Desenvolvimento de comprimidos de azidiol para uso na conservação do leite

Abstract

Among the criteria for milk quality, the bacterial count is assessing the general conditions of hygiene and management adopted in production of milk. For the milk samples being analyzed by laboratories of the Brazilian Network Laboratories Quality Control of Milk; must be added preservative. Due to its bacteriostatic action azidiol is added to the collector containers of milk samples. The azidiol tablet is composed of chloramphenicol, sodium azide, sodium citrate, bromophenol blue. In 2004, BS Pharma started developing the azidiol tablet, however, the resulting formulation did not show adequate mechanical resistence and desintegration rate. Three new proposals of formulations were made. The disintegrants used in the differentiation of the formulations were sodium starch glycolate, croscarmellose sodium and crospovidone. In the pre - formulation flow characteristics and compaction were evaluated. Production was established by direct compression. The method of spectrophotometry in the ultraviolet region has been validated for the determination of chloramphenicol. The method was linear, selective, precise, accurate and robust. By comparing the results of the tests of aspect, thickness, diameter, uniformity of weight, hardness, friability, disintegration time at temperature between 2 and 8 °C, determination of content of chloramphenicol, uniformity of content and interference of formulations - on the total bacterial count by flow cytometry - the formulation containing crospovidone was standardized. The tablets containing crospovidoneshowed all quality parameters demonstrating satisfactory improvement over existing formulation before this project.