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      Understanding the Integrity of Coating for Taste-Masked Granules Before and After Tablet Compression

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          Summary

          Raman microscopy was used to visualize the integrity of a barrier membrane coating at the various stage of chewable tablets development. The effect of substrate morphology and particle characteristics was found to be important in maintaining the integrity of the coating throughout the process of chewable tablets manufacture. Furthermore, the observations from the Raman image analysis provide an understanding of the factors affecting drug release.

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          Coating of pellets with micronized ethylcellulose particles by a dry powder coating technique.

          Pellets were coated with ethylcellulose powder to achieve extended release. The film forming ability of ethylcellulose powder and the effect of formulation factors (plasticizer type and concentration) and curing conditions (curing temperature and time) were investigated. The coating formulation was divided into two components consisting of a powder mixture (polymer plus talc) and a mixture of liquid materials (plasticizer plus binder solution), which were sprayed separately into the coating chamber of a fluidized bed coater (Glatt GPCG-1, Wurster insert). The coated pellets were oven-cured under different conditions (60-80 degrees C, 2-24 h) without and with humidity (100% relative humidity). Propranolol hydrochloride was used as a model drug, and drug release was studied in 0.1 N HCl at 37 degrees C (USP XXV paddle method). Despite the high glass transition temperature of ethylcellulose (133.4 degrees C), micronized ethylcellulose powder can be used for dry powder coating by adjusting the coating temperature, amount and type of plasticizer applied, and curing conditions. 40% plasticizer and a curing step (80 degrees C, 24 h) were required to achieve complete coalescence of the polymer particles and extended drug release of coated pellets. Although ethylcellulose-coated pellets had an uneven surface, extended drug release could be obtained with coating level of 15%. Because of its high glass transition temperature, ethylcellulose-coated pellets showed unchanged drug release profiles upon storage at room temperature for 3 years.
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            Optimised process and formulation conditions for extended release dry polymer powder-coated pellets

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              Author and article information

              Journal
              BJPharm
              British Journal of Pharmacy
              University of Huddersfield Press
              2058-8356
              11 July 2018
              : 2
              : 2 , Proceedings of the 8 th APS International PharmSci 2017
              : S14-S15
              Affiliations
              [a ]Colorcon Ltd, Dartford, UK, DA2 6QD
              [b ]Colorcon Inc, Harleysville, PA, USA
              Author notes
              *Corresponding author. Tel.: +44 1322 627372 Fax: +44 1322 627200 E-mail: mghimire@ 123456colorcon.com
              Article
              10.5920/bjpharm.2017.17
              © 2017, Manish Ghimire, Raxit Mehata, Charlie Cunningham, Ali Rajabi-Shiabhoomi

              This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY) 4.0 https://creativecommons.org/licenses/by/4.0/.

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