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DOI: https://doi.org/10.22263/2312-4156.2024.6.124

O.A. Sushinskaya, N.S. Golyak
Development of the combined anti-inflammatory spray and its technological parameterization
Belarusian State Medical University, Minsk, Republic of Belarus

Vestnik VGMU. 2024;23(6):124-132.

Abstract.
Objectives. To develop the composition of the combined anti-inflammatory spray for external application.
Material and methods. While developing the composition, ibuprofen was used as a non-steroidal anti-inflammatory agent and Artemisia absinthium liquid extract 1:1 - as a herbal component. The choice of the combined spray composition was carried out by means of organoleptic evaluation of the experimental compositions, determination of their physicochemical parameters (relative density, dynamic viscosity, pH) as well as evaluation of dynamic characteristics of atomization (cone angle and static spray torch prints, surface area and volumetric zone of atomization). Physicochemical parameters were determined in accordance with generally accepted pharmacopoeial methods. The methods described in the scientific literature were used to evaluate dynamic parameters. The composition technological indicators (mass and yield of the package contents, homogeneity of the dose mass and number of doses in the package) were determined according to pharmacopoeial methods.
Results. In the course of the development of a combined spray for external application, theobtained composition containing ibuprofen and liquid extract of Artemisia absinthium 1:1 as active components, ethanol 96% as the main solvent, polyethylene glycol 400 as a solubilizer, polyvinylpyrrolidone as a film former and purified water was optimally selected. The dynamic viscosity of the spray was 8.234±0.052 mPa×s, relative density was 0.939±0.001, and pH was 5.19±0.01. The recommended spraying distance of the composition is from 5 to 15 cm, which provides a uniform jet spray with an average spray angle of 32.03° to 44.61° and the largest surface area and atomization surface area of 232.78 cm3 and 345.63 cm3, respectively. The vial content yield averaged 98.50±0.24%, corresponding to 555±1.4 doses.
Conclusions. The composition of the combined spray for external use has been developed. The composition has all necessary organoleptic, physico-chemical and technological characteristics and it can be offered as a promising anti-inflammatory drug.
Keywords: spray, liquid extract, Artemisia absinthium, ibuprofen, nonsteroidal anti-inflammatory drugs, technological characteristics, pharmaceutical technology.

The study was performed as the part of State Scientific Research Program 2 – Chemical processes, reagents and technologies, bioregulators and bioorganic chemistry – subprogram 2.2 – Synthesis and targeted modification of bioprocess regulators (Bioregulators) – tasks 2.2.3. – To obtain and standardize extraction dosage forms with an increased content of biologically active substances (state registration number 20220401, March, 30, 2022).

References

1. Patel A, Bell M, O'Connor C, Inchley A, Wibawa J, Lane ME. Delivery of ibuprofen to the skin. Int J Pharm. 2013 Nov;457(1):9-13. doi: http://dx.doi.org/10.1016/j.ijpharm.2013.09.019
2. Bodhankar M, Kavade V, Patil A. Consequence of calendula oil on the in-vitro percutaneous absorption of diclofenac sodium. J Drug Deliv Ther. 2012 May;2(3):118-120. doi: http://dx.doi.org/10.22270/jddt.v2i3.139
3. Zhitkova RSh. Use of transdermal forms of non-steroidal drugs in physician practice. Sovrem Meditsina. 2016;(1):96-98. (In Russ.)
4. Vinay J, Ravi MC, Murthy GN, Prasanna SM. Formulation and characterization of analgesic and anti-inflammatory transdermal Nanogel containing combination of herbal extract and synthetic drug. J Pharmacogn Phytochem. 2023;12(1):130-134.
5. Jurca T, Józsa L, Suciu R, Pallag A, Marian E, Bácskay I, et al. Formulation of Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents for the Treatment of Rheumatoid Arthritis. Molecules. 2020 Dec;26(1):24. doi: http://dx.doi.org/10.3390/molecules26010024
6. M-vo zdravookhraneniya Resp. Belarus', Tsentr ekspertiz i ispytanii v zdravookhranenii; Sheryakov AA, red. State Pharmacopoeia of the Republic of Belarus: v 2 t: vved v deistvie s 1 yanv 2013 g prikazom M-va zdravookhraneniya Resp Belarus' ot 25.04.2012 g № 453. T 1. Obshchie metody kontrolya kachestva lekarstvennykh sredstv. Molodechno, RB: Pobeda; 2012. 1220 р. (In Russ.)
7. Evraziiskogo ekonomicheskogo soyuza. T 1, ch 1. Moscow, RF: Evraziiskaya ekonomicheskaya komissiya; 2020. 584 р. (In Russ.)
8. Gulenkov AS, Mizina PG. Sprays - pharmaceutical development design (literature review). Voprosy Obespecheniya Kachestva Lekarstvennykh Sredstv. 2023;(3(41)):74-83. (In Russ.)
9. Yankova VG, Gribanova SV, Udyanskaya IL, Krasnyuk II, Lozhkin YuA, Gobyzov OA, i dr. Study of disperse composition of xylometazoline hydrochloride dosed nasal spray drops by the shadow photography method. Farmatsiya. 2015;(5):29-33. (In Russ.)
10. Zagorulko EYu, Teslev AA. Methods of determining atomization characteristics of sprays. V: Innovacii v zdorov'e nacii: sb materialov VI Vseros nauch-prakt konf s mezhdunar uchastiem, Sankt-Peterburg, 14-15 nojab. St. Petersburg, RF: SPHFU; 2018. Р. 128-131. (In Russ.)
11. Lozhkin YuA, Gobyzov OA, Yankova VG, Gribanova SV, Udyanskaya IL, Grigoryeva VYu, i dr. Analysis of disperse composition and dynamic spray characteristics of aerosol-spray forms of throat preparations. Vopr Prakt Pediatrii. 2016;11(6):30-35. (In Russ.)
12. Sushinskaya OA, Golyak NS. Technology of obtaining and standardization of liquid extract of wormwood 1:1. Recept. 2023;(vyp 4, ch 26):474–483. (In Russ.). doi: http://dx.doi.org/10.34883/PI.2023.26.4.008
13. Sushinskaya OA. Quantitative determination of the sum of flavonoids in the liquid extract of bitter wormwood. Vestn VGMU. 2023;22(5):88-96. (In Russ.). doi: http://dx.doi.org/10.22263/2312-4156.2023.5.82
14. Umar AK, Butarbutar M, Sriwidodo S, Wathoni N. Film-forming sprays for topical drug delivery. Drug Des Devel Ther. 2020 Jul:14:2909-2925. doi: http://dx.doi.org/10.2147/DDDT.S256666

Submitted 23.09.2024
Accepted 04.12.2024

Information about authors:
O.A. Sushinskaya – Master of Pharmaceutical Sciences, senior lecturer of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-6801-7285,
e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Olga A. Sushinskaya;
N.S. Golyak – Candidate of Pharmaceutical Sciences, associate professor, head of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-4904-6523.

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