Delivery device and adsorbent

Patent metadata

Field	Value
Publication number	US-2021128829-A1
Application number	US-201917050321-A
Country	US
Kind code	A1
Filing date	Apr 19, 2019
Priority date	Apr 27, 2018
Publication date	May 6, 2021
Grant date	—

Abstract

A delivery device (10, 40, 100) for delivering a substance, such as an insulin formulation, to a patient includes a storage container (12, 112) containing the insulin formulation, a delivery member (20, 42) connected to the storage container by a fluid pathway for injecting the insulin formulation into the patient for delivering the insulin formulation to the patient at a controlled basal flow rate or bolus flow. The delivery device can have a pump mechanism for delivering the substance to the patient. An activated charcoal adsorbent (51 57, 87) or activated carbon is positioned in the fluid pathway between the storage container and the delivery member for removing at least a portion of a phenolic stabilizing agent from the insulin formulation before delivering to the patient. A method of delivering an insulin formulation to a patient includes the step of contacting the insulin formulation with an activated charcoal or activated carbon adsorbent to remove at least a portion of a phenolic stabilizing agent from the insulin formulation before introducing the treated insulin formulation to the patient.

First claim

1 . A delivery device for delivering a substance to a patient, comprising:
a storage container containing the substance; a delivery member connected to said storage container by a fluid pathway for injecting the substance into the patient; and an activated charcoal adsorbent positioned in said fluid pathway between said storage container and said delivery member for removing selected compounds from said substance before delivering to the patient.

2 . The delivery device of claim 1 , where is delivery member comprises a catheter or cannula.

3 . The delivery device of claim 1 , wherein said delivery device is selected from the group consisting of a pen needle assembly, infusion set, catheter, and patch pump including said activated charcoal adsorbent.

4 . The delivery device of claim 1 , wherein said substance comprises an insulin formulation containing a phenolic stabilizing agent, and where said activated charcoal adsorbent is adapted for removing said phenolic stabilizing agent from said insulin formulation before delivering to the patient.

5 . The delivery device of claim 4 , wherein said activated charcoal adsorbent is positioned relative to said delivery member where said insulin formulation passing through said activated charcoal absorbent has a residence time in said delivery member to obtain substantially no denaturing or loss of efficacy before injecting into the patient.

6 . The delivery device of claim 4 , wherein said activated charcoal adsorbent comprises a phosphoric acid treated activated charcoal adsorbent.

7 . The delivery device of claim 6 , further comprising a cartridge containing said activated charcoal adsorbent positioned in said fluid pathway between said storage container and said delivery member, and where said cartridge has a configuration to provide a contact time of the insulin with said activated charcoal to remove a predetermined amount of phenol and/or m-cresol from the insulin.

8 . The delivery device of claim 1 , wherein said delivery device comprises a pen needle assembly including a pen body, an insulin cartridge containing insulin and defining said storage container, and a pen needle having a cannula defining said delivery member; and
where said pen body includes an adsorbent cartridge containing said activated charcoal adsorbent oriented in a flow path between said insulin cartridge and said pen needle.

9 . The delivery device of claim 1 , wherein said substance comprises an insulin formulation containing a phenolic stabilizing agent, and
said delivery device directs said insulin formulation through said fluid pathway, and where said delivery member includes a catheter for delivering a treated insulin formulation to the patient.

10 . The delivery device of claim 9 , wherein said activated charcoal adsorbent is included in an amount to remove at least about 60% by weight of the phenolic stabilizing agent from said insulin formulation over a period of time of at least four days while maintaining an insulin potency of at least about 73% relative to untreated insulin.

11 . The delivery device of claim 9 , wherein said delivery device provides a continuous and controlled delivery of said insulin formulation for a predetermined period of time, and where said activated charcoal absorbent is included in an amount to remove at least about 60% by weight of the phenolic stabilizing agent from said insulin formulation, and said insulin formulation delivered from said infusion set exhibiting an insulin potency of at least about 73% after about 7 days.

12 . The delivery device of claim 11 , wherein said phenolic stabilizing agent is selected from the group consisting of phenol, m-cresol, and mixtures thereof.

13 . A delivery device for delivering an insulin formulation to a patient, said delivery device comprising:
a storage container containing the insulin formulation, where said insulin formulation includes a phenolic stabilizing agent in an amount to stabilize said insulin formulation; a delivery member in fluid communication with said storage container by a fluid pathway for delivering the insulin formulation into the patient; a pump mechanism for delivering the insulin formulation from the storage container to the patient at a controlled basal flow rate; and an activated charcoal adsorbent positioned in the fluid pathway between said storage container and said delivery member for removing at least a portion of the phenolic stabilizing agent from the insulin formulation before delivering to the patient.

14 . The delivery device of claim 13 , wherein said delivery device comprises a pen needle delivery device having a pen body, a cartridge containing said activated charcoal adsorbent coupled to an outlet of said pen body, and a pen needle having a cannula defining said delivery member and coupled to an outlet of said cartridge.

15 . The delivery device of claim 13 , wherein said delivery device includes a catheter for introducing the insulin to the patient.

16 . The delivery device of claim 13 , wherein said activated charcoal comprises a phosphoric acid activated charcoal.

17 . A method of introducing an insulin formulation to a patient and inhibiting irritation at a delivery a delivery site, said method comprising:
directing the insulin formulation through an activated charcoal adsorbent to remove at least a portion of a phenolic stabilizing agent from the insulin formulation to obtain a treated insulin formulation; and introducing said treated insulin formulation into the patient within a time to provide an insulin potency of said treated insulin formulation of at least about 73% relative to the concentration of untreated insulin and a reduced concentration of said phenolic stabilizing agent to inhibit irritation at the delivery site.

18 . The method of claim 17 , wherein said insulin formulation is introduced to said patient by an insulin delivery device, said insulin delivery device including:
a storage container containing said insulin formulation, and injection member connected to said storage container by a fluid flow path; the activated charcoal adsorbent positioned in said fluid flow path; and a dispensing mechanism for directing the insulin formulation from the storage container into contact with the activated charcoal adsorbent to obtain a treated insulin formulation; and said method comprising directing the treated insulin formulation to the injection member;
and introducing the treated formulation into the patient.

19 . The method of claim 18 , wherein said phenolic stabilizing agent is selected from the group consisting of phenol, m-cresol and mixtures thereof.

Assignees

• Becton Dickinson Co

Inventors

• Novak Matthew
• Mainz Emilie
• Rini Christopher
• Roberts Bruce

Classifications

• A61M5/3145

  Filters incorporated in syringes · CPC title

• A61M5/14248 Primary

  of the skin patch type · CPC title

• A61M5/32

  Needles; Details of needles pertaining to their connection with syringe or hub (infusion needles A61M5/158); Accessories for bringing the needle into, or holding the needle on, the body {(A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065)}; Devices for protection of needles {(apparatus specially adapted for cleaning or sterilising needles A61M5/001)} · CPC title

• B01D36/003

  Filters in combination with devices for the removal of liquids (B01D35/185 takes precedence) · CPC title

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title