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Amorphous rotigotine transdermal system

An amorphous and transdermal drug delivery technology, which can be used in nervous system diseases, non-central analgesics, drug combinations, etc. System stability and other issues

Inactive Publication Date: 2011-12-14
MYLAN TECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the prior art does not propose a method for stabilizing an amorphous viscose-dispersed (i.e., drug dispersed in viscose) matrix drug delivery system
Furthermore, the prior art does not suggest a method for re-stabilizing amorphous viscose dispersed drug delivery systems

Method used

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Embodiment Construction

[0050] Generally, the present invention relates to a transdermal delivery device (or "pouch") comprising a backing layer, an adhesive matrix layer, and a release liner, the adhesive matrix comprising a supersaturated concentration of at least one active agent.

[0051] Here, "transdermal" refers to drug delivery through the skin or mucosal tissues. Therefore, unless otherwise stated, the terms "transdermal" and "transmucosal" are used interchangeably. Likewise, the terms "skin", "skin", "dermis", "epidermis", "mucosal membrane" and the like are also used interchangeably unless otherwise indicated.

[0052] The backing layer is a flexible substrate that provides a barrier that prevents the active drug from leaving the desired direction of drug release. All known backing layers capable of fulfilling this purpose can be used in the present invention.

[0053] In some embodiments, the backing layer is composed of a material that is substantially amorphous promoted and free of c...

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PUM

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Abstract

The present invention relates to a transdermal drug delivery device comprising a backing layer, an adhesive matrix layer comprising a supersaturated concentration of rotigotine substantially in amorphous form in said adhesive matrix and a release liner . The invention also relates to a process for the preparation of an adhesive matrix containing a supersaturated concentration of rotigotine substantially in amorphous form. In addition, the present invention relates to methods of stabilizing and reconstituting metastable amorphous drug transdermal systems during their manufacture, storage, shipping and handling.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of the filing date of US Provisional Patent Application No. 61 / 195,319, filed October 6, 2008, which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to transdermal drug delivery systems. Background technique [0004] Drug delivery through the skin has many benefits. First, it is a comfortable, convenient and non-invasive route of administration. In addition, this mode of administration allows for uninterrupted therapy and a higher degree of control of drug concentrations in the blood. [0005] US Patent No. 5,164,190 discloses the transdermal administration of a hydrophobic drug through a diffusion mechanism, wherein the drug is dissolved in a carrier at a concentration of 20% to 80% of the saturation concentration. However, this patent does not propose an amorphous transdermal drug delivery system in which the drug is su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/381
CPCA61K9/7038A61K31/381A61P25/16A61P29/00A61K9/7061A61K9/7069A61K9/7084
Inventor 唐健生约瑟夫·M·戴维瑞斯肯尼斯·J·米勒二世拉塞尔·D·贝斯特
Owner MYLAN TECH INC
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