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EP-4208222-B1 - DRUG SYRINGES WITH A MECHANICAL STOP FOR A SECOND DOSE

EP4208222B1EP 4208222 B1EP4208222 B1EP 4208222B1EP-4208222-B1

Inventors

  • HUBERT, Emma, Louise
  • YAN, HONG
  • PÉREZ, Dolores
  • SCRIMGEOUR, IAN
  • Ramos, David
  • VESOLE, Steven, M.
  • KAPIL, Monica A.
  • GEARY, WILLIAM C.
  • POPLI, Shagun
  • CANNAMELA, MICHAEL
  • NGUYEN, Jimmy, Vinh, Hoang

Dates

Publication Date
20260506
Application Date
20210831

Claims (4)

  1. A drug delivery system (700), comprising: a dispensing head (702) including a proximal tip (704) configured to be positioned in a nose of a patient, the tip having an opening (706) therein, a drug holder (712) containing a drug therein; a plunger (708) configured to move distally in response to a manual user force applied thereto; a body (714) in which the drug holder is disposed; and a mechanical stop; wherein the plunger is configured to move a first predetermined distance distally relative to the dispensing head in a first stage of operation in which the drug is delivered from the drug holder and out of the opening before the mechanical stop prevents further distal movement of the plunger; and wherein the plunger is configured to move a second predetermined distance distally relative to the dispensing head in a second stage of operation in which the drug is delivered from the drug holder and out of the opening; and characterized in that the body has a proximal hole (724) formed in and extending through a sidewall thereof, a distal hole (726) formed in and extending through the sidewall, and an intermediate hole (736) formed in and extending through the sidewall, the intermediate hole being located between the proximal and distal holes; and the mechanical stop comprises a depressible pin (722) that extends radially outward from the plunger and that is configured to be successively seated in and extend through the proximal hole, the intermediate hole, and the distal hole.
  2. The system of claim 1, wherein the depressible pin is configured to be manually pushed radially inward relative to the body after the plunger moves the first predetermined distance and before the plunger moves the second predetermined distance.
  3. The system of any preceding claim, further comprising a viewing window (528) configured to allow a user to visualize whether or not each of the first and second stages of operation have occurred.
  4. The system of any preceding claim, wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan.

Description

FIELD The present disclosure relates generally to drug syringes with a mechanical stop for a second dose and drug products utilizing the same. BACKGROUND There are many different ways in which a drug can be administered to a user. Depending on the drug, intranasal drug delivery can be one of the most effective ways to achieve desired clinical benefits in a timely manner and in a manner that is convenient and comfortable for a patient. Intranasal drug administration is a non-invasive route for drug delivery. Since the nasal mucosa offers numerous benefits as a target tissue for drug delivery, a wide variety of drugs may be administered by intranasal systemic action. Moreover, intranasal drug delivery can avoid the risks and discomfort associated with other routes of drug delivery, such as intravenous drug delivery, and can allow for easy self-administration. Generally, to maximize the efficacy of the drug through intranasal administration, the majority volume of the aerosolized dose of the drug needs to reach the correct region of the nasal cavity. As such, additional measures may need to be taken for effective intranasal drug delivery. For example, the user may need to have a clear nostril, tilt their head back at approximately 45°, close the opposite nostril, and then sniff gently while the dose of drug is administered. In order to coordinate these measures, and given that nasal administration is intimate, self-administration by the user may be desired. Further, due to the nasal cycle (alternating physiological partial congestion of the nasal turbinate to facilitate nasal function) or pathological congestion, one nostril is likely to provide a more effective drug delivery route than the other nostril at any given time. As such, it is desired that an equal dose of the drug be delivered to each nostril of the user to inhibit under-dosing of the drug. Dual-dose intranasal drug delivery devices are available that are designed for self-administration of two distinct aerosolized sprays, one for each nostril, that together constitute one dose of drug. These devices require a series of operational steps that the user needs to properly carry out to effect optimal drug delivery through self-administration. Accordingly, there remains a need for improved nasal drug delivery devices. In JP5888234B2, there is described an administration device capable of discharging a prescribed, equal amount of medicine a number of times by spraying. In EP0526824B1, there is described a syringe nasal sprayer that includes an elongate barrel having an open proximal end, a chamber for retaining fluid and a tip portion extending from a distal end of the barrel having a passageway therethrough communicating with the chamber. In US2764981A, there is described dispensing devices, and more particularly an improved multiple dosage syringe that automatically indicates when each of a number of doses of predetermined volume has been dispensed therefrom. In US2856925A, there is described dispensing devices, and more particularly an improved multiple dosage syringe that automatically indicates when each of a number of doses of predetermined volume has been dispensed therefrom. In KR102066186B1, there is described a syringe for mixing and ejecting an active pharmaceutical ingredient. In US4962868A, there is described an apparatus for dispensing a controlled dose of a liquid fluid such as a liquid medication that includes a dispenser head which is snugly fitted over the needle-shaped end of a syringe filled with the liquid pharmaceutical and including a piston in fully retracted or drawn position. In US2010286513A1, there is described a syringe assembly for sequentially injecting multiple medical fluids. In GB758769A, there is described a holder for a syringe ampoule that holds the ampoule at one end only and provides a plunger rod for the expulsion of medicament. In US2869541A, there is described dispensing devices, and more particularly an improved multiple dosage syringe that automatically indicates when each of a number of doses of predetermined volume has been dispensed therefrom. In US2005004530A1, there is described a syringe that may include various forms of a releasable stop adapted to selectively limit the travel of the syringe plunger within the syringe barrel such that a first amount of therapeutic substance may be discharged from the syringe while a residual supply of the therapeutic substance remains in the syringe. In WO2013145789A1, there is described a metered-dose syringe type spray device in which multiple stages of pushing are possible. In US2020030552A1, there is described a syringe type ejection device capable of reducing an amount of residual liquid is provided. SUMMARY In general, drug syringes with a mechanical stop for a second dose, drug products utilizing the same, and methods of using drug syringes with a mechanical stop for a second dose are provided. The invention is defined by appended claim 1. Further embodiments are