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A kind of deferasirox pharmaceutical composition and its pharmaceutical preparation, preparation method and application

A technology for deferasirox and pharmaceutical preparations, which can be applied in the directions of drug combinations, pharmaceutical formulations, antidote and the like, and can solve problems such as inconvenience for patients

Active Publication Date: 2020-06-26
SINOTHERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This situation is very inconvenient for patients taking deferasirox

Method used

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  • A kind of deferasirox pharmaceutical composition and its pharmaceutical preparation, preparation method and application
  • A kind of deferasirox pharmaceutical composition and its pharmaceutical preparation, preparation method and application
  • A kind of deferasirox pharmaceutical composition and its pharmaceutical preparation, preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] Embodiment 1 deferasirox-HPMCP pharmaceutical composition / physical mixture

[0103] 1. Preparation:

[0104] According to the specific composition and dosage in Table 1-1, deferasirox and carrier material HPMCP (being specifically HP-50) and optional nonionic surfactant (such as TPGS, RH40) are respectively added in the mixer and mixed evenly, and then fed into the feed hopper of the co-rotating twin-screw extruder (Omicron12 of India Steer Company); or by the specific composition and consumption in Table 1-1, the above-mentioned ingredients are directly fed into Feed into the hopper of the co-rotating twin-screw extruder. Set the melting temperature of the co-rotating twin-screw extruder to about 140°C, the screw speed to about 150rpm, and the L / D to 25. The extruded product is cooled, crushed, and sieved to obtain a solid powder, namely this The inventive deferasirox pharmaceutical composition (composition for short, such as composition 1-1, composition 1-4, etc....

Embodiment 2

[0130] The pharmacokinetic research of embodiment 2 deferasirox-HPMCP pharmaceutical composition

[0131] 1. Test preparation

[0132] Test preparation: deferasirox-HPMCP tablet prepared according to the prescription and process of pharmaceutical composition 1-2 and external pharmaceutical excipient composition 2-1 in Example 1, the specification is 500 mg.

[0133] Reference preparation: deferasirox dispersible tablets developed and marketed by Novartis The specification is 500mg, and the inactive ingredients include lactose monohydrate, crospovidone, povidone K30, sodium lauryl sulfate, microcrystalline cellulose, silicon dioxide, and magnesium stearate.

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Abstract

The invention relates to a medicinal composition, a medicinal preparation of the medicinal composition, a preparation method of the medicinal composition, and applications of the medicinal compositionand the medicinal preparation. The medicinal composition comprises an active ingredient, namely, deferasirox, a carrier material, namely, a hydroxypropyl methyl cellulose derivative, and an optionalexisting nonionic surfactant, wherein the medicinal preparation adopts the oral solid dosage form. The medicinal composition and the medicinal preparation of the medicinal composition can be used forpreparing medicines for preventing or treating chronic iron overload.

Description

technical field [0001] The present invention relates to a deferasirox pharmaceutical composition and its pharmaceutical preparation, preparation method and use, in particular to a pharmaceutical composition containing the active ingredient deferasirox and a pharmaceutical preparation containing the pharmaceutical composition, preparation method and uses. Background technique [0002] Deferasirox is an iron chelator with the chemical name 4-[3,5-bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid , structure as shown in formula (I). Deerasirox is a new oral tridentate iron chelator, which is the first oral iron depellant approved by the US FDA for routine administration. Deerasirox is weakly acidic, with pKa of 4.57 for pKa1, 8.71 for pKa2 and 10.56 for pKa3, respectively. In addition, deferasirox is insoluble in water, and its solubility is less than 0.01mg / ml at pH 1-5; its solubility in neutral aqueous solution is 0.2mg / ml; its solubility at pH 7.5 is 0.167mg / ml . ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4196A61K47/38A61P39/04A61P7/00A61P17/00A61P13/12
CPCA61K31/4196A61K47/38
Inventor 钱晓明万建胜方云盛小茜
Owner SINOTHERAPEUTICS
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