Abstract: A nozzle for use in delivering a mixture of aerosol propellant and drug formulation. The nozzle includes a drug product inlet configured to receive a mixture of aerosolized propellant and an intranasal dosage form. The inlet is disposed at the proximal end. A nozzle body is secured to the drug product inlet. Two or more channels are disposed within the body. Two or more orifice apertures are disposed at the distal end of the nozzle.

Abstract: Embodiments relate to a single-use device for delivery of medication into a nasal cavity. In an embodiment, the device includes a propellant canister containing a propellant capable of propelling the compound to the nasal cavity. The propellant canister is displaceable between an unactuated position and an actuated position within the device. The device further includes an actuation element with an actuation lever configured to displace the propellant canister from the unactuated position to the actuated position. The device also includes a puncture element positioned to puncture the propellant canister, which causes the release of the propellant from the propellant canister. The device further includes a dose holding chamber containing a unit dose of the compound. The dose holding chamber is positioned such that propellant flows into the dose holding chamber and causes the compound to be propelled from the dose holding chamber to the nasal cavity of the user.

Abstract: A device for delivering a compound to the olfactory region of the nasal cavity includes an actuator body and a tip that removably couples to the actuator body. The actuator body comprises a propellant channel in fluid communication with a propellant canister. The tip comprises an exit channel, an inlet interface, one or more grooves, and an outlet orifice. The exit channel extends between a proximal end and a distal end of the tip. The inlet interface is positioned about a distal end of the exit channel, and the inlet interface couples to a compound container containing the compound. The grooves are positioned about the inlet interface and direct propellant from the propellant channel into the compound container, thereby agitating and entraining the compound in the compound container with the released propellant. The compound and the propellant then travel through the exit channel and out the outlet orifice.

Abstract: A nasal drug delivery device for delivering a plume derived from a propellant and a drug compound. The drug compound is in an intranasal dosage form in the form of powder, suspension, dispersion, or liquid. The propelled intranasal dosage form is deposited within the upper nasal cavity such as the olfactory region. The drug deposited within the olfactory region is delivered to the brain avoiding the blood-brain-barrier. Hydrofluoroalkane propellant from a pressurized canister is channeled to a diffuser and drug-containing channel where the intranasal dosage form is aerosolized. The aerosolized intranasal dosage form passes through a nozzle thus delivering a plume to the user's upper nasal cavity.

Abstract: Methods are provided for acute treatment of agitation, including agitation in patients with schizophrenia or bipolar disorder, comprising administering to a subject with agitation an effective dose of a dry pharmaceutical composition comprising olanzapine, wherein the dose is administered by an intranasal delivery device that provides, following intranasal administration, (a) a mean peak plasma olanzapine concentration (Cmax) of at least 30 ng/mL, with (b) a mean time to Cmax (Tmax) of olanzapine of less than 0.5 hours. Dry pharmaceutical compositions and devices suitable for intranasal delivery of olanzapine are provided.

Abstract: A compound delivery device for delivering a plume derived from a propellant and a drug formulation. The drug formulation is in an intranasal dosage form in the form of powder, suspension, dispersion or liquid. The propelled intranasal dosage form is deposited within the olfactory region of the nasal cavity. The drug deposited within the olfactory region is delivered to the brain avoiding the blood-brain-barrier. Hydrofluoroalkane propellant from a pressurized canister is channeled to a diffuser and drug-containing chamber where the intra-nasal dosage form is aerosolized. The aerosolized intra-nasal dosage form passes through a nozzle thus delivering a plume to the olfactory region of a user's nasal cavity.

Abstract: A dry pharmaceutical composition is provided that is suitable for respiratory tract delivery of levodopa and DDI for treatment of Parkinson's disease or Parkinson syndrome. The dry pharmaceutical composition comprises levodopa, a dopa decarboxylase inhibitor (DDI) and at least one excipient. A unit dosage form of the dry pharmaceutical composition and a method of treating a patient with Parkinson's disease or Parkinson syndrome by administering the dry pharmaceutical composition are also provided.

Abstract: A device for delivering a compound to the olfactory region of the nasal cavity includes an actuator body and a tip configured to removably couple to the actuator body. The actuator body comprises a propellant channel in fluid communication with a propellant canister. The tip comprises a tip stem, a dip tube, a delivery channel, one or more puncture members, and an outlet orifice. The tip stem receives a compound container containing the compound and the compound container moves between a sealed state and an unsealed state. The one or more puncture members are each configured to puncture the compound container when the compound container is in the unsealed state. Propellant released from the canister travels through the propellant channel and into the punctured compound container, thereby contacting the compound and propelling the compound through the delivery channel and out the outlet orifice.

Abstract: A dry pharmaceutical composition is provided that is suitable for respiratory tract delivery of levodopa and DDI for treatment of Parkinson's disease or Parkinson syndrome. The dry pharmaceutical composition comprises levodopa, a dopa decarboxylase inhibitor (DDI) and at least one excipient. A unit dosage form of the dry pharmaceutical composition and a method of treating a patient with Parkinson's disease or Parkinson syndrome by administering the dry pharmaceutical composition are also provided.

Abstract: A device for delivering a compound to the olfactory region of the nasal cavity includes an actuator body and a tip that removably couples to the actuator body. The actuator body includes a propellant channel in fluid communication with a propellant canister. The tip includes an exit channel, an inlet interface, one or more grooves, and an outlet orifice. The exit channel extends between a proximal end and a distal end of the tip. The inlet interface is positioned about a distal end of the exit channel, and the inlet interface couples to a compound container containing the compound. The grooves are positioned about the inlet interface and direct propellant from the propellant channel into the compound container, thereby agitating and entraining the compound in the compound container with the released propellant. The compound and the propellant then travel through the exit channel and out the outlet orifice.