Substantiation of technology for obtaining capsules of a multi-component drug with neurotropic action

The aim of the work. Theoretical and experimental substantiation a rational technology for obtaining preparation in form capsules based on uridine-5-monophosphate disodium salt, cytidine-5-monophosphate vitamin B6, thioctic acid magnesium lactate dihydrate, determination process parameters that can affect critical quality characteristics active pharmaceutical ingredients product establishing acceptance criteria each parameter to be used batch production control.
 Materials methods. Objects research: masses encapsulation, granulates finished - with conventional name “Neuronucleos”. To obtain capsules, (API) were used: salt (Shanghai Oripharm Co. Ltd., China), Modern Pharmaceutical Co., Ltd..”, pyridoxine hydrochloride (“DSM Nutritional Products GmbH”, Germany), (“Moes Cantabra S.L.”, Spain). indicators studied: description, average mass content uniformity mass, dosage units, dissolution, accompanying impurities, quantitative API. Methods liquid chromatography complexometric titration used.
 Results. It has been established use direct mixing method does not allow encapsulation corresponding indicator "Bulk density". wet granulation fluidized bed substantiated. shown it is difficult perform an API mixture containing acid. two stages: granulate from dihydrate moisturizer solution (sorbitol + salt) then granulate, acid, anhydrous colloidal silicon dioxide stearate by method.
 Conclusions. On basis performed technological research analysis obtained capsule using was chosen. mode substantiated optimal high-quality selected,