# US 11,998,683 B2 · Dry powder inhaler and system for drug delivery

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- Number: US 11,998,683 B2
- Document ID: US11998683B2
- Status: Granted
- Kind: B2
- Application number: 17/665,902
- Filed: 2022-02-07
- Published: 2022-05-19
- Granted: 2024-06-04
- Earliest claimed: 2008-06-13
- Assignees: MannKind Corporation
- Applicants: MannKind Corporation
- Inventors: Chad C. Smutney; P. Spencer Kinsey; Carl R. Sahi; Benoit Adamo; John M. Polidoro; Scott McLean; Dennis Overfield; Anthony Bryant
- Web page: https://patentgrep.com/patent/US11998683B2

## CPC

- A61M 15/0045: {using multiple prepacked dosages on a same carrier, e.g. blisters}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 31/495: having six-membered rings with two {or more} nitrogen atoms as the only ring heteroatoms, e.g. piperazine {or tetrazines}(A61K31/48 takes precedence {; with three nitrogen atoms A61K31/53})
- A61K 38/1709: {from mammals}
- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 38/26: Glucagons
- A61K 38/28: Insulins
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61M 15/0021: {Mouthpieces therefor}
- A61M 15/0023: {retractable}
- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61M 15/0043: {Non-destructive separation of the package, e.g. peeling}
- A61M 15/0048: {the dosages being arranged in a plane, e.g. on diskettes}
- A61M 15/0086: {Inhalation chambers}
- A61M 15/0091: {mechanically breath-triggered}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 47/186: {Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide}
- A61M 2202/064: Powder
- A61M 2205/6081: Colour codes
- A61M 2206/20: having means for promoting or enhancing the flow, actively or passively
- 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)}
- 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)

## Abstract

A breath-powered, dry powder inhaler, a cartridge, and a pulmonary drug delivery system are provided. The dry powder inhaler can be provided with or without a unit dose cartridge for using with the inhaler. The inhaler and/or cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, peptides and proteins such as insulin, oxyntomodulin and glucagon-like peptide.

## Claims

### Claim 1

An inhaler comprising: a housing; a mouthpiece having an oral placement section and an extended portion, the extended portion extending from the oral placement section, configured as a cover which extends over and engages the housing by a locking mechanism; a gear mechanism; and a sled including a cartridge holder; wherein actuation of the gear mechanism moves the sled in a concurrent movement within the housing and wherein the movement of the sled is configured to translocate a cartridge comprising a container, both in the cartridge holder, from a powder containment position to a dosing position.

### Claim 2 (depends on 1)

The inhaler of claim 1, wherein the housing is configured to accommodate the cartridge container.

### Claim 3 (depends on 1)

The inhaler of claim 1, wherein the container is configured to house a dry powder medicament including at least one active ingredient.

### Claim 4 (depends on 3)

The inhaler of claim 3, wherein the at least one active ingredient is a peptide, polypeptide, protein, or a combination thereof.

### Claim 5 (depends on 3)

The inhaler of claim 3, wherein the at least one active ingredient is insulin, glucagon-like peptide 1, oxyntomodulin, peptide YY, exendin, heparin, calcitonin, felbamate, sumatriptan, parathyroid hormone, growth hormone, erythropoietin, AZT, DDI, granulocyte macrophage colony stimulating factor, lamotrigine, chorionic gonadotropin releasing factor, luteinizing releasing hormone, beta-galactosidase, exendin, vasoactive intestinal peptide, an argatroban, anti-SSX-241-49, anti-NY-ESO-1, anti-PRAME, anti-PSMA, anti-Melan-A, anti-tyrosinase, or a combination thereof.

### Claim 6 (depends on 3)

The inhaler of claim 3, wherein the dry powder medicament comprises a diketopiperazine.

### Claim 7 (depends on 6)

The inhaler of claim 6, wherein the diketopiperazine is

### Claim 8 (depends on 3)

The inhaler of claim 3, wherein the at least one active ingredient is a small organic molecule.

### Claim 9 (depends on 3)

The inhaler of claim 3, wherein the at least one active ingredient is an antibiotic.

### Claim 10 (depends on 1)

The inhaler of claim 1, wherein the locking mechanism is a protrusion.

### Claim 11

An inhaler comprising:
a housing;
a mouthpiece having an oral placement section and an extended portion, the extended portion extending from the oral placement section, configured as a cover which extends over and engages the housing by a locking mechanism;
a gear mechanism; and
a sled including a cartridge holder;
wherein actuation of the gear mechanism moves the sled to translocate a cartridge in the cartridge holder from a containment position to a dosing position, and wherein in the dosing position 10% to 70% of total airflow through the inhaler enters and exits the cartridge.

### Claim 12 (depends on 11)

The inhaler of claim 11, wherein the cartridge includes a medicament container.

### Claim 13 (depends on 12)

The inhaler of claim 12, wherein the medicament container is configured to house a dry powder medicament.

### Claim 14 (depends on 13)

The inhaler of claim 13, wherein the dry powder medicament includes at least one active ingredient.

### Claim 15 (depends on 14)

The inhaler of claim 14, wherein the at least one active ingredient is a peptide, polypeptide, protein, or a combination thereof.

### Claim 16 (depends on 14)

The inhaler of claim 14, wherein the at least one active ingredient is insulin, glucagon-like peptide 1, oxyntomodulin, peptide YY, exendin, heparin, calcitonin, felbamate, sumatriptan, parathyroid hormone, growth hormone, erythropoietin, AZT, DDI, granulocyte macrophage colony stimulating factor, lamotrigine, chorionic gonadotropin releasing factor, luteinizing releasing hormone, beta-galactosidase, exendin, vasoactive intestinal peptide, an argatroban, anti-SSX-241-49, anti-NY-ESO-1, anti-PRAME, anti-PSMA, anti-Melan-A, anti-tyrosinase, or a combination thereof.

### Claim 17 (depends on 14)

The inhaler of claim 14, wherein the dry powder medicament comprises a diketopiperazine.

### Claim 18 (depends on 17)

The inhaler of claim 17, wherein the diketopiperazine is

### Claim 19 (depends on 11)

The inhaler of claim 11, wherein the locking mechanism is a protrusion.