Nasal drug products and methods of their use
AssigneeOpiant Pharmaceuticals, Inc.
InventorsRoger CRYSTAL, Michael Brenner WEISS
Life of this patent
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Abstract
Drug products adapted for nasal delivery, comprising a pre-primed device filled with a pharmaceutical composition comprising an opioid receptor antagonist, are provided. Methods of treating opioid overdose or its symptoms with the inventive drug products are also provided.
Claims67
A pharmaceutical formulation for intranasal administration comprising, in an aqueous solution of not more than about 140 μL:
- about 2 mg naloxone hydrochloride;
- about 0.74 mg NaCl;
- about 0.01 mg benzalkonium chloride;
- about 0.2 mg disodium edetate;
- and
- an amount of hydrochloric acid sufficient to achieve a pH of 3.5-5.5.
A single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which comprises per 100 μL of aqueous solution:
- about 2 mg naloxone hydrochloride;
- between about 0.2 mg and about 1.2 mg of an isotonicity agent;
- between about 0.005 mg and about 0.015 mg of a preservative;
- between about 0.1 mg and about 0.5 mg of a stabilizing agent;
- and
- an amount of an acid sufficient to achieve a pH of 3.5-5.5.
Dependencies are inferred from the claim text.