Andriichuk I. Development of composition and technology of chewable tablets with dry oat extract and quercetin

Thesis is about development of composition and technology of chewable tablets with dry oat extract and quercetin. Proposed technology of drug production could be used as methodological approach of analogical medicines creation. The focus of the study was on the investigation of pharmaceutical properties of active pharmaceutical ingredients: powder of dry oat extract and quercetin. During detailed study of pharmaceutical properties were discovered that above-mentioned substance have unsatisfied pharmaceutical properties in order to obtain solid medicines. Thus, it was decided to use additional pharmaceutical procedure in order to get appropriate pharmaceutical properties of dry oat extract powder and quercetin. Wet granulation in a fluidized bed was implemented. It was taken three different series of pharmaceutical composition in order to choose the optimal series which could be used during manufacturing of final product. All granulation related process was performed according GMP. The process of wet granulation in fluidized bed was strictly controlled because from our point of view it is a critical stage of whole technological process. After wet granulation in fluidized bed we have got three different series of granulated materials. Microscopy of dry oat extract, different composition of granulated materials was performed. In order to obtain detailed information of technological properties of granulated materials bulk density, flow ability, residual moisture and fractional composition were studied. Collected data allowed us to proceed with the next technological stage - tableting. The parameters of tableting were strictly controlled as well. So, after tableting process of granulated materials based on powder of dry oat extract and quercetin we have got three different series of chewable tablets. Some of series has hind of scratches of the back of tablet. Nevertheless on series has no visual abnormality. So for further analysis was taken this series. All quality control parameters were studied (according to Ukrainian national Pharmacopeia). Thus, methods of standardization of chewable tablets with oat extract and quercetin were developed. Study of tablet stability was performed. Tablets are considered stable in temperature (25±2) °С humidity (60±5) %. All microbiological tests are in compliance with Ukrainian national Pharmacopeia requirements. To sum up, based on pharmaceutical research a new solid medicines was developed - chewable tablets with dry oat extract and quercetin. Based on modern standards of pharmaceutical studies a new way of chewable tablets production was proposed. All tests and technological stages were done according to GMP and local requirements, regulation.