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Publication Number
US-12070520-B2
Publication Date
2024-08-27
Expiration Date
Abstract
A transdermal drug delivery device is disclosed. Over an extended wear period, the device causes cumulative moderate irritation plus significant irritation of less than 5% and/or achieves a meaningful degree of detachment over a seven day period of less than 20%.
Core Innovation
The invention relates to a non-heat sealed transdermal drug delivery device configured as an extended-wear patch. The device includes an active ingredient layer with a skin-contacting surface and a non-skin contacting surface, where an active ingredient is combined with a pressure sensitive adhesive comprising a polyacrylate pressure sensitive adhesive. The active ingredient layer also includes at least one volatile component at least partly solubilized in the pressure sensitive adhesive of the active ingredient layer.
A release liner is positioned in direct contact with the skin-contacting surface of the active ingredient layer, and an overlay is placed adjacent to the non-skin contacting surface of the active ingredient layer. The overlay includes a polyisobutylene pressure sensitive adhesive layer and an overlay covering, and an internal backing layer is arranged between the active ingredient layer and the overlay. The release liner and the pressure sensitive adhesive layer of the overlay are in direct contact and adhered around the perimeter of the active ingredient layer to form a pressure sensitive adhesive seal between the overlay and the release liner.
The invention further specifies that the solubility of the volatile component in the pressure sensitive adhesive of the overlay is less than the solubility of the volatile component in the pressure sensitive adhesive of the active ingredient layer. This solubility relationship is used to reduce or prevent loss of the volatile component from the active ingredient layer via the pressure sensitive adhesive seal between the overlay and the release liner. The claimed process includes determining relative solubility between the volatile component in the active ingredient-layer pressure sensitive adhesive and overlay pressure sensitive adhesive and selecting the pressure sensitive adhesive accordingly, followed by device fabrication through lamination without heat sealing.
Claims Coverage
The document provides one independent claim, covering a process for making a non-heat sealed transdermal drug delivery device. The independent claim contains multiple inventive requirements: device-layer architecture, relative solubility-based pressure sensitive adhesive selection, and the formation of a perimeter pressure sensitive adhesive seal to reduce volatile loss.
Non-heat-sealed transdermal device architecture with active ingredient polyacrylate pressure sensitive adhesive and volatile component
A transdermal drug delivery device made without heat sealing, including a polymer matrix active ingredient layer with an active ingredient, a pressure sensitive adhesive comprising a polyacrylate pressure sensitive adhesive, and at least one volatile component at least partly solubilized in the pressure sensitive adhesive of the active ingredient layer, with a skin-contacting surface and a non-skin contacting surface.
Overlay and release liner perimeter pressure sensitive adhesive seal to reduce volatile loss
A release liner directly contacting the skin-contacting surface and extending beyond the active ingredient-layer perimeter, and an overlay adjacent to the non-skin contacting surface and extending beyond the active ingredient-layer perimeter. The overlay comprises a polyisobutylene pressure sensitive adhesive layer and an overlay covering, and an internal backing layer is between the active ingredient layer and the overlay; the release liner and the pressure sensitive adhesive layer of the overlay are in direct contact and adhered around the perimeter to form a pressure sensitive adhesive seal between the overlay and the release liner.
Relative solubility selection of active ingredient-layer versus overlay pressure sensitive adhesive to prevent volatile component loss
The solubility of the volatile component in the pressure sensitive adhesive of the overlay is less than the solubility of the volatile component in the pressure sensitive adhesive of the active ingredient layer, such that the pressure sensitive adhesive seal reduces or prevents loss of the volatile component from the active ingredient layer.
Solubility-determined pressure sensitive adhesive selection workflow for active ingredient layer and overlay
A process comprising determining the solubility of the volatile component in one pressure sensitive adhesive relative to the other and selecting a pressure sensitive adhesive so that either the solubility in the pressure sensitive adhesive of the active ingredient layer is greater than in the pressure sensitive adhesive of the overlay, or the solubility in the pressure sensitive adhesive of the overlay is less than in the pressure sensitive adhesive of the active ingredient layer, followed by making the device by fabricating an internal backing layer/active ingredient layer/release liner laminate and laminating the overlay onto the internal backing layer side.
Overall, the claim coverage is anchored in a layered, non-heat sealed transdermal device with an active ingredient layer using a polyacrylate pressure sensitive adhesive and a volatile component, an overlay using a polyisobutylene pressure sensitive adhesive with a perimeter pressure sensitive adhesive seal formed with the release liner, and selecting the pressure sensitive adhesive materials based on measured relative solubility so the overlay pressure sensitive adhesive has lower volatile-component solubility than the active ingredient-layer pressure sensitive adhesive to reduce volatile loss.
Stated Advantages
Reduces or prevents loss of at least one volatile component from the active ingredient layer via the pressure sensitive adhesive seal between the overlay and the release liner.
Aims to minimize skin irritation and maintain adhesion over extended wear, including cumulative moderate irritation plus significant irritation below a stated threshold and meaningful detachment below a stated threshold.
Documented Applications
Extended-wear transdermal dermal delivery patch application intended to minimize skin irritation and maintain adhesion.
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