Apparatus delivering nitroglycerin to the skin, process for the

Details Apparatus delivering nitroglycerin to the skin, process for the Apparatus delivering nitroglycerin to the skin, process for the

1990-08-10

1992-06-30

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424449, 424447, A61F 1302

Patent

active

051261448

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND AND SUMMARY OF THE INVENTION

The invention relates to an apparatus for the controlled delivery or release of nitroglycerin to the human or animal skin, preferably in plaster form, with a backing layer impermeable to the nitroglycerin, pressure sensitive adhesive one or multiple-part reservoir containing nitroglycerin in uniform or irregular distribution and optionally a removable protective layer impermeable to the nitroglycerin; processes for the production thereof; as well as the use thereof.
Nitroglycerin plasters are already known. The production of nitroglycerin plasters is problematical, in that nitroglycerin is explosive and consequently its evaporation should be avoided.
It is preferable to work at temperatures which are as low as possible, particularly at ambient temperature and frequently the nitroglycerin-containing pressure sensitive adhesive layer is produced from the solution. The thus produced, known plaster-like, transdermal, therapeutic systems for the delivery or release of nitroglycerin were able to fulfil the therapeutic requirements, but were complicated and costly to produce.
DE-OS 32 22 800 (ALZA) describes a nitroglycerin plaster, the nitroglycerin-containing matrix being constituted by a nonadhesive, viscous mass obtainable at ambient temperature by thickening a nitroglycerin solution with a rheological agent. U.S. Pat. No. 3,742,951 (CIBA-GEIGY), as well as German Patent 33 15 272 and DE-OS 33 15 245 (LOHMANN/SCHWARZ) describe simply constructed nitroglycerin plasters with pressure sensitive adhesive matrix materials produced from the solution at ambient temperature. It is also known from DE-OS 36 42 931 (CIBA-GEIGY) to use multipart nitroglycerin reservoirs.
The use of solvents in the production of the pressure sensitive adhesive layer is, however, disadvantageous for several reasons. The preparation of the solutions requires at least one further complicated process stage. It involves high technical expenditure and additional costs for handling, whilst for medical purposes extremely pure and therefore expensive solvents must be used for dissolving the adhesive or its starting materials, so as to ensure a corresponding freedom from residue in the transdermal system. Another problem is to ensure freedom from solvents in the plaster and this involves the use of expensive drying sections and suction plants. Additional costs result from the recovery and separation of the solvent, so as to avoid prejudicing the environment. A further risk is constituted by the solvent flammability, particularly in the case of the present explosive active substance. Most organic solvents are also harmful to the human organism, so that complicated protective measures must be taken to protect the working personnel.
The problem of the present invention is therefore to avoid the aforementioned disadvantages of the prior art apparatuses and processes.
According to the invention this problem is solved by an apparatus for delivering nitroglycerin to the skin, in which the nitroglycerin reservoir is produced by using hot melt pressure sensitive adhesive with a processing temperature between 40.degree. and 80.degree. C., preferably 40.degree. and 60.degree. C. and in particularly preferred manner 40.degree. and 55.degree. C.
The nitroglycerin in the hot melt pressure sensitive adhesive can be adsorbed on a carrier, such as lactose, or can be used dissolved in a component of the hot melt pressure sensitive adhesive.
The invention also relates to a process for the production of an inventive apparatus through the continuous or discontinuous application of melted hot melt pressure sensitive adhesive containing the nitroglycerin to be released at a hot melt pressure sensitive adhesive temperature between 40.degree. and 80.degree. C., preferably 40.degree. and 60.degree. C. and in particularly preferred manner 45.degree. and 55.degree. C. to a carrier and optional application of the protective layer material.
A further inventive process has the steps of the continuous or discontinuous application of the me

REFERENCES:
patent: 4668232 (1987-05-01), Cordes et al.
patent: 4797284 (1989-01-01), Lopes et al.
patent: 4840796 (1989-06-01), Sweet et al.

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