Purpose: This work aims to establish if the assays recently introduced by the EMA and USP to characterize transdermal patches (TP) are suitable for medicated plasters (MP). Indeed, TP are developed using pressure sensitive adhesives and non-deformable backing layers, while MP can also use adhesive hydrogels or wooden-non-wooden or elastic backing layers. Methods: Six commercial MP containing NSAIDs were characterized in terms of adhesive performances by tack, shear adhesion, peel adhesion and release liner removal tests and in vitro skin permeation thought human epidermis. Results: Since the adhesive tests developed for TP were substantially borrowed from the adhesive tape industry, some drawbacks can occur when hydrogels and/or stretchable backing layers are used in MP. The main weakness concerns the use of shear adhesion test. This issue could be overcome by applying a very trivial stress by a lighter weight in place of the standard mass. A general remark concerning both TP and MP is related to the mass balance indicated by the EMA draft for the acceptance of the results of in vitro penetration studies. In the draft the mass balance is considered acceptable without further justification when the recovery of the drug substance is in the 90-110% range. At a first glance, some of our preliminary data failed to comply with this requirement. Nevertheless, the proposed range was narrow than that reported for the determination of drug content in two Eur. Ph. monographs, namely “Uniformity of dosage unit” and “Uniformity of content of single-dose preparations”. Conclusion: In our opinion, a novel assay should be studied to test the shear adhesion of adhesive hydrogels. Moreover, the recovery range for acceptance of the mass balance reported in the “study design” of the “in vitro permeation studies” should be changed according to the requirements of uniformity of content. Finally, the EMA should specify if the reference value for mass balance is the nominal drug content (as chosen in the actual set of experiments) or the drug content of the batch under experiment.

Adhesive properties and in vitro skin permeation studies of medicated plasters according to novel indications of USP and EMA / F. Cilurzo, C.G.M. Gennari, F. Selmin, S. Franzé, U.M. Musazzi, P. Minghetti, A. Casiraghi, L. Montanari. - In: THE AAPS JOURNAL. - ISSN 1550-7416. - (2013 Nov 10), pp. 1-1. ((Intervento presentato al convegno AAPS Annual Meeting and Exposition tenutosi a San Antonio nel 2013.

Adhesive properties and in vitro skin permeation studies of medicated plasters according to novel indications of USP and EMA

F. Cilurzo
Primo
;
C.G.M. Gennari
Secondo
;
F. Selmin;S. Franzé;U.M. Musazzi;P. Minghetti;A. Casiraghi
Penultimo
;
L. Montanari
Ultimo
2013

Abstract

Purpose: This work aims to establish if the assays recently introduced by the EMA and USP to characterize transdermal patches (TP) are suitable for medicated plasters (MP). Indeed, TP are developed using pressure sensitive adhesives and non-deformable backing layers, while MP can also use adhesive hydrogels or wooden-non-wooden or elastic backing layers. Methods: Six commercial MP containing NSAIDs were characterized in terms of adhesive performances by tack, shear adhesion, peel adhesion and release liner removal tests and in vitro skin permeation thought human epidermis. Results: Since the adhesive tests developed for TP were substantially borrowed from the adhesive tape industry, some drawbacks can occur when hydrogels and/or stretchable backing layers are used in MP. The main weakness concerns the use of shear adhesion test. This issue could be overcome by applying a very trivial stress by a lighter weight in place of the standard mass. A general remark concerning both TP and MP is related to the mass balance indicated by the EMA draft for the acceptance of the results of in vitro penetration studies. In the draft the mass balance is considered acceptable without further justification when the recovery of the drug substance is in the 90-110% range. At a first glance, some of our preliminary data failed to comply with this requirement. Nevertheless, the proposed range was narrow than that reported for the determination of drug content in two Eur. Ph. monographs, namely “Uniformity of dosage unit” and “Uniformity of content of single-dose preparations”. Conclusion: In our opinion, a novel assay should be studied to test the shear adhesion of adhesive hydrogels. Moreover, the recovery range for acceptance of the mass balance reported in the “study design” of the “in vitro permeation studies” should be changed according to the requirements of uniformity of content. Finally, the EMA should specify if the reference value for mass balance is the nominal drug content (as chosen in the actual set of experiments) or the drug content of the batch under experiment.
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
AAPS
http://abstracts.aaps.org/published/ContentInfo.aspx?conID=43995
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