Barrier therapies supporting the biology of the mucosal barrier-medical devices for common clinical mucosal disorders

摘要

Recently mucosal barrier therapies have been either CE marked or licensed by Food and Drug Administration (FDA) as medical devices. A barrier therapy (BT) uses a physical non-drug mode of action as its sole mechanism to manage a clinical syndrome. A BT is verified as technically or biologically safe having efficacy that has been proven by valid clinical trials. However, it remains unclear what anatomical portions of the mucosa are physically engaged by any given BT. Therefore, this article clarifies the physical basis for clinical efficacy of any given mucosal BT’s. Current regulatory classification of medical devices is defined. More importantly, the biology of mucosal barrier is detailed by structure, compartmental elements and function. A live-function or cross-sectional anatomical perspective of the mucosa is provided. A cross-sectional anatomical perspective of the mucosa is provided in order to highlight the physical point of contact for any given mucosal BT’s. Five traits of an effective mucosal BT are proposed to assess traits of fitness for any given BT. A BT is either classical, possessing four to five traits, or non-classical, possessing three or fewer traits. Among 16 commercially available mucosal BT’s which share nine distinct formulations, most are non-classical BT while two (alginate and polymeric sucralfate) are classical mucosal BT’s.