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Sunitinib malate capsules and preparation method thereof

A technology of sunitinib malate capsules and sunitinib malate, applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as increasing operating costs of enterprises, and reduce operating costs Cost, high safety, low energy consumption

Active Publication Date: 2022-07-12
北京鑫开元医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, in the granulation process, the electrical energy is first converted into mechanical energy, and then the electrical energy is converted into internal energy during drying; if ethanol granulation is used, there may be a huge safety risk, which requires the equipment to have explosion-proof capabilities, which will significantly increase the production capacity of the enterprise. operating costs

Method used

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  • Sunitinib malate capsules and preparation method thereof
  • Sunitinib malate capsules and preparation method thereof
  • Sunitinib malate capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Table 1 Recipe 1

[0039]

[0040] The preparation method of sunitinib malate capsules:

[0041] ①. Treatment of raw and auxiliary materials: Screen the raw materials of sunitinib malate to control the particle size of sunitinib malate to be greater than 30 μm (D90); pass colloidal silicon dioxide and magnesium stearate through a 60-mesh sieve respectively .

[0042] 2. Premixing: get sunitinib malate, starch hydrolyzed oligosaccharide, trehalose, and colloidal silicon dioxide of the recipe, place them in a three-dimensional mixer, and control the rotating speed during mixing to be 15 rpm, and the mixing time is 10min.

[0043] 3. Total mixing: add magnesium stearate into the three-dimensional mixer for further mixing, control the rotating speed during mixing to 15 rpm, and the mixing time to 5 min.

[0044] ④. Filling capsules: Fill the mixed materials in the three-dimensional mixer into capsules.

[0045] ⑤. Packaging: It is packaged in aluminum foil / PVC / Aclar ...

Embodiment 2

[0047] Table 2 Recipe 2

[0048]

[0049]

[0050] The preparation method of sunitinib malate capsules:

[0051] ①. Treatment of raw and auxiliary materials: Screen the raw materials of sunitinib malate to control the particle size of sunitinib malate to be greater than 30 μm (D90); pass colloidal silicon dioxide and magnesium stearate through a 60-mesh sieve respectively .

[0052] 2. Premixing: get sunitinib malate, starch hydrolyzed oligosaccharide, trehalose, and colloidal silicon dioxide of the recipe, place them in a three-dimensional mixer, and control the rotating speed during mixing to be 15 rpm, and the mixing time is 10min.

[0053] 3. Total mixing: add magnesium stearate into the three-dimensional mixer for further mixing, control the rotating speed during mixing to 15 rpm, and the mixing time to 5 min.

[0054] ④. Filling capsules: Fill the mixed materials in the three-dimensional mixer into capsules.

[0055] ⑤. Packaging: It is packaged in aluminum foi...

Embodiment 3

[0057] Table 3 Recipe 3

[0058]

[0059]

[0060] The preparation method of sunitinib malate capsules:

[0061] ①. Treatment of raw and auxiliary materials: Screen the raw materials of sunitinib malate to control the particle size of sunitinib malate to be greater than 30 μm (D90); pass colloidal silicon dioxide and magnesium stearate through a 60-mesh sieve respectively .

[0062] 2. Premixing: get sunitinib malate, starch hydrolyzed oligosaccharide, trehalose, and colloidal silicon dioxide of the recipe, place them in a three-dimensional mixer, and control the rotating speed during mixing to be 15 rpm, and the mixing time is 10min.

[0063] 3. Total mixing: add magnesium stearate into the three-dimensional mixer for further mixing, control the rotating speed during mixing to 15 rpm, and the mixing time to 5 min.

[0064] ④. Filling capsules: Fill the mixed materials in the three-dimensional mixer into capsules.

[0065]⑤. Packaging: It is packaged in aluminum foil...

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Abstract

The invention relates to sunitinib malate capsules and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The sunitinib malate capsule is composed of sunitinib malate, a filler, a glidant and a lubricant. The present invention does not require additional disintegrants, and only by adjusting the formula and the types of auxiliary materials, the dissolution curve of the final prepared sunitinib malate capsule is infinitely close to the dissolution curve of the commercially available product (). The invention adopts a dry preparation process, has high safety, low energy consumption, energy saving and environmental protection, and is beneficial to reducing the operating cost of the enterprise. By optimizing the formula and proportioning, the present invention reduces the dosage of auxiliary materials, the final capsule volume is small, the patient's compliance is good, and the patient's absorption is more favorable.

Description

technical field [0001] The invention relates to sunitinib malate capsules and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Sunitinib malate is a tyrosine kinase inhibitor with the potential to inhibit angiogenesis and anti-tumor effect. It was developed and marketed by Pfizer. Sunitinib is the abbreviation of sunitinib malate, which is yellow to orange powder, soluble in 25 mg / mL acidic aqueous solution (pH is 1.2-6.8). At pH values ​​greater than 6.8, the solubility of sunitinib decreases rapidly. Therefore, sunitinib is classified as a low solubility compound according to the Biopharmaceutical Classification. Sunitinib is non-hygroscopic, the active moiety has no chiral centers, but the final substance is optically active due to the malic acid moiety of the molecule. [0003] The existing preparation process of sunitinib malate mainly adopts a typical wet granulation process. For example, th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/404A61K47/26A61P35/00
CPCA61K31/404A61K9/4808A61K9/4858A61P35/00
Inventor 罗超解亮田爱俊马文文王少绒戴信敏
Owner 北京鑫开元医药科技有限公司
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