Method of injecting octreotide acetate into the body

Patent metadata

Field	Value
Publication number	US-12350475-B2
Application number	US-202218085095-A
Country	US
Kind code	B2
Filing date	Dec 20, 2022
Priority date	Sep 29, 2020
Publication date	Jul 8, 2025
Grant date	Jul 8, 2025

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 permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter. The injector is configured to provide at least one audible feedback during the rotation. The method further includes operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject. The injector is provided with multiple surface portions.

First claim

What is claimed is:

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 the variable dose setter, wherein the injector is configured to provide at least one audible feedback during setting of the dose, and operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject; and
wherein the injector comprises an actuator and an injector body, wherein a visible surface of the actuator has a first chromatic or achromatic value, at least a portion of the variable dose setter has a second chromatic or achromatic value differing from the first chromatic or achromatic value, and a terminal portion of the injector body has a third chromatic or achromatic value differing from the first chromatic or achromatic value and the second chromatic or achromatic value,
wherein the portion of the variable dose setter surrounds at least a portion of the actuator, and the terminal portion of the injector body is proximate to the portion of the variable dose setter, and
wherein the setting of the dose comprises rotating the variable dose setter in at least one direction, wherein the rotating the variable dose setter comprises re-setting the variable dose setter to correct for overdosing.

2. The method of claim 1 , further comprising providing, on the injector, a plurality of indicia only at prescribed doses settable via the variable dose setter without any markings between said prescribed doses.

3. The method of claim 2 , wherein the prescribed doses consist of a 50 μg dose, a 100 μg dose, a 150 μg dose, and a 200 μg dose.

4. The method of claim 2 , further comprising turning the 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.

5. The method of claim 4 , wherein following completion of injection, a zero value appears in the window of the injector.

6. The method of claim 1 , further comprising providing indicia on the cartridge, wherein a first indicium of the indicia positioned closer to the needle of the injector than to the variable dose setter differs visually from a plurality of second indicia of the indicia farther from the needle than the first indicium.

7. The method of claim 6 , further comprising configuring the injector such that when an insufficient amount of the octreotide acetate is stored in the injector, (i) a plunger of the injector is visible at a position between the needle of the injector and the first indicium and (ii) rotation of the variable dose setter is prevented.

8. The method of claim 1 , further comprising priming the injector before delivering one of a plurality of prescribed doses.

9. The method of claim 1 , wherein a maximum dose setting is 200 μg.

10. The method of claim 1 , wherein the injector comprises a re-attachable cap configured for multi-use injection.

11. The method of claim 1 , wherein the injector is configured to be held in one hand of the subject or a care provider with the needle attached to the injector, and is further configured such that the needle is insertable into a needle cover without utilizing the other hand of the subject or the care provider.

12. The method of claim 1 , wherein the second chromatic or achromatic value is lower than the first chromatic or achromatic value.

13. The method of claim 1 , wherein the third chromatic or achromatic value is higher than each of the first chromatic or achromatic value and the second chromatic or achromatic value.

14. The method of claim 1 , wherein the setting of the dose further comprises rotating the variable dose setter to select the dose and axially displacing the variable dose setter to set the dose.

15. 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, wherein the injector is configured to provide at least one audible feedback during the rotation, and operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject,
wherein the injector comprises a first surface portion having a first chromatic or achromatic value, a second surface portion having a second chromatic or achromatic value differing from the first chromatic or achromatic value, and a third surface portion having a third chromatic or achromatic value differing from the first chromatic or achromatic value and the second chromatic or achromatic value,
wherein the first surface portion surrounds the second surface portion, and the third surface portion is proximate to the first surface portion, and
wherein operating the actuator to deliver the octreotide acetate comprises providing a daily dose of up to about 1,500 μg in a first session and a second session, and wherein the first session comprises:
turning the variable dose setter to a maximum dose setting;
delivering, to a first injection site, a first injection at the maximum dose setting;
turning the variable dose setter to one of a plurality of indicia; and
delivering, to a second injection site differing from the first injection site, a second injection following the first injection.

Assignees

• Sun Pharmaceutical Ind Ltd

Inventors

• Patil Satyashodhan Babasaheb
• Agrawal Sudeep Kumar
• Bhowmick Subhas Balaram
• Kane Prashant

Classifications

• A61K9/0019

  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 title

• A61M2210/1021

  Abdominal cavity · CPC title

• A61M2210/083

  Arms · CPC title

• A61M2210/086

  Legs · CPC title

• A61M2205/581

  by audible feedback · CPC title