Drug delivery device and methods for using same
Inventors
MATHAI, Ashanthi • Frost, Michael • Kim, Serena • KOPPENHAGEN, Franciscus • Oringher, Seth
Assignees
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Publication Number
US-11278709-B1
Publication Date
2022-03-22
Expiration Date
Abstract
Devices for intranasal administration of naloxone are disclosed. The devices comprise a foam applicator and are configured to locate an applicator comprising a naloxone composition. in proximity to the middle turbinate and/or inferior turbinate. Naloxone can be delivered to the nasal mucosa by squeezing the nostril against the applicator. The device and methods of using the devices can be used to treat an opioid overdose.
Core Innovation
A method for treating an opioid overdose in a patient is provided by inserting an applicator of a device into the nasal cavity of a nostril. The device includes a handle with a proximate end and a distal end, a nasal stop attached toward the distal end, and an applicator coupled to the distal end, and the applicator comprises a naloxone hydrochloride composition. The distance between the nasal stop and the distal end is from 15 mm to 30 mm.
The method includes bringing the stop into contact with the anterior naris to situate the applicator in proximity to the middle turbinate and the inferior turbinate. Naloxone hydrochloride is administered by squeezing the nostril against the applicator for from 1 second to 5 seconds to release the naloxone hydrochloride composition from the applicator and to administer the naloxone hydrochloride composition to the nasal mucosa. The method is configured to thereby treat the opioid overdose.
After administration to a population of patients, the method provides a plasma naloxone pharmacokinetic profile characterized by a T_max less than 0.3 (±10%) hour and a C_max from 4,400 (±10%) pg/mL to 6,600 (±10%) pg/mL. In a related method, the plasma naloxone pharmacokinetic profile is bioequivalent to a pharmacokinetic profile characterized by a C_max of 5,700 (±10%) pg/mL, a T_max of 0.26 (±10%) hours, and an AUC_last of 8,000 (±10%) pg·hr/mL.
Claims Coverage
The partial content provides two independent claims. The coverage is a nasal administration method that positions a naloxone hydrochloride applicator using a nasal stop at a specified stop-to-distal end distance, administers naloxone by squeezing for a defined time, and recites specified plasma naloxone pharmacokinetic outcomes.
Nasal stop positioning with applicator stop-to-distal end distance 15–30 mm
The method inserts an applicator into a nasal cavity and includes a nasal stop attached toward the distal end, with the distance between the nasal stop and the distal end of the applicator being from 15 mm to 30 mm while bringing the stop into contact with the anterior naris to situate the applicator in proximity to the middle turbinate and the inferior turbinate.
Squeezing-based release of naloxone hydrochloride composition to nasal mucosa for 1–5 seconds
The method administers naloxone by squeezing the nostril against the applicator for from 1 second to 5 seconds to release the naloxone hydrochloride composition from the applicator and to administer the naloxone hydrochloride composition to the nasal mucosa, thereby treating the opioid overdose.
Plasma pharmacokinetic targets defined by Tmax and Cmax after administration
Following administration to a population of patients, the method provides a plasma naloxone pharmacokinetic profile characterized by a T_max less than 0.3 (±10%) hour and a C_max from 4,400 (±10%) pg/mL to 6,600 (±10%) pg/mL.
Bioequivalent plasma pharmacokinetic profile defined by Cmax, Tmax, and AUC_last
Following administration to a population of patients, the method provides a plasma naloxone pharmacokinetic profile that is bioequivalent to a pharmacokinetic profile characterized by a C_max of 5,700 (±10%) pg/mL, a T_max of 0.26 (±10%) hours, and an AUC_last of 8,000 (±10%) pg·hr/mL.
Across the independent claims, the core coverage is a nasal naloxone hydrochloride applicator method that uses a nasal stop to position the applicator near the middle and inferior turbinates with a defined 15–30 mm stop-to-distal end distance, and uses squeezing for 1–5 seconds to release and administer the naloxone to the nasal mucosa. The claimed novelty is further anchored by specified plasma naloxone pharmacokinetic performance targets or bioequivalence to specified C_max, T_max, and AUC_last values.
Stated Advantages
Provides a plasma naloxone pharmacokinetic profile with T_max less than 0.3 (±10%) hour and C_max from 4,400 (±10%) pg/mL to 6,600 (±10%) pg/mL.
Provides a plasma naloxone pharmacokinetic profile that is bioequivalent to a profile characterized by specified C_max, T_max, and AUC_last values.
Documented Applications
Treating an opioid overdose in a patient by intranasal administration of naloxone hydrochloride using a device applicator positioned with a nasal stop.
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