Active substance: Azithromycin
The liquid delivery technologies have utilized spray pump derived technology or pressurized metered dose inhalers pMDIs for rapid jetting of the formulation into the nasal cavity.
In general, nasal formulations are solution or suspension based requiring solvents or stabilizers.
The devices are difficult to manufacture Formulations are less stable Control over deposition site in nasal cavity is poor Deposition of formulation is often concentrated to certain tissues and causes irritation on these areas while not treating other locations within the nasal cavity Positioning of the device during use is critical and heavily dependent on patient use, therefore variability in dosing to target tissues is high DPI device technologies have been applied to nasal delivery predominantly for locally acting drugs.
These formulations have notable advantages such as stability and dose delivery. These can be particularly advantageous for biological drugs and drugs requiring systemic plasma concentrations.
Such devices are activated by nasal inhalation. These devices have also applied known concepts from DPI technology: reservoir dry powder with dose metering mechanisms—or capsule based devices needing piercing mechanisms and special loading procedures before use and after use.
These device concepts inherit the same problems experienced when using DPIs for pulmonary delivery: complicated formulation, and high airflow resistance making it difficult to achieve sufficient nasal dose delivery.
In addition, they suffer from the same in-use variability and regional deposition drawbacks of spray systems.
More particularly, the present invention is designed to directly apply active agents to patients utilizing a novel actuating sphere or bead-like actuator design and an accompanying inhaler to take advantage of these unique properties.
In some embodiments, the present invention also takes advantage of the high performance at low flow rates of a powder dispersion system so that powders can be successfully delivered to different regions of the nasal cavity.
According to one aspect, a dry powder inhaler includes an inlet channel through which air enters the inhaler, and a chamber that receives air from the inlet channel, the chamber being of a size and shape to contain a bead-like actuator to which a powdered medicament is adhered.
An outlet channel is provided through which air and the powdered medicament leave the inhaler to be delivered to a patient. The geometry of the inhaler is such that a flow profile is generated within the chamber that causes the bead-like actuator to oscillate, thus detaching the powdered medicament from the surface of the bead-like actuator to be entrained by the air and delivered to the patient through the outlet channel.
In some embodiments, the cross sectional area of the flow path through the inhaler undergoes a step increase at the entrance to the chamber.
In some embodiments, the outlet channel is comprised in a mouthpiece adapted to be placed within the mouth of the patient. In some embodiments, the outlet channel is comprised in a nasal adapter adapted to conform to the nostrils of the patient.
In some embodiments, the inlet channel is a first inlet channel and the chamber is a first chamber, the dry powder inhaler further comprises a second inlet channel and a second chamber. In some embodiments, air and powdered medicament leaving the first and second chambers are delivered to the outlet channel.
In some embodiments, the outlet channel is a first outlet channel, the dry powder inhaler further comprises a second outlet channel, and air and powdered medicament leaving the first chamber are delivered to the first outlet channel, and air and powdered medicament leaving the second chamber are delivered to the second outlet channel.
In some embodiments, the dry powder inhaler is combined with the bead-like actuator.
In some embodiments, the dry powder inhaler includes a plurality of chambers disposed on a rotary element for selectively aligning any of the chambers with the outlet channel.
According to another aspect, a method utilizes a dry power inhaler that includes an inlet channel, a chamber, and an outlet channel, the chamber holding a bead-like actuator, wherein one or more powdered medicaments are adhered to an outside surface of the bead-like actuator.
A user inhales through the outlet channel, causing air to flow into the inlet channel, through the chamber, and through the outlet chamber, the flowing air also causing the bead-like actuator to oscillate to dislodge powdered medicament from the surface of the bead-like actuator to be entrained in the flowing air and carried through the outlet channel.
In some embodiments, the method further includes separating or opening portions of the inhaler comprising the chamber and the outlet channel, loading the bead-like actuator into the chamber, and re-engaging the two portions of the inhaler.