Epinephrine spray formulations
Inventors
Hartman, Steven • LOBEL, Michelle • Robben, Matthew P. • Dretchen, Kenneth L. • MESA, Michael
Assignees
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Publication Number
US-10925841-B2
Publication Date
2021-02-23
Expiration Date
Abstract
Provided herein are epinephrine spray formulations. Also provided herein are methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatment.
Core Innovation
The invention relates to a bi-dose nasal delivery device and a pre-primed device adapted for delivery of an aqueous pharmaceutical composition into a nostril of a human subject. The pharmaceutical composition comprises epinephrine, or a pharmaceutically acceptable salt thereof, in water, together with diethylene glycol monoethyl ether and additional excipients, including hypromellose, sodium bisulfite or sodium metabisulfite, chlorobutanol or chlorobutanol hemihydrate, citric acid or citric acid monohydrate, and sodium chloride.
The device is configured for nasal spray delivery as one or more sprays into one or both nostrils, and the reservoir contains from about 125 uL to about 250 uL of the pharmaceutical composition. In one form, the bi-dose nasal delivery device administers the composition into a nostril as one or two nasal sprays.
The formulation and delivery concept is oriented toward intranasal treatment associated with anaphylaxis, anaphylactic shock, severe allergic reaction, and bronchial constriction. The disclosed formulation and device are presented with targeted delivery performance and stability over storage.
Claims Coverage
The document contains two independent claims: a bi-dose nasal delivery device and a pre-primed nasal delivery device. Both independent claims define an aqueous epinephrine-containing nasal spray composition with specified component concentration ranges and a nasal delivery device configured for one or more sprays into one or both nostrils, with a defined reservoir volume.
Bi-dose nasal delivery device with aqueous epinephrine nasal spray formulation
A bi-dose nasal delivery device adapted for delivery into a nostril, comprising an aqueous pharmaceutical nasal spray formulation with epinephrine, or a pharmaceutically acceptable salt, in water, diethylene glycol monoethyl ether, hypromellose, sodium bisulfite or sodium metabisulfite, chlorobutanol or chlorobutanol hemihydrate, citric acid or citric acid monohydrate, and sodium chloride, together with a reservoir containing from about 125 uL to about 250 uL, configured to administer as one or two nasal sprays.
Pre-primed device for multi-spray aqueous epinephrine nasal delivery
A pre-primed device adapted for delivery of an aqueous pharmaceutical composition into one or both nostrils, comprising a reservoir containing from about 125 uL to about 250 uL and a composition including epinephrine, or a pharmaceutically acceptable salt, in water, diethylene glycol monoethyl ether, hypromellose, sodium bisulfite or sodium metabisulfite, chlorobutanol or chlorobutanol hemihydrate, citric acid or citric acid monohydrate, and sodium chloride, configured to administer as one or more sprays into one or both nostrils.
Across both independent claims, the core inventive coverage is the combination of an aqueous intranasal epinephrine formulation with specified excipients and concentration ranges, paired with a nasal spray delivery device having a reservoir of about 125 uL to about 250 uL and configured to administer one or more sprays into one or both nostrils.
Stated Advantages
Targeted delivery performance and stability over storage.
Delivery or plume characteristics associated with nasal spray administration.
Documented Applications
Intranasal treatment associated with anaphylaxis, anaphylactic shock, severe allergic reaction, and bronchial constriction.
Treatment of at least one symptom of anaphylaxis or anaphylactic shock by administering a pharmaceutical spray composition via a bi-dose nasal delivery device into at least one nostril of a subject in need.
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