Novel Coating Uniformity Models for Tablet Pan Coaters
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Research Article Novel Coating Uniformity Models for Tablet Pan Coaters Michael Choi,1,5 Stuart C. Porter,2 Betsy Macht,3 and Axel Meisen4
Received 10 September 2020; accepted 19 October 2020 Abstract. Novel mathematical models were developed to predict inter-tablet coating uniformity in terms of coefficients of variation (CV) and acceptance values (AV) for cylindrical tablet pan coaters, operating in batch and continuous modes. The models, based on binomial coating spray and tablet movement distribution functions and on bed geometry, yielded equations and results that are in good agreement with previously reported experimental data, most empirical expressions, and more computationally intensive models. The new model equations are readily useable for process analysis, optimization, scale-up, and manufacturing design and control. KEY WORDS: coating uniformity; acceptance value; scale-up; manufacturing control strategy; continuous manufacturing.
INTRODUCTION Pharmaceutical tablets are typically coated to improve appearance, strength, and taste. In special cases, coating is used to modify the release of an active pharmaceutical ingredient (API) from the tablet core, or to provide an immediate dose of the same or another API onto the surface of the tablet. Regardless of whether the coating is cosmetic or functional, even distribution of coating mass (“coating uniformity”) is a
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PCTS, Inc., PCTS, Inc., 470 Boot Rd. #343, Downingtown, Pennsylvania 19335, USA. 2 PPT Pharm Technologies, Hatfield, Pennsylvania, USA. 3 Walden University, Minneapolis, Minnesota, USA. 4 The University of British Columbia, Vancouver, British Columbia, Canada. 5 To whom correspondence should be addressed. (e–mail: [email protected]) Symbols Abed, cross-sectional bed area; AV, acceptance value
(USP/EP/JP); c, average coating on tablets after the coating process; ci, coating received per pass through the spray zone; ci , average coating on tablets per cycle; c1 , average coating from one continuous bed; CV, coefficient of variation; CVB, coefficient of variation for batch coating; CVC, coefficient of variation for continuous coating; dp, tablet diameter, Sauter or surface-volume diameter used; D, pan diameter; fc, ChoiPorter formulation factor; ff, pan loading = bed volume/pan volume; fr, ratio of bed cycle time to pan cycle time; FB, coating distribution for the batch process; FC, coating distribution for the continuous process; Fm, coating distribution for the continuous process with m beds in series; g, gravitational acceleration; h, bed height; i, denotes the position in the number of cycles or the number of passes through the spray zone; k, k”, kAV, kC, ke, kn, kP, kKW, k’KW,
primary goal of all coating processes. Coating uniformity directly affects quality attributes such as appearance, taste, core dissolution rate, and dosage uniformity, and can also impact downstream processing. For example, film thickness variation can affect blister packaging and laser drilling processes. Despite its importance, direct quantitative measur
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