Perfusion system

Patent metadata

Field	Value
Publication number	US-2020360598-A1
Application number	US-201716075791-A
Country	US
Kind code	A1
Filing date	Feb 9, 2017
Priority date	Feb 9, 2016
Publication date	Nov 19, 2020
Grant date	—

Abstract

A perfusion container for directly administering to patients a dose of an antineoplastic drug calculated according to a patient's parameter, wherein the first perfusion container comprises a solution of antineoplastic drug at a concentration and volume such that the amount of antineoplastic drug in the container is equal to the calculated dose for one patient but less than the calculated dose for a second patient, the calculated dose is provided to first patient within 5% variance by directly administering the full volume of the solution of antineoplastic drug from the first perfusion container, further the first perfusion container is accompanied by a second top-up perfusion container comprising a solution of antineoplastic drug at a concentration and volume such that the calculated dose is provided within 5% variance by directly administering the full volume of the solution of antineoplastic drug from the first perfusion container and the second top-up container to the second patient.

First claim

1 . A perfusion system for enabling hospitals or clinics to directly administer to patients in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, said system comprising:
plurality of perfusion containers, each container comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug, wherein said plurality of perfusion containers comprise a first set of perfusion container (s) comprising a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug and a second set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug and optionally a third set of top-up perfusion containers comprising a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug, and instructions for selecting one or more perfusion container(s) from the first set and if required one or more top-up perfusion container(s) from the second and/or third set for directly administering the calculated dose of the antineoplastic drug from the selected perfusion containers.

2 . The perfusion system as claimed in claim 1 , wherein
the first set of perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug at a first concentration, the second set of top-up perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a second concentration and the optional third set of top-up perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a third concentration.

3 . The perfusion system as claimed in claim 2 , wherein the first, second and/or third concentrations are the same or different.

4 . The perfusion system as claimed in claim 2 , wherein volumes of solution in the individual containers is the same or different.

5 . The perfusion system as claimed in any of claims 1 to 4 , wherein the patient parameter is selected from body surface area, body-weight, renal function or hepatic function.

6 . The perfusion system as claimed in claim 2 , wherein the first concentration, second concentration, and third concentration are different.

7 . The perfusion system as claimed in claim 6 , wherein the first concentration is higher than the second concentration and the second concentration is higher than the third concentration.

8 . The perfusion system as claimed in claim 2 , wherein each of the first set of perfusion containers, the second set of top-up perfusion containers, and/or the third set of top-up perfusion containers each comprise a plurality of containers containing different volumes of ready-to-infuse, aqueous perfusion solution of an antineoplastic drug.

9 . The perfusion system as claimed in claim 8 , wherein the first concentration is higher than the second concentration and the second concentration is higher than the third concentration.

10 . A method for directly administering to a patient in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, the method comprising the steps of:
providing the perfusion system as claimed in claim 1 ; calculating the dose according to a patient parameter, selecting one or more perfusion container(s) from the first set of perfusion container(s) and if necessary from the second and/or third set of top-up perfusion container(s) required for directly administering the calculated dose and directly administering to the patient in need thereof, the perfusion solution in the selected containers.

11 . The method as claimed in claim 10 , wherein the first set of perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of an antineoplastic drug at a first concentration, the second set of top-up perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a second concentration and the optional third set of top-up perfusion containers comprises a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a third concentration.

12 . The method as claimed in claim 11 , wherein the first, second and/or third concentrations are the same or different.

13 . The method as claimed in claim 11 , wherein volumes of solution in the individual containers is the same or different.

14 . The method as claimed in any of claims 10 to 13 , wherein the patient parameter is selected from body surface area, body-weight, renal function or hepatic function.

15 . The method as claimed in claim 11 , wherein the first concentration, second concentration, and third concentration are different.

16 . The method as claimed in claim 15 , wherein the first concentration is higher than the second concentration and the second concentration is higher than the third concentration.

17 . The method as claimed in claim 11 , wherein each of the first set of perfusion containers, the second set of top-up perfusion containers, and/or the third set of top-up perfusion containers each comprise a plurality of containers containing different volumes of ready-to-infuse, aqueous perfusion solution of an antineoplastic drug.

18 . The method as claimed in claim 17 , wherein the first concentration is higher than the second concentration and the second concentration is higher than the third concentration.

19 . A perfusion container configured to be one of perfusion containers in the perfusion system of claim 1 , wherein the perfusion container comprises a ready to infuse perfusion solution of a partial dose of an antineoplastic drug for some patients in the patient population, wherein the dose is calculated according to a patient parameter.

20 . A method for directly administering to a patient in need thereof a dose of an antineoplastic drug calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, the method comprising the steps of:
providing perfusion container(s) as claimed in claim 19 ; calculating the dose according to a parameter for any given patient in the patient population, selecting one or more perfusion containers from the first set of perfusion container(s) and if necessary from the second or third set of perfusion containers, required for directly administering the calculated dose, and directly administering to the patient in need thereof, the perfusion solution in the selected containers.

21 . The perfusion system as claimed in claim 1 wherein the number of containers per set is 1 or 2

22 . The perfusion system as claimed in claim 21 wherein the number of containers per set is 1.

23 . The method according to claim 10 wherein the number of containers per set is 1 or 2

24 . The method according to claim 23 wherein the number of containers per set is 1.

25 . A perfusion container for directly administering to patients a dose of an antineoplastic drug calculated according to a patient's parameter, wherein the first perfusion container comprises a solution of antineoplastic drug at a concentration and volume such that the amount of antineoplastic drug in the container is equal to the calculated dose for one patient but less than the calculated dose for a second patient, the calculated dose is provided to first patient within 5% variance by directly administ

Assignees

• Sun Pharmaceutical Ind Ltd

Inventors

• Bhowmick Subhas Balaram
• Kane Prashant
• Kumar Samarth
• Ganorkar Kirti

Classifications

• A61J1/10 Primary

  Bag-type containers · CPC title

• A61M5/16827

  controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407) · CPC title

• A61M5/1407

  Infusion of two or more substances · CPC title

• A61J1/12

  with means for holding samples of contents · CPC title

• A61M2205/6009

  for matching patient with his treatment, e.g. to improve transfusion security · CPC title