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Sitagliptin metformin tablet preparation and preparation method thereof

A technology of metformin and metformin hydrochloride, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. Production cost and process complexity, increased secretion of insulin and glucagon, etc., to achieve the effects of good fluidity, excellent content uniformity, and good product quality

Pending Publication Date: 2022-04-12
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The onset of type 2 diabetes (T2DM) will lead to insufficient insulin secretion and increased glucagon secretion, and a single oral hypoglycemic drug cannot take care of the above two symptoms at the same time, making it difficult for patients to achieve the ideal blood sugar control effect
Too many excipients will increase the production cost and the complexity of the process, but choosing fewer excipients will make it difficult to maintain the drug uniformity, compressibility and fluidity of the tablet. How to meet the needs of reducing the amount of excipients and ensuring tablet performance at the same time The direction of in-depth research

Method used

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  • Sitagliptin metformin tablet preparation and preparation method thereof
  • Sitagliptin metformin tablet preparation and preparation method thereof
  • Sitagliptin metformin tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1: preparation of sitagliptin metformin tablet preparation of the present invention

[0033] 1. Prescription

[0034] Specifications per tablet: 50mg / 850mg, prescription quantity 3000 tablets, see Table 1 for details;

[0035] Table 1

[0036]

[0037] Note: Opadry powder is mixed with pure water to prepare 15% coating liquid before use for coating.

[0038] 2. Preparation process

[0039] Step 1: take metformin hydrochloride and pulverize through a 100-mesh sieve;

[0040] Step 2: mixing metformin hydrochloride with the binder to obtain mixture 1;

[0041]Step 3: Set the hot-melt extrusion temperature to 120°C-140°C, and the extrusion speed to 300rpm-500rpm. After the temperature reaches the set temperature, take the mixture 1 for hot-melt extrusion to obtain an extrudate.

[0042] Step 4: cooling the extrudate obtained in step 3, cutting, sieving and pulverizing;

[0043] Step 5: Mix the granules obtained in Step 4 with sitagliptin phosphate monohy...

Embodiment 2

[0044] Embodiment 2: preparation sitagliptin metformin tablet preparation

[0045] 1. Prescription

[0046] Specifications per tablet: 50mg / 850mg, prescription quantity 3000 tablets, see Table 2 for details;

[0047] Table 2

[0048]

[0049]

[0050] Note: Opadry powder is mixed with pure water to prepare 15% coating liquid before use for coating.

[0051] 2. Preparation process

[0052] With embodiment 1.

Embodiment 3

[0053] Embodiment 3: preparation sitagliptin metformin tablet preparation

[0054] 1. Prescription

[0055] Specifications per tablet: 50mg / 850mg, prescription quantity 3000 tablets, see Table 3 for details;

[0056] table 3

[0057]

[0058] Note: Opadry powder is mixed with pure water to prepare 15% coating liquid before use for coating.

[0059] 2. Preparation process

[0060] With embodiment 1.

[0061] Embodiment: 4: prepare sitagliptin metformin tablet preparation

[0062] 1. Prescription

[0063] The specification of each tablet is 50mg / 850mg, and the prescription quantity is 3000 tablets, see Table 4 for details;

[0064] Table 4

[0065]

[0066]

[0067] Note: Opadry powder is mixed with pure water to prepare 15% coating liquid before use for coating.

[0068] 2. Preparation process

[0069] Step 1: take metformin hydrochloride and pulverize through a 100-mesh sieve;

[0070] Step 2: Mix metformin hydrochloride, sitagliptin phosphate monohydrate an...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and discloses a sitagliptin metformin tablet preparation and a preparation method thereof. The preparation is prepared from metformin hydrochloride, sitagliptin phosphate monohydrate, an adhesive and a lubricant through a hot melt extrusion method. According to the invention, a hot melt extrusion technology is adopted, metformin hydrochloride and an adhesive are mixed, the mixture is melted, extruded and conveyed in a hot melt extruder to obtain solid dispersion strips, the solid dispersion strips are cut off, crushed and sieved, the sieved solid dispersion strips are mixed with sitagliptin phosphate monohydrate, and then a lubricant is added for mixing, so that prepared particles are uniform and have better fluidity and good compressibility; in the production process, few auxiliary materials are needed, the production cost is reduced, the production procedures are reduced, the content and content uniformity of the obtained product far exceed the product quality requirements, the reproducibility is good, continuous operation can be achieved, continuous production is achieved, and the difference between batches is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sitagliptin metformin tablet preparation and a preparation method thereof. Background technique [0002] The onset of type 2 diabetes mellitus (T2DM) will lead to insufficient insulin secretion and increased glucagon secretion, and a single oral hypoglycemic drug cannot take care of the above two symptoms at the same time, making it difficult for patients to achieve the ideal blood sugar control effect. Aiming at the pathogenesis of type 2 diabetes, it combines drugs with different hypoglycemic mechanisms to make up for the treatment limitations of a single oral hypoglycemic drug and achieve longer-lasting and more effective blood sugar control. The new oral hypoglycemic drug DPP-4 inhibitor is different from the traditional oral hypoglycemic drugs, by reducing the inactivation of glucagon-like peptide-1 (GLP-1) in the body and increasing the level of GLP-1,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/12A61K31/4985A61K31/155A61P3/10
Inventor 谢双华辛永涛张伟明唐洋明余品香
Owner HYBIO PHARMA
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