Parenteral dosage form of carboplatin

Patent metadata

Field	Value
Publication number	US-12508269-B2
Application number	US-201917768021-A
Country	US
Kind code	B2
Filing date	Aug 30, 2019
Priority date	Aug 31, 2018
Publication date	Dec 30, 2025
Grant date	Dec 30, 2025

Abstract

A parenteral dosage form having an infusion container filled with an aqueous solution in volumes ranging from 40 ml to 500 ml comprising 1 mg/ml to 2 mg/ml of carboplatin, wherein the solution contains known impurity of 1, 1-cyclobutanedicarboxylic acid in an amount of not more than 1.0% by weight of carboplatin and the solution remains physically stable when stored at room temperature.

First claim

We claim:

1 . A parenteral dosage form having an infusion container filled with an aqueous solution in a volume ranging from 40 ml to 500 ml, the aqueous solution comprising 1 mg/ml to 2 mg/ml of carboplatin and 0.02 mg/ml to 2.0 mg/ml of ammonium sulphate, wherein
the aqueous solution contains known impurity of 1,1-cyclobutanedicarboxylic acid in an amount of not more than 1.0% by weight of carboplatin and the solution remains physically stable when stored at room temperature.

2 . The parenteral dosage form of claim 1 , wherein the solution comprises 1 mg/ml of carboplatin and a dissolved oxygen content in the range of about 5 ppm to 50 ppm.

3 . The parenteral dosage form of claim 2 , wherein the ammonium sulphate is in an amount ranging from 0.2 mg/ml to 2.0 mg/ml and the dissolved oxygen content is in an amount ranging from about 5 ppm to 10 ppm.

4 . The parenteral dosage form of claim 2 , wherein the dissolved oxygen content is in an amount ranging from about 10 ppm to 50 ppm.

5 . The parenteral dosage form of claim 3 , wherein the volume of the aqueous solution is 50 ml.

6 . The parenteral dosage form of claim 1 , wherein the aqueous solution is free of dextrose.

7 . A parenteral dosage form of claim 1 , wherein the solution comprises 2 mg/ml of carboplatin and a dissolved oxygen content in the range of about 5 ppm to 50 ppm.

8 . The parenteral dosage form of claim 7 , wherein the dissolved oxygen content is in an amount ranging from about 10 ppm to 50 ppm.

9 . The parenteral dosage form of claim 7 , wherein the ammonium sulphate is in an amount ranging from 0.5 mg/ml to 2.0 mg/ml and the dissolved oxygen content is an amount ranging from about 5 ppm to 10 ppm.

10 . The parenteral dosage form of claim 8 , wherein the volume of the aqueous solution is 50 ml.

11 . The parenteral dosage form of claim 1 , wherein the aqueous solution is free of chloride salts.

12 . The parenteral dosage form of claim 1 , wherein the infusion container is a perfusion bag, an infusion bag, or a flexible pouch.

13 . The parenteral dosage form of claim 12 , wherein the parenteral dosage form has been subjected to autoclaving.

14 . The parenteral dosage form of claim 1 , wherein the aqueous solution has a pH in the range of about 4.0 to 6.0.

15 . The parenteral dosage form of claim 1 , wherein the aqueous solution has a pH in the range of 4.5 to 5.5.

16 . The parenteral dosage form of claim 1 , wherein the aqueous solution is free of dextrose and sodium chloride.

17 . The parenteral dosage form of claim 1 , wherein the aqueous solution is free of one or more of chelating agents, preservatives, buffering or pH adjusting agents, solubilizers, co-solvents, and osmogens.

18 . The parenteral dosage form of claim 1 , wherein the aqueous solution is a ready-to-administer aqueous solution.

19 . The parenteral dosage form of claim 2 , wherein the volume of the aqueous solution is 40 ml, 60 ml, 80 ml, 100 ml, 150 ml, 200 nl, 300 ml, 330 ml, 360 ml, 390 ml, 430 ml, 470 ml, or 500 ml.

Assignees

• Sun Pharmaceutical Ind Ltd

Inventors

• Kumar Samarth
• Soni Maheshkumar Parasmal
• Bhowmick Subhas Balaram
• Kane Prashant

Classifications

• A61K47/02

  Inorganic compounds · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title

• A61J3/002

  Compounding apparatus specially for enteral or parenteral nutritive solutions (bottling liquids B67C) · CPC title

• A61J1/10

  Bag-type containers · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title