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Context: The recognized properties of shark liver oil support its use as a raw material, of natural origin, in pharmaceutical formulations. Aims: To develop a formulation of hard capsules containing microencapsulated shark liver oil, by spray drying, and to evaluate the stability. Methods: The stability of the emulsions was evaluated, at room temperature and refrigeration, by means of heat stress tests and destabilization by centrifugation, determining the organoleptic characteristics, pH and conductivity. The oil microencapsulation process was carried out, through the spray drying process on a laboratory and industrial scale, evaluating the established physical-chemical parameters. The technological development of the hard capsules was carried out, using the dry method, carrying out the stability, shelf life and accelerated studies, respectively. Results: The emulsions maintained their stability under the evaluated conditions. The results obtained in the industrial scaling demonstrate the feasibility of scaling the spray drying method for the microencapsulation of the shark liver oil mixture. The quality parameters of the hard capsules, containing the microencapsulated oil, fulfilled with the established limits, demonstrating their stability for 24 months. Conclusions: The reproducibility of the technological process established on a laboratory and industrial scale was demonstrated, as well as the homogeneity of the properties of the microencapsulated oil. The design and development of a hard capsule formulation was achieved, containing microencapsulated oil, with adequate physical, chemical and microbiological stability, for 24 months. |
