Prefilled syringes and kits thereof

• US 9,393,367 B2
• Filed: 04/03/2015
• Issued: 07/19/2016
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Otter Pharmaceuticals LLC (Assertio Holdings, Inc.)
• Original Assignee: Antares Pharma Incorporated
• Inventors: Dave, Kaushik J., Capone, Dominic P., Wotton, Paul K., Sadowski, Peter L.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/678,449
• Publication Number:
  US 20150209512A1
• Time in Patent Office: 473 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/178 Syringes
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system

Abstract

The present disclosure relates, in part, to a kit including at least two prefilled syringes. The first prefilled syringe includes a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent.

Claims

1. A medical kit comprising:

a first kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the first kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg,

wherein the volume of the pharmaceutical composition in the prefilled syringes of the first kit is greater than 0.01 ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml, and

wherein the first kit does not include an autoinjector, and

a second kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the second kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg,

wherein the volume of the pharmaceutical composition in the prefilled syringes of the second kit is greater than 0.01 ml but less than or equal to 1ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml,

wherein the second kit does not include an autoinjector, and

wherein the volume of the prefilled syringes of the second kit is different than the volume of the prefilled syringes of the first kit.

2. A method to provide methotrexate comprising:

providing a first kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the first kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg

wherein the volume of the pharmaceutical composition in the prefilled syringes of the first kit is greater than 0.01 ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml; and

wherein the first kit does not include an autoinjector and

providing a second kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the second kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg,

wherein the volume of the pharmaceutical composition in the prefilled syringes of the second kit is greater than 0.01 ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml,

wherein the second kit does not include an autoinjector, and wherein the volume of the prefilled syringes of the second kit is different than the volume of the prefilled syringes of the first kit.

3. The method of claim 2, further comprising:

providing a third kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the third kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg

wherein the volume of the pharmaceutical composition in the prefilled syringes of the third kit is greater than 0.01 ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml,

wherein the third kit does not include an autoinjector, and

wherein the volume of the prefilled syringes of the third kit is different than the volume of the prefilled syringes of the first and second kits.

4. The method of claim 3, further comprising:

providing a fourth kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the fourth kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5mg to about 25 mg,

wherein the volume of the pharmaceutical composition in the prefilled syringes of the fourth kit is greater than 0.0 1ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml,

wherein the fourth kit does not include an autoinjector, and

wherein the volume of the prefilled syringes of the fourth kit is different than the volume of the prefilled syringes of the first, second and third kits.

5. The method of claim 4, further comprising:

providing a fifth kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes,

wherein the prefilled syringes of the fifth kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutically acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg,

wherein the volume of the pharmaceutical composition in the prefilled syringes of the fifth kit is greater than 0.01 ml but less than or equal to 1 ml and the concentration of the methotrexate in the prefilled syringes is 25 mg/ml,

wherein the fifth kit does not include an autoinjector, and

wherein the volume of the prefilled syringes of the fifth kit is different than the volume of the prefilled syringes of the first, second, third and fourth kits.

6. The method according to claim 2, wherein the dose of methotrexate in the prefilled syringes of the first kit is selected from the group consisting of 7.5mg, 10mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

7. The method according to claim 3, wherein the dose of methotrexate in the prefilled syringes of the third kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

8. The method according to claim 4 wherein the dose of methotrexate in the prefilled syringes of the fourth kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

9. The method according to claim 5, wherein the dose of methotrexate in the prefilled syringes of the fifth kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

10. The method according to claim 2, wherein the volume of the prefilled syringes of the first kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

11. The method according to claim 3, wherein the volume of the prefilled syringes of the third kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

12. The method according to claim 4, wherein the volume of the prefilled syringes of the fourth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

13. The method according to claim 5, wherein the volume of the prefilled syringes of the fifth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

14. The method according to claim 13, wherein the volume of the prefilled syringes of the first kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

15. The method according to claim 14, wherein the volume of the prefilled syringes of the second kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

16. The method according to claim 15, wherein the volume of the prefilled syringes of the third kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

17. The method according to claim 16, wherein the volume of the prefilled syringes of the fourth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.