Combined dosage form based on film and gel: technological research, search for ways of use

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Abstract

Introduction. The optimal solution for effective wound treatment is the creation of minimally invasive dosage forms that combine prolonged delivery of drugs and high adhesion to the site of application. The creation of a combined dosage form in the form of a film with a gel applied to it allows to increase the duration of the agent's presence on the affected area, providing a stable effect of the active component on cells and tissues.

Research objective. to create a combined dosage form in the form of a film with an applied mucoadhesive gel containing an antibacterial and wound-healing component, respectively.

Material and methods. Film samples were prepared on the basis of gelatin, samples based on MC, Na-CMC, Na-alginate, carbopol 940 were obtained as mucoadhesive gels. In order to provide antibacterial action, the polyvalent bacteriophage Sextaphag was introduced into the composition of the films and gels. L-arginine was added to the dosage form as a reparation stimulator.

Results. Application of the gel increases the film thickness, reduces the strength characteristics, but significantly increases the extensibility of the material. The mucoadhesiveness indices are significantly improved when using gels based on carbopol. The moisture absorption and vapor permeability indices have satisfactory values, which indicate the maintenance of a favorable environment for wound healing. An experiment on laboratory animals showed an increase in the wound defect regeneration index when using the developed composition compared to the traditional product (Levomekol).

Conclusion. The developed combined dosage form has the necessary characteristics for effective wound treatment. This combination provides increased fixation on the wound surface and a prolonged therapeutic effect. The presence of a bacteriophage in the composition of the developed product provides reliable protection against infections.

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About the authors

Victoria Yuryevna Rytchenkova

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: rytchenkovavy@mail.ru
ORCID iD: 0009-0005-0784-9685

Assistant Professor, Department of Pharmacognosy, Pharmaceutical Technology and Biotechnology

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

Sergey Viktorovich Poroyskiy

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Email: poroyskiy@mail.ru
ORCID iD: 0000-0001-6990-6482

Doctor of Medical Sciences, Associate Professor, Rector, Head of the Department of Extreme Medicine and Life Safety

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

Eleonora Fedorovna Stepanova

Federal State Budgetary Educational Institution of Higher Education “Volgograd State Medical University” of the Ministry of Health of the Russian Federation

Email: e.f.stepanova@mail.ru
ORCID iD: 0000-0002-4082-3330

Doctor of Pharmaceutical Sciences, Professor, Professor of the Department of Pharmaceutical Technology with a Course in Medical Biotechnology, Pyatigorsk Medical and Pharmaceutical Institute

Russian Federation, Kalinina, 11, Pyatigorsk, 357500

Sergey Vitalievich Rytchenkov

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Email: rytchenkovs@gmail.com
ORCID iD: 0009-0005-7597-4138

Candidate of Pharmaceutical Sciences, Senior Lecturer of the Department of Pharmacognosy, Pharmaceutical Technology and Biotechnology

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

Guzel Nailevna Genatullina

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Email: genatullina@mail.ru
ORCID iD: 0000-0001-5417-4477

Candidate of Biological Sciences, Associate Professor, Deputy Head of the Research Center, Head of the Laboratory of Microbiological and Molecular Genetic Research

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

Anna Leonidovna Yasenyavskaya

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Email: yasen_9@mail.ru
ORCID iD: 0000-0003-2998-2864

MD, PhD, Associate Professor, Head of the Research Center, Professor of the Department of Pharmacognosy, Pharmaceutical Technology and Biotechnology

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

Marina Aleksandrovna Samotrueva

Federal State Budgetary Educational Institution of Higher Education “Astrakhan State Medical University” of the Ministry of Health of the Russian Federation

Email: ms1506@mail.ru
ORCID iD: 0000-0001-5336-4455

Doctor of Medical Sciences, Professor, Vice-Rector for Research and Innovation Work, Head of the Department of Pharmacognosy, Pharmaceutical Technology and Biotechnology

Russian Federation, Bakinskaya, 121, Astrakhan, 414000

References

  1. Плетнева И.В., Петрухина Д.А., Покровская Ю.С. Разработка технологии и исследование биорастворимых пленок лекарственных противовоспалительного действия. Медико-фармацевтический журнал «Пульс». 2021; 23 (2): 80–6. http://dx.doi.org/10.26787/nydha-2686-6838-2021-23-2-80-86. [Pletneva I.V., Petrukhina D.A., Pokrovskaya Y.S. Development of technology and study of biosoluble films of medicinal anti-inflammatory action. Medical and pharmaceutical journal "Pulse". 2021; 23 (2): 80–6. doi: 10.26787/nydha-2686-6838-2021-23-2-80-86 (in Russian)].
  2. Borbolla-Jiménez, F.V.; Peña-Corona, S.I.; Farah, S.J.; Jiménez-Valdés, M.T.; Pineda-Pérez, E.; Romero-Montero, A.; Del Prado-Audelo, M.L.; Bernal-Chávez, S.A.; Magaña, J.J.; Leyva-Gómez, G. Films for Wound Healing Fabricated Using a Solvent Casting Technique. Pharmaceutics. 2023; 15 (7): 1914. doi: 10.3390/pharmaceutics15071914.
  3. Patel S., Srivastava S., Singh M.R., Singh D. Preparation and optimization of chitosan-gelatin films for sustained delivery of lupeol for wound healing. International J. of biological macromolecules. 2018; 107: 1888–97. doi: 10.1016/j.ijbiomac.2017.10.056.
  4. Agubata C.O., Mbah M.A., Akpa P.A., Ugwu G. Application of self-healing, swellable and biodegradable polymers for wound treatment. J. of Wound Care. 2021; 30 (Sup9a): 41–50. https://doi.org/10.12968/jowc.2021.30.Sup9a.IV.
  5. Москвина А.Л. Современные раневые покрытия ветеринарного применения (обзор). Вестник Марийского государственного университета. Серия «Сельскохозяйственные науки. Экономические науки». 2023; 9 (2): 155–61. doi: 10.30914/2411-9687-2023-9-2-155-161. [Moskvina A.L. Modern wound dressings for veterinary use (review). Bulletin of the Mari State University. Series "Agricultural Sciences. Economic Sciences". 2023; 9 (2): 155–61.doi: 10.30914/2411-9687-2023-9-2-155-161 (in Russian)].
  6. Cook M.T., Shorthouse D. Reconceptualising mucoadhesion for future medicines. RSC Pharmaceutics. 2024;1(5):949-957. doi: 10.1039/D4PM00149D.
  7. Майорова А.В., Сысуев Б.Б., Ханалиева И.А., Вихрова И.В. Современный ассортимент, свойства и перспективы совершенствования перевязочных средств для лечения ран. Фармация и фармакология. 2018; 6 (1): 4–32. doi: 10.19163/2307-9266-2018-6-1-4-32. [Mayorova A.V., Sysuev B.B., Khanalieva I.A., Vikhrova I.V. Modern range, properties and prospects for improving dressings for wound treatment. Pharmacy and Pharmacology. 2018; 6 (1): 4–32. doi: 10.19163/2307-9266-2018-6-1-4-32 (in Russian)].
  8. Ковязина Н.А. Исследование физико-химических свойств пластин лекарственных на основе биодеградируемых криоструктурированных полимеров. Медицинский альманах. 2017; 6 (51): 162–6. [Kovyazina N.A. Study of physicochemical properties of medicinal plates based on biodegradable cryostructured polymers. Medical almanac. - 2017; 6 (51): 162–6 (in Russian)].
  9. Харенко Е.А., Ларионова Н.И., Демина Н.Б. Мукоадгезивные лекарственные формы: количественная оценка взаимодействия пленок из синтетических и природных полимеров со слизистой тканью. Химико-фармацевтический журнал. 2008; 42 (7): 17–24. https://doi.org/10.30906/0023-1134-2008-42-7-17-24. [Kharenko E.A., Larionova N.I., Demina N.B. Mucoadhesive dosage forms: quantitative assessment of the interaction of films made of synthetic and natural polymers with mucous tissue. Chemical-pharmaceutical journal. 2008; 42 (7): 17–24. doi: 10.30906/0023-1134-2008-42-7-17-24 (in Russian)].
  10. Woertz C., Preis M., Breitkreutz J., Kleinebudde P. Assessment of test methods evaluating mucoadhesive polymers and dosage forms: An overview. European Journal of Pharmaceutics and Biopharmaceutics. 2013; 85 (3): 843–53. doi: 10.1016/j.ejpb.2013.06.023.
  11. Sikora M., Wąsik S., Semaniak J., Drulis-Kawa Z., Wiśniewska-Wrona M., Arabski M. Chitosan-based matrix as a carrier for bacteriophages. Applied Microbiology and Biotechnology. 2024; 108 (1): 6–21. doi: 10.1007/s00253-023-12838-0.
  12. Рытченков С.В., Поройский С.В., Степанова Э.Ф., Татаренко-Козьмина Т.Ю., Плетень А.П. Фармацевтическая разработка адгезивного геля на базе биодеградируемого природного комплекса. Вопросы биологической, медицинской и фармацевтической химии. 2024; 27 (5): 23–30. doi: 10.29296/25877313-2024-05-03. [Rytchenkov S.V., Poroisky S.V., Stepanova E.F., Tatarenko-Kozmina T.Y., Pleten A.P. Pharmaceutical development of an adhesive gel based on a biodegradable natural complex. Issues of Biological, Medical and Pharmaceutical Chemistry. 2024; 27 (5): 23–30. doi: 10.29296/25877313-2024-05-03 (in Russian)]
  13. Рытченкова В.Ю. Рытченков С.В., Степанова Э.Ф. Фармако-технологический анализ гелевых основ, используемых для создания ранозаживляющих средств. Фармацевтическое дело и технология лекарств. 2024; 5 (29): 33–40. doi: 10.33920/med-13-2405-04. [Rytchenkova V.Y., Rytchenkov S.V., Stepanova E.F. Pharmaco-technological analysis of gel bases used to create wound healing agents. Pharmaceutical business and drug technology. 2024; 5 (29): 33–40. doi: 10.33920/med-13-2405-04 (in Russian)].
  14. Cano-Vicent A., Tuñón-Molina A., Martí M., Serrano-Aroca А. Biocompatible Chitosan Films Containing Acetic Acid Manifested Potent Antiviral Activity against Enveloped and Non-Enveloped Viruses. International J. of Molecular Sciences. 2023; 24 (15): 12028. doi: 10.3390/ijms241512028.
  15. Ковязина Н.А. Изучение физико-химических свойств пленок лекарственных секстафаг. Вестник ВГУ. Серия: химия, биология, фармация. 2022; 1: 78–84. [Kovyazina N.A. Study of physicochemical properties of films of medicinal sextaphag. VSU Bulletin. Series: chemistry, biology, pharmacy. 2022; 1: 78–84. (in Russian)].
  16. Pinto A.M., Pereira R., Martins A.J., Pastrana L.M., Cerqueira M.A., Sillankorva S. Designing an antimicrobial film for wound applications incorporating bacteriophages and ε-poly-l-lysine. International J. of Biological Macromolecules. 2024; 268: 131963. doi: 10.1016/j.ijbiomac.2024.131963.
  17. Shatabayeva E.O., Kaldybekov D.B., Ulmanova L., Zhaisanbayeva B.A., Mun E.A., Kenessova Z.A., Kudaibergenov S.E. Khutoryanskiy V.V. Enhancing mucoadhesive properties of gelatin through chemical modification with unsaturated anhydrides. Biomacromolecules. 2024; 25 (3): 1612–28. doi: 10.1021/acs.biomac.3c01183.
  18. Савустьяненко А.В. L-аргинин ускоряет заживление ран: новые механизмы и данные клинических исследований. Травма. 2018; 19 (1): 27–33. doi: 10.22141/1608-1706.1.19.2018.127299. [Savustyanenko A.V. L-arginine accelerates wound healing: new mechanisms and clinical trial data. Trauma. 2018; 19 (1): 27–33. doi: 10.22141/1608-1706.1.19.2018.127299. (in Russian)].
  19. Durmus A.S., Tuzcu M., Ozdemir O., Orhan C., Sahin N., Ozercan I.H., Komorowski J.R., Ali S. et al. Arginine silicate inositol complex accelerates cutaneous wound healing. Biological trace element research. 2017; 177: 122–31. doi: 10.1007/s12011-016-0857-2.
  20. Андреев А.А., Глухов А.А., Остроушко А.П., Боев С.Н., Лаптиёва А.Ю., Григорьева Е.В., Коновалов П.А., Архипов Д.В. Моделирование асептических и септических ран мягких тканей. Бюллетень экспериментальной биологии и медицины. 2022; 173 (3): 272–8. [Andreev A.A., Glukhov A.A., Ostroushko A.P., Boev S.N., Laptieva A.Y., Grigorieva E.V., Konovalov P.A., Arkhipov D.V. Modeling of aseptic and septic wounds of soft tissues. Bulletin of Experimental Biology and Medicine. 2022; 173 (3): 272–8. doi: 10.47056/0365-9615-2022-173-3-272-278 (in Russian)].
  21. Рытченкова В.Ю. Рытченков С.В., Степанова Э.Ф. Фармако-технологический анализ гелевых основ, используемых для создания ранозаживляющих средств. Фармацевтическое дело и технология лекарств. 2024; 5 (29): 33–40. doi: 10.33920/med-13-2405-04. [Rytchenkova V.Y., Rytchenkov S.V., Stepanova E.F. Pharmaco-technological analysis of gel bases used to create wound healing agents. Pharmaceutical business and drug technology. 2024; 5 (29): 33–40. doi: 10.33920/med-13-2405-04. (in Russian)].
  22. Рытченков С.В., Поройский С.В., Степанова Э.Ф., Татаренко-Козьмина Т.Ю., Плетень А.П. Фармацевтическая разработка адгезивного геля на базе биодеградируемого природного комплекса. Вопросы биологической, медицинской и фармацевтической химии. 2024; 27 (5): 23–30. doi: 10.29296/25877313-2024-05-03.

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