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Sheet and liquid combination systems for dermal drug delivery

A thin-layer, medium-liquid technology, applied in nervous system diseases, antipyretics, drug combinations, etc.

Active Publication Date: 2014-02-19
张洁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is difficult to obtain different expected onset times if these two drug ingredients are placed in the same "single component" product

Method used

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  • Sheet and liquid combination systems for dermal drug delivery
  • Sheet and liquid combination systems for dermal drug delivery
  • Sheet and liquid combination systems for dermal drug delivery

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0073] The following system containing a thin layer and a vehicle fluid that can provide skin anesthesia or analgesia is an example of an embodiment of the present invention.

[0074] (1) In this and other examples, tetracaine or TC refers to tetracaine base unless otherwise stated. Tetracaine (base) (purchased from Spectrum Chemical) of the United States Pharmacopoeia specification was dissolved in a 70:30 volume ratio isopropanol aqueous solution (Western Family brand) to obtain a 10% (weight ratio) tetracaine solution. In this and other examples, "70% isopropanol" or "70% isopropanol solution" or "rubbing alcohol" refers to Western Family brand rubbing alcohol (70% isopropanol, 30% water, volume ratio) (2) Laminate a layer of gauze (Dusoft brand non-woven fabric, Dumex, No. 84122, single layer) to a layer of polyurethane film (Tegaderm film from 3M, purchased from Ortho-Med) to form a composite Thin layer. (3) Distribute 0.72 g of 10% tetracaine solution evenly on the gauze ...

example 2

[0079] In order to obtain skin anesthesia or analgesia, the inventors created a system containing a thin layer and a medium liquid as described below, and used the system as an exemplary embodiment of the present invention.

[0080] Step 1: Heat 10 grams of polyvinyl alcohol (PVA, sample from Amresco, with a molecular weight of 30,000 to 50,000) and 90 grams of distilled water to about 70°C and stir until a uniform 10% (weight ratio) PVA solution is obtained.

[0081] Step 2: Add 5 grams of the 10% PVA solution obtained in Step 1 to 6 grams of rubbing alcohol. Shake the container until a homogeneous solution is obtained.

[0082] Step 3: Add 0.58 g of tetracaine base (U.S. Pharmacopoeia specification, purchased from Spectrum Chemical Company) to the solution of step 2. Shake the container until all the tetracaine particles are dissolved to obtain a solution containing 5% tetracaine and 4.3% PVA.

[0083] Step 4: Hang a piece of gauze (Non-Woven Sponges from Dusoft, product number 841...

example 4

[0102] Mix 3.04 grams of the 25% PVA solution in step 1 of Example 3, 4.55 grams of rubbing alcohol, and 0.51 grams of tetracaine base until a transparent solution containing 6.3% tetracaine and 9.4% VPA is obtained. Spread about 6.7 grams (about 7 ml) of this solution evenly on a 190 square cm gauze and 3M9832 composite film (same as the composite film in step 3 of Example 3), and dry it in the oven. The dried thin layer contains 2.2 mg tetracaine and 3.3 mg PVA per square centimeter.

[0103] The following experiment uses distilled water as the medium liquid to test the abrasion resistance and anesthesia effect of the above system.

[0104] Spray distilled water with a spray bottle onto the left forearm of a human subject. The water droplets of distilled water densely covered the skin area, but did not form a continuous water layer.

[0105] Place a 2 x 3 cm thin layer (containing 2.2 mg of tetracaine and 3.3 mg of PVA per square cm) on the vehicle liquid already on the skin, wit...

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Abstract

A dermal drug delivery system is provided which comprises at least two components, for example, a sheet of a solid and flexible material, and a vehicle liquid comprising a solvent and optionally other ingredients. A drug, which can be unstable in said solvent but needs the solvent for being delivered into the skin, can be impregnated in the sheet. Other ingredients, such as agents for fastening the drug on the sheet can also be impregnated in the sheet. These two components may be stored separately and joined either shortly before or at the time of application. To use the system, the vehicle liquid may be applied either on the target skin area or on the sheet, and the sheet may then be applied on the target skin area so that the vehicle liquid is positioned between the sheet and the skin and brought into contact with the ingredients impregnated in the sheet. After the sheet and the vehicle liquid are combined in this way, the ingredients in the sheet and in the vehicle liquid are joined to form a combined formulation that is capable of delivering a drug through the skin at a desired rate. The sheet may have low enough permeability to the solvent or its vapor to control the time it takes for the solvent to evaporate across the sheet. When an appropriate local anesthetic agent, such as a tetracaine, is the drug, some embodiments of the system can have wide applications in anesthesia and pain control.

Description

technical field [0001] related application [0002] This application claims priority to US Provisional Patent No. 61 / 411,728, filed November 9, 2010, entitled "Thin Layer and Liquid Combination Transdermal Drug Delivery System." This patent application is hereby fully incorporated by reference. Background technique [0003] Transdermal drug delivery systems (including drug formulations used on the skin or mucous membranes) are widely used not only to treat various diseases in "surface organs" (such as skin and mucous membranes), but also to treat deeper organs (such as musculoskeletal ) in the disease. Some transdermal drug delivery systems are even used to deliver drugs to the central nervous system. [0004] Almost all transdermal drug delivery products on the market are "single part" products, that is, the user does not need to combine or combine two or more drugs before or during application. Such "single-part" products include various creams, salves, patches, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70
CPCA61K9/7023A61F13/00063A61K9/70A61P17/02A61P23/02A61P25/02A61P29/00
Inventor 张洁
Owner 张洁
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