Desenvolvimento farmacotécnico de suspensão de micofenolato de mofetila preparada com o veículo Gute® obtida por transformação de forma farmacêutica

Abstract

The liquid dosage forms are most suitable for use in pediatrics and in patients who can not swallow tablets, as well as being more flexible in adjusting the dose, facilitate the administration of medications. As most of the drugs available on the market are in the form of tablets and capsules, the only way to circumvent the unique therapeutic needs of some patients is to convert from pharmaceutical dosage forms to off-label use. The present work had as main objective to develop a formulation of suspension of Mofetil Mycophenolate (MMF) from the tablets, through transformation of tablets to be manipulated, since liquid formulations of MMF are not commercially available in the country. To that end, a specific formulation was considered in order to evaluate the applicability with the use of the Gute® vehicle, developed by the Pharmaceutics Laboratory of the Federal University of Ceará, incorporated to the active pharmaceutical ingredient at the concentration of 100 mg/ml. The characterization of these tablets was carried out, in which the average weight was determined, according to the Brazilian Pharmacopoeia, followed by its grinding and subsequent extraction of MMF for the spectrophotometric evaluation in ultraviolet in its wavelengths at maximum absorbance, according to the proposed model by Costa (2009), author of the MMF monograph. With the suspension ready, spectrophotometry was performed in ultraviolet and measured sedimentation volume, relative density, pH, rheological behavior and viscosity and optical microscopy, according to the Brazilian Pharmacopoeia requirement. The feasibility of this suspension in the Gute® vehicle was satisfactorily demonstrated, however, it is necessary also the stability study for a better physico-chemical and microbiological characterization, evaluation and selection of suitable storage system for this formulation. Monitoring of therapeutic stability and bioavailability testing so that they can be useful in improving clinical information and practical use in hospitals.