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
DOI:
https://doi.org/10.24959/nphj.24.130Keywords:
mathematical planning of an experiment; biopharmaceutical factors; two-factor experiment; variance analysisAbstract
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.
References
Hroshovyi, T. A., Martseniuk, V. P., Kucherenko, L. I., Vronska, L. V., Hureieva, S. M. (2008). Matematychne planuvannia eksperymentu pry provedenni naukovykh doslidzhen v farmatsii. Ternopil.
Hroshovyi T. A., Belei N. M., Kucherenko L. I. (2007). Optymizatsiia tekhnolohichnykh protsesiv stvorennia likarskykh zasobiv za dopomohoiu metematychnoho planuvannia eksperymentu. Farmatsevtychnyi chasopys, 1, 21-29.
Palchevska, T. A., Saliy, O. O., Baula, O. P., Palchevskyі, K. V., Onіshchuk O. M. (2021). The role of excipients of trometamolum and meglumine in the formation of biopharmaceutical properties of medicinal products of various pharmacites. Farmatsevtychnyi Zhurnal, 76, 4, 64-75. doi: 10.32352/0367-3057.4.21.06.
Hroshovyi, T. A., Demchuk, M. B., Beley, N. M., Nayda, Y. V., Pavliuk, B. V. (2020). Dyzain eksperymentu pry provedenni doslidzhen iz stvorennia tabletovanykh likarskykh zasobiv. Farmatsevtychnyi chasopys, 2, 101-110. doi: 10.11603/2312-0967.2020.2.11204.
Pelekh, I. R., Bilous, S. B. (2018). Suchasni pidkhody do zastosuvannia emulhatoriv ta konservantiv u skladi dermatolohichnykh likarskykh zasobiv. Farmatsevtychnyi chasopys, 3, 52-57. doi: 10.11603/2312-0967.2018.3.9453.
Zarmpi, P., Flanagan, T., Meehan, E., Mann, J., Fotaki, N. (2020). Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants. AAPS J. 22, 46. doi: 10.1208/s12248-019-0406-y.
N Politis, S., Colombo, P., Colombo, G., M Rekkas, D. (2017). Design of experiments (DoE) in pharmaceutical development. Drug development and industrial pharmacy, 43, 6, 889-901. doi: 10.1080/03639045.2017. 1291672.
Fukuda, I., Pinto, C., Moreira, C., Saviano, A., Lourenço, F. (2018). Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD). Brazilian Journal оf Pharmaceutical Sciences, 54 (spe), e01006. doi: 10.1590/s2175-97902018000001006.
Kutova, O., Sahaidak-Nikitiuk, R., Kovalevska, I. (2021). The method for identification of mathematical models in two-factor pharmaceutical research. Social Pharmacy In Health Care, 7, 3, 3-11. doi: 10.24959/sphhcj.21.227.
Krowczynski, L., Krasowaka H. (1975). Metody analityczne stosowane w badaniach biofarmaceutycznych. Biul. Inform. Inst. przem. Pharm, 23, 3. 284-293.
Derzhavna farmakopeia Ukrainy (2015). / DP «Naukovo-ekspertnyi farmakopeinyi tsentr». Kharkiv.
Roik, M. V., Prysiazhniuk, O. I., Denysiuk, V. O. (2017). Ohliad prohramnykh zasobiv statystychnoho analizu danykh. Efektyvna ekonomika, 7. Available at: http://www.economy.nayka.com.ua.
Goldet, G., Howick, J. (2013). Understanding GRADE: an introduction. Journal of evidence-based medicine, 6, 1, 50-54. doi: 10.1111/jebm.12018.
Demchuk, M., Chubka, M., Hroshovyi, T. (2019). The the method of random balance for studying the influence of excipientsʼ quantities on technological parameters of metformin orodispersible tablets. International Journal of Applied Pharmaceutics, 11, 3, 168-175. doi: 10.22159/ijap.2019v11i3.32792.
Downloads
Published
Issue
Section
License
Copyright (c) 2024 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
