Reduced volume formulation of glatiramer acetate and methods of administration
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsAyelet Altman, Tomer El-Gad, Doris Saltkill, Dalton Tomlinson, Paul Greenhalgh, David George Robinson
Life of this patent
Estimating the term…
Abstract
A method for reducing frequency of relapses in a human patient afflicted with relapsing-remitting multiple sclerosis (RAMS) comprising administering to the patient 0.5 ml of an aqueous pharmaceutical solution of 20 mg glatiramer acetate and 20 mg mannitol and an injection assisting device for facilitating the administration of the pharmaceutical solution.
Claims20
A method for reducing frequency of relapses in a human patient afflicted with relapsing-remitting multiple sclerosis (RRMS) comprising administering to the patient by subcutaneous injection 0.5 ml of an aqueous pharmaceutical solution which contains in solution 20 mg glatiramer acetate and 20 mg mannitol.
2-36. (canceled)
A unit dose of 0.5 ml of an aqueous pharmaceutical solution which contains in solution 20 mg glatiramer acetate and 20 mg mannitol.
38-48. (canceled)
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 and configured to substantially contrast in color with 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 shell 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 amount of compression force on the second outer shell.
Dependencies are inferred from the claim text.