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Double-layer tablet containing metformin hydrochloride and empagliflozin, and preparation method thereof

A metformin hydrochloride tablet, metformin hydrochloride technology, applied in the field of bilayer tablets containing metformin hydrochloride and empagliflozin and its preparation, drug compound preparation for treating and/or improving type 2 diabetes and its preparation

Inactive Publication Date: 2017-12-05
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Based on this, it is very interesting to develop a double-layer tablet that can not only control the slow release of metformin hydrochloride that is easily soluble in water, but also ensure the rapid release of insoluble empagliflozin, so that it has the desired dissolution rate and stability. Challenging, but also a current need

Method used

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  • Double-layer tablet containing metformin hydrochloride and empagliflozin, and preparation method thereof
  • Double-layer tablet containing metformin hydrochloride and empagliflozin, and preparation method thereof
  • Double-layer tablet containing metformin hydrochloride and empagliflozin, and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] According to the composition shown in Table 1, the double-layer tablet of the present invention is prepared, and the specific steps are:

[0105] 1) preparing metformin hydrochloride sheet-layer granules;

[0106] a) Sodium hydroxymethyl cellulose (50g) is dissolved in water to prepare a binder with a concentration of 10%;

[0107] b) Metformin hydrochloride (850g), hydroxypropyl methylcellulose K4M (400g), magnesium stearate (15g), and talcum powder (15g) were passed through a 100-mesh sieve respectively;

[0108] c) Add the sieved metformin hydrochloride and hydroxypropyl methylcellulose K4M to the SHK-10B multi-pot wet mixing rapid granulator and mix, wherein the stirring blade is 800rpm, the cutter is 2000rpm, and 120s;

[0109] d) Add the adhesive prepared in step a), and use a high-speed shear granulator to granulate, wherein the stirring blade is 800rpm, the cutter is 2000rpm, and 180s;

[0110] e) Use the UN1GLATT fluidized bed to dry the granules obtained in st...

Embodiment 2

[0135] The composition of table 4 bilayer tablet

[0136]

[0137]

[0138] The preparation method is the same as in Example 1, and according to the solubility determination method described in Example 1, six double-layer tablets are randomly selected to measure the dissolution rate of metformin hydrochloride sheet and empagliflozin sheet respectively, and the results are shown in Table 5 and Table 5 respectively. Table 6 shows. It can be known from the table that the metformin hydrochloride slow-release layer releases steadily within 12 hours; the empagliflozin layer basically reaches full dissolution within 30 minutes.

[0139] Table 5 metformin hydrochloride sheet release test results

[0140]

[0141] Table 6 Empagliflozin tablet dissolution test results

[0142]

Embodiment 3

[0144] Table 7 Composition of bilayer tablet

[0145]

[0146] The preparation method is the same as in Example 1, and according to the solubility determination method described in Example 1, six double-layer tablets are randomly selected to measure the dissolution rate of metformin hydrochloride sheet and empagliflozin sheet respectively, and the results are shown in Table 8 and Table 8 respectively. Table 9 shows. It can be known from the table that the metformin hydrochloride slow-release layer releases steadily within 12 hours; the empagliflozin layer basically reaches full dissolution within 30 minutes.

[0147] Table 8 Metformin Hydrochloride Tablet Release Test Result

[0148]

[0149]

[0150] Table 9 Empagliflozin tablet dissolution test results

[0151]

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Abstract

The present invention provides a double-layer tablet containing metformin hydrochloride and empagliflozin, wherein the metformin hydrochloride tablet layer is a sustained-release layer, the empagliflozin tablet layer is a rapid-release layer, and the metformin hydrochloride sustained-release layer is 12-24 h sustained-release layer. The invention further provides a preparation method of the double-layer tablet, and uses of the double-layer tablet in preparation of drugs for treatment and / or improvement of type 2 diabetes. According to the present invention, with the double-layer tablet containing metformin hydrochloride and empagliflozin, the sustained release property of the metformin hydrochloride and the rapid dissolution of the empagliflozin are ensured; the double-layer tablet is taken twice a day, and can provide the important significant for the improvement of the clinical treatment of diabetes patients; and the method has advantages of simple preparation process, low production cost and product stability improving, and can ensure the mixing uniformity of the two active components in the production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a drug compound preparation for treating and / or improving type 2 diabetes and a preparation method thereof, in particular to a double-layer tablet containing metformin hydrochloride and empagliflozin and a preparation method thereof. Background technique [0002] At present, my country has become the country with the largest number of diabetic patients in the world. According to the latest data, as of 2014, the number of diabetic patients in China has reached 114 million, accounting for about one-third of the total number of diabetic patients in the world. Diabetes is divided into type 1 and type 2, and type 2 diabetes accounts for more than 90% of the diabetic population. Type 2 diabetes patients in my country account for 93% to 95%. Type 2 diabetes is a lifelong disease that usually begins in middle age or later in life, but can begin at any age. The ability to produ...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/7048A61P3/10A61K31/155
CPCA61K9/0002A61K9/2086A61K31/155A61K31/7048A61K2300/00
Inventor 阎卉王成港
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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