Succinic acid trelagliptin orally-disintegrating tablets and preparing method thereof

A technology of troxagliptin succinate and orally disintegrating tablets, which is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. problem, to achieve the effect of easy swallowing, good promotion prospects, and short disintegration time

Inactive Publication Date: 2016-04-20
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] So far, the troxagliptin succinate preparations on the market are only ordinary tablets, with a single dosage form, which cannot meet the medication needs of special patients (such as dysphagia, patients who do not cooperate with medication, and severely disabled patients)

Method used

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  • Succinic acid trelagliptin orally-disintegrating tablets and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1%

[0032] Preparation:

[0033] (1) Micronize trexagliptin succinate, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0034] (2) After sieving and mixing troxagliptin succinate, mannitol, lactose, carboxymethyl starch sodium of 5% prescription quantity and aspartame, add povidone ethanol aqueous solution with a prescription quantity of 20% , to prepare soft materials;

[0035] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0036] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of sodium carboxymethyl starch to the dry granules obtained in (3), and mix well;

[0037] (5) Determining the content of intermediates, determining the weight of the tablet and pressing it to obtain the tablet.

Embodiment 2

1%

[0040] Preparation:

[0041] (1) Micronize trexagliptin succinate, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0042] (2) After sieving and mixing troxagliptin succinate, mannitol, lactose, 5% croscarmellose sodium and aspartame in the prescribed amount, add 25% prescription amount of hydroxypropyl Cellulose-based ethanol aqueous solution to prepare soft materials;

[0043] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0044] (4) Add magnesium stearate and the remaining amount of croscarmellose sodium to the dry granules obtained in (3), and mix well;

[0045] (5) Determining the content of intermediates, determining the weight of the tablet and pressing it to obtain the tablet.

Embodiment 3

1%

[0048] Preparation:

[0049] (1) Micronize trexagliptin succinate, grind the rest of the excipients separately and pass through a 100-mesh sieve;

[0050] (2) After sieving and mixing troxagliptin succinate, mannitol, xylitol, crospovidone with a prescription volume of 3%, aspartame, and lemon essence, add 20% prescription volume Hydroxypropyl cellulose ethanol aqueous solution to prepare soft materials;

[0051] (3) Granulate through a 20-mesh sieve, dry in an oven at 50°C until the moisture content of the granules is between 1.5 and 3.5%, and pass through a 24-mesh sieve for granulation;

[0052] (4) Add micropowder silica gel, magnesium stearate, and the remaining amount of crospovidone to the dry granules obtained in (3), and mix well;

[0053] (5) Determining the content of intermediates, determining the weight of the tablet and pressing it to obtain the tablet.

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Abstract

The invention discloses succinic acid trelagliptin orally-disintegrating tablets and a preparing method thereof. The orally-disintegrating tablets are a medicine composition prepared from succinic acid trelagliptin, filler, a disintegrating agent, a wetting agent, a binding agent, a flavoring agent and a lubricating agent. Wet granulation and tabletting methods are adopted for the preparing method. The succinic acid trelagliptin orally-disintegrating tablets are simple in preparing process, low in cost, convenient to take, quick in effect taking and high in bioavailability, the medicine taking compliance of patients can be improved through the dosage form, and treatment on diseases is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing trexagliptin succinate and a preparation method thereof. technical background [0002] Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia caused by defects in insulin secretion or its biological effects. Long-term hyperglycemia can lead to chronic damage and even dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. According to estimates by the International Diabetes Federation, there are now 371 million diabetics in the world, one-third of which are from China. Unfortunately, there is currently no cure for diabetes. Clinically, oral medication and insulin therapy are mainly used to control diabetes. [0003] In March 2015, Trexagliptin succinate, a new type of DPP-IV inhibitor developed by Takeda Corporation of Japan, was approved for marketing, becoming...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/513A61K47/36A61K47/38A61K47/46A61P3/10
CPCA61K9/0056A61K9/2054A61K9/2059A61K9/2068A61K31/513
Inventor 石娟张庭
Owner BEIJING VENTUREPHARM BIOTECH
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