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Stabilized picoplatin oral dosage form

A dosage form, the technology of picoplatin, used in the field of cancer treatment, can solve problems such as low stability, uncomfortable infusion, and deformity

Inactive Publication Date: 2015-01-21
ENCARTA INC
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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 known to be particularly susceptible to photodegradation in solution (e.g. IV dosage forms)
Picoplatin is orally bioavailable, but its low stability in water, instability, toxicity, and teratogenic tendencies make it difficult to prepare effective oral dosage forms

Method used

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  • Stabilized picoplatin oral dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] containing TiO 2 or CaSO 4 Impurities formed from picoplatin in solutions of

[0107] 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.

[0108] Table 1

[0109]

[0110] 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

[0112] Fe as a function of time 2+ Effect of Concentration on TCAP Formation from Picoplatin

[0113] 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.

[0114] Table 2

[0115] 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 a substantially 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

[0001] This application is a divisional application of the invention patent application with the application date of February 8, 2008, the Chinese patent application number of 2008800113572, and the invention title of "stabilized oral dosage form of picoplatin". technical field [0002] 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 [0003] 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. [0004] The structure of pi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/38A61K9/16A61K9/48A61K47/42A61K47/38A61K47/26A61K31/555A61P35/00A61K33/243
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 ENCARTA INC
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