Gateway Analytical has added new analytical testing and consulting services for OINDPs, the company has announced. New services include identification and particle size distribution (PSD) analysis of agglomerated materials and assessment of agglomerates' effect on PSD measurements. Gateway already offers ingredient specific particle sizing and other tests for MDIs, … [Read more...] about Gateway Analytical expands OINDP services
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Drug and Therapeutics Bulletin article warns that health professionals do not understand how to use inhalers properly
An article posted on October 4, 2012 on the BMJ publication Drug and Therapeutics Bulletin article asks, "who needs teaching?" when it comes to inhaler technique. The article points out that an overwhelming number of health professionals have a poor understanding of how to use inhalers and are therefore in no position to teach patients how to use the devices. The … [Read more...] about Drug and Therapeutics Bulletin article warns that health professionals do not understand how to use inhalers properly
MannKind completes patient recruitment for two Afrezza studies
MannKind Corporation says that it has completed recruitment of patients for two Phase 3 studies of Afrezza inhaled insulin. One of the studies will assess HbA1c levels in Type 1 diabetes patients using either injected rapid-acting insulin, Afrezza delivered with the MedTone inhaler, or Afrezza delivered by MannKind's next generation inhaler. The second study involves … [Read more...] about MannKind completes patient recruitment for two Afrezza studies
Malvern launches new particle characterization system
Malvern Instruments has launched the Morphologi G3-ID particle characterization system, which combines Raman spectroscopy with particle imaging to provide simultaneous identification of particle size, particle shape, and chemical composition. According to the company, the system "is proving especially valuable are in determining component-specific particle properties … [Read more...] about Malvern launches new particle characterization system
Study shows better absorption for dry powder intranasal sumatriptan than nasal or oral Imitrex
OptiNose has announced results of a randomized, single-dose, four-way cross-over PK study demonstrating that 20% less of its intranasal dry powder sumatriptan product delivered into the nose than Imitrex nasal spray resulted in over 60% more sumatriptan in the blood in the first 15 minutes. The 16 mg dose of the Optinose product also resulted in over 30% more in … [Read more...] about Study shows better absorption for dry powder intranasal sumatriptan than nasal or oral Imitrex
Fresenius Kabi makes acetylcysteine inhalation solution available
Fresenius Kabi has announced the availability of 30 ml vials acetylcysteine inhalation solution, 20%, helping to alleviate a shortage of the product in the US. The company is marketing the inhalation solution in the US under a licensing agreement with Innopharma, whose ANDA was approved by the FDA in September 2012. The company's President and CEO John Ducker … [Read more...] about Fresenius Kabi makes acetylcysteine inhalation solution available
EC approves Seebri Breezhaler
As expected, the European Commission has approved Novartis's Seebri Breezhaler glycopyrronium bromide DPI for the treatment of COPD. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for glycopyrronium in June 2012. The announcement comes just days after the announcement of the approval of Seebri … [Read more...] about EC approves Seebri Breezhaler
Microdose announces completion of Phase 1 studies for inhaled RSV treatment
MicroDose Therapeutx has completed the Phase 1 clinical program for its inhaled antiviral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus infection and plans to present data from the three studies at the upcoming International Respiratory Syncytial Virus Symposium. The company announced completion of the first two studies in April 2012. … [Read more...] about Microdose announces completion of Phase 1 studies for inhaled RSV treatment
Seebri inhalation capsules approved in Japan
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Novartis's Seebri glycopyrronium bromide inhalation capsules, delivered by the Breezhaler DPI, for the treatment of COPD. The product should be available in Japan by the end of 2012. The glycopyrronium inhalation formulation was co-developed by Sosei and Vectura, which licensed it to Novartis … [Read more...] about Seebri inhalation capsules approved in Japan
British Pharmacopoeia publishes policy document on inhaled products
The British Pharmacopoeia (BP) Inhaled Products Working Party has published its recommendations for BP monographs for inhalation as of September 17, 2012. According to the document, "Safety and efficacy are critical considerations; the Working Party has taken the view that the inhalation monographs would ensure products that are safe and efficacious by maintaining … [Read more...] about British Pharmacopoeia publishes policy document on inhaled products