Reduced volume formulation of glatiramer acetate and methods of administration

• US 8,920,373 B2
• Filed: 07/14/2010
• Issued: 12/30/2014
• Est. Priority Date: 07/15/2009
• Status: Expired due to Fees

• Current Assignee: Teva Pharmaceutical Industries Limited
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Altman, Ayelet, El-Gad, Tomer, Saltkill, Doris, Tomlinson, Dalton, Greenhalgh, Paul, Robinson, David George
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US13/384,021
• Publication Number:
  US 20120232017A1
• Time in Patent Office: 1,630 Days
• Field of Search: 604/117, 604/130, 604/131, 604134-137, 604/156, 604/157, 604/187, 604208-211, 604/218, 604/220
• US Class Current: 604/130
• CPC Class Codes: A61K 38/02 Peptides of undefined number of amino acids; Derivatives thereof
• CPC Class Codes: A61K 38/16 Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof enzyme inhibitors A61K38/005
• 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

Abstract

The present invention provides an improved injection assisting device wherein the improvement comprises an injection lock indicator located between the first and the second outer shell and the outside of the indicator window, configured to indicate to a user whether the injection locking member is in a locked state, and configured to substantially contrast in color with both the first outer shell and the second outer shell, which first and second outer shells contrast in color with each other, and configured to be substantially shielded from a view of a user in the presence of the predetermined amount of compression force on the second outer shell.

Claims

1. An improved injection assisting device comprising:

a first outer shell having a first internal cavity with first and second oppositely arranged openings and

a second outer shell movably and removably connectable to the first outer shell, the second outer shell having a second internal cavity with at least a first opening oriented towards the second opening of the first outer shell;

a button configured to initiate an injection;

an injection locking member configured to prevent the initiation of an injection in the absence of a predetermined compressive force moving the second outer shell to the first outer shell;

an injection energy storing member configured to absorb and retain a predetermined amount of injection energy applied to a syringe located within at least one of the first and second cavities during an injection;

an injection actuator configured, upon the initiation of an injection, to apply the injection energy to the syringe so as to displace a predetermined amount of matter from within the syringe; and

an injection completion indicator inside an indicator window, configured to indicate to a user when the predetermined amount of matter has been displaced from within the syringe,

wherein the improvement comprises;

an injection lock indicator located between the first and the second outer shells and outside of the indicator window, configured to indicate to a user whether the injection locking member is in a locked state, and configured to substantially contrast in color with both the first outer shell and the second outer shell, which first and second outer shells contrast in color with each other, and configured to be substantially shielded from a view of a user in the presence of the predetermined compression force on the second outer shell.

2. The injection assisting device of claim 1, wherein the improvement further comprises an attention director configured to direct a user'"'"'s attention to the injection completion indicator.

3. The injection assisting device of claim 2, wherein the attention director is configured to direct a user'"'"'s attention to the direction of the injection.

4. The injection assisting device of claim 2, wherein the attention director is configured to direct a user'"'"'s attention to the injection lock indicator.

5. The injection assisting device of claim 2, wherein the attention director is configured to direct a user'"'"'s attention to the direction of force to be applied to unlock the locking member.

6. The injection assisting device of claim 2, wherein:

a color of the attention director is configured to substantially contrast with a color of proximally located components, and

a shape of the attention director is configured to direct a user'"'"'s attention to the injection completion indicator.

7. The injection assisting device of claim 1, further comprising an injection force storage indicator configured to indicate to a user whether at least the predetermined amount of injection energy is stored in the injection energy storing member.

8. The injection assisting device of claim 1, wherein the improvement further comprises an outer grip member disposed on an outer surface of the second outer shell.

9. The injection assisting device of claim 8, wherein the outer grip member is formed of a material softer than the second outer shell.

10. The injection assisting device of claim 1, wherein ridges exist in an outer surface of the outer grip member so as to increase friction between the outer grip member and a human hand.

11. The injection assisting device of claim 1, wherein the improvement further comprises a ring member between the first outer shell and the second outer shell configured to substantially contrast with a color of the first outer shell, a color of the second outer shell, and a color of the injection lock indicator.

12. The injection assisting device of claim 1, further comprising a needle penetration depth adjustment member and a syringe needle cap remover member.

13. The injection assisting device of claim 12, wherein the improvement further comprises the syringe needle cap remover member configured to substantially correspond in color with the button configured to initiate an injection.

14. The injection assisting device of claim 1, wherein the improvement further comprises the injection actuator configured to displace 0.5 ml of liquid from the syringe.

15. The injection assisting device of claim 14, wherein the syringe contains in a 0.5 ml solution 20 mg of glatiramer acetate.

16. The injection assisting device of claim 1, wherein the improvement further comprises the injection lock indicator configured to be substantially shielded from the view of a user when the injection locking member is not in a locked state.