Methods of mathematical planning of the experiment and their use in the development of the composition of the ointment with essential oil thymus vulgaris l. For vaginal application




mathematical planning of an experiment; biopharmaceutical factors; two-factor experiment; variance analysis


One of the most important pharmaceutical factors is excipients, their nature and quantity, which increase the pharmacological activity and safety of APIs by creating dosage forms that are optimal in composition, properties, and type, and/or by changing the chemical modification of the molecule responsible for the pharmacological effect of the
active substance. Variability or variation in the number of excipients and the use of different excipients with the same intended functionality can complicate the release rate and bioavailability of drugs. The use of mathematical methods
at the stage of the experiment planning reduces the total number of experiments and at the same time provides reliable results.
Aim. To study the most used types of mathematical planning of the experiment, and select the most acceptable model for developing the optimal composition of a vaginal ointment with the thyme (Thymus vulgaris L.) essential oil.
Results and discussions. To develop the optimal composition of the ointment, 10 bases containing various excipients (factor A) and 6 excipients as an emulsifier (factor B) were used. The concentration of the thyme essential oil was 5 % in all samples. The degree of thymol release in the in vitro study using the equilibrium dialysis method was chosen as the criterion for choosing the optimal composition. The selection of excipients for the development of a soft
dosage form was carried out using the method of the a priori ranking since both bases and emulsifiers were selected as the most widely used in the pharmaceutical technology, with known characteristics, safety profile, application experience.
Conclusions. The degree of influence of each factor has been determined, and the series of Duncan’s test have been constructed for each factor – by factor a: а3 > а5 > а4 > а6 > а2 > а8 > а7 > а10 > а9> а1, and by factor b: b2 > b3 > b5 > b4 > b6 > b1. Based on the mathematical planning of the experiment, an ointment base and an emulsifier for developing the composition of a vaginal gel with the thyme oil have been determine.

Author Biographies

L. A. Fukleva, Zaporizhzhya State Medical and Pharmaceutica University, Ukraine

Candidate of Pharmacy (Ph.D.), senior lecturer of the Department of Pharmacy Management, Economics and Pharmaceutical Technology

О. О. Saliy, Kyiv National University of Technologies and Design

Candidate of Pharmacy (Ph.D.), associate professor of the Department of Industrial Pharmacy

О. P. Bаulа, Kyiv National University of Technologies and Design

Candidate of Chemistry (Ph.D.), associate professor of the Department of Industrial Pharmacy

L. O. Puchkan, Zaporizhzhya State Medical and Pharmaceutica University, Ukraine

Candidate of Pharmacy (Ph.D.), Associate Professor of the Department of Drug Technology

О. V. Hrechana, Zaporizhzhia State Medical and Pharmaceutical University

Candidate of Pharmacy (Ph.D.), associate professor of the Department of Pharmacognosy, Pharmacology and Botany


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