Inhalation Technology Videos and Podcasts

October 27, 2009

Video and audio podcasts are making their way into every field on the web, and I’m happy to recommend some free media presentations on inhalation technology published on a blog maintained by the Center for Integration and Innovative Technology (CIMIT).  CIMIT is a non-profit consortium of Boston teaching hospitals and engineering schools. There are two [...]

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Inhalation Quick Links – Week of 10/11/09

October 14, 2009

MicroDose Therapeutx Announces Initiation of Phase I Study with Inhaled Atropine (9/29/09) – Evaluated in MicroDose’s dry powder inhaler as an antidote for nerve agent poisoning. AFRESA Phase 3 Data Show Sustained Glycemic Control, Normal Lung Function in Patients over Four Years of Treatment (10/2/09) Microcapsules Deliver Chemo Direct to Lung Tumor (10/13/09) – Technology [...]

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Battle of the MDI and DPI Patent Trends

September 27, 2009

I thought it would be interesting to look at the numbers of patents for metered dose inhalers and dry powder inhalers that have been issued over time and see what trends emerge.  Let’s start with the DPIs.  The figure below shows the approximate1 numbers of U.S. utility patents issued for dry powder inhaler devices and [...]

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Inhalation Quick Links – Week of 9/13/09

September 15, 2009

Altair Therapeutics Reports Successful Phase I Study of Inhaled AIR645 (9/14/09) -  evaluated as a non-steroidal anti-inflammatory control medication for asthma, delivered via nebulization Kamada Presents Data on Inhaled Alpha-1 Antitrypsin in Cystic Fibrosis Patients at the European Respiratory Society Meeting 2009, Vienna (9/14/09) -  delivered via an optimized Investigational eFlow Nebulizer System (PARI Pharma [...]

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New Regulatory Perspectives on Nebulizer Devices

September 8, 2009

A recently published article1 provides new insights into the U.S. regulatory review of nebulizer devices.  The FDA”s Reviewer Guidance Document2 on this topic was published in 1993. Here are a few highlights and some of the differences between the two documents based on my interpretation: The 1993 Reviewer Guidance focuses on the review of 510(k) [...]

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Inhalation Quick Links – Week of 8/30/09

August 31, 2009

Two high-profile, high-dollar thefts occurred this month of inhaled drug products. GSK announced the theft of two lots of Advair Diskus (more than 25,000 inhalers) worth about $5.5 million.  In a separate incident, Dey, a subsidiary of Mylan, reported that two lots of Albuterol Sulfate Inhalation Solution were stolen from a tractor trailer in Texas.  [...]

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MMAD and GSD Calculator

August 23, 2009

There are numerous methods to calculate the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) for an aerodynamic particle size distribution generated via cascade impactor.  One can plot the cumulative distribution and effective cutoff diameters on log probability graph paper (as prescribed by USP<601>), or one can use computer algorithms to automate the [...]

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Dry Powder Inhalable Vaccine on the Horizon

August 19, 2009

What could be the world’s first dry powder inhalable vaccine is expected to enter clinical trials next year in India.  The measles vaccine, developed by Robert Sievers of Activ-Dry and the University of Colorado, is a combination of high-tech particle engineering and an ultra-simple delivery device.  The live attenuated vaccine is formulated with myo-inositol, and [...]

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Cascade Impactors on Ice

August 7, 2009

It is well known that the aerodynamic particle size distributions of pharmaceutical aerosols, as measured with cascade impactors, can vary as a function of the ambient conditions during the test.  For an MDI or DPI, the concern is usually particle size changes as a function of ambient humidity.  For a nebulizer, there is a growing [...]

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Inhalation Quick Links – Week of 7/26/09

August 2, 2009

FDA Approves TYVASO (Treprostinil) Inhalation Solution (7/30/09) – United Therapeutics received approval for their treatment of pulmonary arterial hypertension (PAH). SkyePharma and Novartis Pharma Terminate Contracts on Formoterol CentihalerTM Dry Powder Inhaler (7/17/09) MannKind Corporation Releases New Information on Market Potential of AFRESA (Fast-Acting Inhaled Insulin) (7/14/09)

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