Stabilized picoplatin oral dosage form

A dosage form, picoplatin technology, applied in the field of anti-cancer organic platinum drug picoplatin, can solve problems such as instability, uncomfortable infusion, and difficulty in preparing oral dosage forms

Inactive Publication Date: 2010-03-24
PONIARD PHARMA INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Intravenous administration is uncomfortable due to the need for a needle inserted into the vein and the fact that the patient must remain still for a considerable period of time while administering a relatively large volume of picoplatin solution
Picoplatin is also

Method used

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  • Stabilized picoplatin oral dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] containing TiO 2 or CaSO 4 Impurities formed from picoplatin in solutions of

[0106] Picoplatin solution and TiO 2 solution, pure OPADRY (without TiO 2 ) solution, and containing TiO 2 or CaSO 4 Mix with the standard coating OPADRY solution. After standing, the solution was analyzed by HPLC for the amount of picoplatin degradation products 2-picoline and trichloroplatinate (TCAP). The results are shown in Table 1.

[0107] Table 1

[0108]

[0109] show CaSO 4 OPADRY coating does not cause picoplatin to occur as in TiO 2 or TiO 2 Degradation observed in OPADRY products,.

Embodiment 2

[0111] Fe as a function of time 2+ Effect of Concentration on TCAP Formation from Picoplatin

[0112] Preparation of FeSO 4 solution, and it was added to the aqueous solution of picoplatin to obtain Fe as shown in the table below 2+ the final concentration. The percentage of TCAP formed by conversion of picoplatin was determined by HPLC at the indicated time points and is shown in Table 2 in percent.

[0113] Table 2

[0114] Fe 2+ (ppm)

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Abstract

The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt% picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt% of a filler comprising asubstantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt% of a lubricant. The dosage form can further include a dispersant.

Description

technical field [0001] The technical field of the present invention is an oral dosage form of an anticancer organoplatinum drug picoplatin, a method for preparing the oral dosage form and a method for using the oral dosage form to treat cancer. Background technique [0002] Picoplatin is a next-generation organoplatinum drug that holds promise for the treatment of many types of malignancies, including those that have become resistant to previous organoplatinum agents such as cisplatin or carboplatin Malignant tumor. Picoplatin has shown promise in the treatment of a variety of cancers or tumors, including small cell lung cancer, colorectal cancer, and hormone-resistant prostate cancer. [0003] The structure of picoplatin is: [0004] [0005] It is named cis-amminedichloro(2-picoline)platinum(II), or [SP-4-3]-ammine(dichloro)(2-picoline)platinum(II). The compound is a planar complex of divalent platinum, which is tetracoordinated and has three different ligand types. ...

Claims

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Application Information

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IPC IPC(8): A61K33/24A61K31/28A01N55/02A61K33/243
CPCA61K9/2866A61K33/24A61K31/28A61P35/00A61K33/243A61K9/20A61K33/28
Inventor A·J·利C·A·普罗西夏伊E·S·Y·王C·M·吉安多米尼科
Owner PONIARD PHARMA INC
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