RESUMO
Combination therapy has various advantages over monotherapy. In the last decade, interest in developing a combination of two or more Active Pharmaceutical Ingredients (API) in a single dosage form (monolithic or bilayer tablet) has increased in the pharmaceutical industry, promoting patient convenience and compliance. Bilayer tablets can be a primary option to avoid chemical incompatibilities between API by physical separation, and to enable the development of different drug release profiles (immediate release with extended release). Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, therapeutic, marketing to name a few. To reduce capital investment, quite often existing but modified tablet presses are used to develop and produce such tablets. This article explains why the development and production of quality bi-layer tablets needs to be carried out on purpose-built tablet presses to overcome common bi-layer problems, such as layer-separation, insufficient hardness, inaccurate individual layer weight control, cross-contamination between the layers, reduced yield etc. Using a modified tablet press may therefore not be best approach in producing a quality bi-layer tablet under GMP conditions, especially when high production output is required. There are various applications of the bi-layer tablet consists of monolithic partially coated or multilayered matrices.