Substantiation of the composition of a semi-solid dosage form with a probiotic component for use in dermatology
One of the important issues in the pharmaceutical development of a semisolid preparation for dermal use is the scientific and experimental justification for choosing the base-carrier of active substances.
The aim of this study was to experimentally substantiate the choice of rational combination of excipients in the development of a semisolid dosage form with a probiotic component for use in dermatology.
Materials and methods. Hydrophilic gelling agents were used as excipients in the study: Sepiplus 400, Aristoflex AVC, Carbopol 934, hydroxyethylcellulose HEC, sodium alginate. Physical and chemical, pharmaco-technological and microbiological methods were used to select the optimal basis. Colloidal stability was determined using a laboratory centrifuge at a speed of 6000 rpm for 5 min, an electronic thermometer and a water bath laboratory. Thermostability was determined in the thermostat at (40±2) °C for 24 hours. Investigation of the rheological properties of the samples was performed using a Rheolab QC (Anton Paar, Austria) rheoviscometer using a system of coaxial cylinders C-CC27/SS. The kinetics of water absorption of the samples were studied by dialysis through a semipermeable Cuprophan membrane, Type 150 pm at a temperature of (34±2) °C. The number of viable lactobacilli cells was determined by surface seeding on Petri dishes with dense MRS medium.
Research results. The results of the study of the number of viable lactobacilli cells showed that the lowest number of viable cells was in sample based on HEC. Tests for thermostability and colloidal stability showed that for sample No. 5 based on sodium alginate, stratification was observed in the experiment, which indicates its instability. These samples were excluded. Samples on Sepiplus 400 and Aristoflex AVC on a set of rheological features have advantages both consumer and technological; and sample on t Aristoflex AVC has the best indicators of osmotic activity and the viability of cells in the dynamics for this study.
Conclusions. As a result of physical and chemical (organoleptic, colloidal and thermostability), pharmaco-technological (osmotic and structural and mechanical properties) and microbiological studies (number of viable lactobacilli cells) studies it was found that further work should be carried out with a sample based on gelling agent Aristoflex AVC, which has the most optimal performance in this development for a semisolid dosage form with a probiotic component for use in dermatology
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