The ability to identify, characterize and control efficiently the solid forms of an active pharmaceutical ingredient (API) is a critical knowledge to guarantee the quality of medicines and to protect the intellectual property. In this area it is intended to establish a multidisciplinary discussion forum joining Latin American professionals belonging to academic research institutions, governmental laboratories, pharmaceutical industry and regulatory agencies that act in Research and Development, Products Formulation, Quality Control, New Products and Processes, and similar areas. In order to fortify the interaction among these professionals the following initiatives will be developed:

The oral administration of medicines in solid formularizations is, in general, the most convenient, cheap and safe, and, therefore the most common. However, its therapeutical effectiveness is directly related to the characteristics of the API in the solid state. The crystalline structure (polymorphism), crystalline habit (morphology) and the particle size have a tremendous practical and commercial impact from the initial research until the manufacture of the final product.

Polymorphism is defined as the ability of a molecule (API) to exist under more than one crystalline form, which determines properties such as compressibility, hygroscopicity, stability and solubility. The crystalline structure and its derived properties derived can be modified during the development and formulation processes. New crystalline forms may be originated in the presence of different solvent, due to the co-precipitation, in the presence of impurities and/or under different crystallization conditions, giving rise to new polymorphs, solvates, salts, co-crystals and amorphous phases. As a consequence, the search and, especially, the selection of the optimal solid form is a basic stage in the development process of a new API. To define the production processes that guarantee to reproducibly obtain the desired solid form (habit, solvate, and polymorph) and particle size of an organic molecule is a difficult task that may origin expensive delays in the commercialization of a medicine

The dominion of the crystallization technology of active ingredients represents a strategic knowledge that allows guaranteeing the effectiveness of a medicine and the protection of the intellectual property. The constant increase of the litigations due to infraction of patents involving polymorphs and/or pseudo-polymorphs has transformed the relation between crystalline forms and intellectual property legislation into a topic of mayor importance for the pharmaceutical industry. The development of new crystalline forms is a reasonable alternative for the protection of patents allowing the extension of the exclusiveness of the market, but also to facilitate the access of new formularizations.

One of the main aspects of the polymorphism related to the regulation of the medicine market is the effect that the solid form may have in the bioequivalence/bioavailability, and, therefore, in the therapeutical effectiveness. Specially, in a market where generic and innovator medicines coexist, the active ingredient cannot purely be considered under a molecular vision but changes in the solid state properties due to the crystalline form must take into account in order to guarantee the interchangeability between these medicines.