FIELD OF THE INVENTION

This disclosure relates to dry powder delivery devices and more specifically to dry powder delivery devices for the delivery of therapeutic dry powders to the pulmonary system.

BACKGROUND OF THE INVENTION

The use of inhalation devices for the treatment of a variety of respiratory diseases is an area of large interest. Inhalation provides for the delivery of therapeutic drugs to treat, e.g., asthma, COPD and site-specific conditions, with reduced systemic adverse effects. A major challenge is providing a device that delivers an accurate, consistent, and verifiable dose, with an inhalation plume size that is suitable for successful delivery of medication to the targeted location in the body such as the lung passageways.

Currently most inhaler systems such as metered dose inhalers (MDI) and pressurized metered dose inhalers (p-MDI) or pneumatic and ultrasonic-driven devices generally produce drops with high velocities and a wide range of droplet sizes including large droplet that have high momentum and kinetic energy. Droplets and aerosols with such high momentum do not reach the distal lung or lower pulmonary passageways but are deposited in the mouth and throat. As a result, larger total drug doses are required to achieve the desired deposition in targeted areas. These large doses increase the probability of unwanted side effects.

Dry powder inhalers (DPIs) are portable devices available as an alternative to MDI devices. Dry powder inhalers rely on adequate patient effort to deliver the dose. In general, the efficacy of DPIs can be affected by environmental conditions such as temperature and humidity. Since higher patient inspiratory flow is necessary to operate a DPI, they are not recommended for children less than five years of age. Unlike the MDI, where the design is relatively uniform for each device, DPI devices tend to vary depending on the device, which may contribute to patient and health care provider confusion. As such, improvements are needed to provide DPIs that provide the efficient delivery to the pulmonary system of users.

In particular, there is a need for a DPI device that delivers particles of a suitable size range, avoids aggregate formation and insures adequate particle dispersion that delivers a dose that is accurate, consistent and verifiable, and provides feedback regarding correct and consistent usage of the inhaler to patient and professional such as physician, pharmacist or therapist.

SUMMARY OF THE INVENTION

In certain aspects, the disclosure provides a breath actuated dry powder delivery device for delivering a powder as a plume of particles to the pulmonary system of a subject. In certain aspects, the disclosure relates to a dry powder delivery device and method for generating a plume of powder particles having an average diameter of less than about 5-6 μm or a range of particle size that is consistent with the particle size distribution of the original powder formulation. In certain aspects, the dry powder delivery device comprises a dry powder dispersal mechanism comprised of an energy source configured to generate a plume of powder particles having an average particle diameter of less than about 5-6 μm, or a range of particle size that is consistent with the particle size distribution of the original powder formulation.

In certain embodiments, the breath actuated dry powder delivery device may include a housing comprising a mouthpiece located at an airflow exit side of the housing, and a laminar flow element; a cartridge disposed within or removably attached to the housing, for receiving a volume of powder; a powder dispersion mechanism, the powder dispersion comprising an energy source configured to generate and disperse a plume of particles from a powder received in the cartridge; and at least one differential pressure sensor positioned within the housing.

In certain embodiments, the at least one differential pressure sensor may be configured to activate the energy source of the powder dispersion mechanism upon sensing a pre-determined pressure change within the housing to thereby generate the plume of particles. The laminar flow element may be located at an airflow entrance side of the housing, wherein the housing, laminar flow element, and mouthpiece are configured to facilitate laminar airflow across an exit side of the powder dispersion mechanism and to provide sufficient laminar airflow through the housing during use. The powder dispersion mechanism may be configured to generate the plume of particles wherein at least about 70% of the particles have an average particle diameter of less than about 6 microns, such that at least about 70% of the mass of the generated particles is delivered in a respirable range to the pulmonary system of a subject during use.

Other aspects relate to methods for generating and delivering a powder as a plume of particles to the pulmonary system of a subject in a respirable range, the method comprising: (a) generating a plume of particles via an breath actuated dry powder delivery device of the disclosure, wherein at least about 70% of the particles have an average particle diameter of less than about 6 microns; and delivering the plume of particles to the pulmonary system of the subject such that at least about 70% of the mass of the generated particles is delivered in a respirable range to the pulmonary system of the subject during use.

While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the detailed descriptions are to be regarded as illustrative in nature and not restrictive.

