# US 11,439,807 B2 · System for the transdermal delivery of active ingredient

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- Number: US 11,439,807 B2
- Document ID: US11439807B2
- Status: Granted
- Kind: B2
- Application number: 16/657,147
- Filed: 2019-10-18
- Published: 2020-02-13
- Granted: 2022-09-13
- Earliest claimed: 2013-12-20
- Assignees: LTS Lohmann Therapie-Systeme AG
- Applicants: LTS Lohmann Therapie-Systeme AG
- Inventors: Mohammad Sameti; Ronald Hackbarth; Klaus Schumann; Christoph Schmitz
- Web page: https://patentgrep.com/patent/US11439807B2

## CPC

- A61N 1/0448: {Drug reservoir}
- A61K 31/27: of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
- A61K 31/4468: having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 38/2271: {Neuropeptide Y}
- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61K 38/28: Insulins
- A61K 38/36: Blood coagulation or fibrinolysis factors
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61N 1/0428: {Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs}
- A61N 1/0436: {Material of the electrode}
- A61N 1/303: {Constructional details (electrodes for external use A61N1/0428)}
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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}
- A61M 2207/00: Methods of manufacture, assembly or production
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a transdermal therapeutic system (TTS) for delivering pharmaceutical active ingredients. The TTS includes a cover layer and at least one active-ingredient-containing carrier material. At least one retaining element is located between the active-ingredient-containing carrier material and the cover layer, with the retaining element fixing the active-ingredient-containing carrier material onto the cover layer. The invention further relates to a method for fastening an active-ingredient-containing carrier material to a cover layer of a TTS in the presence of hook-and-loop strip segments and the use of a hook-and-loop strip in transdermal or iontophoretic administration of pharmaceutical or therapeutic active ingredients to patients.

## Claims

### Claim 1

A transdermal therapeutic system (TTS) for the delivery of therapeutic actives, comprising a backing layer having a first side, at least one active-containing carrier material, and one or more electrodes;
wherein the active-containing carrier material is releasably secured to the backing layer by one or more retaining elements, wherein the active-containing carrier material consists of a fibrous nonwoven web, a textile material, a woven fabric, a knitted fabric not produced by weft knitting with independently-movable needles, a sponge-shaped material, a sponge cloth or a gel-forming polymer,
the one or more electrodes are present between the active-containing carrier material and the backing layer such that the active-containing carrier material entirely covers said one or more electrodes,
said first side of said backing layer is disposed on said active-containing carrier material and
said first side of said backing layer comprises said one or more retaining element(s).

### Claim 2 (depends on 1)

The TTS as claimed in claim 1, wherein the therapeutic actives have a cationic structure and the carrier material is liquid saturated.

### Claim 3 (depends on 1)

The TTS as claimed in claim 1, wherein the one or more retaining elements of the backing layer is/are an elongately shaped segment of a hook side of a hook and loop tape whereby the active-containing carrier material assumes the function of the loop side of said hook and loop tape.

### Claim 4 (depends on 3)

The TTS as claimed in claim 3, wherein the one or more elongately shaped hook sides of the hook and loop tape are situated on the backing layer only in a part of the area corresponding to the active-containing carrier material, said hook side of said hook and loop tape having a shape that matches the side edges or circumference of the active-containing carrier material shape.

### Claim 5 (depends on 4)

The TTS as claimed in claim 4, wherein two or more hook and loop tapes are arranged as circumferential strips having a width ranging from 2 to 15 mm.

### Claim 6 (depends on 3)

The TTS as claimed in claim 3, wherein the elongately shaped hook and loop tape has a width that may vary, and the hook and loop tape does not cover an entire area of the backing layer whereover the active-containing carrier material in the TTS extends.

### Claim 7 (depends on 6)

The TTS as claimed in claim 6, wherein the elongately shaped hook and loop tape covers only a or one part of the active-containing carrier material area.

### Claim 8 (depends on 6)

The TTS as claimed in claim 6, wherein said TTS comprises two or more hook and loop tapes arranged on opposite sides of the area wherover the active-containing carrier material in the TTS extends.

### Claim 9 (depends on 3)

A method for transdermal or iontophoretic administration of therapeutic actives to patients in need of treatment with such actives comprising administering a TTS as claimed in claim 3, wherein said TTS includes a hook side of a hook and loop tape to attach an active-containing liquid-saturated carrier material to an occlusive backing layer, wherein said therapeutic actives have a cationic structure with amino or imino groups in their molecule.

### Claim 10 (depends on 9)

The method as claimed in claim 9 for the transdermal iontophoretic administration of analgesics, antiemetics or other central nervous system drugs or peptides.

### Claim 11 (depends on 10)

The method as claimed in claim 10, wherein the analgesics are fentanyl or morphine, the antiemetic is granisetron, the other central nervous system drugs are rivastigmine or galantamine, and the peptides are peptide hormones or blood coagulation factors or growth hormones.

### Claim 12 (depends on 11)

The method as claimed in claim 11, wherein the peptide hormones are insulin or oxytocin.

### Claim 13 (depends on 9)

The method as claimed in claim 9, wherein the active-containing carrier material is a liquid-saturated carrier material which serves as a matrix or reservoir wherefrom the therapeutic actives are delivered to the skin and then pass through the skin either passively or with iontophoretic augmentation.

### Claim 14 (depends on 1)

The TTS as claimed in claim 1, wherein the TTS is attachable to skin via a pressure-sensitive adhesive overplaster or via a uniform or patterned pressure-sensitive adhesive implementation of that side of the backing layer which faces the skin, wherein said active-containing carrier material is free from pressure-sensitive adhesive.

### Claim 15 (depends on 1)

The TTS as claimed in claim 1, wherein the backing layer is an occlusive backing layer which is a barrier layer for liquids and water vapor.

### Claim 16 (depends on 15)

The TTS as claimed in claim 15, wherein the occlusive backing layer consists of a self-supported plastic film and has a thickness in the range from 5 to 300 μm.

### Claim 17 (depends on 16)

The TTS as claimed in claim 16, wherein the plastic film is polyethylene or polypropylene or polyester or polyurethane or polyamide and has a thickness in the range from 10 to 200 μm.

### Claim 18 (depends on 16)

The TTS as claimed in claim 16, wherein the plastic film has a thickness in the range from 12 to 150 μm.

### Claim 19 (depends on 1)

The TTS as claimed in claim 1, wherein the active-containing carrier material has a round or oval shape and the elongately shaped hook and loop tape has an arcuate circular segment shape with a radius corresponding to the radius of the round or oval liquid-saturated carrier material.

### Claim 20 (depends on 1)

The TTS as claimed in claim 1, wherein the active-containing carrier material is a liquid-saturated carrier material.

### Claim 21

A transdermal therapeutic system (TTS) for the delivery of therapeutic actives, comprising
a backing layer having a first side adhered to one or more segments of a hook side of a hook and loop tape; and
an active-containing carrier material,
wherein
the active-containing carrier material is a liquid-saturated carrier material,
the carrier material consists of a nonwoven web, a textile material, a woven fabric or a knitted fabric not produced by weft knitting with independently-movable needles,
the active-containing carrier material is secured to the backing layer via the one or more segments of the hook side of the tape that are hookingly engaged to the fibers of the carrier material.

### Claim 22

A transdermal therapeutic system (TTS) for the delivery of therapeutic active comprising
(i) a backing layer having a first side, said first side adhered to one or more segments of a hook side of a hook and loop tape; and
(ii) a liquid saturated active-containing carrier material releasably secured within a sealed package, wherein
said carrier material consist of fibers in the form of a fibrous nonwoven web, a textile material, a woven fabric, a knitted fabric not produced by weft knitting with independently-movable needles, a sponge-shaped material, a sponge cloth or a gel-forming polymer,
the active-containing carrier material functions as the loop side of said hook and loop tape,
and the active-containing carrier material is hookingly engaged to the backing layer by the one or more segments of the hook side of a hook and loop tape.
