US2022387421A1PendingUtilityA1

Drug products for intranasal administration and uses thereof

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Assignee: SUMMIT BIOSCIENCES INCPriority: Feb 5, 2020Filed: Aug 5, 2022Published: Dec 8, 2022
Est. expiryFeb 5, 2040(~13.5 yrs left)· nominal 20-yr term from priority
Inventors:Gregory G. PlucinskiAdrian RaicheKristi R. Sims
A61K 9/0043A61K 9/08A61K 47/12A61K 31/485A61K 47/10A61P 25/36A61M 11/007A61M 15/08A61M 2209/06
49
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Claims

Abstract

Provided herein are drug products adapted for nasal delivery comprising a device and a pharmaceutical composition comprising an opioid receptor antagonist or unit doses thereof, pharmaceutical compositions comprising an opioid receptor antagonist, and methods of use and preparation thereof.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An aqueous pharmaceutical composition comprising naloxone hydrochloride in an amount of about 8% to about 11% by weight based on the total weight of the aqueous pharmaceutical composition, glycerin in an amount of about 1% to about 2% by weight based on the total weight of the aqueous pharmaceutical composition, and a citrate buffer in an amount of about 0.2% to about 0.4% by weight based on the total weight of the aqueous pharmaceutical composition. 
     
     
         2 . The aqueous pharmaceutical composition of  claim 1 , comprising naloxone hydrochloride in an amount of about 8% by weight based on the total weight of the aqueous pharmaceutical composition. 
     
     
         3 . The aqueous pharmaceutical composition of  claim 1 , comprising naloxone hydrochloride in an amount of about 9% by weight based on the total weight of the aqueous pharmaceutical composition. 
     
     
         4 . The aqueous pharmaceutical composition of  claim 1 , comprising naloxone hydrochloride in an amount of about 10% by weight based on the total weight of the aqueous pharmaceutical composition. 
     
     
         5 . The aqueous pharmaceutical composition of  claim 1 , comprising glycerin in an amount of about 1% to about 1.5% by weight based on the total weight of the aqueous pharmaceutical composition. 
     
     
         6 . The aqueous pharmaceutical composition of  claim 1 , wherein the pH of the composition is about 4.3. 
     
     
         7 . The aqueous pharmaceutical composition of  claim 1 , wherein the osmolality of the composition is about 560 mOsm/kg.

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