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Vortioxetine freeze-dried orally disintegrating tablet and preparation method thereof

The technology of oral disintegrating tablet and vortioxetine is applied in the field of vortioxetine freeze-dried orally disintegrating tablet and its preparation field, which can solve the problems of gritty feeling, slow oral disintegration, complicated preparation process, etc., and improve the taste. and disintegration time, the effect of improving compliance

Inactive Publication Date: 2015-09-02
AVENTIS PHARMA HAINAN
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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 vortioxetine orally disintegrating tablets in the prior art, such as complicated preparation process, slow oral disintegration, and gritty feeling, the present invention proposes a vortioxetine freeze-dried orally disintegrating tablet and a preparation method thereof. Using appropriate excipients and preparation methods to improve oral disintegration time and mouthfeel of vortioxetine and improve patient compliance

Method used

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  • Vortioxetine freeze-dried orally disintegrating tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Vortioxetine 20 g Mannitol 60 g Chitosan 10 g Tragacanth Gum 0.5 g tert-butyl hydroxyanisole 0.5 g Acesulfame K 0.2 g sodium citrate 8.8 g

[0027] Its preparation method comprises the following steps:

[0028] The specific preparation method is as follows: mix vortioxetine, mannitol, chitosan, tragacanth gum, tert-butyl hydroxyanisole, acesulfame potassium and sodium citrate evenly, and add the prescribed amount of Purified water, mixed to make a homogeneous solution; vacuum degassing the solution, and accurately pouring it into a mold; pre-freezing for 1-60 minutes, transferring it to a freeze dryer, and freeze-drying for 1-10 hours to obtain the fermented acid of the present invention. Orally disintegrating tablets of tioxetine. The taste is not bitter or gritty, and the oral disintegration time is 20 s.

Embodiment 2

[0030] Vortioxetine 20 g Mannitol 60 g Purulan 10 g xanthan gum 0.5 g tert-butyl hydroxyanisole 0.5 g Acesulfame K 0.2 g sodium citrate 8.8 g

[0031] Its preparation method comprises the following steps:

[0032] The specific preparation method is as follows: mix vortioxetine, 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 the 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 wodi of the present invention. Xetine orally disintegrating tablets. The taste is not bitter and gritty, and the oral disintegration time is 22 s.

Embodiment 3

[0034] Vortioxetine 5 g Mannitol 25 g Purulan 21 g xanthan gum 35 g tert-butyl hydroxyanisole 4 g Acesulfame K 2 g sodium citrate 8 g

[0035] Its preparation method comprises the following steps:

[0036] The specific preparation method is as follows: mix vortioxetine, 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 vacuum degassing the solution, pour it into the mold accurately; after pre-freezing for 1-60 min, transfer it to a freeze dryer, freeze-dry for 1-10 h, and then obtain the wodi of the present invention Xetine orally disintegrating tablets. The taste is sweet, without gritty feeling, and the oral disintegration time is 27 s.

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Abstract

The invention discloses a vortioxetine freeze-dried orally disintegrating tablet and a preparation method thereof. The vortioxetine freeze-dried orally disintegrating tablet with the vortioxetine as an active pharmaceutical ingredient comprises, by weight, 2%-75% of vortioxetine, 10%-85% of a skeleton supporting agent, 2%-55% of binder, 0.5%-55% of a suspending agent, 0.5%-30% of antioxidant, 0.2%-10% of corrigent, a defined amount of pH regulator and a defined amount of injection water. The vortioxetine freeze-dried orally disintegrating tablet is prepared through a freeze-drying device and has the advantages of being high in disintegrating speed, high in dissolution rate, good in stability and convenient to take and carry, and the compliance of a patient to take medicine is greatly improved.

Description

technical field [0001] The invention relates to a pharmaceutical preparation in the field of oral rapid release, in particular to a freeze-dried orally disintegrating tablet of vortioxetine and a preparation method thereof. Background technique [0002] In today's society, with the increasingly tense pace of life, the number of patients with depression is astonishing. The pathogenesis of depression is mainly due to the low content of central norepinephrine (NE), 5-hydroxytryptamine (5-HT) and dopamine (DA) in the body and the decline of their receptor function. The functions of monoamine neurotransmitters in the brain are relatively complex, among which 5-HT seems to play a basic role in controlling sensory responses, NE is mainly related to insomnia and inattention, and DA controls more running and cognitive functions. These neurotransmitters have complex interactions, and together affect the human body's psychological behaviors such as anxiety and tension. [0003] Vorti...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/495A61P25/24
Inventor 李艳莉马莉
Owner AVENTIS PHARMA HAINAN
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