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Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl

a technology of silicone adhesive and fentanyl, which is applied in the direction of bandages, biocide, drug compositions, etc., can solve the problems of more drug degradation and/or evaporation during coating and drying, and achieve the effects of improving the adhesion of transdermal devices to skin, improving the transdermal release of fentanyl, and reducing residual amounts of fentanyl

Inactive Publication Date: 2006-09-21
MYLAN PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0034] An adhesive layer according to the present invention was found to provide improved transdermal release of fentanyl, as well as improved adhesion of transdermal devices to skin. Also with the present invention, greater amounts of fentanyl can be delivered from the patch than from solution-based matrix patches, thus leaving lower residual amounts of fentanyl in the patch after administration.

Problems solved by technology

6) that other solvents, such as heptane and toluene, are not suitable because they require higher processing temperatures and thus result in more drug degradation and / or evaporation during coating and drying.

Method used

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  • Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl
  • Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl
  • Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0113] Fentanyl free base (0.0245 kg) is uniformly dispersed in 360 Medical Fluid, 100cSt (0.061 kg), in a glass jar with the help of a Ultra-Turrax T8 dispersing unit for 20 minutes. This premix is added slowly to heptane-solvated BIO-PSA® 7-4201 (0.751 kg), 70% w / w solids content, with continuous mixing utilizing a Glass-Col mixer. This is mixed for 20 minutes. Using a Warner-Mathis KTF coater, the mixture is then coated onto a release liner (Scotchpak® 1022) and then dried at 78° C. for about 10 minutes to obtain a coat weight of 99.1 g / m2. The dried film is then laminated onto a backing film (MediFlex®1000). Patches of appropriate size are then die-cut from the laminate prior to analyses.

example 2

[0114] Fentanyl free base (3.20 g) and 360 Medical Fluid, 100 cSt (4.00 g) are added in a 4 ounce glass jar. To this jar half of the pre-weighed heptane-solvated BIO-PSA® 7-4201 (103.34 g), 70.45% w / w solids content, is added. This mix is then homogenized with the help of a dispersing unit (D7801, Dottingen, TYP-1020 L) for 3 minutes. To this mixture the remaining half of the heptane-solvated BIO-PSA® 7-4201 is added. This blend is mixed with a simple lab blender for 3 minutes. Using a fixed knife, the blend is then coated onto a release liner (ScotchPak™ 1022) and then dried at 75° C. for 10 minutes to obtain a coat weight of 90-100 g / m2. The dried film is then laminated onto a backing film (Mediflex® 1000). Patches of appropriate size are then die-cut from the laminate prior to analysis.

example 3

[0115] Fentanyl free base (2.00 g) is homogenized in 360 Medical Fluid-100 cSt (5.00 g) in a 4 ounce glass jar with the help of a dispersing unit (D7801, Dottingen, TYP-1020 L) for 3 minutes. To this premix heptane-solvated BIO-PSA® 7-4201 (61.43 g), 70% w / w solids content, is added. This blend is mixed with a simple lab blender for 3 minutes. Using a fixed knife, the blend is then coated onto a release liner (ScotchPak™ 1022) and then dried at room temperature for 5 minutes and 70° C. for 10 minutes to obtain a coat weight of 90-100 g / m2. The dried film is then laminated onto a backing film (Mediflex® 1000). Patches of appropriate size are then die-cut from the laminate prior to analysis.

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Abstract

Silicone adhesive formulations are provided, in which fentanyl particles are suspended one or more a solvated silicone adhesives. The formulations can be used for manufacturing improved, matrix-type transdermal devices for administering fentanyl.

Description

FIELD OF THE INVENTION [0001] The present invention relates generally to the field of transdermal drug delivery. More particularly, the present invention relates to fentanyl suspension-based, silicone pressure sensitive adhesive formulations and their use in making devices for improved transdermal delivery of fentanyl. BACKGROUND OF THE INVENTION [0002] A pressure sensitive adhesive is a material that adheres to a surface with slight pressure and releases from the surface with negligible transfer of the adhesive to the surface. Silicone pressure sensitive adhesives in particular have been used for transdermal drug delivery, which involves administering a drug by adhering a drug-containing device or patch to a patient's skin. [0003] One type of transdermal patch is a polymer matrix or monolithic device in which the active agent is contained in a polymer matrix film through which the active agent diffuses to the skin. Such patches are preferred because they are relatively simpler to m...

Claims

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Application Information

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IPC IPC(8): A61K31/445A61K9/70
CPCA61K9/7069Y10T156/10A61K31/445A61P25/04
Inventor MILLER, KENNETH J. IIGOVIL, SHARAD K.BHATIA, KULJIT SINGH
Owner MYLAN PHARMA INC