during storage.
Conclusions:
- Curing operations can be effectively performed under dynamic conditions within coating equipment.
- Dynamic curing provides a time-efficient and industrially attractive alternative to static curing for film-coated solid dosage forms.
- Further understanding of film-coating structures and post-curing aging phenomena was achieved.
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