Cinacalcet hydrochloride solid dispersion tablet and preparation technology thereof

A technology of cinacalcet hydrochloride and solid dispersion, which is applied in the field of cinacalcet hydrochloride solid dispersion tablet and its preparation to achieve the effect of improving dissolution rate

Inactive Publication Date: 2015-12-02
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a kind of cinacalcet hydrochloride solid dispersion tablet preparation process, solves the cinacalcet hydrochloride tablet dissolution rate and the preparation process problem.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Immediate Release Tablets

[0031] prescription

quantity

Content / %

Cinacalcet hydrochloride

30mg

15.0

povidone

30mg

15.0

Mannitol

50mg

25.0

microcrystalline cellulose

70mg

35.0

hypromellose

8mg

4.0

Croscarmellose Sodium

10mg

5.0

Magnesium stearate

2mg

1.0

Total

200mg

100

[0032] 1) Cinacalcet hydrochloride and povidone are respectively passed through a 100 mesh sieve;

[0033] 2) Ultrasonic dissolve cinacalcet hydrochloride and povidone together in an appropriate amount of absolute ethanol, put it on a rotary evaporator at 40-50°C to recover the ethanol under reduced pressure, and dry it in a vacuum oven at 40-50°C for 18-24 hours Equilibrate in a desiccator for 18 to 24 hours, crush and pass through an 80-mesh sieve to obtain a solid dispersion of cinacalcet hydrochlor...

Embodiment 2

[0047] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Immediate Release Tablets

[0048] prescription

quantity

Content / %

Cinacalcet hydrochloride

30mg

13.04

povidone

60mg

26.09

Mannitol

50mg

21.74

microcrystalline cellulose

70mg

30.43

hypromellose

8mg

3.48

Croscarmellose Sodium

10mg

4.35

Magnesium stearate

2mg

0.87

Total

230mg

100

[0049] 1) Cinacalcet hydrochloride and povidone are respectively passed through a 100 mesh sieve;

[0050] 2) Ultrasonic dissolve cinacalcet hydrochloride and povidone together in an appropriate amount of absolute ethanol, put it on a rotary evaporator at 40-50°C to recover the ethanol under reduced pressure, and dry it in a vacuum oven at 40-50°C for 18-24 hours Equilibrate in a desiccator for 18 to 24 hours, crush and pass through an 80-mesh sieve to obtain a solid dispersion of cinacalcet hyd...

Embodiment 3

[0064] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Immediate Release Tablets

[0065] prescription

quantity

Content / %

Cinacalcet hydrochloride

30mg

11.54

povidone

90mg

34.62

Mannitol

50mg

19.23

microcrystalline cellulose

70mg

26.92

hypromellose

8mg

3.08

Croscarmellose Sodium

10mg

3.85

Magnesium stearate

2mg

0.77

Total

260mg

100

[0066] 1) Cinacalcet hydrochloride and povidone are respectively passed through a 100 mesh sieve;

[0067] 2) Ultrasonic dissolve cinacalcet hydrochloride and povidone together in an appropriate amount of absolute ethanol, put it on a rotary evaporator at 40-50°C to recover the ethanol under reduced pressure, and dry it in a vacuum oven at 40-50°C for 18-24 hours Equilibrate in a desiccator for 18 to 24 hours, crush and pass through an 80-mesh sieve to obtain a solid dispersion of cinacalcet hyd...

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PUM

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Abstract

The invention discloses a preparation technology of a Cinacalcet hydrochloride solid dispersion tablet, and belongs to the technical field of preparation of medicinal preparations. The technology is characterized in that the Cinacalcet hydrochloride solid dispersion tablet is prepared through a solid dispersion process and a powder direct tabletting process. The in vitro dissolution rate of Cinacalcet hydrochloride is characterized by 40-80% at 5-10min, 80-90% at 15-20min and 90-100% at 30-45min. The technology has the advantages of simple process, safety, controllable quality, low cost, short production cycle, and suitableness for large-scale industrial production.

Description

Technical field: [0001] The invention relates to a cinacalcet hydrochloride solid dispersion tablet and a preparation process thereof, belonging to the technical field of preparation of pharmaceutical preparations. Background technique [0002] Cinacalcet hydrochloride (cinacalcethydrochloride) is the first drug approved by the FDA in the second generation of calcimimetic agents. In March 2004, the FDA approved the production of cinacalcet hydrochloride tablets from Amgen Company. The trade name is Sensipar, and the specifications 30mg, 60mg and 90mg (calculated as cinacalcet); in October 2004, the European Union approved the listing of the product of Amgen Company, the product name is Mimpara, and the specifications are 30mg, 60mg, 90mg (calculated as cinacalcet); in 2008 In January, cinacalcet hydrochloride tablets produced by Kyowa Hakko Kirin Co., Ltd. were launched in Japan, under the product name REGPARA, and the specifications are 25mg and 75mg (calculated as cinacalc...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/38A61P5/22
Inventor 王东凯杨文涛张欢杨磊
Owner SHENYANG PHARMA UNIVERSITY
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