Technological studies on the development of the corrected dosage form base

Abstract

Aim. The aim was to substantiate and to study excipients, in particular thickeners, in development of the base composition of the combined syrup containing herbal compound, applied for the treatment of hepatobiliary system and gallbladder.

Methods. Analytical, retrospective, logical methods were used for the literature data analysis; marketing analysis – for research of the national market pharmaceutical segment in relation to excipients in syrups studies; physical and organoleptic methods.

Results. According to the given research results, substances, used as excipients in syrups production and registered in Ukraine, were determined. It was found, that saccharose (38%), as well as sorbitol and lactulose (19% each), and among synthetic compounds Sodium saccharin (13%) are most commonly used as sweeteners in syrups. Moreover, the use of saccharose in syrups by the national manufacturers far exceeds its use by the international producers (75% and 25%, respectively). The most commonly used thickeners are cellulose derivatives (HEC and CMC – 60% and 34%, respectively) and gums (23%). Only 25% of the national manufacturers use thickeners as excipients.

Results have shown that the samples 3 and 4 with HEC concentration 0,3 and 0,4% had poor consistency as for syrup. Syrup sample 5 (with HEC content 0,5 ± 0,2 %) is a viscous liquid, which is dosed easily, with mass dosing deviation no more than ± 3 %, that meets the SPhU requirements. Therefore, according to the dynamic viscosity and organoleptic properties indexes, the concentration of hydroxyethyl cellulose was determined for the developed syrup – 0,5 ± 0,1 %.

Conclusion. The advisability of using of the thickener – hydroxyethyl cellulose in concentration of 0,5%  – in the combined syrup development was theoretically substantiated and experimentally proved