Perfusion system

Patent metadata

Field	Value
Publication number	US-11253642-B2
Application number	US-202017127541-A
Country	US
Kind code	B2
Filing date	Dec 18, 2020
Priority date	Feb 9, 2016
Publication date	Feb 22, 2022
Grant date	Feb 22, 2022

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

The invention claimed is:

1. A perfusion system for enabling hospitals or clinics to directly administer a dose of an antineoplastic drug to any patient in a patient population in need thereof, the dose calculated according to a patient parameter, wherein the parameter varies over a range in the patient population, said system comprising:
a plurality of perfusion containers, each perfusion container consisting essentially of a ready-to-infuse, aqueous perfusion solution of the antineoplastic drug contained within the perfusion container and one outlet for withdrawal of the aqueous perfusion solution from the perfusion container during direct administration to a patient, wherein said plurality of perfusion containers comprise (a) a first set of perfusion containers consisting essentially of a first ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a first antineoplastic drug concentration and (b) a second set of top-up perfusion containers consisting essentially of a second ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a second antineoplastic drug concentration; and
instructions for selecting one or more perfusion containers from the first set and if required one or more top-up perfusion containers from the second set for directly administering a calculated dose of the antineoplastic drug to a patient from the patient population from the selected perfusion containers such that the amount of antineoplastic drug in the one or more perfusion containers from the first set and if required the one or more top-up perfusion containers from the second set is equal to or less than ±5% of the calculated dose, wherein
the perfusion system is to be used on any patient in the patient population regardless of the calculated dose, and
the aqueous perfusion solutions contained within each of the plurality of perfusion containers are to be administered to the patient without any manipulation of the aqueous perfusion solutions prior to said administration.

2. The perfusion system according to claim 1 , wherein the patient parameter is selected from body surface area, body-weight, renal function and hepatic function.

3. The perfusion system according to claim 1 , wherein the number of containers per the first set and/or the second set is 1-4.

4. The perfusion system according to claim 3 , wherein the number of containers per the first set and/or the second set is 1.

5. The perfusion system according to claim 1 , wherein:
said plurality of perfusion containers further comprise a third set of top-up perfusion containers, each top-up perfusion container of the third set consists essentially of the ready-to-infuse, aqueous perfusion solution of the antineoplastic drug at a third antineoplastic drug concentration contained within the top-up perfusion container and one outlet for withdrawal of the aqueous perfusion solution from the top-up perfusion container during direct administration to a patient; and
the instructions further comprise instructions for selecting, if required, one or more top-up perfusion container(s) from the third set for directly administering the calculated dose of the antineoplastic drug from the selected perfusion containers.

6. The perfusion system according to claim 5 , wherein the first antineoplastic drug concentration and the second antineoplastic drug concentration are different.

7. The perfusion system according to claim 6 , wherein
each of the perfusion containers in the first set of perfusion containers consists essentially of a first volume of the aqueous perfusion solution of the antineoplastic drug;
each of the perfusion containers in the second set of perfusion containers consists essentially of a second volume of the aqueous perfusion solution of the antineoplastic drug; and
each of the perfusion containers in the third set of perfusion containers consists essentially of a third volume of the aqueous perfusion solution of the antineoplastic drug, wherein the first volume, the second volume, and the third volume are different.

8. The perfusion system according to claim 7 , wherein the antineoplastic drug is selected from carboplatin, oxaliplatin, vincristine, vinblastine, vinorelbine, vindesine, pemetrexed, gemcitabine, irinotecan, topotecan, methotrexate, docetaxel, paclitaxel, doxorubicin, daunonibicin, epirubicin, idarubicin, streptozocin, mitomycin, gentamicin, tenoposide, 5-fluorouracil, ifosfamide, cyclophosphamide, mechlorethamine, carmustine, dacarbazine, cladribine, clofarabine, fulvestrant, pegfilgrastim, pamidronate, zoledronic acid, mitoxantrone, leukovorin, etoposide, triplatin, picoplatin, satraplatin, lobaplatin, and pharmaceutically acceptable salts thereof.

9. The perfusion system according to claim 6 , wherein the first antineoplastic drug concentration, second antineoplastic drug concentration, and third antineoplastic drug concentration are different.

10. The perfusion system according to claim 9 , wherein the first antineoplastic drug concentration is higher than the second antineoplastic drug concentration and the second antineoplastic drug concentration is higher than the third antineoplastic drug concentration.

11. The perfusion system according to claim 6 , wherein at least one of the first set of perfusion containers, the second set of top-up perfusion containers, and the third set of top-up perfusion containers are a plurality of containers containing different volumes of ready-to-infuse, aqueous perfusion solutions of the antineoplastic drug.

12. The perfusion system according to claim 11 , wherein the first antineoplastic drug concentration is higher than the second antineoplastic drug concentration and the second antineoplastic drug concentration is higher than the third antineoplastic drug concentration.

13. The perfusion system according to claim 5 , wherein the first antineoplastic drug concentration and the second antineoplastic drug concentration are the same.

14. The perfusion system according to claim 5 , wherein at least two of the first antineoplastic drug concentration, the second antineoplastic drug concentration, and the third antineoplastic drug concentration are different.

15. The perfusion system according to claim 5 , wherein at least two of the first antineoplastic drug concentration, the second antineoplastic drug concentration, and the third antineoplastic drug concentration are the same.

16. The perfusion system according to claim 5 , wherein each of the first antineoplastic drug concentration, the second antineoplastic drug concentration, and the third antineoplastic drug concentration are the same.

17. A plurality of perfusion containers for directly administering a dose of an antineoplastic drug to any patient in a patient population in need thereof, the dose for a patient of the patient population calculated according to a parameter of the patient, wherein
a first perfusion container consists essentially of a first solution of the antineoplastic drug contained within the perfusion container and one outlet for withdrawal of the aqueous perfusion solution from the perfusion container during direct administration to a first patient of the patient population, the first solution having a first antineoplastic drug concentration and a first volume such that the amount of the antineoplastic drug in the container is equal to the calculated dose for the first patient but less than the calculated dose for a second patient of the patient population, and
the first perfusion container is accompanied by a second top-up perfusion container consisting essentially of a second solution

Assignees

• Sun Pharmaceutical Ind Ltd

Inventors

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

Classifications

• A61J1/10 Primary

  Bag-type containers · CPC title

• A61K31/7068

  having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid · CPC title

• A61K31/513

  having oxo groups directly attached to the heterocyclic ring, e.g. cytosine · CPC title

• A61K31/519

  ortho- or peri-condensed with heterocyclic rings · 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