Ultrasonically sealed transdermal drug delivery systems

• US 5,268,179 A
• Filed: 02/14/1992
• Issued: 12/07/1993
• Est. Priority Date: 02/14/1992
• Status: Expired due to Term

• Current Assignee: Novartis Corporation (Novartis Ag)
• Original Assignee: Ciba-Geigy Corporation (Novartis Ag)
• Inventors: Rudella, Michael D.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/837,456
• Time in Patent Office: 662 Days
• Field of Search: 424/449, 424/448, 156/73.1, 156/73.2, 156/73.3, 206/440
• US Class Current: 424/449
• CPC Class Codes: A61F 2013/0296 for making transdermal patches (chemical processes excluded)
• 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

Abstract

A method of sealing transdermal drug delivery system components together which comprises contacting the surfaces of the components to be sealed together with each other and exposing the contacted surfaces to ultrasonic forces while said surfaces are still in contact to produce a seal of said surfaces in a predetermined manner.

Claims

1. A method of making a transdermal drug delivery device said device comprising a backing layer and a second layer, said second layer contacting said backing layer and adhered thereto with a seal, said device further comprising an active agent located within said second layer or within a region defined by said backing layer and said second layer, wherein said backing layer is impermeable to said active agent and said second layer is permeable to said active agent or an activated form of said active agent, said method comprising forming said seal ultrasonically by applying an ultrasonic frequency of about 18 kHz to about 22 kHz in a desired sealing pattern for a period of about 250 msec to about 950 msec along with a substantially simultaneous pressure of about 318 lbs to about 566 lbs.

2. A transdermal drug delivery device produced by the method of claim 1.

3. The method of claim 1 wherein said transdermal drug delivery device backing layer is a first laminate of an active agent impermeable member and an ultrasonically sealable first member and wherein said second layer contacts said ultrasonically sealable first member of said first laminate.

4. The method of claim 1 wherein said second layer is a laminate of a non-ultrasonically sealable second member and an ultrasonically sealable third member, wherein said ultrasonically sealable third member of said second layer contacts said backing layer, and said ultrasonically sealable third member and said non-ultrasonically second member are permeable to said active agent or said activated active agent.

5. The method of claim 3 wherein said second layer is a laminate of a non-ultrasonically sealable second member and an ultrasonically sealable third member, wherein said ultrasonically sealable third member of said second layer contacts said ultrasonically sealable first member, and said ultrasonically sealable third member and said non-ultrasonically sealable second member are permeable to said active agent or said activated active agent.

6. The method of claim 1 wherein said active agent is within said second layer.

7. The method of claim 1 wherein said active agent is within the space defined by said backing layer and second layer.

8. The method of claim 1 wherein said ultrasonic frequency is from about 19 kHz to about 21 kHz.

9. The method of claim 8 wherein said ultrasonic frequency is about 20 kHz.

10. The method of claim 1 wherein said ultrasonic frequency is applied for about 450 msec to about 750 msec.

11. The method of claim 1 wherein said pressure is about 389 lb to about 459 lb.