SELF-PRESERVING COMPOSITIONS AND MULTI-USE DISPENSERS FOR ADMINISTERING ALPHA-1062
A self-preserving anti-microbial pharmaceutical composition, including a compound Alpha-1062 or salt thereof, wherein the composition is essentially absent of additional antimicrobial preservatives. In some examples, the compositions are in the form of a liquid. Also disclosed is a multi-use dispenser configured for transmucosal administration of a pharmaceutical composition in the form of a liquid including Alpha-1062 or salt thereof and Alpha-1062 or salt thereof for use in the treatment of neurological disease in a subject, wherein said subject suffers additionally from a microbial infection, or for use in treating a microbial infection. Also disclosed is a method of killing a microorganism or a method for disinfecting, e.g., disinfecting a pharmaceutical composition, including contacting a microorganism with Alpha-1062 or salt thereof.
1 . A self-preserving anti-microbial pharmaceutical composition comprising a compound Alpha-1062 or salt thereof, wherein the composition is essentially absent of additional antimicrobial preservatives.
2 . The self-preserving pharmaceutical composition according to claim 1 , wherein the composition is in liquid form.
3 . The self-preserving pharmaceutical composition according to claim 2 , wherein the composition is a solution, emulsion or a suspension.
4 . The self-preserving pharmaceutical composition according to claim 1 , wherein the compound Alpha-1062 or salt thereof is present at a concentration of 1 to 200 mg/mL.
5 . The self-preserving pharmaceutical composition according to claim 4 , wherein the compound Alpha-1062 or salt thereof is present at a concentration of 5 to 100 mg/mL.
6 . The self-preserving pharmaceutical composition according to claim 5 , wherein the compound Alpha-1062 is present as a gluconate salt at a concentration of 50 to 100 mg/mL.
7 . The self-preserving pharmaceutical composition according to claim 6 , wherein the Alpha-1062 gluconate salt is present at a concentration of 70 to 90 mg/mL.
8 . The self-preserving pharmaceutical composition according to claim 1 , wherein the compound Alpha-1062 is present at a concentration sufficient to reduce 1×10 4 to 1×10 6 colony-forming units per mL (CFU/mL) of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and/or Aspergillus brasiliensis to <100 CFU/mL within 14 days treatment, according to the United States Pharmacopeia Chapter 51 preservative test (USP 51).
9 . The self-preserving pharmaceutical composition according to claim 8 , wherein the compound Alpha-1062 is present at a concentration sufficient to reduce 1×10 4 to 1×10 6 colony-forming units per mL (CFU/mL) of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and/or Aspergillus brasiliensis to <10 CFU/mL within 14 days treatment, according to the United States Pharmacopeia Chapter 51 preservative test (USP 51).
10 . A multi-use dispenser configured for transmucosal administration of a pharmaceutical composition in the form of a liquid, wherein the liquid comprises the self-preserving anti-microbial composition according to claim 1 .
11 . The multi-use dispenser according to claim 10 , wherein the dispenser is configured for intranasal administration.
12 . The multi-use dispenser according to claim 10 , wherein the dispenser is configured for administration in the oral cavity.
13 . The multi-use dispenser according to claim 10 , wherein the dispenser is configured for multiple individual administration events of 10 to 300 μL and wherein said dispenser comprises a total volume of liquid composition of 1 to 100 mL.
14 . The multi-use dispenser according to claim 13 , wherein the dispenser is configured for multiple individual administration events of 20 to 200 μL and wherein said dispenser comprises a total volume of liquid composition of 2 to 50 mL.
15 . A method for the treatment of a neurological disease in a subject, wherein said treatment comprises administering multiple doses of the self-preserving anti-microbial composition according to claim 1 to the subject from the same dispenser.
16 . A method for the treatment of a neurological disease in a subject, comprising administering a compound Alpha-1062 or salt thereof to the subject, wherein said subject suffers additionally from a microbial infection.
17 . A method for the treatment of a microbial infection in a subject, comprising administering a compound Alpha-1062 or salt thereof to the subject.
18 . The method according to claim 16 , wherein the microbial infection is present in the nasal cavity, oral cavity, paranasal sinuses and/or the nasolacrimal duct of the subject.
19 . A method of killing a microorganism comprising contacting the microorganism with an effective amount of a composition comprising a compound Alpha-1062 or a salt thereof.
20 . The method according to claim 19 , wherein the microorganism is a bacterium, yeast or fungus.
21 . The method according to claim 19 , wherein the microorganism is a human pathogen.
22 . The method according to claim 19 , wherein the microorganism is Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and/or Aspergillus brasiliensis.
23 . The method according to claim 17 , wherein the microbial infection is present in the nasal cavity, oral cavity, paranasal sinuses and/or the nasolacrimal duct of the subject.
24 . A self-preserving anti-microbial pharmaceutical composition according to claim 1 , wherein the composition is absent of additional antimicrobial preservatives and is in the form of a liquid, wherein the composition is present in a multi-use dispenser configured for intranasal administration, wherein the dispenser is configured for multiple individual administration events of 10 to 300 μL, and wherein said dispenser comprises a total volume of liquid composition of 1 to 100 mL.