Cinacalcet hydrochloride containing pharmaceutical composition and preparation method thereof

A technology of cinacalcet hydrochloride and its composition, which is applied in the field of pharmaceutical composition containing cinacalcet hydrochloride and its preparation, to achieve the effects of good stability, increased drug safety, and accelerated disintegration rate

Active Publication Date: 2016-01-06
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the cinacalcet hydrochloride pharmaceutical composition, add this type of surfa

Method used

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  • Cinacalcet hydrochloride containing pharmaceutical composition and preparation method thereof
  • Cinacalcet hydrochloride containing pharmaceutical composition and preparation method thereof
  • Cinacalcet hydrochloride containing pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Preparation prescription: 25mg dose

[0031] Element Dosage (g) proportion% Cinacalcet hydrochloride 27.5 34.4% pregelatinized starch 21.5 26.9% microcrystalline cellulose 21.5 26.9% Crospovidone-internal 3.125 3.9% Crospovidone - Extra 1.875 2.3% purified water 30.0 -- Methylcellulose 3.0 3.7% Polysorbate 0.5 0.6% Magnesium stearate 1.0 1.3% Chip 80 100%

[0032] Tablet core preparation: Weigh cinacalcet hydrochloride, microcrystalline cellulose, pregelatinized starch, and cross-linked povidone according to the prescription, mix evenly, add 30g of purified water as a soft material for binder, and use a 20-mesh sieve Granulate, dry in an oven at 55-65°C, sieve through a 24-mesh sieve for granulation, add methylcellulose, polysorbate, and magnesium stearate, mix evenly, and compress into tablets to obtain tablet cores.

[0033] Coating: Prepare a coating solution with a concentration ...

Embodiment 2

[0035] Preparation prescription: 25mg dose

[0036] Element Dosage (g) proportion% Cinacalcet hydrochloride 27.5 34.4% pregelatinized starch 30.0 37.5% microcrystalline cellulose 15.0 18.7% Crospovidone-internal 1.5 1.9% Crospovidone - Extra 1.5 1.9% purified water 30.0 -- Methylcellulose 0.5 0.6% Polysorbate 3.0 3.7% Magnesium stearate 1.0 1.3% Chip 80 100%

[0037] Tablet core preparation: Weigh cinacalcet hydrochloride, microcrystalline cellulose, pregelatinized starch, and cross-linked povidone according to the prescription, mix evenly, add 30g of purified water as a soft material for binder, and use a 20-mesh sieve Granulate, dry in an oven at 55-65°C, sieve through a 24-mesh sieve for granulation, add methylcellulose, polysorbate, and magnesium stearate, mix evenly, and compress into tablets to obtain tablet cores.

[0038] Coating: Prepare a coating solution with a concentration of 1...

Embodiment 3

[0040] Preparation prescription:

[0041] Element Dosage (g) proportion% Cinacalcet hydrochloride 27.5 34.4% pregelatinized starch 15.0 18.7% microcrystalline cellulose 30.0 37.5% Crospovidone-internal 2.0 2.5% Crospovidone - Extra 1.0 1.3% purified water 30.0 -- Methylcellulose 2.0 2.5% polyvinyl alcohol 2.0 2.5% Magnesium stearate 0.5 0.6% Chip 80 100%

[0042]Tablet core preparation: Weigh cinacalcet hydrochloride, microcrystalline cellulose, pregelatinized starch, and cross-linked povidone according to the prescription, mix evenly, add 30g of purified water as a soft material for binder, and use a 20-mesh sieve Granulate, dry in an oven at 55-65°C, sieve through a 24-mesh sieve for granulation, add methyl cellulose, polyvinyl alcohol, and magnesium stearate, mix evenly, and compress into tablets to obtain tablet cores.

[0043] Coating: Prepare a coating solution with a concentration of...

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Abstract

The invention relates to a cinacalcet hydrochloride containing pharmaceutical composition and a preparation method thereof. The composition contains cinacalcet hydrochloride, a specific surfactant, and other pharmaceutically acceptable excipients such as a filling agent, a disintegrating agent, an adhesive, and a lubricant. In a wet granulation film coating process adopted in the invention, by simplifying auxiliary materials in a preparation formulation, the safety of medication usage is improved, the production process is simplified, the production cycle is shortened, the production cost is reduced, prepared cinacalcet hydrochloride tablets are good in appearance, and the dissolution effect of the tablets is significantly improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing cinacalcet hydrochloride and a preparation method thereof. Background technique [0002] The chemical name of Cinacalcet Hydrochloride is N-((1R)-1-(1-naphthyl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine salt salt, its structural formula is: [0003] [0004] Cinacalcet hydrochloride has a chiral center and the active ingredient is in the R configuration. Cinacalcet hydrochloride is a white or off-white non-hygroscopic crystalline powder with a stable crystal form at room temperature. The water solubility of this product is very low, but it is very soluble in some organic solvents, such as methanol and ethanol. At the same time, the particle size and crystal form of the raw material have a great influence on the dissolution and bioavailability of the preparation. [0005] Cinacalcet hydrochloride is a calcimimetic ag...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/137A61K47/38A61K47/36A61K47/22A61K47/32A61P5/20A61P13/12
Inventor 赵焰平高莹吴昀杨芳卢迪刘亚男
Owner BEIJING TIDE PHARMA
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