A kind of Ipagliflozin tablet and preparation method thereof

A technology of ixagliflozin and prescription, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. It can solve the problems of low dissolution rate, unstable quality, and particle size requirements, etc. problems, to achieve simple production process, high drug dissolution rate, and good stability

Active Publication Date: 2018-06-01
CHANGSHA BAISHUN BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Since Ipagliflozin is a poorly water-soluble drug, the absorption of the drug mainly depends on the dissolution rate of the drug. The existing Ipagliflozin preparations have defects such as unstable quality, low dissolution rate, and requirements for particle size.

Method used

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  • A kind of Ipagliflozin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Ipagliflozin Tablet Core Prescription (Specification: 50mg):

[0032] Ipagliflozin 50.0 g

[0033] Polyethylene glycol 6000 100.0 g

[0034] Crospovidone 16.0 g

[0035] Magnesium stearate 2.0 g

[0036] A total of 1000 pieces were made

[0037] Coating Solution Prescription:

[0038] Opadry 85F18422 6.0 g

[0039] Purified water 44.0 g

[0040] Preparation:

[0041] 1. Preparation of drug-containing tablet cores

[0042] ① Processing of raw and auxiliary materials: Mix Ipagliflozin and polyethylene glycol 6000 evenly, and sieve the cross-linked povidone with an 80-mesh sieve for later use;

[0043] ② Add 1.2kg of absolute ethanol to the above mixture of Ipagliflozin and polyethylene glycol 6000, heat in a water bath at 65°C, and stir until completely dissolved;

[0044] ③ After complete dissolution, raise the temperature to 90°C to recover absolute ethanol. When the absolute ethanol is recovered to 60-80ml, add 12.0g crospovidone and mix well to make a soft m...

Embodiment 2

[0054] Ipagliflozin Tablet Core Prescription (Specification: 100mg):

[0055] Ipagliflozin 100.0 g (dry and pure)

[0056] Macrogol 4000 100.0 g

[0057] Croscarmellose Sodium 20.0 g

[0058] Micronized silica gel 2.0 g

[0059] A total of 1000 pieces were made

[0060] Coating Solution Prescription:

[0061] Opadry 85F42129 14.0 g

[0062] 75% ethanol 186.0 g

[0063] Preparation:

[0064] 1. Preparation of drug-containing tablet cores

[0065] ① Processing of raw and auxiliary materials: Mix Ipagliflozin hemihydrate and polyethylene glycol 4000 evenly, and sieve croscarmellose sodium with an 80-mesh sieve for later use;

[0066] ②Add 1.5kg of absolute ethanol to the above mixture of Ipagliflozin Hemihydrate and Polyethylene Glycol 4000, heat in a water bath at 60°C, and stir until completely dissolved;

[0067] ③ After complete dissolution, raise the temperature to 88°C to recover absolute ethanol, and when the absolute ethanol is recovered to 85-100ml, add 15.0g ...

Embodiment 3

[0077] Ipagliflozin Tablet Core Prescription (Specification: 100mg):

[0078] Ipagliflozin 100.0 g

[0079] Povidone 150.0 g

[0080] Croscarmellose Sodium 30.0 g

[0081] Magnesium stearate 3.0 g

[0082] A total of 1000 pieces were made

[0083] Coating Solution Prescription:

[0084] Opadry 85F18422 20.0 g

[0085] 70% ethanol 230.0 g

[0086] Preparation:

[0087] 1. Preparation of drug-containing tablet cores

[0088] ① Processing of raw and auxiliary materials: mix iggliflozin and povidone evenly, and sieve croscarmellose sodium with a 60-mesh sieve for later use;

[0089] ② Add 3.0kg of absolute ethanol to the above mixture of ixagliflozin and povidone, heat in a water bath at 75°C, and stir until completely dissolved;

[0090] ③ After complete dissolution, heat up to 90°C to recover absolute ethanol. When the absolute ethanol is recovered to 120-180ml, add 20.0g of cross-linked carmellose sodium and mix well to make a soft material;

[0091] ④ Wet granulati...

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PUM

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Abstract

The invention discloses an lpragliflozin tablet and a preparation method thereof. The lpragliflozin tablet consists of an active ingredient lpragliflozin as well as a water-soluble solid dispersion carrier, a disintegrating agent and a lubricant. The lpragliflozin tablet prepared by the preparation method disclosed by the invention is free of special requirements on the grain size of the active ingredient, low in energy consumption, high in bioavailability, stable and reliable in quality, does not need superfine grinding, has a dissolution rate over 90%, solves the defects of poor active ingredient solubility and low bioavailability, and has a market development prospect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, relates to an iogliflozin tablet and a preparation method thereof, and simultaneously provides an iogliflozin tablet with high quality, safety and stability. Background technique [0002] According to the statistics of the International Diabetes Federation, there were 151 million diabetic patients in the world in 2000, and currently there are 285 million diabetic patients in the world. If the current growth rate is maintained, it is estimated that by 2030, nearly 500 million people worldwide will suffer from diabetes, including type 2 diabetes patients. Accounted for more than 90%. Chronic vascular complications of diabetes pose a great threat to the life and quality of life of patients, and bring heavy economic burdens to families and individuals. [0003] Ipragliflozin was jointly developed by Japan's Astellas and Japan's Kotobuki Pharma and was approved by the Japanese Min...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/30A61K47/10A61K47/38A61K31/381A61P3/10
Inventor 不公告发明人
Owner CHANGSHA BAISHUN BIOTECH
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