Pharmaceutical coating technology

This chapter contains a comprehensive listing of research papers, reviews, book chapters and theses covering the subject of pharmaceutical film coating. Coating is a very extensive subject and so this bibliography is restricted to those publications of direct pharmaceutical relevance or authorship. Nonpharmaceutical polymer science or coating processes of other industries are not included. While the listing is extensive, it is by no means exhaustive. Indeed, the author would welcome notification of any missing articles in order that this work can be included in the next edition.

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Some common practical questions and suggested answers During the development of coating formulae and processes, common problems tend to recur. This section brings together a collection of typical queries and provides suggested solutions. 1. Question: What major process and formulation parameters do I need to take into account in the change from organic solvent coating to aqueous coating? Answer: Looking first of all at the formulation-based parameters, there is a need to increase the solids loading of the coating suspension to something like 12 %w/w if using a typical HPMC-based formula.

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Modified release coatings John E.Hogan SUMMARY Relevant aspects of the composition and performance of modified release coatings are considered in this chapter. Initially, the basic characteristics of multiparticulate systems are described and comparisons are made with the performance of whole tablets intended for modified release. The properties and effects of the polymers and plasticizers which are used in modified release coatings are illustrated with examples from the literature. This further develops the basic treatment of these materials provided in Chapter 2.

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Film coat quality Michael E.Aulton and Andrew M.Twitchell SUMMARY This chapter discusses the desirable properties of polymer film coats with respect to their end usage. The mechanical properties of films were discussed fully in Chapter 12 and so this chapter concentrates on other aspects of film quality such as gloss and roughness, uniformity of film thickness and defects such as cracking, edge splitting, picking, bridging and foam filling of intagliations, etc.

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Mechanical properties of film coats Michael E.Aulton SUMMARY This chapter discusses the need for a film coat to possess the correct mechanical properties. One of the requirements of a film coat is that it should provide adequate protection to the dosage form. The capacity of the film coat to afford physical protection depends to a large extent on its mechanical characteristics. After considering those desirable properties, the chapter explains how to assess such properties. It also explains the need for a standardized approach to film preparation prior to testing.

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Validation of tablet coating processes Graham C.Cole SUMMARY Validation is a concept that means different things to different people. This chapter will highlight all the activities that are necessary to ensure that all aspects of the coating process are fully documented from design through to operation, to provide compliance with regulatory requirements. ‘If it hasn’t been documented, it hasn’t been done.’ FDA 11.

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Automation of coating processes Graham C.Cole SUMMARY Current Good Manufacturing Practice (cGMP) and the demands of the regulatory authorities worldwide requires greater care in the design of manufacturing facilities, the selection of materials used in their construction, their layout, the equipment used in the preparation of tablets to be coated and the coating operation. It is claimed that robotic systems will eventually take over all processing tasks! (Kanig & Rudic, 1986).

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Environmental considerations: treatment of exhaust gases from film-coating processes Graham C.Cole SUMMARY Solvents such as acetone, methylene chloride, chloroform, ethanol and methanol must be prevented from entering the environment. Two options are available: convert all the processes to aqueous-based formulations or recover all the solvent by the use of an appropriate system. Recovery is expensive and is generally the reason for pharmaceutical companies to convert coating formulations to aqueous systems or formulate aqueous coating for all new products.

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