Process for preparing Cinacalcet hydrochloride tablets or capsules

A kind of technology of cinacalcet hydrochloride and capsule, applied in the field of preparation of pharmaceutical preparations

Inactive Publication Date: 2011-09-28
四川晖瑞医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • Process for preparing Cinacalcet hydrochloride tablets or capsules
  • Process for preparing Cinacalcet hydrochloride tablets or capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Sustained Release Tablets

[0026] prescription

quantity

content%

Cinacalcet hydrochloride

33mg

18.33%

6000

15mg

8.33%

Mannitol

20mg

11.11%

microcrystalline cellulose

70mg

38.89%

Crospovidone

13mg

7.22%

partially pregelatinized starch

27mg

15.00%

Magnesium stearate

2mg

1.12%

Total

180g

100%

[0027] 1) Cinacalcet hydrochloride was crushed through a 100-mesh sieve, and mannitol, microcrystalline cellulose, crospovidone, and partially pregelatinized starch were passed through a 60-mesh sieve.

[0028] 2) Add to the mixer and mix for 15 minutes,

[0029] 3) Dry granulation in the dry granulator, and the granules pass through a 20-mesh sieve.

[0030] 4) Mix the granules of operation 3) with magnesium stearate evenly.

[0031] 5 tablets

[0032] 30mg 180mg / tablet 100 tablets

[0033...

Embodiment 2

[0046] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Sustained Release Tablets

[0047] prescription

quantity

content%

Cinacalcet hydrochloride

33mg

16.50%

polyethylene glycol 6000

15mg

7.50%

Mannitol

25mg

12.50%

microcrystalline cellulose

75mg

37.50%

Crospovidone

18mg

9.00%

partially pregelatinized starch

32mg

16.00%

Magnesium stearate

2mg

1.00%

Total

200mg

100%

[0048] 1) Cinacalcet hydrochloride was crushed through a 100-mesh sieve, and mannitol, microcrystalline cellulose, crospovidone, and partially pregelatinized starch were passed through a 60-mesh sieve.

[0049] 2) Add to the mixer and mix for 15 minutes,

[0050] 3) Dry granulation in the dry granulator, and the granules pass through a 20-mesh sieve.

[0051] 4) Mix the granules of operation 3) with magnesium stearate evenly.

[0052] 5 tablets

[0053] 30mg 200mg / tabl...

Embodiment 3

[0067] Preparation of Cinacalcet Hydrochloride 30mg, 60mg, 90mg Sustained Release Tablets

[0068] prescription

quantity

content%

Cinacalcet hydrochloride

33mg

15.00%

polyethylene glycol 6000

15mg

6.82%

Mannitol

30mg

13.64%

microcrystalline cellulose

80mg

36.36%

Crospovidone

23mg

10.45%

partially pregelatinized starch

37mg

16.82%

Magnesium stearate

2mg

0.91%

Total

220mg

100%

[0069] 1) Cinacalcet hydrochloride was crushed through a 100-mesh sieve, and mannitol, microcrystalline cellulose, crospovidone, and partially pregelatinized starch were passed through a 60-mesh sieve.

[0070] 2) Add to the mixer and mix for 15 minutes,

[0071] 3) Dry granulation in the dry granulator, and the granules pass through a 20-mesh sieve.

[0072] 4) Mix the granules of operation 3) with magnesium stearate evenly.

[0073] 5 tablets

[0074] 30mg 220mg / tab...

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PUM

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Abstract

The invention discloses a process for preparing Cinacalcet hydrochloride tablets or capsules and belongs to the technical field of medicinal preparations. The preparation process comprises performing dry-process granulation according to one formula; and tabletting or filling capsules by using three dosages according to a ratio. The in-vitro release of the Cinacalcet hydrochloride is characterized in that: 40 to 80 percent of Cinacalcet hydrochloride is released within 5 to 10 minutes; 80 to 90 percent of the Cinacalcet hydrochloride is released within 15 to 20 minutes; and 90 to 100 percent of Cinacalcet hydrochloride is released within 30 to 45 minutes. In the process, the procedures are simple and safety, the quality is controllable, the cost is low, and the production period is short. The process is suitable for large-scale industrial production.

Description

Technical field: [0001] The invention relates to a preparation process of cinacalcet hydrochloride tablet or capsule, which belongs to the technical field of preparation of pharmaceutical preparations. Background technique [0002] Trade Name: Sensipar (Amgen) Cinacalcet Hydrochloride is a calcimimetic that lowers parathyroid hormone (PTH) levels in the body when it is used in combination with vitamin D analogs and phosphate binders. and serum calcium levels. The drug was approved by the US Food and Drug Administration (FDA) on March 8, 2004. Biotechnology company Amgen (Amgen Inc) announced on July 30, 2004 that the new drug Mimpara produced by the company has been recommended by the EU Human Medicines Committee. The drug was approved by the FDA in March this year. The generic name is cinacalcet HCI, and it is marketed in the United States under the trade name Sensipar. Cinacalcet is the first drug of its kind to be approved by the FDA. Elevated PTH level is a sign of h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/48A61K31/137A61P5/22A61P5/20A61K9/20
Inventor 刘海峰姚晨贾贵琼赵虎
Owner 四川晖瑞医药科技有限公司
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