Dermal therapeutic system made of a meltable poly (meth) acrylate

• US 5,730,999 A
• Filed: 05/17/1996
• Issued: 03/24/1998
• Est. Priority Date: 03/27/1993
• Status: Expired due to Fees

• Current Assignee: Roehm GmbH Chemische Fabrik
• Original Assignee: Roehm GmbH Chemische Fabrik
• Inventors: Assmus, Manfred, Lehmann, Klaus, Petereit, Hans-Ulrich
• Primary Examiner(s): KULKOSKY, PETER F
• Application Number:
  US08/650,025
• Time in Patent Office: 676 Days
• Field of Search: 264/173.16, 264/174.1, 424/443, 424/449
• US Class Current: 424/443
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 2300/40 characterised by a specific therapeutic activity or mode of action
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate
• CPC Class Codes: C08L 33/14 of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C08L 35/02 Homopolymers or copolymers of esters C08L35/06, C08L35/08 take precedence

Abstract

A dermal therapeutic system which exhibits a prolonged release of a drug comprising at least one pharmaceutical agent combined with poly(meth)acrylates in the form of at least one layer of the therapeutic system, the poly(meth)acrylates being a mixture, which is produced from a melt, comprising (1) at least one (meth)acrylic polymer containing functional groups and (2) at least one (meth)acrylic polymer which regulates the flow behavior of the poly(meth)acrylate mixture and which contains no functional groups or only insignificant amounts of functional groups.

Claims

1. A dermal therapeutic system which exhibits a prolonged release of a drug, comprising:

at least one melt coated layer of at least one pharmaceutical agent and a mixture of poly(meth)acrylates comprising (1) at least one (meth)acrylic polymer containing functional groups having a glass transition temperature Tg of -10°

to 100°

C. and (2) at least one (meth)acrylic polymer having a glass transition temperature Tg ranging from -70°

to 80°

C. which regulates the melt flow behavior of the poly(meth)acrylate mixture and which contains no functional groups or only insignificant amounts of functional groups, wherein the weight amount of polymer component (1) to polymer component (2) ranges between 20;

1 and 1;

20 onto a support of a foil, textile or paper.

2. The dermal therapeutic system as claimed in claim 1, wherein said glass transition temperature of the poly(meth)acrylate (2) ranges from 10°

-70°

C.

3. The dermal therapeutic system as claimed in claim 1, wherein the poly(meth)acrylate containing functional groups is a cationic polymer with amino or ammonium groups.

4. The dermal therapeutic system as claimed in claim 1, wherein the poly(meth)acrylate containing functional groups is an anionic polymer with carboxy or carboxylate groups.

5. The dermal therapeutic system as claimed in claim 1, wherein the poly(meth)acrylate containing functional groups is a non-ionic polymer with alcoholic hydroxy groups.

6. The dermal therapeutic system as claimed in claim 1, wherein the at least one or more layers contain from 0.2 to 50 wt % of said at least one pharmaceutical agent.

7. The dermal therapeutic system as claimed in claim 1, wherein said pharmaceutical agent is a corticosteroid, an analgetic agent, an antihypertensive agent, an antibiotic, an anesthetic, a fungicide, vitamins, an anti-epileptic, a coronary vasodilator, an antihistamine, an antipsoriatic agent, hormones and antiemetics.

8. The dermal therapeutic system as claimed in claim 1, wherein the polymer/drug system contains low-molecular weight softeners.

9. A process for the manufacture of the dermal therapeutic system according to claim 1, comprising:

mixing at least one pharmaceutical agent with said poly(meth)acrylates, said mixed poly(meth)acrylates comprising said functional group containing (meth)acrylic polymer (1) and said non-functional group containing (meth)acrylic polymer (2) and optional excipients;

heating the mixture to melt the same; and

spreading the molten material in a thin layer onto a support of a foil, textile or paper.

10. The process of claim 9, wherein the support is removable.