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FDA draft guidance albuterol sulfate metered dose inhaler MDI

FDA’s Draft Guidance on Albuterol Sulfate MDIs

In April 2013, the FDA published its Draft Guidance for studies recommended to establish in vitro and in vivo bioequivalence (BE) for metered dose inhalers (MDIs) containing albuterol sulfate.  A revision to the draft was published in June 2013. The recommended in vitro studies for the Test (T) and Reference (R) products are single actuation…

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Inhalers On the Move

Inhalers On the Move

Primatene Mist No Longer On the Shelves – The only over-the-counter asthma inhaler is no longer available as of Jan 1st, as part of the phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs). Civitas Therapeutics Announced Positive Results from clinical study of CVT-301, an inhaled L-Dopa formulation for Parkinson’s disease. FDA Psychopharmacologic Drugs Advisory Committee Recommends…

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Inhalation Dosage Form Selection – MDI vs DPI vs Nebulizer

Inhalation Dosage Form Selection: MDI vs. DPI vs. Nebulizer

Sponsors frequently ask for our help in selecting an appropriate dosage form for their inhalation product.  The decision of metered dose inhaler (MDI) versus dry powder inhaler (DPI) versus nebulized product is sometimes made based on marketing or competitive factors.  For example, if there is an interest in a higher barrier-to-entry product, then a DPI…

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MMAD GSD NGI ACI FPD FPF PSD

How Do YOU Calculate MMAD?

A recent Pharmacopeial Forum (PF) article1 aims to stimulate thinking on the methodologies used to calculate mass median aerodynamic diameter (MMAD).  The article presents several MMAD calculation techniques as alternatives to the US Pharmacopeia (USP) method. Because our lab performs this calculation on a routine basis (and I publish a separate website dedicated to the…

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Cirrus Pharmaceuticals’ RDD 2010 poster

Cirrus Pharmaceuticals’ RDD 2010 Poster

A colleague and I presented a poster this week at the Respiratory Drug Delivery (RDD) 2010 conference in Orlando.  The poster was entitled “Fine Particles for Inhalation Generated In Situ During MDI Filling”.  The work describes our development of a precipitation process for generating respirable particles during MDI filling, using HFA propellant as an anti-solvent.1…

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Asthma Inhaler Earth

Inhalation Quick Links – March 2010

MannKind’s Insulin Afrezza Fails to Win Approval 3/15/10 – FDA did not cite safety concerns but requested updated safety data. FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis 3/11/10 FDA Approves Cayston(R) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with…

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Future of Inhalers

Inhaler 2.0 – What’s the Future of Inhalation Devices?

In a previous post, Inhalation Report looked at the patent trends in the inhalation arts and posed the question of what would spark the next cycles  of innovation.  In this post, let’s focus the crystal ball on inhalation devices.  It’s no secret that the pharmaceutical industry has been a slow adopter of new manufacturing technologies.1…

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Inhalation Quick Links – Dec 2009

Spiriva Inhaler Approved to Reduce Flares of COPD 12/18/09 Onbrez Breezhaler Bronchodilator Cleared for COPD 12/3/09 US Approves Kiwi Asthma Inhaler 12/1/09 – Nexus6′s Smartinhaler Technology puts a microprocessor on an inhaler to record a year’s worth of dosage data that can be downloaded by doctors, hospitals, and researchers. Alexza Announces Submission AZ-004 (Staccato(R) Loxapine)…

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Andersen Cascade Impactor – Rest in Peace

Andersen Cascade Impactor: Rest in Peace?

For new inhalation projects coming into our lab, the Next Generation ImpactorTM (NGI) is our impactor of choice for aerodynamic particle size testing.   There are two primary reasons for this preference:  1) Use of the NGI is somewhat more efficient than the Andersen cascade impactor (ACI) due to easier assembly and disassembly; and 2)…

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The Virtual Lung Project

Scientists at UNC are building a predictive computer simulation of the human lung.  The Virtual Lung Project is already providing insights into the mechanism of mucocilliary clearance and is expected to accelerate the development of treatments for cystic fibrosis and other diseases of the lung. Here following links describe the project in more detail: Virtual…

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Inhalation Quick Links – Week of 11/8/09

Cipla Launches Generic Flu Drugs 11/11/09 – Cipla announced that it has launched generic versions of oseltamivir and zanamivir in its local market. Migraine Sufferers Find Faster Relief with Spray Medication 11/11/09 Mometasone Furoate Triumphs Over Beclomethasone Dipropionate in Patients with Mild Asthma: Presented at ACAAI 11/10/09 – This study, funded by Schering-Plough, compared mometasone…

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Inhalation Technology Videos and Podcasts

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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