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Development of a method of comparative analysis based on consumer properties of polymer compositions illustrated by adhesive plates

https://doi.org/10.33380/2305-2066-2025-14-2-2029

Abstract

Introduction. Polymer compositions, which are the basis of most dosage forms intended for application to the skin, including transdermal patches, determine both the biopharmaceutical properties of the drug and the consumer properties of the dosage form. Consumer properties are important for the patient. They determine the patient's commitment not only to therapy, but also to a specific manufacturer. Adhesive plates of colostomy bags are used for fixing ostomy bags and protecting the skin of the peristomal area. They are characterized by a set of consumer properties that determine their quality and may be a good model for studying the influence of consumer properties on patient preferences.

Aim. Development of comparative analysis method of adhesive plates polymer compositions based on consumer properties.

Materials and methods. To achieve the research goal, a set of methods was used, including bibliographic, analytical, comparative, survey and structural-functional analysis. To determine the weighting coefficients of various consumer characteristics of adhesive plates, a survey of experts was conducted.

Results and discussion. The main consumer properties of adhesive plates of ostomy pouches have been determined, which include: no adhesive residue on the skin after removal, ease of removal, wearing time, flexibility, ease of use, resistance to moisture and secretions, comfort of use, adhesion, strength of adhesion to the skin, prevention of leakage and no peristomal complications. Based on expert evaluation, weighting coefficients for each consumer property were determined, and a methodology for comparative evaluation of adhesive plates of ostomy pouches was proposed. The methodology can be used for comparative analysis of adhesive plates from different manufacturers.

Conclusion. A methodology for the comparative evaluation of ostomy pouches was successfully developed. It can be used as a basis for developing a similar methodology for evaluating skin-applied dosage forms based on their consumer properties.

About the Authors

M. A. Mandrik
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University); A. V. Topchiev Institute of Petrochemical Synthesis, RAS (TIPS RAS)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991; 
29, Leninsky prospekt, Moscow, 119991



S. A. Albagachiev
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991



L. A. Korol
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991



E. A. Shemetova
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991



I. I. Krasnyuk
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991



G. V. Ramenskaya
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991



I. A. Sadkovskii
I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University); A. V. Topchiev Institute of Petrochemical Synthesis, RAS (TIPS RAS)
Russian Federation

8/2, Trubetskaya str., Mosсow, 119991; 
29, Leninsky prospekt, Moscow, 119991



References

1. Virgin-Elliston T., Nonboe P., Boisen E. B., Koblauch H. Evaluating the Performance and Perception of a Stoma Bag Full-Circle Filter in People with a Colostomy or an Ileostomy—Two Randomized Crossover Trials. Healthcare. 2023;11(3):369. DOI: 10.3390/healthcare11030369.

2. Gilpin V., Magee N., Scott C., Pourshahidi L. K., Gill C. I. R., Simpson E. E. A., McCreadie K., Davis J. Evolution of Ostomy Pouch Design: Opportunities for Composite Technologies to Advance Patient Care. Journal of Composites Science. 2024;8(10):388. DOI: 10.3390/jcs8100388.

3. Kotler P., McDougall G. H. G. Marketing essentials. Toronto: Prentice-Hall Canada Inc; 1984. 556 p.

4. Harold A. Linstone, Murray Turoff. The delphi method. Reading: Addison-Wesley; 1975. 620 p.

5. Nasa P., Jain R., Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World Journal of Methodology. 2021;11(4):116–129. DOI: 10.5662/wjm.v11.i4.116.

6. Bonnichsen O. Elicitation of ostomy pouch preferences: a discrete-choice experiment. The Patient: Patient-Centered Outcomes Research. 2011;4(3):163–175. DOI: 10.2165/11586430-000000000-00000.

7. Chaumier D., Gadrat C. Relevance of a new flexible convex stoma appliance. WCET Journal. 2017;37(3):26–28.

8. Treloar L. R. G. The physics of rubber elasticity. Oxford: Clarendon Press, Oxford University Press; 1975. 324 p.

9. Augustus Edward Hough Love. A treatise on the mathematical theory of elasticity: Fourth edition. Cambridge: Cambridge: at the University Press; 1959. 662 p.

10. Jacob Lubliner. Plasticity theory. Mineola: Dover Publications Incorporated; 2013. 544 p.

11. Södergård B., Tredal I., Hemmingsson I., Leven M., Dorange A. C. Patient preference of ostomy pouching systems–focus group interviews with stoma care patients. Value in Health. 2014;17(295):A39.

12. Cilurzo F., Gennari C. G. M., Minghetti P. Adhesive properties: a critical issue in transdermal patch development. Expert Opinion on Drug Delivery. 2012;9(1):33–45. DOI: 10.1517/17425247.2012.637107.

13. Spencer T. S., Smith S. E., Conjeevaram S. Adhesive interactions between polymers and skin in transdermal delivery systems. Abstracts of papers of the american chemical society. 1990;200:75.

14. Hedegaard C., Ajslev T., Zeeberg R., Hansen A. S. Leakage and peristomal skin complications influences user comfort and confidence and are associated with reduced quality of life in people with a stoma. WCET Journal. 2020;40(4):23–29. DOI: 10.33235/wcet.40.4.23-29.

15. Doctor K., Colibaseanu D. T. Peristomal skin complications: causes, effects, and treatments. Chronic Wound Care Management and Research. 2016;4:1–6. DOI: 10.2147/CWCMR.S93615.

16. Down G., Vestergaard M., Ajslev T. A., Boisen E. B., Nielsen L. F. Perception of leakage: data from the Ostomy Life Study 2019. British Journal of Nursing. 2021;30(22):4–12. DOI: 10.12968/bjon.2021.30.22.S4.

17. Nafees B., Størling Z.M., Hindsberger C., Lloyd A. The ostomy leak impact tool: development and validation of a new patient-reported tool to measure the burden of leakage in ostomy device users. Health and Quality of Life Outcomes. 2018;16(1):231. DOI: 10.1186/s12955-018-1054-0.

18. Nafees B., Rasmussen M., LLoyd A. The Ostomy-Q: Development and Psychometric Validation of an Instrument to Evaluate Outcomes Associated with Ostomy Appliances. Ostomy Wound Management. 2017;63(1):12–22.

19. Prieto L., Thorsen H., Juul K. Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. Health and Quality of Life Outcomes. 2005;3(1):62. DOI: 10.1186/1477-7525-3-62.

20. Le Ber F. Using a novel breathable silicone adhesive (Sil2™ technology) in stoma appliances to improve peristomal skin health: answering the key questions. British Journal of Nursing. 2020;29(16):16–21. DOI: 10.12968/bjon.2020.29.16.S16.

21. Berg K. Randomized cross-over comparison of adhesively-coupled colostomy pouching systems. Journal of Wound, Ostomy and Continence Nursing. 2005;32(3S):S24. DOI: 10.1097/00152192-200505002-00080.

22. Sagap I., Loo G. H., Azman Z. A. M., Mazlan L., Gan S. Y., Eng H. S., Henry F. Randomised controlled trial to assess and compare the performance and safety of two-piece ostomy appliances. British Journal of Nursing. 2022;31(22):34–42. DOI: 10.12968/bjon.2022.31.22.S34.

23. Taroc A.-M. A guide for adhesive removal: Principles, practice, and products: Combining skill and knowledge ensures safe removal. American Nurse Today. 2017;12(10):24–27.

24. Hansen D. Skin adhesives for ostomy care applications. Water diffusion in polymer composites & its effect on adhesion. PhD Dissertation, version of record. Lyngby: Technical University of Denmark; 2020. 146 p.

25. Richbourg L., Fellows J., Arroyave W. D. Ostomy pouch wear time in the United States. Journal of Wound, Ostomy & Continence Nursing. 2008;35(5):504-508. DOI: 10.1097/01.WON.0000335962.75737.b3.

26. de Freitas Perella C. G. Consumer Preferences in the Portuguese Ostomy Care Market. Master’s Thesis. 2021.

27. Denyer J. Reducing pain during the removal of adhesive and adherent products. British Journal of Nursing. 2011;20(8):30–35. DOI: 10.12968/bjon.2011.20.Sup8.S28.

28. Stroebech E., Hansen M., Loevdal A. L. V., Emme N. P. Ostomy base plate and methods of preventing contamination of the adhesive of the base plate. United States patent US 20230301817A1. 2023 Sep. 28.


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Mandrik M.A., Albagachiev S.A., Korol L.A., Shemetova E.A., Krasnyuk I.I., Ramenskaya G.V., Sadkovskii I.A. Development of a method of comparative analysis based on consumer properties of polymer compositions illustrated by adhesive plates. Drug development & registration. 2025;14(2):170-183. (In Russ.) https://doi.org/10.33380/2305-2066-2025-14-2-2029

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)