Selectable dosage transdermal delivery system

• US 5,336,213 A
• Filed: 09/28/1992
• Issued: 08/09/1994
• Est. Priority Date: 04/08/1992
• Status: Expired due to Fees

• Current Assignee: Americare Technology Incorporated
• Original Assignee: International Medical Associates, Inc.
• Inventors: D'Angelo, Joseph P., Schur, Henry
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/952,049
• Time in Patent Office: 680 Days
• Field of Search: 424/449, 424/448, 602/41, 602/43, 602/52, 602/54, 602/57, 602/58, 602/63, 602/901, 206/531, 206/532, 206/533, 206/538
• US Class Current: 604/890.1
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• 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: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A transdermal drug delivery system is disclosed. The system comprises a laminate composite of a patch/skin permeable membrane; a transfer gel layer disposed on said permeable membrane; a permeable membrane disposed on said transfer gel layer; a plurality of sectional drug reservoirs for receiving medicament disposed on the transfer gel layer; and activation means for releasing medicament from said drug reservoirs for contact with skin of a patient. The medicament in contained in the reservoirs at varying amounts and/or concentrations, providing for selectable dosage, for sequential delivery, for sequential activation, for variable unit dose drug delivery in transdermal application.

Claims

1. A transdermal drug delivery system, comprising a laminate composite of:

(a) a first permeable membrane to be placed in contact with a patient'"'"'s skin;

(b) a transfer gel layer disposed on said first permeable membrane;

(c) a second permeable membrane disposed on said transfer gel layer;

(d) a reservoir structure disposed above said second permeable membrane, said reservoir structure having a plurality of drug reservoirs formed therein for receiving medicament;

(e) activation means for releasing medicament from said drug reservoirs for contact with the skin of the patient;

said activation means comprising a dial rotatably supported on said reservoir structure, and puncture pins supported in said dial.

2. The transdermal drug delivery system according to claim 1, further comprising a capillary distribution layer disposed between said second permeable membrane and said reservoir structure, said capillary distribution layer being means for causing uniform distribution of medicament into said transfer gel and for assuring substantially complete emptying of a respectively activated drug reservoir.

3. The transdermal drug delivery system according to claim 2, further comprising means for transferring the medicament from said drug reservoirs to said capillary distribution layer and for assuring complete and even draining of a respective drug reservoir upon activation.

4. The transdermal drug delivery system according to claim 3, wherein said transferring means are one of wicking action means, osmotic pressure means, and pressurized medicament well.

5. The transdermal drug delivery system according to claim 1, wherein said activation means further comprise means for locking said dial in a respective rotational position after a given dosage of medicament is released.

6. The transdermal drug delivery system according to claim 1, further comprising means for preventing an accidental release of medicament.

7. The transdermal drug delivery system according to claim 1, further comprising indicator means for indicating initiation of administration of a unit dose from a respective drug reservoir upon activation.

8. The transdermal drug delivery system according to claim 7, wherein said indicator means are one of visual, olfactory and auditory signal means.

9. The transdermal drug delivery system according to claim 1, further comprising means for securing said laminate composite to the skin of the patient.

10. The transdermal drug delivery system according to claim 1, wherein said drug reservoirs are provided to receive varying amounts and concentrations of medicament, and including means for selecting a given dosage of medicament to be administered by releasing medicament from a given drug reservoir.

11. The transdermal drug delivery system according to claim 1, wherein said drug reservoirs are provided to receive varying amounts and concentrations of medicament, and further comprising means for individually and sequentially selecting given drug reservoirs for sequential administration of medicament to the skin of the patient.

13. The transdermal drug delivery system according to claim 10, further comprising a capillary distribution layer disposed between said second permeable membrane and said reservoir structure, said capillary distribution layer being means for causing uniform distribution of medicament into said transfer gel and for assuring substantially complete emptying of a respectively activated drug reservoir.

14. The transdermal drug delivery system according to claim 13, further comprising means for transferring the medicament from said drug reservoirs to said capillary distribution layer and for assuring complete and even draining of a respective drug reservoir upon activation.

15. The transdermal drug delivery system according to claim 14, wherein said transferring means are one of wicking action means, osmotic pressure means, and pressurized medicament well.

12. A transdermal drug delivery system, comprising a laminate composite of:

a first permeable membrane to be placed in contact with a patient'"'"'s skin;

a transfer gel layer disposed on said first permeable membrane;

a second permeable membrane disposed on said transfer gel layer;

a reservoir structure disposed above said second permeable membrane, said reservoir structure having a plurality of drug reservoirs formed therein for receiving medicament, wherein said reservoir structure with said drug reservoirs includes;

(a) an impervious lower layer having a plurality of windows formed therein, said windows comprising seal means to be punctured for releasing medicament from a respective drug reservoir for contact with the skin of the patient;

(b) an impervious upper layer disposed above said lower layer and having channels formed therein for receiving puncture pins and having a plurality of windows formed therein, said windows formed in said upper layer being aligned with said windows formed in said lower layer; and

activation means for releasing medicament from said drug reservoirs for contact with the skin of the patient.

16. The transdermal drug delivery system according to claim 12, wherein said activation means comprise a dial rotatably supported on said reservoir structure, puncture pins supported in said dial, and means for locking said dial in a respective rotational position after a given dosage of medicament is released.

17. The transdermal drug delivery system according to claim 12, further comprising means for preventing an accidental release of medicament.

18. The transdermal drug delivery system according to claim 12, further comprising indicator means for indicating initiation of administration of a unit dose from a respective drug reservoir upon activation.

19. The transdermal drug delivery system according to claim 18, wherein said indicator means are one of visual, olfactory and auditory signal means.

20. The transdermal drug delivery system according to claim 12, further comprising means for securing said laminate composite to the skin of the patient.

21. The transdermal drug delivery system according to claim 12, wherein said drug reservoirs are provided to receive varying amounts and concentrations of medicament, and further comprising means for selecting a given dosage of medicament to be administered by releasing medicament from a given drug reservoir.

22. The drug delivery system according to claim 12, wherein said drug reservoirs are provided to receive varying amounts and concentrations of medicament, and further comprising means for individually and sequentially selecting given drug reservoirs for sequential administration of medicament to the skin of the patient.