Pharmaceutical composition containing BPI-7711 and preparation method of pharmaceutical composition

A technology of BPI-7711 and composition, applied in the field of pharmaceutical preparations, can solve the problems of difficult industrial production and long-term storage of pharmaceuticals, increasing the risk of exceeding the limit of microbes of pharmaceuticals, and accelerating the degradation of pharmaceuticals, so as to avoid exposure to humidity and heat, Ensure stability and controllability, and ensure the effect of the production process

Pending Publication Date: 2020-03-24
BETA PHARMA (SHANGHAI) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The hygroscopicity of the agent will cause the agent to gradually absorb moisture during storage and use. Excessive water content will accelerate the degradation of the agent and increase the risk of the agent exceeding the limit of microorganisms
The photosensitivity of pharmaceuticals usually leads to the degradation of pharmaceuticals due to exposure to strong light during manufacture, storage and use, making it difficult for industrial production and long-term storage of pharmaceuticals

Method used

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  • Pharmaceutical composition containing BPI-7711 and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing BPI-7711 and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing BPI-7711 and preparation method of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Calculated by making 1000 capsules, the components of the capsules are as follows:

[0031]

[0032] Among them: BPI-7711 particle size D 90 : 200μm, microcrystalline cellulose particle size pH102 D 90 : 204μm, lactose monohydrate particle size D 90 : 200 μm.

[0033] Prepare according to the following process:

[0034] a. Sieving: pass microcrystalline cellulose pH102, lactose monohydrate, and croscarmellose sodium through a 45-mesh sieve; use another 45-mesh sieve to pass through BPI-7711, and weigh the prescribed amount of BPI-7711 after sieving ;

[0035] b. Premixing: Put the sieved material into a 1L hopper mixer, set the mixer speed to 20 rpm, and mix for 24 minutes;

[0036] c. Mixing: Pass the colloidal silica through a 45-mesh sieve and add it to the mixer in step b, set the mixer speed to 20 rpm, and continue mixing for 14 minutes;

[0037] d. Lubrication: After passing the magnesium stearate through a 45-mesh sieve, add it to the c-step mixer, set t...

Embodiment 2

[0040] Calculated by making 1000 capsules, the components of the capsules are as follows:

[0041]

[0042] Among them: BPI-7711 particle size D 90 60μm, microcrystalline cellulose particle size D 90 : 100μm, lactose particle size D 90 : 105 μm.

[0043] Prepare according to the following process:

[0044] a. Sieving: pass microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium through a 45-mesh sieve; use another 45-mesh sieve to pass through BPI-7711, and weigh the prescribed amount of BPI-7711 after sieving;

[0045] b. Premixing: put the sieved material into a 500L hopper mixer, set the mixer speed to 20 rpm, and mix for 24 minutes;

[0046] c. Mixing: Pass the colloidal silica through a 45-mesh sieve and add it to the mixer in step b, set the mixer speed to 20 rpm, and continue mixing for 14 minutes;

[0047] d. Lubrication: After passing the magnesium stearate through a 45-mesh sieve, add it to the c-step mixer, set the mixer speed to 20 rpm, an...

Embodiment 3

[0050] Calculated by making 1000 capsules, the components of the capsules are as follows:

[0051]

[0052]

[0053] Among them: BPI-7711 particle size D 90 : 120μm, microcrystalline cellulose pH102 particle size D 90 : 200μm, lactose particle size D 90 : 205 μm.

[0054] Prepare according to the following process:

[0055] a. Sieving: pass microcrystalline cellulose PH102, lactose monohydrate, and croscarmellose sodium through a 45-mesh sieve; use another 45-mesh sieve to pass through BPI-7711, and weigh the prescribed amount of BPI-7711 after sieving ;

[0056] b. Premixing: Put the sieved material into a 1L hopper mixer, set the mixer speed to 20 rpm, and mix for 24 minutes;

[0057] c. Mixing: Pass the colloidal silica through a 45-mesh sieve and add it to the mixer in step b, set the mixer speed to 20 rpm, and continue mixing for 14 minutes;

[0058] d. Lubrication: After passing the magnesium stearate through a 45-mesh sieve, add it to the c-step mixer, set t...

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Abstract

The invention discloses a pharmaceutical composition containing BPI-7711 and a preparation method of the pharmaceutical composition. The pharmaceutical composition containing BPI-7711 comprises a capsule agent and a capsule shell, and the capsule agent comprises the following components in percentage by weight: 15-50% of BPI-7711 main drug, 45-80% of a diluent, 2-6% of a disintegrating agent and 0.5-4% of a lubricant. A direct powder filling method is adopted for preparation. The pharmaceutical composition disclosed by the invention is extremely quick to dissolve out, high in bioavailability,stable in quality and suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing BPI-7711 and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] BPI-7711 was developed by Beerta Pharmaceuticals and disclosed in International Patent No. WO2017 / 218892. It belongs to the third generation of EGFR-TKI. Epidermal growth factor receptor (EGFR, Her1, ErbB1) is the main member of the ErbB family of four structurally related cell surface receptors, the other members are Her2 (Neu, ErbB2), Her3 (ErbB3) and Her4 (ErbB4). EGFR exerts its primary cellular function through its intrinsic catalytic tyrosine protein kinase activity. The receptor is activated by binding to growth factor ligands, such as epidermal growth factor (EGF) and transforming growth factor-alpha (TGF-α), the catalytically inactive EGFR monomer is transformed into a catalytically active homopolymer and heterodimer. These catalytically ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/506A61K47/38A61P35/00
CPCA61K9/4866A61K31/506A61P35/00
Inventor 余成武李欣汤春张晓霞J·彭D·张
Owner BETA PHARMA (SHANGHAI) CO LTD
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