Patent Title- Particulate compositions for pulmonary delivery
Inventors and Affiliation – Batycky; Richard P. (Newton, MA), Edwards; David A. (Boston, MA), Lipp; Michael M. (Framingham, MA)
Key Words- Spray-dried, vaccine, pulmonary, powder, inhaler
The main focus of the patent
This patent describes a method to make pharmaceuticals and vaccines that were previously only administered by injection available by inhalation. Specifically, the patent describes a method for creating hollow, collapsible drug micron size particles whose properties make them suitable for administration by inhalation.
Limited technical details
Physiochemical properties such as particle size, morphology, electrostatic charge interactions and moisture content are known to influence the overall stability, efficiency and delivery of dry particles used in inhalation therapies. The patents by Edwards et al. (U.S. Pat. No. 7,384,649 and 7182961) identify and list specific properties of particles that render them easily dispersible (mass median diameter of at least about 5 microns, surface area parameter greater than 2, tap density of less than 0.4 g/cm3, a median geometric diameter greater than 5 μm, and an external surface area greater than about 5 m2/g and being able to efficiently penetrate into the lungs when dispensed from a dry powder inhaler. The spray drying method described in the patent creates dry powder pharmaceutical compositions containing the active drug and the vehicle that are hollow, spherical collapsible particles having the above mentioned properties. The patent also goes on to describe specific spray drying conditions required to minimize the average wall thickness of the shells of these particles to less than 150 nanometers, a way to measure and collect particles having the required minimized average wall thickness and finally a method to administer them to the respiratory tract of a patient in need of the drug.
Implications/applications and sectors that are addressed by patent/technology
The patent can potentially have widespread applications in any of the forms inhalation therapy using metered-dose inhalers and nebulizers examples include, beta 2 receptor agonists (used in asthma), corticosteroids, antivirals, antibiotics, and cromolyn (used for preventing symptoms of asthma), the area which the inventors are immediately focusing is its application to vaccines, which are traditionally administered by injection, but could be administered by inhalation. Vaccines given by inhalation There are ongoing clinical trials using a spray dried form of the commonly used injectible Bacille Calmette Guerin (BCG) tuberculosis vaccine as an aerosol.
Inhaled (Needle-free) vaccinations through mucosal surfaces such as nasal passages and lungs are not currently widespread but could represent an emerging market. These vaccines can potentially address shortcomings of conventional injection vaccines such as low acceptance rates (by virtue of being relatively easier and pain-free) and additionally avoid the problems of needle stick injury and contamination as well as the need for trained personnel. Another advantage that a spray dried powder formulation created by this technology can offer is stability at room temperature which would remove the need for refrigeration during storage and transport, a major barrier in developing countries where vaccines for diseases such as tuberculosis are used. Early studies using the spray dried form of the BCG vaccine have demonstrated to be more effective in animal models than an injectable version
Market: In the specific instance of the tuberculosis vaccine, the worldwide incidence of the disease is about 8 million. However the main market is in the developing countries, especially Asia and sub Saharan Africa where immunization is still a major tool for preventing the disease. In the US, the BCG is not recommended as a means to control TB because of the unproven efficacy of the vaccine in its current form thereby making the development of a more effective alternative an attractive option.
History of the Inventors:
David Edwards, a biomedical engineering professor at Harvard University, he founded Advanced Inhalation Research, Inc., a company that made inhaled form of drugs such as growth hormone and epinephrine and was acquired by Alkermes in 1999. He also co-founded a company called Pulmatrix in 2003 which focuses on respiratory infectious disease. Their products inhibit the formation and transport of infectious aerosols within the lungs thereby decreasing both disease severity as well as spread. Both companies were funded and backed by Polaris Venture Partners.
For the current patent, Edwards, through an international nonprofit he established called Medicine in Need, or MEND has moved the first inhalable TB vaccine candidate into the clinical trial stage.
Richard P. Batycky was the Vice President, Pulmonary Research and Development at Alkermes , Inc. and is currently the Chief Scientific Officer and Senior Vice President of Research and Development at Pulmatrix Inc.
Michael Lipp was the Director of Formulation Development at Alkermes , Inc. and is currently Senior Director of Development at Pulmatrix Inc.
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