SELECTION OF EXCIPIENTS FOR L-TRIPTOPHANE TABLETS WITH THIOTRIAZOLINE BY WET GRANULATION
DOI:
https://doi.org/10.11603/2312-0967.2017.4.8344Keywords:
L-tryptophan, thiotriazoline, tablets, excipients, wet granulation method, pharmacological and technological parameters of tablets, mathematical planning of the experiment.Abstract
The message 2.Influence of the excipients on pharmaco-technological parameters of L-tryptophan with thiotriazolin tablets obtained by wet granulation.
The aim of the work. Creation of a new tablet with neuro psychotropic effect based on L-tryptophan and thiotriazoline. Selection of optimal excipients, study of their effect on hardness of tablets, friability, disintegration, the external appearance of coatings of L-tryptophan and thiotriazoline tablets after 6 months of storage.
Materials and Methods. The active substances: L-tryptophan and thiotriazoline in a ratio of 4:1, excipients – fillers, disintegrants, binders, solubilizers). The tablets were compressed by wet granulation method. The effect of excipients on tablets containing L-tryptophan and thiotriazoline was studied according to the following parameters: hardness, friability, decomposition, external appearance of coatings after 6 months of storage.
Results and Discussion. The results of analysis of variance showed that 5 % solution of HPMC have the best effect on the hardness among binders; sodium croscarmellose have the best effect among disintegrants; mixture of MCC 101+Solani amylum+ Lactose monohydrate – among fillers. Solubilizers have minimum effect on hardness of L-tryptophan with thiotriazoline.
Aёrosilum have the maximum effect on friability of L-tryptophan with thiotriazoline among solubilizers; among disintegrants – Polyplasdone XL 10;
The mixture of MCC 101+Solani amylum+calcium dihydrogen phosphate anhydrous have the best effect on the time of disintegration time of tablets.
Sodium starch glycolate and MCC 101+Solani amylum+ basic magnesium carbonate have the best effect on the external appearance of coatings of tablets after six months of storage.
Conclusions. The effect of the four groups of excipients on the hardness, friability, disintegration time, the external appearance of coatings after six months of storage of L-tryptophan with thiotriazoline tablets was studied. The following excipients were selected in order to obtain optimal composition tablets with L-tryptophan and thiotriazoline: mixture of MCC 101 + Solani amylum + basic magnesium carbonate, sodium starch glycolate, 5 % solution of HPMC 5, Aёrosilum, calcium stearate. L -tryptophan with thiotriazoline tablets were obtained in using of these excipients which meet the requirements of the SPU regarding tablets.
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