Dry powder drug delivery system and methods
First Claim
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1. A dry powder inhaler comprising:
- at least one rigid air conduit and a housing configured to accept a cartridge, the cartridge comprising a lid anda movable container having a dry powder, the container configured to move relative to the cartridge lid from a storage position to a dispensing position to form a flow path between one or more inlet ports and one or more dispensing ports within the inhaler; and
wherein the dry powder inhaler is configured to emit greater than about 75% of a dry powder from the container as powder particles in a single inhalation, and the powder particles emitted have a volumetric median geometric diameter of less than about 5 microns when the single inhalation generates a peak inspiratory pressure of about 2 kPa within two seconds.
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Abstract
A pulmonary drug delivery system is disclosed, including a breath-powered, dry powder inhaler, and a cartridge for delivering a dry powder formulation. The inhaler and cartridge can be provided with a drug delivery formulation comprising, for example, a diketopiperazine and an active ingredient, including, small organic molecules, peptides and proteins, including, insulin and glucagon-like peptide 1 for the treatment of disease and disorders, for example, endocrine disease such as diabetes and/or obesity.
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Citations
20 Claims
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1. A dry powder inhaler comprising:
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at least one rigid air conduit and a housing configured to accept a cartridge, the cartridge comprising a lid and a movable container having a dry powder, the container configured to move relative to the cartridge lid from a storage position to a dispensing position to form a flow path between one or more inlet ports and one or more dispensing ports within the inhaler; and wherein the dry powder inhaler is configured to emit greater than about 75% of a dry powder from the container as powder particles in a single inhalation, and the powder particles emitted have a volumetric median geometric diameter of less than about 5 microns when the single inhalation generates a peak inspiratory pressure of about 2 kPa within two seconds. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of delivering of a dry powder using a high resistance dry powder inhaler comprising:
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a) providing a dry powder inhaler with an airflow resistance value ranging from about 0.065 (√
kPa)/liter per minute to about 0.200 (√
kPa)/liter per minute, the inhaler containing a dose of the dry powder within a movable container configured to move within the inhaler from a storage position to a dispensing position to form a flow path between one or more inlet ports and one or more dispensing ports within the inhaler,b) applying sufficient force to reach a peak inspiratory pressure of at least 2 kPa within 2 seconds; and c) generating an area under the curve in the first second (AUC0-1 sex) of a inspiratory pressure versus time curve of at least about 1.0, 1.1 or 1.2 kPa*sec; wherein greater than 75% of the dose of the dry powder is discharged or emitted from the inhaler as powder particles. - View Dependent Claims (17, 18, 19, 20)
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Specification