OPTIMIZATION OF COMPOSITION AND TECHNOLOGY OF TABLETS BASED ON SCUTELLARIA BAICALENSIS DRY EXTRACT

Анотація

OPTIMIZATION OF COMPOSITION AND TECHNOLOGY OF TABLETS BASED ON SCUTELLARIA BAICALENSIS DRY EXTRACT

H.  D. Slipchenko¹, O. A. Ruban¹, N. M. Beley²

National University of Pharmacy¹, Kharkiv

Horbachevsky Ternopil State Medical University ²

Introduction.The pilot experiment study of the impact of quantitative factors on some indicators showed that their increase did not improve all pharmaco-technological properties for tableting powdery mass and the quality of tablets based on the extract of Scutellaria baicalensis code-named "Skutex". In order to find the optimal composition of the studied tablets it was necessary to determine the optimal ratio of the excipients in the tablet DF in narrower ranges. For this purpose the symmetric rotatable composite uniform-plan of 2nd order was used.

Results and discussions.During the process of making "Skutex" tablets formulation according to the plan of the experiment in the cases when factors were studied at lower levels or lower "star" points, the average tablet mass was increased with the addition of dried starch in the required quantities.

The obtained results were subjected to statistical analysis, which allowed to detect not only significant factors but also to establish the presence (or absence) of interaction among the factors studied. As the result, equations for each parameter were obtained and then used as the base for single-factor figures building.

The granulated tableting mass flowability, according to the equation, depends only on the content of lactose monohydrate of GranuLac 200 brand in its composition. The studies showed that, regardless of the studied levels of factors х₁ і х₂, the flowability most noticeably improves with the increased GranuLac content within the tableting mass from 0.1 to0.2 g per tablet.

The research showed that the increasing content of GranuLac200 inthe composition of "Skutex" tablets positively affects the stability of tablets to crushing, and

this effect almost does not depend on the studied level of factors х₁ and х₃.

So, the abrasion of Scutellaria extract tablets depends on the content of GranuLac 200, as well as on the ratio of this excipient with sodium croscarmellose.

Based on the research results of Scutellaria baicalensis extract tablets disintegration the regression based on the research results of Scutellaria baicalensis extract tablets disintegration.

Disintegration time of the studied tablets slightly increases with the increasing content of MCC in their composition, but does not exceed 15 minutes.

Since sodium croscarmellose is a leavening agent, it is obvious that the increase of its content improves the process of the studied tablets disintegration. This dependence is most expressed within the range of 0.12 -0.032 gcroscarmellose sodium per tablet.

The analysis showed that the top level of lactose monohydrate of GranuLac 200 brand provides the satisfactory value of flowability, abrasion and resistance to crushing. The further increase of the content of the excipient from 0.2 to 0.21 gper tablet is not reasonable as it practically does not improve the above-mentioned statements but negatively affects the disintegration of tablets. Therefore it was decided to stabilize factor х₂ on the upper level.

Since the MCC and sodium croscarmellose only affect disintegration of tablets based on Scutellaria baicalensis extract, while determining their optimal quantities the results of the previous experiment were also taken into account. Accordingly, it was decided to stabilize factors х₁ і х₅  at a lower level.

Conclusions. So, based on symmetric composite rotatable design of 2nd order the theoretically-grounded composition of tablets code-named "Skutex" was obtained which was also proved experimentally.

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