Parenteral dosage form of carboplatin

A technology for parenteral and external preparations, which is applied in the field of parenteral dosage forms, and can solve problems such as the decrease in the determination of carboplatin

Pending Publication Date: 2021-04-09
SUN PHARMA INDS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Carboplatin assays ...

Method used

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  • Parenteral dosage form of carboplatin
  • Parenteral dosage form of carboplatin
  • Parenteral dosage form of carboplatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0059] Comparative Examples 1A to 1D and Examples 1E to 1H.

[0060] Table 1. Effect of various parameters on the physical stability of carboplatin solutions after being subjected to extreme stress conditions of autoclaving at 121° C. for 7 minutes.

[0061]

[0062]

[0063] The parenteral dosage forms of Examples 1A, 1C, 1D, 1E, 1G, 1H were prepared as follows: Take the water for injection into a stainless steel container. Add the required amount of mannitol to the water and stir until it is completely dissolved. A solution of ammonium sulfate stock (0.5 mg / ml to 50 mg / ml) was added with continuous stirring. No ammonium sulfate was added to Sample 1A. Add the required amount of carboplatin with continuous stirring until it dissolves. Make up the volume with water for injections. The solution was stirred and filtered through a 0.2μ filter. The resulting solution is filled into flexible infusion containers with a filling volume of 50 ml. The flexible infusion con...

Embodiment 2H to 2

[0072] Table 3: Effect of various parameters on physical stability after exposure to extreme stress conditions of autoclaving at 121°C for 7 minutes.

[0073]

Embodiment 2

[0074] Parenteral dosage forms of Examples 2A, 2C, 2D, 2F, 2G, 2I, 2J and 2L were prepared as follows: Take the water for injection into a stainless steel container. Add the required amount of mannitol to the water and stir until it is completely dissolved. No mannitol was added to sample 2D. In the case of Examples 2C, 2D, 2G, 2I, 2J and 2L, the ammonium sulfate stock solution was added with continuous stirring. In the case of Example 2F, ammonia was added instead of ammonium sulfate with continuous stirring. In Example 2A, neither ammonium sulfate nor ammonia was added to the water. The required amount of carboplatin was added to the resulting solution with continuous stirring until it dissolved. Make up the volume with water for injections. The solution was stirred and filtered through a 0.2μ filter. The resulting solution is filled into flexible infusion containers with a filling volume of 50 ml. The flexible infusion container is then wrapped with a second aluminu...

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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.

Description

technical field [0001] The present invention relates to storage stable aqueous solutions of carboplatin and parenteral dosage forms containing it. Background technique [0002] Carboplatin is a platinum coordination compound with the chemical name [1,1-cyclobutanedicarboxy(2-)-0,0’]diamine. It is available as a lyophilized powder and a preconcentrated aqueous solution (10 mg / ml) from Bristol-Myers Squibb under the trade name Commercially available. [0003] From numerous references and from According to the package insert, the reconstituted carboplatin solution is only stable for 8 hours. In fact, Cheung YW et al. Am J Hosp Pharm.1987 Jan; 44(1):124-30; Swell GJ et al. JClin Pharm Ther.1987 Dec; 12(6):427-32; R. Gust and B. Schnurr: Monatshefte fu rChemie 1999; 130:637-44; All of these references report that reconstituted carboplatin solutions are highly unstable. Myres et al., Journal of Oncology Pharmacy Practice, 2016 Feb;22(1):31-6 reported that despite storage ...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/555A61K31/282A61K33/02A61K33/243
CPCA61K31/555A61K9/0019A61K9/08A61K47/26A61K47/02A61J1/10A61J3/002
Inventor 撒玛利亚·库马尔马赫什库马尔·帕拉斯马尔·索尼苏巴斯·巴拉姆·布霍米克普拉尚·凯恩
Owner SUN PHARMA INDS
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