Justification of temperature control for production suppositories with Glifazin

Abstract

The intensive search for new anti-diabetic drugs, carried out in the National pharmaceutical university in recent years led to the creation of complex drug "Glifazin" on base of which the composition and technology of suppositories with hypoglycemic effect were developed. Now comprehensive physicochemical and pharmacological study of the dosage form are going on. This paper presents results of determining the critical parameters of technology of suppositories witn Glifazin produced by molding - temperature control of homogenization and molding of suppository mass. This mode, as shown in the work, grounded on the analysis of rheological behavior of the system in the temperature range in which it is the transition from the liquid state of Newtonian type flow to the plastic-bound state of non-Newtonian flow type. This interval for suppository mass with Glifazin is in the range 45-60 ° C. Materials and methods. As the object of the study the suppositories with Glifazin 0.1 g and polietylenoxide base on which they are prepared were taken. The study of structural and mechanical (rheological) properties of suppository base and suppository mass were performed on a rotary viscometer «Reotest-2" (Germany) with coaxial cylinders and the temperature range 45-60 °C. Determination of hardening temperature, resistance of suppositories to decay and their dissolution time were measured by methods of the State Pharmacopoeia of Ukraine. Determination of uniformity suppository mass was assessed by quantitative content of Glifazin in selected samples by using UV spectrophotometry method at 271 nm against a standard sample of Onozid. Results and discussion. The analysis of rheogram shows that the suppository mass with Glifazin in the test temperature range has falseplastice type of flow. The presence of hysteresis loops indicates that this system has dispersed thixotropic properties. Thus, an increase in temperature leads to a decrease in the area of the hysteresis loop and at 60 °C type flow close to Newton. Adding of Glifazin into a suppository basis significantly changes its reoparameters - increases structural viscosity and increases thixotropic properties of system, due to the influence of the concentration of solids in the system, resulting in reduced her mobility. So important when justifying production technology suppositories is an optimal temperature casting of suppository mass. Other important technological factors whose influence was investigated in this study were speed and time of mixing suppository mass. The result of the research was the study of temperature, speed and time of mixing of suppository mass that is moving but, because of the structuring system started, the processes of sedimentation of solid phase is not occurring, and suppositories prepared in all respects comply with State Pharmacopoeia of Ukraine. Conclusions. 1. The structural and mechanical properties of suppository poliethylenoxide bases and suppositories with vegetable substance Glifazin in the temperature range from 45 °C to 60° C were studied. 2. Influence of temperature, speed and time of mixing suppository mass on the rheological properties and basic properties of Pharmaceutical Manufacturing suppositories were studied. It is shown that homogenization of suppository mass with the rotation speed mixers 0.9 s-1 at 55 ° C for 1 h gives a suppository that meet the requirements of SPU. 3. On the basis of the data obtained reasonable basic technological parameters of suppositories with Glifazin were proposed: homogenization temperature (55 ° C) temperature dosing (52-53 ° C), frequency (0.9 s-1) and the mixing time (30-60 min ). The results of studies were used in the development and standardization of technology rectal suppositories Glifazin to treat diabetes type 2.