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Pharmaceutical composition containing dapagliflozin as well as preparation method and application of pharmaceutical composition

A composition and drug technology, applied in the pharmaceutical composition containing dapagliflozin and its preparation field, can solve the problems of complex preparation process, poor dissolution in vitro, large particle size of raw materials, etc. Controllable and reproducible results

Pending Publication Date: 2021-11-16
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the existing Dapagliflozin pharmaceutical composition has the following problems: 1) The preparation process of most new preparations is relatively complicated, the possibility of large-scale production is low, the difficulty is relatively large, and the therapeutic effect needs further verification; 2) Changing the prescription may appropriately improve the physical and chemical quality of the drug, but compared with the long-term use of the original prescription preparation, there are certain safety hazards; 3) Both safety and efficacy need to be further verified
A high-energy granulation process is required, because once the wet granulation process is completed, it needs to be dried. The use of spray drying granulation can slightly reduce energy consumption, and there are also problems of large particle size of the raw material drug and poor dissolution in vitro

Method used

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  • Pharmaceutical composition containing dapagliflozin as well as preparation method and application of pharmaceutical composition
  • Pharmaceutical composition containing dapagliflozin as well as preparation method and application of pharmaceutical composition
  • Pharmaceutical composition containing dapagliflozin as well as preparation method and application of pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] This embodiment provides a pharmaceutical composition containing Dapagliflozin, the preparation raw materials of the pharmaceutical composition containing Dapagliflozin include the following components (1000 preparation units):

[0044]

[0045] The preparation method of the pharmaceutical composition containing dapagliflozin described in this embodiment comprises the following steps:

[0046] (1) The D90 of 10g is Dapagliflozin of 15 μ m, the lactose of 140g, the microcrystalline cellulose of 140g, the sodium starch glycolate of 27g, the colloidal silicon dioxide of 5g and the magnesium stearate of 4g, add and mix Mix evenly in the machine to get mixed powder;

[0047] (2) Add the mixed powder obtained in step (1) into a dry granulator for granulation. The equipment parameters are: roller pressure 25 bar, feeding 18 rpm, roller speed 8 rpm, crushing 100 rpm, granulation aperture 1 mm, to obtain granules;

[0048] (3) Mix the granules obtained in step (2), 5 g of si...

Embodiment 2

[0050] This embodiment provides a pharmaceutical composition containing Dapagliflozin, the preparation raw materials of the pharmaceutical composition containing Dapagliflozin include the following components (1000 preparation units):

[0051]

[0052] The preparation method of the pharmaceutical composition containing dapagliflozin described in this embodiment comprises the following steps:

[0053] (1) Dapagliflozin, 140g of lactose, 140g of microcrystalline cellulose, 13.5g of carboxymethyl starch sodium, 5g of colloidal silicon dioxide and 4g of magnesium stearate with 10g of D90 being 20 μm, added Mix evenly in the mixer to obtain mixed powder;

[0054] (2) Add the mixed powder obtained in step (1) into a dry granulator for granulation. The equipment parameters are: roller pressure 25 bar, feeding 18 rpm, roller speed 8 rpm, crushing 100 rpm, granulation aperture 1 mm, to obtain granules;

[0055] (3) Mix the granules obtained in step (2), 13.5 g of sodium starch glyc...

Embodiment 3

[0057] This embodiment provides a pharmaceutical composition containing Dapagliflozin, the preparation raw materials of the pharmaceutical composition containing Dapagliflozin include the following components (1000 preparation units):

[0058]

[0059] The preparation method of the pharmaceutical composition containing dapagliflozin described in this embodiment comprises the following steps:

[0060] (1) Dapagliflozin, 140g of lactose, 140g of microcrystalline cellulose, 13.5g of carboxymethyl starch sodium, 5g of colloidal silicon dioxide and 4g of magnesium stearate with 10g of D90 being 20 μm, added Mix evenly in the mixer to obtain mixed powder;

[0061] (2) Add the mixed powder obtained in step (1) into a dry granulator for granulation. The equipment parameters are: roller pressure 45bar, feeding 20rpm, roller speed 10rpm, crushing 100rpm, granulation aperture 1mm, to obtain granules;

[0062] (3) Mix the granules obtained in step (2), 13.5 g of sodium starch glycolat...

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Abstract

The invention provides a pharmaceutical composition containing dapagliflozin as well as preparation method and application of the pharmaceutical composition. The pharmaceutical composition is prepared from the following raw materials: dapagliflozin of which D90 is less than 30 microns, lactose, microcrystalline cellulose, silicon dioxide, carboxymethyl starch sodium and magnesium stearate. According to the pharmaceutical composition disclosed by the invention, the D90 particle size of the raw material medicines is controlled to be less than 30 microns, so that the in-vitro dissolution capacity is fully improved; and by selecting the auxiliary materials, the stability of the dapagliflozin is ensured, and meanwhile, the dissolution rate and the rate of the dapagliflozin can be effectively improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing dapagliflozin, a preparation method and application thereof. Background technique [0002] Diabetes mellitus is a common endocrine and metabolic disease characterized by hyperglycemia accompanied by disturbances in sugar, fat and protein metabolism caused by insufficient insulin secretion and / or action defects. [0003] Dapagliflozin Tablets, jointly developed by Bristol-Myers Squibb and AstraZeneca, is a new type of anti-diabetic drug that was approved by the European Commission for marketing in November 2012 under the trade name Forxiga. In January 2014, it was approved for marketing by the US FDA, and the product name was Farxiga. It was approved by CFDA in March 2017 and became the first SGLT2 inhibitor listed in China for the treatment of type 2 diabetes. The Chinese product name is Anda Tang, and the s...

Claims

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Application Information

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IPC IPC(8): A61K31/351A61K47/02A61K47/12A61K47/26A61K47/36A61K47/38A61P3/10A61K9/16
CPCA61K31/351A61K47/26A61K47/38A61K47/02A61K47/36A61K47/12A61K9/1652A61P3/10
Inventor 胡瑾李贞宣景安李玲玲
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA