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Pharmaceutical composition prepared by dry granulation technology

A dry granulation and composition technology, which is used in drug combinations, antitumor drugs, pharmaceutical formulations, etc.

Inactive Publication Date: 2016-01-06
NANJING CHIA TAI TIANQING PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, Pfizer and a small number of domestic companies have applied for patents on the synthesis method of the drug in my country. At present, there are no patents related to Papoclide preparations applied by domestic and foreign companies or individuals.

Method used

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  • Pharmaceutical composition prepared by dry granulation technology
  • Pharmaceutical composition prepared by dry granulation technology
  • Pharmaceutical composition prepared by dry granulation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] This example prepares the pharmaceutical composition with Papoclide free base. (1000 formulation units)

[0028]

[0029]

[0030] Add Papoclite free base, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate (added internally), and lactose, and mix well. After mixing, the material is put into the dry granulator for granulation. The equipment parameters are: oil pressure 35-50Kg / cm 2 , Feeding 8Hz, tablet pressing 18Hz, granulation 10Hz, granulation aperture 1mm. Take the granules and powder after granulation, add magnesium stearate (additional), mix well, compress into tablets or fill capsules.

Embodiment 2

[0032] This example prepares the pharmaceutical composition with Papoclide free base. (1000 formulation units)

[0033]

[0034] Combine Papoclite free base, colloidal silicon dioxide, and mix well. Add microcrystalline cellulose, sodium starch glycolate, magnesium stearate (added in), lactose, and mix well. After mixing, the material is put into the dry granulator for granulation. The equipment parameters are: oil pressure 35-50Kg / cm 2 , Feeding 8Hz, tablet pressing 18Hz, granulation 10Hz, granulation aperture 1mm. After granulation, add sodium carboxymethyl starch (additional) and magnesium stearate (additional) to the granules and powder, mix well, press into tablets or fill capsules, see the process flow chart figure 1 .

Embodiment 3

[0036] This example prepares the pharmaceutical composition with Papoclide free base. (1000 formulation units)

[0037]

[0038]

[0039] Combine Papoclite free base, colloidal silicon dioxide, and mix well. Add microcrystalline cellulose, sodium starch glycolate, magnesium stearate (added in), lactose, and mix well. After mixing, the material is put into the dry granulator for granulation. The equipment parameters are: oil pressure 35-50Kg / cm 2 , Feeding 8Hz, tablet pressing 18Hz, granulation 10Hz, granulation aperture 1mm. After granulation, add sodium carboxymethyl starch (additional) and magnesium stearate (additional) to the granules and powder, mix well, press into tablets or fill capsules.

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PUM

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Abstract

The invention belongs to the field of medicine preparations, and relates to a pharmaceutical composition prepared by a dry granulation technology. With palbociclib or a pharmaceutical salt thereof as an effective component, proper auxiliary materials such as a filler, a disintegrant, a flow aid and a lubricant are added; and the pharmaceutical composition is prepared by tabletting or capsule filling after dry granulation. The preparation provided by the invention is designed aiming at the properties and characteristics of the palbociclib or the pharmaceutical salt thereof; the palbociclib can be rapidly released; and meanwhile, various requirements such as clinical medication, patient compliance and industrial large-scale production can be met.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition prepared by a dry granulation process. Background technique [0002] About 1.2 million women in the world suffer from breast cancer every year. Breast cancer accounts for 10% of all cancers, 32% of female cancer incidence and 15% of female cancer mortality. China is one of the countries with the fastest-growing incidence of breast cancer. According to statistics released by the China Anti-Cancer Association, the incidence of breast cancer in my country has been increasing at a rate of 3% per year in recent years, becoming the cancer with the fastest-growing mortality rate in cities. The age of onset also showed a gradually younger trend. Breast cancer has become the number one killer of urban women, with a higher incidence in big cities such as Beijing, Shanghai, and Guangzhou. In Shanghai, where the situation is the worst, the incidence ra...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K9/48A61K31/519A61P35/00
Inventor 章晓骅陆洁徐丹朱春霞田舟山谢军李惠
Owner NANJING CHIA TAI TIANQING PHARMA
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