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Publication Number
US-11541192-B2
Publication Date
2023-01-03
Expiration Date
Abstract
The present invention relates to a handheld vibrating mesh nebuliser for delivery of a medicament to the respiratory system in therapy. The present invention also relates to a supply container for loading the nebuliser with liquid medicament. The present invention also relates to a kit for delivery of a medicament to a respiratory system and a method of loading a vibrating mesh nebuliser with liquid medicament from a supply container. The present invention also relates to compositions for use in a method of treatment of a respiratory disease in a patient by therapy.
Core Innovation
The disclosed invention relates to a handheld vibrating mesh nebuliser for delivering a medicament to a respiratory system. The nebuliser includes a housing having a reservoir for a liquid medicament, and the device delivers the medicament as an aerosol generated by a vibrating mesh structure. The liquid medicament comprises unfractionated heparin, or a physiologically acceptable salt or derivative, together with an inorganic salt, and is configured for inhaled delivery to respiratory patients.
A core aspect of the invention is the combination of unfractionated heparin, or a physiologically acceptable salt or derivative, with specified average molecular weight, concentration, and an inorganic salt within specified total concentration limits. The unfractionated heparin or salt or derivative has an average molecular weight of from >8 to 40 kDa, the concentration in the liquid medicament is from 15 to 40 mg/mL, and the total concentration of the inorganic salt in the liquid medicament is from 10 to 300 mM.
The invention further specifies device and medicament characteristics for delivering the heparin-containing liquid medicament as an inhalable aerosol. In one aspect, the nebuliser includes an aerosol generator comprising a vibratable membrane containing a plurality of apertures, with aerosol delivery through an outlet port, and a gas venting inlet configured to mix incoming gas with the aerosol. The disclosed example results include respirable particle fractions and HPLC data indicating heparin structural integrity after nebulisation.
The invention addresses a therapeutic need in respiratory disease by enabling delivery of heparin-containing medicaments to the respiratory system, including for COPD and mucus hypersecretion. The document also describes potential combination medicament use with a second therapeutic agent and/or a DNase, with therapeutic-intent distinctions and defined types.
Claims Coverage
The provided claims content includes one independent claim with multiple dependent claim refinements. Across the family summary, the inventive features focus on a handheld vibrating mesh nebuliser architecture, a liquid medicament formulation containing unfractionated heparin or a physiologically acceptable salt or derivative with defined molecular weight and concentration plus inorganic salt within defined total concentration, and optional additional co-medicaments and narrowed device aerosol-delivery components.
Handheld vibrating mesh nebuliser for respiratory delivery
A vibrating mesh nebuliser delivers a medicament to a respiratory system, with a housing having a reservoir for a liquid medicament, and the nebuliser is a handheld device.
Unfractionated heparin with specified molecular-weight range
The liquid medicament comprises unfractionated heparin or a physiologically acceptable salt thereof or a derivative thereof, wherein the unfractionated heparin or the physiologically acceptable salt thereof or the derivative thereof has an average molecular weight of from >8 to 40 kDa.
Heparin concentration and inorganic-salt total concentration limits
The concentration of the unfractionated heparin or the physiologically acceptable salt thereof or the derivative thereof in the liquid medicament is from 15 to 40 mg/mL, wherein the total concentration of the inorganic salt in the liquid medicament is from 10 to 300 mM.
Aerosol generator with vibratable membrane apertures and gas venting delivery
The nebuliser includes an aerosol generator with a vibratable membrane containing apertures, wherein the aerosol generator aerosolises at least a portion of a medicament, and the nebuliser includes a gas venting inlet configured to mix incoming gas with the aerosol and deliver the resulting aerosol-gas mixture through a passage to an outlet port.
Optional second therapeutic agent and/or DNase with defined options
The liquid medicament includes a second therapeutic agent and/or a DNase, with specified options for the type of second agent and DNase and defined heparin-to-second-agent/DNase ratio ranges, and further specifies whether heparin and the second therapeutic agent are intended to have therapeutic effects or only the second therapeutic agent is intended to have therapeutic effect.
Overall, the claim coverage centers on a handheld vibrating mesh nebuliser configured to deliver an inhalable liquid medicament comprising unfractionated heparin or a physiologically acceptable salt or derivative with defined average molecular weight and concentration, together with an inorganic salt within specified total concentration limits. Dependent claim refinements further narrow heparin molecular-weight subranges and include device aerosol-delivery structure features, plus optional inclusion of a second therapeutic agent and/or a DNase with defined options and therapeutic-intent distinctions.
Stated Advantages
Enables nebulised delivery of heparin-containing liquid medicaments using a handheld vibrating mesh nebuliser, including polymeric, high-viscosity glycosaminoglycans.
Nebulisation yields respirable aerosol particle fractions for inhaled delivery.
HPLC data indicate nebulisation does not degrade heparin structural integrity.
Documented Applications
Inhaled delivery to respiratory patients, including COPD and mucus hypersecretion.
Combination therapy delivery using nebulised heparin formulations together with a second therapeutic agent and/or a DNase.
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