Method invoking tabletting compression force control for optimizing tabletted formulation parameters

摘要

There is disclosed a method for standardizing, in terms of a pre- established range of acceptable in vitro release and/or in vivo response, production of tabletted formulations which have a dependency on tablet hardness, through control of the maximum tabletting compression force developed by the tablet press employed, and for providing an individual momentary as well as permanent readout in digital form of the maximum compression force developed for each tabletting event. One or more tablets are compressed from a particular batch of formulation at selected different press compression force settings. These tablets are processed to derive data regarding in vitro release and/or in vivo response with a determination of an optimum value being made directly from or by interpolation of the resulting data. This optimum value is correlated to a press setting and the press is then set thereat for the tabletting of the bulk of the batch of formulation. Transducer means appropriately mounted on the press effect a signal output representative of the compression force developed for each tabletting event. The transducer output is processed to derive only the true maximum developed compression force for each tabletting event. The derived force is then displayed and recorded in digital form.