MANUFACTURE PROCESSES DESIGN FOR TABLETS WITH BIOLOGICAL ACTIVE INGREDIENTS

Abstract

The biological active ingredients have gradually become more attractive therapeutic molecules than small molecular drugs due to their high selectivity and efficacy, but fewer side effects. Owing to the poor stability and limited permeability through gastrointestinal (GI) tract and epithelia, the therapeutic biologicals are usually administered by parenteral route. Given the big demand for oral administration in clinical use, a variety of researches focused on developing new technologies to overcome GI barriers of biologicals, such as enteric coating, enzyme inhibitors, permeation enhancers, nanoparticles, as well as intestinal microdevices. One of the current trends in the pharmaceutical industry is the manufacture of more patient-friendly medications. The tablets are non-invasive formulations that are easy to handle in consumption since they can be supplied at home. However, biomolecules have specific characteristics that make them different from chemical ingredients. The objective of this work is to highlight the aspects that must be taken into account to develop this type of production from the laboratory to its commercialization. The industrial drug manufacturing process is undergoing a significant transformation; the quality systems traditionally used in the development and manufacturing of drugs have rapidly evolved towards development and manufacturing processes that use the principles of quality by design (QbD), whose philosophy It is quality planning, together with adequate risk management to achieve the desired quality profile and for the medicine to guarantee its therapeutic efficacy.