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Orally disintegrating tablet of cariprazine and preparation method thereof

A technology of orally disintegrating tablets and cariprazine, which is applied in the field of cariprazine orally disintegrating tablets and its preparation, can solve the problems of drug efficacy, taste, taking compliance and production cost, and the difficulty of large-scale production. problem, to achieve the effect of cool and slightly sweet taste, low production cost, and improved therapeutic effect

Inactive Publication Date: 2018-05-01
ZHEJIANG JINGXIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to overcome the orally disintegrating tablet dosage form of cariprazine in the prior art, and it is difficult to balance the efficacy, mouthfeel, taking compliance, production cost and large-scale production of orally disintegrating tablets. Based on the defects of the tool, a cariprazine orally disintegrating tablet and a preparation method thereof are provided

Method used

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  • Orally disintegrating tablet of cariprazine and preparation method thereof
  • Orally disintegrating tablet of cariprazine and preparation method thereof
  • Orally disintegrating tablet of cariprazine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: Preparation of cariprazine orally disintegrating tablets (specification 1.5 mg, calculated as cariprazine)

[0051] The formula composition of cariprazine orally disintegrating tablet is shown in Table 1.

[0052] Table 1

[0053]

[0054]

[0055] Cariprazine orally disintegrating tablet preparation method is as follows:

[0056] (1) According to the formula in Table 1, mix cariprazine hydrochloride, diluent, flavoring agent, and internally added disintegrant (that is, the internally added disintegrant) evenly, and then use a multifunctional fluidized bed top spray One-step granulation is carried out in a one-step granulation process, and an aqueous binder solution is added during the one-step granulation process to obtain granules after granulation; wherein, the mass percentage of the binder in the binder solution is 2.5%;

[0057] (2) Sizing the obtained granules, passing through an 80-mesh sieve, adding an additional disintegrating agent (that ...

Embodiment 2

[0058] Embodiment 2: Preparation of cariprazine orally disintegrating tablets (specification 3.0 mg, calculated as cariprazine)

[0059] The formula composition of cariprazine orally disintegrating tablet is shown in Table 2.

[0060] Table 2

[0061]

[0062] Prepare cariprazine orally disintegrating tablets according to the formula in Table 2, and the specific operation steps are the same as in Example 1; wherein, the solvent in the binder solution is an aqueous ethanol solution, and the mass percent of the binder in the binder solution is 1%.

Embodiment 3

[0063] Embodiment 3: Preparation of cariprazine orally disintegrating tablets (specification 6.0 mg, calculated as cariprazine)

[0064] The formula composition of cariprazine orally disintegrating tablet is shown in Table 3.

[0065] table 3

[0066]

[0067] Cariprazine orally disintegrating tablets were prepared according to the formula in Table 3, and the specific operation steps were the same as in Example 1; wherein, the mass percentage of the binder in the binder solution was 5%.

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Abstract

The invention discloses an orally disintegrating tablet of cariprazine and a preparation method thereof. The orally disintegrating tablet of cariprazine comprises, by mass, 0.8 to 3.6% of cariprazinehydrochloride, 0 to 2.0% of a binder, 16 to 48% of a disintegrating agent, a diluent and a lubricant. The orally disintegrating tablet of cariprazine can be rapidly disintegrated and dissolved out inthe oral cavity, has good hardness and wear resistance, and can improve the compliance of patients, mitigate the burden of nursing people, effectively prevent psychopaths from hiding and spitting cariprazine and improve treatment effect. The preparation method for the orally disintegrating tablet of cariprazine is simple, can carry out production in conventional workshops for oral solid preparations, has low production cost and is capable of realizing large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cariprazine orally disintegrating tablet and a preparation method thereof. Background technique [0002] Cariprazine Hydrochloride Capsules was approved by the FDA in September 2015. The manufacturer of the original drug is Jirui Pharmaceutical Factory. It was developed and promoted by Forest Laboratory. It is used for the treatment of mania and mixed schizophrenia and overt bipolar disorder symptom. Cariprazine is a partial D3 / D2 receptor agonist that preferentially binds to D3 receptors and has advantages over traditional psychotropic drugs (acting solely on D2) (low incidence of extrapyramidal side effects, negative treatment of symptoms). In the human body, it is metabolized by P450 enzyme system into active metabolites DCAR and DDCAR. In a stable state, 70% is DDCAR, and the half-life is as long as 2-3 weeks, which is about 20 days. [0003] Orally disinte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/495A61K47/38A61P25/18A61P25/24
CPCA61K9/0056A61K9/2054A61K31/495
Inventor 黄悦梁思齐
Owner ZHEJIANG JINGXIN PHARMA
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