Investigation of in vitro permeability of ketorolac tromethamine through a semipermeable membrane in the process of pharmaceutical development of transdermal therapeutic system

T. A. Shyteyeva, E. M. Bezchasnyuk, S. N. Gubar, I. V. Rusak

Abstract


Nowadays in the world practice of pharmaceutical production, there has been a recent increase of producing controlled-release medicines, primarily transdermal therapeutic systems (TTs).

Aim. To investigate the in vitro ketorolac tromethamine permeability during the pharmaceutical development of the transdermal dosage form of this medical substance, to determine of the quantitative parameters of the process and to analyze the possibility of developing TTS for anti-inflammatory and analgesic activity.

Materials and methods. The API in vitro permeability study through cellophane membrane was carried out by dialysis using a Valia-Chien diffusion device.

Results. The processes of in vitro ketorolac tromethamine penetration through the semipermeable membrane are investigated. The basic kinetic parameters of the process are determined. The scientific methodological approaches to the development of a transdermal therapeutic system are considered.

Conclusions. The analysis of character, description of the mathematical model and determination of the kinetic parameters of the permeability process of the investigated medical substance of the ketorolac tromethamine allow to assess its potential for the creation of TTS and to substantiate the further algorithm for the development of TTS anti-inflammatory and analgesic action with this API.


Keywords


in vitro permeability; ketorolac tromethamine; transdermal therapeutic system

References


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GOST Style Citations


1.         Transdermal patches : history, development and pharmacology / M. N. Pastore, Y. N. Kalia, M. Horstmann, M. S. Roberts // British J. of Pharmacol. – 2015. – Vol. 172, Issue 9. – P. 2179–2209. doi: 10.1111/bph.13059

2.         Kadam, A. S. Transdermal drug delivery : an overview / A. S. Kadam, M. P. Ratnaparkhi, Sh. P. Chadhary // Intern. J. of Res. and Development in Pharmacy and Life Sci. – 2014. – Vol. 3, Issue 4. – Р. 1042–1053. – Avaible at : http//www.ijrdpl.com

3.         Flowers, F. P. Transdermal and topical drug delivery / F. P. Flowers // Theory to Clinical Practice. – 2008. – Vol. 38, Issue 4. – Р. 726–727.

4.         Transdermal & Intradermal Drug Delivery Systems 2017. – Avaible at : http://www.pharmaedresources.com/brochures/Transdermal2017.pdf

5.         Гончаров, Н. А. Локальная терапия остеоартроза НПВС с чрескожным механизмом введения [Электронный ресурс] / Н. А. Гончаров // Мед. совет. – 2011. – № 7–8. – Режим доступа : http://www.remedium.ru/drugs/doctor/rheu–matology/detail.php

6.         Composition and method for relieving pain and inflammation, treatment of erectile dysfunction, and treatment of acne. Patent US20160220684 A1 / Nordquist R. E., Rosacker J. A., Patrick J. D. – №US14/933,53 ; declared 19.04.2016 ; published 04.08.2016.

7.         Monolithic matrix transdermal delivery system for delivering ketorolac tromethamine. Patent US5804214 A, CA2166780A1 / Wong O., Nguyen T. N. – №US08/581,531, PCT/US1994/007544 ; declared 06.07.1994 ; published 08.09.1998.

8.         Transdermal delivery of the active enantiomer of ketorolac. Patent US5589498 A, A61K31/35, A61K31/445, A61K31/405 / Mohr J. M., Baker R. W., Nakaji L. A. – №US08/470,648 ; declared 06.06.1995 ; published 31.12.1996.

9.         Reservoir–type plaster containing ketorolac. Patent WO1993024114 A1, A61P25/04, A61K47/34 / Mukae K. –№ PCT/JP1993/000674 ; declared 21.05.1993 ; published 09.12.1993.

10.       Державна фармакопея України : в 3 т. / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2–е вид. – Х. : Український науковий фармакопейний центр якості лікарських засобів, 2015. – Т. 1. – 1128 с.





DOI: https://doi.org/10.24959/uekj.18.5

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