Pharmaceutical composition for treating breast cancer and preparation method of pharmaceutical composition

A composition and technology for breast cancer, which are applied in directions such as drug combinations, pharmaceutical formulations, and non-active ingredients medical preparations, can solve the problems of low dissolution rate, poor dissolution rate, large difference in tablet weight, etc. The method is simple and easy to control, the product has good stability, and the effect of small difference in tablet weight

Inactive Publication Date: 2018-05-11
孟斯琴
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the international patent application publication WO2014128588, it is necessary to use a bulk drug of palbociclib with a larger particle size in order to improve its physical and chemical properties and the production capacity of the preparation product, but if the particle size is large, its fluidity is not satisfactory, especially Using powder direct compression or dry granulation, it is necessary to control the smaller particle size to meet the dissolution requirements
[0007] CN106667952A discloses a preparation method of a palbociclib pharmaceutical composition, which is firstly mixing lactose, microcrystalline cellulose, palbociclib raw material, a part of sodium carboxymethyl starch and magnesium stearate, and drying granulation, and then mixed with silicon dioxide, the remaining sodium carboxymethyl starch, and magnesium stearate; the obtained pharmaceutical composition has good content uniformity,

Method used

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  • Pharmaceutical composition for treating breast cancer and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating breast cancer and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating breast cancer and preparation method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0040]

[0041] Preparation:

[0042] (1) Weighing according to the prescription quantity;

[0043] (2) Adhesive preparation: add methyl cellulose to purified water at 80-90 ° C, the weight percentage of methyl cellulose and purified water is 1:19, stir until completely dissolved, and wait until the temperature is naturally cooled to 30 ° C use;

[0044] (3) Add palbociclib, lactitol, microcrystalline cellulose, and polacrilin potassium to the wet mixing granulator and mix, then add the prepared binder, stir for 150-180S, and the stirring frequency is 40Hz , to prepare soft material;

[0045] (4) Place the granulated soft material in a fluidized bed dryer, dry at 60-65°C for 3-4 hours, granulate, and control the particle size to 280 μm-320 μm and moisture content to 0.55%-0.65%;

[0046] (5) adopt high-speed tablet press machine to carry out tabletting;

[0047] (6) Packaging.

Embodiment 4

[0049] composition

[0050] Palbociclib, lactitol, microcrystalline cellulose, and polacrilin potassium were added into a mixer and mixed for 4 minutes, and directly compressed into tablets.

Embodiment 5

2％

[0053] (1) Take each component by weight percentage of the component;

[0054] (2) Pulverize the weighed palbociclib through a 100-mesh sieve, respectively pass through a 60-mesh sieve for lactitol and polacrilin potassium, then mix them uniformly, and dry granulate;

[0055] (3) Mix the granules obtained above with microcrystalline cellulose, and press into tablets.

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly discloses pharmaceutical composition for treating breast cancer and a preparation method of the pharmaceutical composition. The pharmaceutical composition is prepared from components in percentage by mass as follows: 26%-30% of palbociclib, 38%-40% of lactitol, 28%-32% of microcrystalline cellulose, 1%-3% of polacrilin potassium and 1%-3% of methylcellulose. The composition is suitable for wet granulation, and tablets prepared through wet granulation have high dissolution rate, low impurity content, good fluidity, small tablet weight difference and good stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition for treating breast cancer and a preparation method thereof. Background technique [0002] Palbociclib, chemical name 6-acetyl-8-cyclopentyl-5-methyl-2-[5-(1-piperazinyl)pyridin-2-ylamino]-8H-pyridine And[2-3-d]pyrimidin-7-one, whose trade name is Ibrance, is a new oral drug developed by Pfizer for the treatment of metastatic breast cancer. Palbociclib is a cyclin-dependent kinase 4, 6 The inhibitory drugs mainly prevent cells from G1 phase to S phase by inhibiting CDK4 / 6 activity, thereby inhibiting DNA synthesis. Clinical trial studies have found that palbociclib combined with letrozole is very effective for postmenopausal patients with locally invasive breast cancer or newly diagnosed estrogen receptor (ER) positive, HER-2 negative patients. Palbociclib was approved for marketing by the US Food and Drug Administration (FDA) on February ...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K31/519A61P35/04
CPCA61K31/519A61K47/38
Inventor 孟斯琴
Owner 孟斯琴
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