Transdermal delivery system

• US 5,736,154 A
• Filed: 03/11/1996
• Issued: 04/07/1998
• Est. Priority Date: 03/11/1996
• Status: Expired due to Fees

• Current Assignee: Fuisz Technologies Limited (Bausch Health Cos., Inc.)
• Original Assignee: Fuisz Technologies Limited (Bausch Health Cos., Inc.)
• Inventors: Fuisz, Richard C.
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US08/613,710
• Time in Patent Office: 757 Days
• Field of Search: 424/449, 424/448
• US Class Current: 424/449
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A drug delivery system useful in treating individuals having maladies requiring topical, subcutaneous and intra-lesional administration of one or more drugs for a prolonged period of time. A method for treating individuals with noduloulcerative carcinomas using the present invention drug delivery system and intra-lesional administration of interferon to the individual in a controlled, sustained release manner such that long-term therapeutic levels of interferon are provided to the individual. A method of treating an individual having certain skin infections using the present invention drug delivery system including topical and/or subcutaneous administration of one or more drugs to the individual in a controlled, sustained release manner such that long-term therapeutic levels of the drug(s) are provided to the individual.

Claims

1. A dermal multi-layered intralesional drug delivery system consisting essentially of:

a top layer;

a control membrane attached to the top layer, forming at least one internal chamber; and

a bottom layer releasably attached to the control membrane;

said at least one chamber containing interferon for intra-lesion, passive treatment of an individual with a carcinoma treatable with intralesional interferon,

wherein the interferon does not pass into the bloodstream during delivery.

2. The drug delivery system of claim 1, wherein the control membrane is attached to the top layer such that two or more internal chambers are formed.

3. The drug delivery system of claim 2, wherein attachment between the control membrane and the top layer is stronger than attachment between the internal chambers, such that pressure applied to the delivery system will rupture the attachment between the internal chambers before the attachment between the control membrane and the top layer ruptures.

4. The drug delivery system of claim 1, wherein the interferon is homogenized.

5. The drug delivery system of claim 4, wherein the interferon is homogenized using soybean lecithin.

6. The drug delivery system of claim 5, wherein the interferon is homogenized using soybean lecithin in the presence of water and an apolar solvent.

7. The drug delivery system of claim 1, wherein the interferon is human natural leukocytic interferon.

8. The drug delivery system of claim 1, wherein the interferon is recombinant interferon alpha, beta 2b and/or 2c.

9. The drug delivery system of claim 1, wherein at least one encapsulating agent is used to prevent systemic absorption of the interferon.

13. The method of claim 10, wherein the drug delivery system is the transdermal delivery system of claim 1.

10. A method for treating an individual having a nonduloucerative or basal cell carcinoma, comprising:

administering interferon intra-lesionally by attachment of at least one passive trandermal patch drug delivery system to an individual, said drug delivery system passively releasing an effective dosage of interferon without drug passage into the bloodstream for a predetermined period of time.

11. The method of claim 10, wherein the interferon is human natural leukocytic interferon.

12. The method of claim 10, wherein the interferon is recombinant interferon alpha, beta 2b and/or 2c.