Test methods for adhesive polymer compositions in development and quality control for stoma care products on the example of adhesive baseplates (review)

Introduction. Adhesive baseplates, designed to fix ostomy bags and protect the skin of the peristomal area of ostomy patients, are a key element of an ostomy bag or urine bag. The functionality of adhesive baseplates is ensured by a set of their technical characteristics and design features, which makes the choice of appropriate baseplate testing methods an important aspect in the development, production and quality control of these medical devices.

Text. For testing adhesive baseplates, methods provided by Russian and international standards, as well as those not included in them, can be used. The methods provided by the standards include description of appearance (size), testing of adhesive strength, study of surface pH, as well as tests for wet integrity and water absorbancy. Methods not included in the standards for adhesive plates, but widely described in the scientific literature and used by researchers in practice include testing of some adhesive and mechanical properties, such as tack, shear strength, as well as tensile or bending tests to characterize the strength and deformation properties of the baseplate material. In addition, for adhesive baseplates, methods for testing medical properties common to all medical devices that are exposed to skin can be used. Besides this, it is shown how the adhesive properties of baseplates can be predicted based on the rheological properties of the adhesive layer, and factors important in the selection of materials modeling skin for in vitro tests are described.

Conclusion. The review presents a detailed description of methods of interest for testing adhesive baseplates, in particular their general principles and conditions of implementation, as well as methods that allow predicting the adhesive properties of plates and determining the relationship between adhesion tests in vivo and in vitro. A number of the described methods are of interest to include in normative documentation for adhesive baseplates tests, subject to their unification and modification taking into account the characteristics of this medical device.

1. Tsujinaka S., Tan K.-Y., Miyakura Y., Fukano R., Oshima M., Konishi F., Rikiyama T. Current management of intestinal stomas and their complications. Journal of the Anus, Rectum and Colon. 2020;4(1):25–33. DOI: 10.23922/jarc.2019-032.

2. Martin S. T., Vogel J. D. Intestinal stomas. Indications, management, and complications. Advances in Surgery. 2012;46(1):19–49. DOI: 10.1016/j.yasu.2012.04.005.

3. Berti-Hearn L., Elliott B. Urostomy care. A guide for home care clinicians. Home Healthcare Now. 2019;37(5):248–255. DOI: 10.1097/NHH.0000000000000792.

4. Naumenko L. L., Zhirnova L. V. Recommendations for the rational selection of stoma care products in the IPRA of disabled people with impaired excretory functions. Mediko-socialnye problemy invalidnosti. 2019;1:22–29. (In Russ.)

5. Hedegaard C. J., Ajslev T. A., 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. World Council of Enterostomal Therapists Journal. 2020;40(4):23–29. DOI: 10.33235/wcet.40.4.23-29.

6. Cramer K., Fattman G., Nguyen-DeMary T. Ostomy appliance with moldable adhesive. United States patent US 8708987B2. 2014 Apr. 29. Available at: https://patents.google.com/patent/US8708987B2/en. Accessed 02.08.2024.

7. Andersen B. V., Hansen M. To control bending in a skin plate for use in an ostomy appliance. United States patent US 8684983B2. 2014 Apr. 1. Available at: https://patents.google.com/patent/US8684983B2/en. Accessed 02.08.2024.

8. Chaumier D., Gadrat C. Relevance of a new flexible convex stoma appliance. World Council of Enterostomal Therapists Journal. 2017;37(3):26–31.

9. McNichol L., Cobb T., Depaifve Y., Quigley M., Smitka K., Gray M. Characteristics of convex skin barriers and clinical application. Results of an international consensus panel. Journal of Wound Ostomy & Continence Nursing. 2021;48(6):524–532. DOI: 10.1097/won.0000000000000831.

10. Alaei S., Omidian H. Mucoadhesion and mechanical assessment of oral films. European Journal of Pharmaceutical Sciences. 2021;159:105727. DOI: 10.1016/j.ejps.2021.105727.

11. Schroeder I. Z., Franke P., Schaefer U. F., Lehr C.-M. Development and characterization of film forming polymeric solutions for skin drug delivery. European Journal of Pharmaceutics and Biopharmaceutics. 2007;65(1):111–121. DOI: 10.1016/j.ejpb.2006.07.015.

12. Garcia M. A., Pinotti A., Martino M. N., Zaritzky N. E. Characterization of composite hydrocolloid films. Carbohydrate polymers. 2004;56(3):339–345. DOI: 10.1016/j.carbpol.2004.03.003.

13. Takeuchi Y., Ikeda N., Tahara K., Takeuchi H. Mechanical characteristics of orally disintegrating films: Comparison of folding endurance and tensile properties. International Journal of Pharmaceutics. 2020;589:119876. DOI: 10.1016/j.ijpharm.2020.119876.

14. 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.

15. Minghetti P., Cilurzo F., Casiraghi A. Measuring adhesive performance in transdermal delivery systems. American Journal of Drug Delivery. 2004;2:193–206. DOI: 10.2165/00137696-200402030-00004.

16. Omura Y., Kenji O., Hocevar B. J. Development of methods for skin barrier peeling tests. Journal of Wound Ostomy & Continence Nursing. 2006;33(5):510–517. DOI: 10.1097/00152192-200609000-00009.

17. Raynaud J.-P., Augès M., Liorzou L., Turlier V., Lauze C. Adhesiveness of a new testosterone-in-adhesive matrix patch after extreme conditions. International Journal of Pharmaceutics. 2009;375(1–2):28–32. DOI: 10.1016/j.ijpharm.2009.03.025.

18. Queen D., Martin G. P., Marriott C., Fairbrother I. E. Assessment of the potential of a new hydrocolloid dermatological patch (Actiderm) in the treatment of steroid-responsive dermatoses. International Journal of Pharmaceutics. 1988;44(1–3):25–30. DOI: 10.1016/0378-5173(88)90096-8.

19. Jin S. G., Yousaf A. M., Jang S. W., Son M.-W., Kim K. S., Kim D.-W., Li D. X., Kim J. O., Yong C. S., Choi H.-G. In vivo wound-healing effects of novel benzalkonium chloride-loaded hydrocolloid wound dressing. Drug Development Research. 2015;76(3):157–165. DOI: 10.1002/ddr.21253.

20. Minghetti P., Cilurzo F., Montanari L. Evaluation of adhesive properties of patches based on acrylic matrices. Drug Development and Industrial Pharmacy. 1999;25(1):1–6. DOI: 10.1081/ddc-100102135.

21. Maillard-Salin D.G., Bécourt P., Couarraze G. A study of the adhesive–skin interface: correlation between adhesion and passage of a drug. International Journal of Pharmaceutics. 2000;1:121–126. DOI: 10.1016/s0378-5173(00)00369-0.

22. Ginn M. E., Noyes C. M., Jungermann E. The contact angle of water on viable human skin. Journal of Colloid and Interface Science. 1968;26(2):146–151. DOI: 10.1016/0021-9797(68)90306-8.

23. Satas D., editor. Handbook of Pressure Sensitive Adhesive Technology. Third edition. Warwick: Satas & Associates; 1999. 1017 p.

24. Lir I., Haber M., Dodiuk-Kenig H. Skin surface model material as a substrate for adhesion-to-skin testing. Journal of Adhesion Science and Technology. 2007;21(15):1497–1512. DOI: 10.1163/156856107782844783.

25. Renvoise J., Burlot D., Marin G., Derail C. Adherence performances of pressure sensitive adhesives on a model viscoelastic synthetic film: a tool for the understanding of adhesion on the human skin. International Journal of Pharmaceutics. 2009;368(1–2):83–88. DOI: 10.1016/j.ijpharm.2008.09.056.

26. Ho K. Y., Dodou K. Rheological studies on pressure-sensitive silicone adhesives and drug-in-adhesive layers as a means to characterise adhesive performance. International Journal of Pharmaceutics. 2007;333(1–2):24–33. DOI: 10.1016/j.ijpharm.2006.09.043.

27. Chang E. P. Viscoelastic windows of pressure-sensitive adhesives. The Journal of Adhesion. 1991;34(1–4):189–200. DOI: 10.1080/00218469108026513.

28. Shaw M. T., MacKnight W. J. Introduction to polymer viscoelasticity. 3rd edition. Hoboken: John Wiley & Sons; 2005. 316 p. DOI: 10.1002/0471741833.

29. Menard K. P., Menard N. R. Dynamic mechanical analysis. Third edition. 3rd edition. Boca Raton: CRC Press; 2020. 280 p. DOI: 10.1201/9780429190308.

30. 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. 2021;30(8):19. DOI: 10.12968/bjon.2021.30.sup8.19.

31. Cazón P., Morales-Sanchez E., Velazquez G., Vázquez M. Measurement of the water vapor permeability of chitosan films: A laboratory experiment on food packaging materials. Journal of Chemical Education. 2022;99(6):2403–2408. DOI: 10.1021/acs.jchemed.2c00449.

32. Steinhagen E., Colwell J., Cannon L. M. Intestinal stomas— postoperative stoma care and peristomal skin complications. Clinics in Colon and Rectal Surgery. 2017;30(03):184–192. DOI: 10.1055/s-0037-1598159.