Tecnologia de obtenÃÃo de revestimento aquoso gastro- resistente para comprimidos de bisacodil 5mg - prÃ-formulaÃÃo e desenvolvimento do processo de revestimento

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

Intestinal constipation is a symptom that affects a large section of the population across the world and has multiple and various causes. For this reason the consumption of laxatives is on the rise. Bisacodyl is, at present, the drug that is most often prescribed for this complaint. As it acts locally and intestinally, bisacodyl can be found in the form of enteric coated tablets. The objective of this work is development the aqueous enteric for bisacodil tablets. There was a need for a pre-formulation study to select the core and development and optimization of the aqueous coating process in conventional system, establishing parameters for critical variables. The coating process was analyzed to find out the resistence of the coated pills in an acid medium and to conduct an acid permeability test, as well as to determine the efficiency of the process. Subsequently, scale up transference was carried out and the coating process using conventional system compared with that using automatized machine. A method was also developed to dissolve the substance for delayed release. A comparative study was carried out of this medicine and the market reference medication Dulcolax. The results obtained on optimization of the coating process for the time of dispersion of the enteric polymer was 45 minutes, the theoretical weight gain was 10%, the peristaltic pump pressure 3 Bar, the dispersal release rate 8 mL/min, the distance from the hot air insufflator to the tablet bed was 34 cm, the distance of gun to tablet bed was 20 cm and the pan speed 45 rpm. It was thus shown that the tendency in modern industrial pharmaceutics is to use the aqueous system for coating and this can be used with conventional equipment, without commitment to quality, thereby lowering the cost and the toxicity in comparison to the process using organic solvents

ASSUNTO(S)

farmacia bisacodil comprimidos gastro-resistentes constipaÃÃo intestinal sistema aquoso para revestimento

ACESSO AO ARTIGO

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