Avaliação da secagem de metformina 850mg em leito fluidizado industrial

Abstract

The oral administration of drugs for systemic effects is the most common way used in medical treatment. Among these, drugs as tablets are the most used. The granulation is a process that seeks to improve the transportation of powder in the compacting machine by the agglomeration of particles. The fluidized bed drying added to "spray dryer" technique is commonly used to form granules that reaches the required characteristics of a uniform grain, with strict control of final humidity of the granules and relatively short process when compared to other techniques for drugs production. Metformin is a drug displayed as hydrochloride and orally administered as coated tablets. It is indicated for the treatment of type 2 Diabetes mellitus. In order to improve productivity in an industrial fluidized bed used in the granulation and drying of Metformin, it is necessary to evaluate the effects of operation conditions used in the process, as particulate material and in the production process. For that purpose, it was performed the study of fluiddynamic granulation and drying of Metformin in fluidized bed in order to investigate the minimum fluidization velocity for the process of this drug. The influence of temperature and speed of drying air in processing time of the formula, and the average particle size were also evaluated. The experiments were elaborated based on the Evolutionary Operation Theory, proposed by Box (1957). It performed the shaping at drying stage. With these experiments was possible to reduce to zero the reworks of batches caused by the formation of preferential channels, which could occur deposition polymer solution on the particulate material. It was also possible to reduce the average processing time in 8 minutes, adding greater productivity and savings for the company where the work was developed. The results achieved, besides the gain in productivity, guide to where efforts should be directed to continue improving productivity, providing a practical methodology for applying the technique that can be applied in the production of other drugs that use the granulation process in fluidized bed.