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Prasad Ghugarkar*, Kapileswar Swain, Vijay Suggala, Pankaj Adsare, Dadapeer Shaik


Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, increment in therapeutic efficacy etc. Bi-layer tablet is a new era for the successful development of controlled release formulation along with various features to provide a way of successful drug delivery system and it is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. Bi-layer tablets can be primary option to avoid chemical incompatibilities between APIs by physical separation and to enable the development of different drug release profiles. The present article provides a review on the oral drug delivery system, types of tablets, Bilayer tablet manufacturing, various tablet presses used, quality and GMP requirements for high production output and recent developments in the field of Bilayer technology and why development and production of quality bi-layer tablets need to be carried out on purpose built tablet presses, such as layer separation, insufficient hardness, inaccurate individual layer weight control, cross contamination between the layers, reduced yield.

Keywords: Bilayer tablet, GMP requirements, tablet presses, compression force.

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