SUBSTANTIATION OF TECHNOLOGICAL PARAMETERS OF THE PROCESS OF MAKING A CREAM FOR INFECTIOUS AND PURULENT-INFLAMMATORY DISEASES OF A SKIN TREATMENT

Authors

  • V. O. Tarasenko Ukrainian Military Medical Academy, Kyiv, Ukraine,
  • O. V. Pidlisniy Ukrainian Military Medical Academy, Kyiv, Ukraine,
  • N. O. Koziko National Medical University named A. A. Bogomolets, Kyiv, Ukraine,
  • A. M. Solomenniy Ukrainian Military Medical Academy, Kyiv, Ukraine,

DOI:

https://doi.org/10.22141/2306-2436.8.5.2019.198388

Keywords:

structural and mechanical studies, rheology, structural viscosity, cream, plasticity, thixotropy

Abstract

Baskground. Pharmacotechnological studies, in particular the study of structural and mechanical parameters, serve to assess the quality of the medicinal product at the stage of creation, production, storage and use. The study of rheological characteristics of a cream has both theoretical and practical interest and is necessary for the choice of optimal conditions (temperature and speed of mixing) of preparation, transportation and packaging of the cream. The purpose of the surway was to study of the effect of temperature, speed and duration of mixing on the structural and mechanical parameters of the developed antibacterial and anesthetic cream for the treatment of infectious and purulent skin diseases to obtain a stable drug, in terms of its rheological characteristics. Materials and methods. The authors used active pharmaceutical ingredients, such as miramistin, anesthetics (gift sample from Dr. Reddy's labs, Hyderabad, India), CO2 chamomile extract (Ukraine), and excipients - propylene glycol, glycerol (Loba Chemie Pvt. Ltd., Mumbai, India), polyethylene oxide-400, emulsion wax, emulsifier № 1, vaseline oil (Sigma-aldrich, Germany). The studies were performed using a RV 2.1 "Reotest" rotary viscometer (Germany) according to the standard method according to the State Pharmacopoeia of Ukraine. The measurements were performed at different temperature modes at shear rates from 1,5 to 1332,0 s-1. The thermostat was carried out with the help of an ultra thermostat included with the unit. After calculating the shear stress at the determined shear rates, the structural viscosity of the test specimens was calculated. The data obtained are necessary for the construction of the flow charts of the cream. They reflect the dependence of the tangent shear stress (tr) on the shear rate (Dr), which is used to estimate the lubrication ability. When studying the rheological properties of the developed cream as a control used cream-placebo (without active pharmaceutical ingredients). Statistical analysis of the obtained results were made using Statistica 6.0 (StatSoft Inc., USA). The results were considered statistically reliable at P<0,05. Results. The article presents the results of the study of technological parameters (temperature, speed and duration of mixing) of the process of making a cream for the treatment of infectious and purulent-inflammatory diseases of the skin. The authors investigate the pharmacotechnological factors and their influence on the structural and mechanical parameters of the studied cream in order to obtain a stable drug, in terms of its rheological characteristics. Research has shown that the process of introducing the cream components to the base and homogenizing the cream can be carried out at a temperature of 40-45°C, because at such a temperature the system has a low viscosity, which will ensure a uniform distribution of substances and save energy. It is determined that in order to maintain the physical stability of the developed cream, the dosing process is better conducted at a temperature of 25-30°C. A study of the dependence of structural viscosity on the shear rate gradient for cream at different temperatures in the range of 25°C to 60°C showed that the viscosity of the cream decreases with increasing shear rate gradient. Сonclusions. A comprehensive study of rheological parameters can serve as an assessment of the quality of the medicinal product at the stage of creation, production, storage and use. Studies of the rheological properties of the cream have shown that prolonged machining helps to reduce its viscosity and this may be critical to the quality of the cream.

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Published

2019-10-01

Issue

Section

Medicine