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Lyophilized orally disintegrating tablets of trelagliptin succinate

A technology of trelagliptin succinate and orally disintegrating tablet is applied in the field of freeze-dried orally disintegrating tablet of trilagliptin succinate and its preparation field, which can solve the complex preparation process and slow oral disintegration of ordinary oral disintegrating tablet. , poor compliance and other problems, to achieve the effect of improving taste and disintegration time, and improving compliance

Inactive Publication Date: 2016-03-30
BEIJING KANG LISHENG PHARMA TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the shortcomings of poor patient compliance of troxagliptin succinate tablets and the complicated preparation process of ordinary orally disintegrating tablets, slow oral disintegration, and gritty feeling in the prior art, the present invention proposes a freeze-dried troxagliptin succinate tablet. Orally disintegrating tablet and preparation method thereof, by adopting suitable auxiliary materials and preparation method, improving the oral disintegration time and mouthfeel of troxagliptin succinate and improving patient compliance

Method used

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  • Lyophilized orally disintegrating tablets of trelagliptin succinate
  • Lyophilized orally disintegrating tablets of trelagliptin succinate
  • Lyophilized orally disintegrating tablets of trelagliptin succinate

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Effect test

Embodiment 1

[0027] Trexagliptin succinate freeze-dried orally disintegrating tablets are prepared from the following components, and the dosage is 1000 tablets:

[0028]

[0029] Its preparation method comprises the following steps:

[0030] The specific preparation method is as follows: mix troxagliptin succinate, mannitol, chitosan, tragacanth gum, tert-butyl hydroxyanisole, acesulfame potassium and sodium citrate, and add prescription Mix a certain amount of purified water to make a uniform solution; vacuum degas the solution and inject it into the mold accurately; after pre-freezing for 1-60 minutes, transfer it to a lyophilizer and freeze-dry for 1-10 hours to obtain the amber of the present invention Trexagliptin Orally Disintegrating Tablets. The taste is not bitter, no gritty feeling, and the oral disintegration time is 20s.

Embodiment 2

[0032] Trexagliptin succinate freeze-dried orally disintegrating tablets are prepared from the following components, and the dosage is 1000 tablets:

[0033]

[0034]

[0035] Its preparation method comprises the following steps:

[0036] The specific preparation method is as follows: mix troxagliptin succinate, mannitol, pullulan, xanthan gum, tert-butyl hydroxyanisole, acesulfame potassium and sodium citrate evenly, and add the prescribed amount of purified water, mixed to make a homogeneous solution; after the solution is vacuum degassed, it is accurately injected into a mold; after pre-freezing for 1-60 minutes, it is transferred to a freeze dryer, and freeze-dried for 1-10 hours to obtain the succinic acid of the present invention Trexagliptin orally disintegrating tablets. The taste is not bitter or gritty, and the oral disintegration time is 22s.

Embodiment 3

[0038] Trexagliptin succinate freeze-dried orally disintegrating tablets are prepared from the following components, and the dosage is 1000 tablets:

[0039]

[0040] Its preparation method comprises the following steps:

[0041] The specific preparation method is as follows: mix troxagliptin succinate, mannitol, pullulan, xanthan gum, tert-butyl hydroxyanisole, acesulfame potassium and sodium citrate evenly, and add the prescribed amount of purified water, mixed to make a homogeneous solution; after the solution is vacuum degassed, it is accurately injected into a mold; after pre-freezing for 1-60 minutes, it is transferred to a freeze dryer, and freeze-dried for 1-10 hours to obtain the succinic acid of the present invention Trexagliptin orally disintegrating tablets. The taste is sweet, without gritty feeling, and the oral disintegration time is 27s.

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Abstract

The invention discloses lyophilized orally disintegrating tablets of trelagliptin succinate and a preparation method thereof. Trelagliptin succinate is used as a medicament active component, and the tablets comprise the following raw materials and auxiliary materials by weight: 2-75% of trelagliptin succinate, 10-85% of a frame supporting agent, 2-55% of an adhesive, 0.5-55% of a suspending agent, 0.5-30% of an anti-oxidant, 0.2-10% of a corrigent, a proper amount of a pH regulator, and a proper amount of injection water. The lyophilized orally disintegrating tablets are prepared by a lyophilization device. The lyophilized orally disintegrating tablets has the advantages of fast disintegration speed, high dissolution rate, good stability, usage convenience, portability, and substantially enhanced medication compliance of patients.

Description

technical field [0001] The invention relates to a pharmaceutical preparation in the category of oral rapid release, in particular to a freeze-dried orally disintegrating tablet of troxagliptin succinate and a preparation method thereof. Background technique [0002] Type 2 diabetes has become an increasingly popular disease, and its high-frequency complications (such as diabetic foot, blindness, renal failure, etc.) not only affect the quality of life of patients, but may also lead to shortened life span. [0003] Trexagliptin succinate tablets were approved for marketing in Japan in March 2015. They are produced by Takeda Pharmaceutical Co., Ltd. of Japan. The dosage forms are 50mg and 100mg tablets, and the trade name is Zafatek. It is a once-weekly dipeptidyl peptidase IV (DPP-4) inhibitor that controls blood glucose levels through selective and sustained inhibition of DPP-4. DPP-4 is an enzyme that triggers the inactivation of incretins (glucagon-like peptide-1 (GLP-1) ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/513A61P3/10
CPCA61K9/205A61K9/0056A61K9/2018A61K9/2059A61K31/513
Inventor 程刚
Owner BEIJING KANG LISHENG PHARMA TECH DEV
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