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Dry powder drug delivery system and methods

A dry powder and dry powder inhaler technology, applied in the directions of drug combination, drug formula, drug device, etc., can solve the problems of lack of patient compliance, poor disaggregation, and inconvenient equipment.

Inactive Publication Date: 2013-03-20
MANNKIND CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007]Dry powder inhalers developed for pulmonary drug delivery have thus far achieved limited efficacy due to lack of availability and / or manufacturing cost
Some chronic problems with prior art inhalers include lack of device durability, inconsistent dosing, device inconvenience, poor disaggregation, problems with delivery based on separation from propellant use, and / or lack of patient compliance

Method used

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  • Dry powder drug delivery system and methods
  • Dry powder drug delivery system and methods
  • Dry powder drug delivery system and methods

Examples

Experimental program
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Effect test

example 1

[0191] Measuring the resistance and flow distribution of a dry powder inhaler-cartridge system

[0192] Several dry powder inhaler designs were tested to measure their resistance to flow, an important characteristic determined in part by the geometry or configuration of the inhaler pathway. Inhalers that exhibit higher resistance require a higher pressure drop to produce the same flow rate as lower resistance inhalers. Briefly, to measure the resistance of each inhaler and cartridge system, various flow rates were applied to the inhaler and the resulting pressure on the inhaler was measured. These measurements can use a vacuum pump attached to the mouth of the inhaler to provide a pressure drop, and a flow controller and pressure gauge to vary the flow and record the resulting pressure. According to Bernoulli's principle, when the square root of pressure drop is plotted against flow velocity, the resistance of an inhaler is the slope of the linear portion of the curve. In th...

example 2

[0199] Measurement of particle size distribution using an inhalation system with insulin preparations

[0200] For the cartridge-inhaler system set as described herein ( Figure 1-9 inhalers and Figure 22-30 Insulin and fumaryl diketopiperazine particles in various amounts (mg) of formulations shown in kit 170) were prepared using adapters (Mannkind Corporation, U.S. Patent Application No. 12 / 727,179, for teachings on related subject matter, The disclosure of this application is hereby incorporated by reference) for the measurement of the particle size distribution by a laser diffraction apparatus (HELOS Laser Diffraction System, Synpatek Corporation). Connect the device at one end to tubing suitable for a flow meter (TSI Corporation, model 4043) and a valve for regulating the pressure or flow rate from a compressed air source. When the laser system is activated and the laser beam is ready to measure the plume, a pneumatic valve is actuated to allow the powder to be expelle...

example 4

[0215] Measurement of Predictive Deposition by Anderson Step Impaction

[0216] Experiments were performed by using Anderson stepped impaction to collect step plate powder deposits during administration of a simulated dose with a flow rate of 28.3 LPM. A flow rate of 28.3 LPM produces a pressure drop of approximately 6 kPa across the inhalation system (DPI+cartridge). The deposits on the stepped plates were analyzed gravimetrically using filters and an electronic balance. For inhaler performance, 10 mg, 6.6 mg and 3.1 mg fill sizes of the cohesive powder were evaluated respectively. Each impaction was performed using 5 cartridges. The amount of accumulated powder collected on Step 2-F was measured in terms of aerodynamic particle size less than 5.8 μm. The proportion of accumulated powder amount relative to the cartridge fill was determined and presented as a percentage of the respirable fraction (RF) relative to the fill weight. The data are shown in Table 4.

[0217] Th...

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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 g!ucagon-i!ke peptide (1) for the treatment of disease and disorders, for example, endocrine disease such as diabetes and / or obesity.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application No. 61 / 411,775, filed November 9, 2010, and U.S. Provisional Patent Application No. 61 / 357,039, filed June 21, 2010, the entire disclosures of which are adopted by Incorporated by reference. technical field [0003] The present disclosure relates to a dry powder inhalation system for delivering a drug to the pulmonary airways and pulmonary circulation for the treatment of a disease or disorder, the dry powder inhalation system comprising a dry powder inhaler, a cartridge and a pharmaceutical composition. Background technique [0004] Drug delivery systems for disease treatment that introduce active ingredients into the circulatory system are numerous and include oral, transdermal, inhalation, subcutaneous and intravenous injection. Drugs delivered by inhalation are usually delivered using positive pressure in air relative to atmospheric pressu...

Claims

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Application Information

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IPC IPC(8): A61M15/00A61K38/095
CPCA61M2015/0043A61M2015/0025A61M11/06A61M2205/6081A61M15/0091A61M2202/064A61M2205/6045A61M15/0028A61M15/0025A61M15/0043A61P9/00A61P9/08A61P25/00A61P43/00A61M15/00A61M15/06B65D83/06A61M15/0021
Inventor 查得·C·斯穆尼班诺特·阿达莫约翰·M·波利多洛P·斯般瑟儿·堪赛丹尼斯·欧文菲尔德卡尔·萨伊克里斯汀·碧灵斯马克·T·马力诺
Owner MANNKIND CORP
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