RESUMO
ABSTRACT The search for new pharmaceutical dosage forms and different drug delivery systems already used in therapeutics is a global trend, serving as an opportunity to expand the portfolio for the pharmaceutical industry. In this context, multiparticulate systems, such as pellets, granules, and minitablets, represent an attractive alternative, given the range of possibilities they provide. Among the methods used in the production of these systems, we highlight the process of extrusion-spheronization for pellet manufacture, wet granulation and hot-melt extrusion for the obtention of granules, and direct compression for minitablets. Although highly versatile, depending on the technology chosen, many processes and formulation variables can influence the ensuing stages of manufacture, as well as the final product. Therefore, the characterization of these small units is of fundamental importance for achieving batch homogeneity and optimal product performance. Analyses, including particle size distribution, morphology, density, porosity, mechanical strength and disintegration, are example tests used in this characterization. The objective of this review was to address the most widely used tests for the physical evaluation of multiparticulate systems.
Assuntos
Preparações Farmacêuticas , Fenômenos Físicos/classificação , Composição de Medicamentos/estatística & dados numéricos , Peneiramento de Líquidos , Sistemas de Liberação de Medicamentos , Formas de Dosagem , Habilidades para Realização de Testes/métodosRESUMO
Os sistemas multiparticulados contêm o fármaco subdividido em unidades funcionais, que podem ser pellets, grânulos ou minicomprimidos. Oferecem vantagens tecnológicas e biofarmacotécnicas quando comparados aos sistemas monolíticos, apresentando ainda benefícios terapêuticos para os pacientes. Por isso, têm se destacado cada vez mais dentre as novas formas farmacêuticas e sistemas de liberação de fármacos. Os minicomprimidos possuem diâmetro igual ou inferior a 2 - 3 mm e são obtidos através do processo de compressão, utilizando máquinas de comprimir convencionais adaptadas com punções múltiplos. Quanto ao aspecto tecnológico, oferecem vantagens em relação aos pellets e grânulos. O objetivo desta revisão é, portanto, abordar os principais aspectos tecnológicos envolvidos na sua obtenção, destacando suas vantagens e aplicações.
In multiparticulate systems, the drug is subdivided into functional units, which may be in the form of pellets, granules or minitablets. They have technological and biopharmacotechnical advantages over monolithic systems and also offer therapeutic benefits to patients. For these reasons, they have gained prominence among new pharmaceutical dosage forms and drug delivery systems. Minitablets are between 2 and 3 mm in diameter or smaller and are manufactured by means of the direct compression process, with a conventional tablet press adapted with multi-tip punches. In technological terms, they have advantages over both pellets and granules. The objective of this review is, therefore, to discuss the main technological features of minitablet production, highlighting their advantages and applications.