Device Technology — Patient-focused Dry Powder Inhalers

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Device Technology MannKind Corporation 1 T he Dreamboat system was designed to be an efficient, simple, and low cost breath-pow- ered inhaler technology platform that is adapt- able to a broad range of products and therapies. High flow resistance coupled with a concept called “flow balance” enables convenient inhaler formats that are easy to use and function consis- tently with low patient inhalation efforts. S elf-administration of pulmonary products is driven by patient compliance, so the inhalers must be user-friendly and perform consis- tently. To this end, MannKind technology uses the patient’s inhalation effort to deliver the dose in a single inhalation. This system efficiently and aggressively focuses the energy supplied by the patient directly onto the dry powder resulting in high delivery performance. W hen utilized with MannKind’s Technosphere ® formulations, greater than 90% of the powder is delivered to the patient with ~70% of that delivered in the respirable range. The Dreamboat Inhalation System shows M annKind’s approach to pulmonary delivery of APIs with a dry powder inhalation for- mula is based on adherence to several key principles: Simplicity through breath-powered delivery Consistency using high flow resistance Adaptability for a variety of powders and user groups Modularity of a platform-based delivery technology Portability with a discreet, small system Scale-ability in high- and low-volume applications Sensitivity to environmental exposure T hrough extensive clinical experience and market research MannKind has developed a new line of cost effective, innovative breath- powered devices. Our first embodiment, called Dreamboat™, is a reusable patient-friendly inhaler utilizing unit dose cartridges. Dreamboat Overview Dreamboat Technology Dreamboat Development Patient-focused Dry Powder Inhalers Powder Intersection Mouthpiece Inlet Cartridge Inlet To Patient Flow Path Dreamboat Inhaler Flow Path

Transcript of Device Technology — Patient-focused Dry Powder Inhalers

Page 1: Device Technology — Patient-focused Dry Powder Inhalers

Device Technology

MannKind Corporation

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The Dreamboat system was designed to be an efficient, simple, and low cost breath-pow-

ered inhaler technology platform that is adapt-able to a broad range of products and therapies. High flow resistance coupled with a concept called “flow balance” enables convenient inhaler formats that are easy to use and function consis-tently with low patient inhalation efforts.

Self-administration of pulmonary products is driven by patient compliance, so the inhalers

must be user-friendly and perform consis-tently. To this end, MannKind technology uses the patient’s inhalation effort to deliver the dose in a single inhalation. This system efficiently and aggressively focuses the energy

supplied by the patient directly onto the dry powder resulting in high delivery performance.

When utilized with MannKind’s Technosphere® formulations, greater than

90% of the powder is delivered to the patient with ~70% of that delivered in the respirable range. The Dreamboat Inhalation System shows

MannKind’s approach to pulmonary delivery of APIs with a dry powder inhalation for-

mula is based on adherence to several key principles:

Simplicity through breath-powered delivery

Consistency using high flow resistance

Adaptability for a variety of powders and user groups

Modularity of a platform-based delivery technology

Portability with a discreet, small system

Scale-ability in high- and low-volume applications

Sensitivity to environmental exposure

Through extensive clinical experience and market research MannKind has developed

a new line of cost effective, innovative breath-powered devices. Our first embodiment, called Dreamboat™, is a reusable patient-friendly inhaler utilizing unit dose cartridges.

Dreamboat Overview

Dreamboat Technology

Dreamboat Development

Patient-focused Dry Powder Inhalers

Powder IntersectionMouthpiece Inlet

Cartridge Inlet

To Patient

Flow Path

Dreamboat Inhaler Flow Path

Page 2: Device Technology — Patient-focused Dry Powder Inhalers

Device Technology

MannKind Corporation

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For more information about MannKind Corporation and its technology, visit: http://www.mannkindcorp.com

very little change in performance over a wide range of relevant pressure drops (flow rates) and produces high bioavailability. In addition, a handling study has shown the device is compat-ible with pediatric use.

The manufacture of the Dreamboat Inhalation System is cost effective, featuring a 5-part

inhaler and a 2-part cartridge that are:

Highly amenable to automatic (top down) assembly

Scaled to 16 cavity and 96 cavity component molding

Manufactured from standard compliant resins: PBT, ABS, PP, and HDPE resins

The Dreamboat inhalation system is being expanded to a variety of other inhaler em-

bodiments featuring the same user appeal and performance. Adjustments to meet the needs of specific API formulations and specific clinical indications can be easily implemented.

In addition, the Dreamboat principles have been used to develop the “Cricket” device family.

This novel pulmonary delivery device is designed for acute, time of need, and short duration treat-ments. It offers significant advantage in a single use, 2-part low cost format.

Dreamboat Development (continued)

MannKind’s Vision

Dreamboat Delivery Performance

Cumulative Geometric Particle Size Distributionsat Various Inhalation Pressures

0102030405060708090

100

0 2 4 6 8 10 12 14 16 18 20Geometric Diameter (µm)

Cum

ulat

ive

Dis

trib

utio

n (%

)

2 kPa

4 kPa

6 kPa

8 kPa

Dreamboat Inhaler and Cartridge Assembly

MouthpieceCover

Mouthpiece

Top

Rack

Bottom

Lid

Cup

Multi-use Dreamboat Family

Disposable Cricket Family

Patient-focused Dry Powder Inhalers