IP Library Granted Patent US 7,351,431
Granted Patent B2
US 7,351,431 · App. 10/489,917 · Granted Apr 1, 2008

Freeze-dried pharmaceutical preparation

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Quick Facts
Patent No.
US 7,351,431
App. No.
10/489,917
Granted
Apr 1, 2008
Kind
B2
Abstract

For clinical application of cis[((1R,2R)-1,2-cyclohexanediamine-N,N′)bis(R 1 )]platinum(II) (R 1 is an alkanoyloxy group having 6 to 20 carbon atoms), the present invention aims at providing a formulation which prevents layer separation and changes in viscosity, shows fine suspendability, and which is easy to handle during administration. The formulation of the present invention is a lyophilized formulation for injection obtained by dissolving a cis[((1R,2R)-1,2-cyclohexanediamine-N,N′)bis(R 1 )]platinum(II) in 2-methyl-2-propanol and lyophilizing this solution, which has a central particle size distribution of around 3-25 μm and a D90% value of not more than 40 μm.

Claims (5)

1. A method to produce a lyophilized formulation comprising a cis[((1R,2R)-1,2-cyclohexanediamine-N,N′)bis(tetradecanoyloxy)]platinum(II) as a main ingredient, comprising the following steps:

(1) a step of dissolving a cis[((1R,2R)-1,2-cyclohexanediamine-N,N′)bis(tetradecanoyloxy)]platinum(II) in 2-methyl-2-propanol,

(2) a step of adjusting a water content of said solution to 1.0-6.0 mg/mL,

(3) a step of quickly freezing said solution, and

(4) a step of lyophilizing said frozen solution.

Assignments (2)
MERGER Recorded Dec 16, 2005
From: SUMITOMO PHARMACEUTICALS COMPANY, LTD.
To: DAINIPPON SUMITOMO PHARMA CO., LTD.
Reel/Frame 017089/0420 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2004
From: MIZUNO, KIMIHIRO
To: SUMITOMO PHARMACEUTICALS CO., LTD.
Reel/Frame 015282/0195 →