Canagliflozin tablet and preparation method thereof

A technology of canagliflozin tablets and canagliflozin, which is applied in the direction of pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of unstudied preparation stability, particle fluidity and friability related nature

Active Publication Date: 2020-10-16
CHANGZHOU HANSOH PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stability of the formulation and the related properties of particle flow and friability were not studied

Method used

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  • Canagliflozin tablet and preparation method thereof
  • Canagliflozin tablet and preparation method thereof
  • Canagliflozin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Embodiment 1 filler ratio investigation

[0061] Table 1

[0062]

[0063]

[0064] in conclusion:

[0065] Investigation of filler ratio: From the data results, it can be known that the increase in the proportion of microcrystalline cellulose will increase the bulk density of the particle intermediate, improve the compressibility of the particle, and have no significant difference between the angle of repose and the brittleness of the plain tablet. However, the dissolution is slow, and when the ratio of anhydrous lactose to microcrystalline cellulose is 1:1, it can dissolve quickly.

Embodiment 2

[0066] Embodiment 2 disintegrating agent dosage and adding mode investigation

[0067] Table 2

[0068]

[0069] in conclusion:

[0070] Investigation on the amount of disintegrant and the method of addition: In the prescription research, the cumulative dissolution rate was used as the main index of investigation. The results showed that the amount of disintegrant and the method of addition had an impact on the dissolution of plain tablets, and adding about 6% internally could achieve rapid dissolution. dissolution.

Embodiment 3

[0071] Embodiment 3 Adhesive type investigation

[0072] table 3

[0073]

[0074] in conclusion:

[0075] Binder type investigation: The effects of two kinds of binders, polyvinylpyrrolidone and hypromellose, on the dissolution, friability, compressibility and fluidity of plain tablets were compared and investigated. The results showed better dissolution using polyvinylpyrrolidone as the binder.

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PUM

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Abstract

The invention provides a canagliflozin tablet and a preparation method thereof. The canagliflozin tablet is prepared from the following raw and auxiliary materials in percentage by weight: 50%-60% ofcanagliflozin, 32%-40% of a filling agent, 5%-7% of a disintegrating agent, 1%-3% of an adhesive and 0.5%-1% of a lubricating agent. The product adopts a wet granulation process, the preparation process is simple, easy to operate, high in reproducibility and suitable for industrial large-scale production, and the obtained canagliflozin tablet is quick to dissolve out and high in stability of eachbatch.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a canagliflozin tablet and a preparation method thereof. Background technique [0002] Type II diabetes, also known as non-insulin-dependent diabetes, accounts for about 90% of the total number of diabetic patients. Most of the onset is after the age of 35, and the onset is slow and hidden. The main causes are overweight or obesity, too little physical activity and stress (stress, fatigue, mental stimulation, trauma, surgery, etc.), which lead to insulin secretion defects, which in turn lead to a gradual decrease in the body's sensitivity to insulin and increased blood sugar, thereby lead to type II diabetes. [0003] Canagliflozin is a sodium glucose cotransporter 2 (SGLT-2) inhibitor, which prevents the glucose in the renal tubule from being reabsorbed smoothly into the blood and is excreted with the urine, thereby reducing the blood drug concentration. It is suitabl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/26A61K47/38A61K47/32A61K31/381A61P3/10
CPCA61K9/2018A61K9/2054A61K9/2027A61K9/2866A61K9/284A61K31/381A61P3/10
Inventor 王纯王小雷徐丹陈玮琦黄道省
Owner CHANGZHOU HANSOH PHARM CO LTD
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