A kind of cariprazine hydrochloride injection preparation and its preparation method and application

A technology for cariprazine hydrochloride and injection preparations, which are applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients.

Active Publication Date: 2022-03-04
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the current prior art lacks research on parenteral administration preparations of cariprazine and its salts

Method used

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  • A kind of cariprazine hydrochloride injection preparation and its preparation method and application
  • A kind of cariprazine hydrochloride injection preparation and its preparation method and application
  • A kind of cariprazine hydrochloride injection preparation and its preparation method and application

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Embodiment Construction

[0025] Based on the deficiencies in the prior art, the present invention has prepared an injection containing cariprazine hydrochloride through in-depth investigation and research. The preparation can be in the form of an aqueous suspension or in the form of a freeze-dried formulation. The former can be used directly. The latter is mixed with the supporting sterile water for injection and formulated into a suspension solution for use, and is used for intramuscular injection or subcutaneous injection. Compared with oral cariprazine hydrochloride capsules, the advantages of the invention include:

[0026] (1) Cariprazine hydrochloride exists as low-solubility granules in the suspension solution, which can continuously release the drug after injection, can significantly reduce the number of administrations, avoid peak-to-valley fluctuations, and thereby improve the patient's treatment compliance and safety;

[0027] (2) The drug loading of this preparation is relatively high, and ...

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Abstract

The invention provides a cariprazine hydrochloride injection preparation and its preparation method and application. When the injection preparation is used, it is a suspension aqueous solution, wherein the concentration of cariprazine hydrochloride is relatively high, and the stability is good, and a higher dosage can be obtained in a limited injection volume, and it can also be used according to the long-acting administration time. The dose can be flexibly adjusted, and by controlling the particle size distribution and the injection dose, a long-acting effect can be achieved. After injection, the preparation can release cariprazine continuously for at least 1 week, and can be administered once a week or more. Long dosing intervals to increase patient compliance. The invention also provides a preparation method of the cariprazine hydrochloride injection preparation, the injection preparation prepared by the method has good stability and high safety, the method is simple and easy, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cariprazine hydrochloride injection preparation and its preparation method and application. Background technique [0002] Cariprazine is an atypical antipsychotic drug, which belongs to the dopamine D2, D3 receptor partial agonist, and is mainly used for the treatment of adult schizophrenia and bipolar mania. [0003] At present, only Cariprazine Hydrochloride Capsules of Forest Laboratory is on the market. This product is an oral preparation and requires daily administration to maintain its blood concentration. However, due to the need for frequent administration, the patient's medication compliance is poor. [0004] In the prior art, the research mainly aims at improving the bioavailability, stability and the like of cariprazine hydrochloride administered orally. However, the current prior art lacks research on parenteral administration preparations of cariprazine ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K9/19A61K47/26A61K31/495A61P25/18
CPCA61K47/26A61K9/0019A61K9/10A61K9/19A61K31/495
Inventor 宋平朱思琪赵步文游劲松黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD
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