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Patent Awarded for COPD Dry Powder Inhaler Formula

lung illustration

(Kai Stachowiak, Pixabay)

9 May 2017. A formulation for dry powder inhalers to treat respiratory diseases that its developers say delivers medication to the lungs more efficiently received a U.S. patent. The U.S. Patent and Trademark Office today awarded patent number 9,642,798 to two inventors, and assigned the rights to Pulmatrix Inc. in Lexington, Massachusetts.

Pulmatrix develops inhaled medications to treat serious respiratory disorders, including COPD, short for chronic obstructive pulmonary disease. COPD is a progressive respiratory disorder that makes it difficult to breathe, and causes coughing, wheezing, shortness of breath, and tightness in the chest. The leading cause of COPD is cigarette smoking, but other irritants like chemical fumes or air pollution can contribute to the condition.

Two major forms of the disease are emphysema, where walls between air sacs in the lungs are damaged and chronic bronchitis, where  the lining of the airways is constantly irritated and inflamed. COPD is a major cause of disability and the third leading cause of death in the U.S.

Pulmatrix says the patent covers the dry powder technology underlying its products, called iSperse, short for inhaled small particles easily respirable and emitted, applied to COPD treatments. The iSperse dry particles, says the company, overcome a serious problem with current dry-powder inhalers, namely the sticking of medication particles in the mouth and throat, which limits delivery of drugs into the lungs where they’re needed. The powder particles are smaller, denser, and milled to be more aerodynamic to avoid being deposited in the mouth or throat.

The company says iSperse can be adapted to many kinds of drug compounds and biologics. In the case of COPD, Pulmatrix delivers tiotropium bromide, a key ingredient in the drug Spiriva, made by Boehringer Ingelheim Pharmaceuticals, approved for COPD as well as asthma. Pulmatrix says its lead product, code-named PUR0200, delivers tiotropium bromide to the lungs more completely and efficiently, making it possible to uses doses only about 20 percent of those in other inhaler formulations.

PUR0200 completed early stage clinical trials, with intermediate-stage studies next in line. The latest early-stage trial, reported in July 2016 tested 7 different formulations of PUR0200, for their ability to deliver drug payloads to the body. Results show comparable concentrations in blood samples from the 42 participants in all 7 of the formulations of PUR0200 similar to current inhaled COPD drugs, but in smaller doses. Safety profiles of PUR0200 were similar to current COPD drugs, with no serious adverse effects reported. An earlier study shows PUR0200 improves lung functions in people with moderate to severe COPD, but also in smaller doses than current drugs.

In March 2017, Pulmatrix received a European patent protecting its general dry powder technology, similar to a U.S. patent awarded in September 2016. The company is developing PUR0200 initially for the European market, with drug maker Mylan holding an option to license and commercialize PUR0200 outside the U.S.

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