Aripiprazole formulations having increased injection speeds

• US 9,526,726 B2
• Filed: 05/25/2016
• Issued: 12/27/2016
• Est. Priority Date: 03/20/2014
• Status: Active Grant

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Inventors: Hickey, Magali B., Vandiver, Jennifer
• Primary Examiner(s): CORNET, JEAN P
• Application Number:
  US15/164,473
• Publication Number:
  US 20160263111A1
• Time in Patent Office: 216 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants

Abstract

The present invention relates to pharmaceutical compositions comprising a compound of Formula (I) that are useful for the intramuscular delivery of antipsychotic drugs using rapid injection rates.

Claims

1. A kit for the treatment of schizophrenia, wherein the kit comprises a therapeutically effective amount of a pharmaceutical composition and further comprises instructions for intramuscular injection, wherein the instructions specify a continuous intramuscular injection within 10 seconds, wherein said pharmaceutical composition comprises:

(a) 24-30 weight percent Compound 1;

2. The kit according to claim 1, wherein the said pharmaceutical composition comprises:

(a) about 26.6 weight percent Compound 1;

3. The kit according to claim 1, wherein the administration is instantaneous.

4. The kit according to claim 1, wherein the kit further comprises a 20 to 23 gauge needle.

5. The kit according to claim 4, wherein the needle is a 20 gauge needle.

6. The kit according to claim 1, wherein the injection is administered to the subject in the dorsal gluteal muscle.

7. The kit of claim 1, wherein the kit further comprises a container for containing the pharmaceutical composition.

8. The kit of claim 7, wherein the container is a prefilled syringe.

9. A kit for the treatment of schizophrenia, wherein the kit comprises a therapeutically effective amount of a pharmaceutical composition and further comprises instructions for intramuscular injection, wherein the instructions specify a continuous intramuscular injection within 10 seconds, wherein said pharmaceutical composition comprises:

(a) 24-30 weight percent Compound 1;

10. The kit of claim 9, wherein the said pharmaceutical composition comprises:

(a) about 26.6 weight percent Compound 1;

11. The kit according to claim 9, wherein the administration is instantaneous.

12. The kit according to claim 9, wherein the kit further comprises a 20 to 23 gauge needle.

13. The kit according to claim 12, wherein the needle is a 20 gauge needle.

14. The kit according to claim 9, wherein the injection is administered to the subject in the dorsal gluteal muscle.

15. The kit of claim 9, wherein the kit further comprises a container for containing the pharmaceutical composition.

16. The kit of claim 15, wherein the container is a prefilled syringe.