Composition and method for controlling drug delivery from silicone adhesive blends

a technology of silicone adhesive and blend, which is applied in the direction of pharmaceutical delivery mechanism, bandage, sheet delivery, etc., can solve the problems of increased shear of pressure-sensitive adhesive materials, limited commercial application of transdermal drug delivery systems, and loss of cohesivity and adhesion,

Inactive Publication Date: 2005-01-27
NOVEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0013] It is the object of the present invention to provide compositions and methods for delivering active agents and, in particular, amine-functional and basic drugs, that are otherwise adversely affecting or affected by silicone-based polymers in adhesive compositions of transdermal systems, that reliably prevent/inhibit crystallization of t

Problems solved by technology

However, only limited commercial exploitation of transdermal drug delivery systems has been achieved due in large part to the many practical problems to be overcome with real systems.
These problems include the solubility of the drug in the polymeric or adhesive layer, the effect of the drug on the polymeric or adhesive layer, delivery of the drug to the skin and through the stratum corneum at a constant rate over a prolonged period, and stability of the transdermal drug delivery system during storage prior to use.
However, fentanyl and other amine-functional drugs including, for example nitroglycerin, scopolamine, clonidine, nicotine, tetracain, ramipril and enalapril, that are desirable to be delivered transdermally can interact with silicone adhesives by acting as catalysts for the condensation of silicone-bonded hydroxyl groups (thereby resulting in loss of cohe

Method used

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  • Composition and method for controlling drug delivery from silicone adhesive blends
  • Composition and method for controlling drug delivery from silicone adhesive blends
  • Composition and method for controlling drug delivery from silicone adhesive blends

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examples

[0033] The following specific examples are included as illustrative of topical systems and compositions within the contemplation of the invention. These examples are in no way intended to be limiting of the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art to which the invention pertains. The weight percentages in the examples are based on dry weight of the total transdermal composition, unless otherwise noted.

[0034] As used herein, the term, “flux” is defined as the absorption of the drug through the skin or mucosa, and is described by Fick's first law of diffusion:

J=−D(dCm / dx), [0035] where J is the flux in g / cm2 / sec, D is the diffusion coefficient of the drug through the skin or mucosa in cm2 / sec and Dcm / dx is the concentration gradient of the drug across the skin or mucosa.

[0036] The following commercially available products were used in the example: “BIO-PSA 7-4202 and 7-4502 are trademarks of Dow Corning Corporation, Medical...

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Abstract

Compositions and methods for controlling transdermal drug delivery, particularly of amine-functional and basic drugs, comprising a blend of a first silicone-based polymer having a reduced silanol concentration and a second silicone-based polymer have a substantial or high silanol concentration. The blend of such silicone-based polymers, particularly pressure-sensitive silicone adhesives, provides sufficient drug solubility and reduced initial drug delivery onset to permit a prolonged delivery duration at a substantially zero-order rate of delivery.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 488,928 filed Jul. 21, 2003, which is expressly incorporated by reference in its entirety.BACKGROUND OF THE INVENTION [0002] 1. Field of Invention [0003] The present invention relates to the transdermal delivery of drugs from a silicone-based polymeric mixture. More particularly the present invention relates to methods and compositions for the controlled transdermal delivery of drugs that are otherwise adversely affecting or affected by silicone-based adhesives, such as basic and amine-functional drugs. [0004] 2. Description of Related Art [0005] Delivery of certain drugs transdermally has been known to be theoretically possible for many years. However, only limited commercial exploitation of transdermal drug delivery systems has been achieved due in large part to the many practical problems to be overcome with real systems. These problems include the solubil...

Claims

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Application Information

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IPC IPC(8): A61K9/70
CPCA61K9/7069
Inventor HOUZE, DAVID
Owner NOVEN PHARMA
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