Fluorescein-labeled nerve targeting peptide formulations and related methods
AssigneeAlume Biosciences, Inc.
InventorQuyen T. NGUYEN
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Abstract
Disclosed herein are pharmaceutical compositions containing (a) a fluores-cein-labeled nerve targeting peptide of formula (I): or pharmaceutically acceptable salt, solvate, hydrate, isomer, tautomer, racemate, or isotope thereof; (b) an additive comprising a pH-adjusting agent, a buffering agent, a bulking agent, a tonicity-adjusting agent, a preservative, or any combination thereof; and (c) an aqueous vehicle, wherein a pH of the composition ranges from about 7 to about 9, and a concentration of the peptide in the aqueous composition ranges from about 25 mg/mL to about 200 mg/mL, based on a total volume of the aqueous composition. Also disclosed are methods for preparing and using the pharmaceutical compositions described herein.
Claims80
An aqueous pharmaceutical composition, comprising:
- (a) a fluorescein-labeled nerve targeting peptide of formula (I):
- or pharmaceutically acceptable salt, solvate, hydrate, isomer, tautomer, racemate, or isotope thereof;
- (b) an additive comprising a pH-adjusting agent, a buffering agent, a bulking agent, a tonicity-adjusting agent, a preservative, or any combination thereof;
- and
- (c) an aqueous vehicle,
- wherein:
- a pH of the composition ranges from about 7 to about 9;
- and
- a concentration of the peptide in the aqueous composition ranges from about 25 mg/mL to about 200 mg/mL, based on a total volume of the aqueous composition.
A lyophilized pharmaceutical composition, comprising:
- (a) a fluorescein-labeled nerve targeting peptide of formula (I):
- or pharmaceutically acceptable salt, solvate, hydrate, isomer, tautomer, racemate, or isotope thereof;
- and
- (b) an additive comprising a pH-adjusting agent, a buffering agent, a bulking agent, a tonicity-adjusting agent, a preservative, or any combination thereof,
- wherein a water content of the lyophilized composition ranges from about 0.2% (w/w) to about 2.0% (w/w), relative to a total mass of the lyophilized composition.
Dependencies are inferred from the claim text.