Claims for Patent: 11,534,553

Summary for Patent: 11,534,553

Title:	Method of injecting octreotide acetate into the body
Abstract:	A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes providing, on the injector, a plurality of indicia only at prescribed doses of 50 μg, 100 μg, 150 μg and 200 μg settable via the dose setter without indicia between said prescribed doses; and permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter, wherein the injector is configured to provide at least one audible feedback during the rotation.
Inventor(s):	Satyashodhan Babasaheb Patil, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Prashant Kane
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US17/564,772
Patent Claims:	1. A method of treating one or more of acromegaly, carcinoid tumors or vasoactive intestinal peptide tumors by providing and/or injecting octreotide acetate for a subject in need thereof, comprising: storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and an actuator, the injector comprising a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of about 2,500 μg/mL; permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter to one of a plurality of indicia of prescribed doses, wherein there are no indicia between the indicia of the prescribed doses, wherein the injector is configured to provide at least one audible feedback during the rotation of the dose setter, and wherein the actuator is operable to discharge the octreotide acetate from the cartridge through the needle; and providing a daily dose of up to about 1,500 μg in two or more sessions, wherein the two or more sessions comprise a first session and a second session; in the first session, providing a dose in excess of a maximum dose setting by two or more injections, comprising turning the dose setter to the maximum dose setting; delivering, to a first injection site, a first injection at the maximum dose setting; turning the dose setter to one of the plurality of indicia; and delivering, to a second injection site differing from the first injection site, a second injection, wherein the injector is configured to correct for overdosing by allowing, after the dose setter is set to a dose higher than a desired dose setting, rotation of the dose setter to re-set the dose setter to a prescribed dose among the prescribed doses. 2. The method of claim 1, wherein the maximum dose setting is 200 μg. 3. The method of claim 1, wherein the injector comprises a re-attachable cap configured for multi-use injection. 4. The method of claim 1, wherein the method further comprises: in the second session, turning the dose setter to the maximum dose setting; delivering, to a third injection site, a third injection at the maximum dose setting; turning the dose setter to one of the plurality of indicia; and delivering, to a fourth injection site differing from the third injection site, a fourth injection. 5. The method of claim 1, wherein the prescribed dose is 50 μg, 100 μg, 150 μg or 200 μg. 6. The method of claim 1, wherein the injector is configured to be held in one hand of the subject with the needle attached to the injector, and is further configured such that the needle is insertable into a needle cover without utilizing another hand of the subject. 7. The method of claim 1, further comprising turning a body of the injector until one of the plurality of indicia corresponding to one of the prescribed doses appears in a window of the injector. 8. The method of claim 1, wherein re-setting the dose comprises rotation of the dose setter until the prescribed dose appears in a window of the injector. 9. The method of claim 1, wherein the first injection is followed in succession by the second injection. 10. The method of claim 1, wherein all of the daily dose is delivered during the two or more sessions, the two or more sessions consisting of the first session and the second session. 11. The method of claim 1, wherein the prescribed doses consist of a 50 μg dose, a 100 μg dose, a 150 μg dose, and a 200 μg dose.