Document Detail


Modeling of pan coating processes: Prediction of tablet content uniformity and determination of critical process parameters.
MedLine Citation:
PMID:  20091834     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We developed an engineering model for predicting the active pharmaceutical ingredient (API) content uniformity (CU) for a drug product in which the active is coated onto a core. The model is based on a two-zone mechanistic description of the spray coating process in a perforated coating pan. The relative standard deviation (RSD) of the API CU of the coated tablets was found to be inversely proportional to the square root of the total number of cycles between the spray zone and drying zone that the tablets undergo. The total number of cycles is a function of the number of tablets in the drying zone, the spray zone width, the tablet velocity, the tablet number density, and the total coating time. The sensitivity of the RSD to various critical coating process parameters, such as pan speed, pan load, spray zone width, as well as tablet size and shape was evaluated. Consequently, the critical coating process parameters needed to achieve the desired API CU were determined. Several active film coating experiments at 50, 200, and 400 kg using various pan coaters demonstrated that good correlation between the model predictions and the experimental results for the API CU was achieved.
Authors:
Wei Chen; Shih-Ying Chang; San Kiang; Alexander Marchut; Olav Lyngberg; Jennifer Wang; Venkatramana Rao; Divyakant Desai; Howard Stamato; William Early
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of pharmaceutical sciences     Volume:  99     ISSN:  1520-6017     ISO Abbreviation:  J Pharm Sci     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-04-30     Completed Date:  2010-08-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985195R     Medline TA:  J Pharm Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3213-25     Citation Subset:  IM    
Copyright Information:
(c) 2010 Wiley-Liss, Inc. and the American Pharmacists Association
Affiliation:
Engineering Technologies, Process R&D, Bristol-Myers Squibb Co, New Brunswick, New Jersey, USA. wei.chen1@bms.com
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MeSH Terms
Descriptor/Qualifier:
Drug Compounding* / methods
Models, Chemical
Tablets, Enteric-Coated / chemistry*
Chemical
Reg. No./Substance:
0/Tablets, Enteric-Coated

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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