An improved dry powder drug delivery system

A technology of dry powder and powder granules, which is applied in the directions of drug delivery, powder delivery, spray delivery, etc., and can solve problems such as inconvenient equipment, lack of patient cooperation, and poor de-aggregation

Active Publication Date: 2012-05-02
MANNKIND CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Dry powder inhaler products developed to date for pulmonary delivery have had limited success due to lack of practicality and / or high manufacturing costs
Some of the persistent problems observed with prior art inhalers include: Insufficient reliability of the device, use of propellants for powder delivery, inconsistent dosing, poor fitment, poor disaggregation and / or lack of patient cooperation

Method used

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  • An improved dry powder drug delivery system
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  • An improved dry powder drug delivery system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0175] Measuring resistance and flow distribution of dry powder inhaler-cartridge systems:

[0176] Several dry powder inhaler designs were tested to measure their resistance to flow, an important characteristic determined in part by the geometry or structure of the inhaler pathway. Inhalers with high resistance require a greater 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 be achieved using a vacuum pump mounted to the mouthpiece of the inhaler to supply the 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 rate, the resistance of an inhaler is the slope of the linear portion of the curve. In these...

Embodiment 2

[0183] Measurements of the particle size distribution using an inhalation system with an insulin preparation

[0184] In the cartridge-inhalation system described herein ( Figure 1-9 inhalers and Figure 22-30 A formulation of insulin and fumaryl diketopiperazine particles provided with various amounts (in milligrams) of cartridges 170 as shown was subjected to particle size distribution measurements. One end of the device was fitted to the piping which was fitted to a flow meter (TSI, Inc. Model 4043) and valves to regulate pressure or flow from a compressed air source. Once the laser system is activated and the laser beam is ready to measure the puff, the gas valve is activated to allow the powder to be expelled from the inhaler. The laser system automatically measures the plume leaving the inhaler device based on predetermined measurement conditions. The laser diffraction system is operated by software integrated with the device and controlled by a computer program. Me...

Embodiment 3

[0194] Measuring powder discharge from cartridges as a measure of inhalation system performance

[0195] Experiments were performed using the inhalation system described herein, which uses Figure 1-9 Multiple inhaler prototypes pictured in and Figure 22-30 The prototype of the cartridge 170 shown in FIG. Multiple cartridges are used per inhaler. Each cartridge is weighed on an electronic balance before being filled. Each cartridge is filled with a predetermined mass of powder, weighed again, and each filled cartridge is then placed in the inhaler and tested for efficiency in emptying the powder formulation, which is the Technosphere Insulin (Insulin-FDKP; usually 3-4 U insulin / mg powder, about 10-15% w / w) powder batches. Use multiple pressure drops to characterize consistency of performance. Table 3 shows the results of this test in which emissions were measured using 35 cartridges per inhaler. In the data in Table 3, all tests were performed using the same batch of c...

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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, peptides and proteins such as insulin and glucagon-like peptide 1 for the treatment of endocrine disease, for example, diabetes and / or obesity.

Description

[0001] Cross References to Related Applications [0002] Pursuant to Title 35, United States Code, Section 119(e), this application claims U.S. Provisional Patent Application No. 61 / 157,506, filed March 4, 2009, U.S. Provisional Patent Application No. 61 / 157,506, filed July 2, 2009 61 / 222,810 and the priority of US Provisional Patent Application No. 61 / 258,184, filed November 4, 2009, the contents of each of which are hereby incorporated by reference in their entirety. technical field [0003] The present disclosure relates to a dry powder (dry powder) inhalation system comprising a dry powder inhaler; a cartridge; and a pharmaceutical composition for delivering a drug to the pulmonary tract and pulmonary circulation for the treatment of diseases such as diabetes and obesity . [0004] All documents cited in this specification and the documents cited therein are hereby incorporated by reference in their entirety, where appropriate for additional or alternative details, featu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/495A61K38/28A61M15/00A61K9/00A61K47/18
CPCA61K38/29A61M2015/0035A61K38/28A61K38/1816A61M2015/0021A61K31/495A61M15/0021A61M15/0035A61M2202/064A61M15/0028A61K38/193A61P5/50A61K9/0053A61K9/0073A61K9/0075A61K31/496
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·R·萨伊克里斯汀·碧灵斯马克·T·马力诺
Owner MANNKIND CORP
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