Nitroglycerin-containing patch, a process for the production and

Details Nitroglycerin-containing patch, a process for the production and Nitroglycerin-containing patch, a process for the production and

1995-09-29

1997-09-23

Phelan, D. Gabrielle

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

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

424449, A61F 1302

Patent

active

056701640

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to an active substance-containing patch for the controlled release of nitroglycerin to the human and animal skin; it has a backing layer which is impermeable to the nitroglycerin and a pressure-sensitive adhesive mono- or multi-layer reservoir comprising nitroglycerin in non-uniform or uniform distribution. The invention further relates to the use of such patches.
Nitroglycerin patches have already been known for some time. The manufacture of nitroglycerin patches is problematic inasmuch as nitroglycerin is explosive and evaporation as well as thermal and mechanical stresses must therefore be avoided to the greatest possible extent.
It is preferable to operate at temperatures which are as low as possible, in particular at room temperature, the nitroglycerin-containing pressure-sensitive adhesive layer frequently being manufactured from a solution. The known patch-like transdermal therapeutic systems for releasing nitroglycerin which are produced in such a manner perform their therapeutic functions, however, production is too expensive.
DE-OS 3222800 (ALZA) describes a nitroglycerin patch using as nitroglycerin-containing matrix a non-adhesive viscous mass obtained by thickening a nitroglycerin solution with a rheological agent at room temperature. Also, U.S. Pat. No. 3,742,951 (CIBA-GEIGY) and DP-PS 3315272 and DE-OS 3315245 (LOHMANN/SCHWARZ) describe nitroglycerin patches of a simple construction having pressure-sensitive adhesive matrix materials which are produced at room temperature from solution.
It is also known to use multi-part nitroglycerin reservoirs, e.g. from DE-OS 3642931 (CIBA-GEIGY).
Pressure-sensitive hot melt adhesives are generally known from EP-A2-175562; however, there is no indication with respect to whether and how these are to be selected for active substance reservoirs, in particular for those containing nitroglycerin.
Generic nitroglycerin patches are described in EP-A 0204968; here a pressure-sensitive adhesive reservoir made of rubber and a tackifying resin is used with nitroglycerin. The pressure-sensitive adhesive reservoir is manufactured from solution, resulting in the problem of withdrawing solvent residues and, in some cases, that of consequently evaporating nitroglycerin.
The use of solvents in the manufacture of the pressure-sensitive adhesive layers is disadvantageous for several reasons. The manufacture of the solutions requires high technical expense since the devices have to be explosion-proof. For medical purposes, absolutely pure and therefore expensive solvents have to be employed to dissolve the adhesives or their starting materials. Another problem is to obtain solvent-free patches, requiring expensive drying and extraction plants. In addition, costs caused by recovery and separation of the solvents to prevent environmental load are involved. Also, the inflammability of the solvents means an additional risk, in particular with the explosive active substance concerned. Furthermore, most organic solvents are harmful to human organisms so that expensive measures must be taken to protect the staff.
A nitroglycerin patch is known from DE-3743946, this is manufactured by coating a nitroglycerin-containing adhesive from a melt at 40.degree.-80.degree. C.
However, in practice the coating involves severe difficulties due to the high viscosity of the coating mass. Owing to the polymeric compounds (e.g. ethylene-vinyl-acetate-copolymers) contained in the nitroglycerin-containing adhesive the viscosity is extremely high so that the manufacture of the nitroglycerin-containing patches is rendered extremely difficult.
Accordingly, it is the object of the present invention to avoid the above disadvantages and to provide a pressure-sensitive hotmelt adhesive allowing perfect processing on a commercial scale.
This object is achieved in that processable melts are obtained by dispensing with polymeric compounds and exclusively using resins.
In this connection, there is a wide scope for formulating the reservoir on the basis of hot melt pressure-sensitiv

REFERENCES:
patent: 3742951 (1973-07-01), Zaffaroni
patent: 5273757 (1993-12-01), Jaeger
patent: 5306502 (1994-04-01), Jaeger

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