Cariprazine hydrochloride injection preparation, and preparation method and use thereof

A technology of cariprazine hydrochloride and injection preparations, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Active Publication Date: 2018-07-10
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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  • Cariprazine hydrochloride injection preparation, and preparation method and use thereof
  • Cariprazine hydrochloride injection preparation, and preparation method and use thereof
  • Cariprazine hydrochloride injection preparation, and preparation method and use thereof

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Embodiment Construction

[0023] Based on the deficiencies of the prior art, the present invention has prepared an injection containing cariprazine hydrochloride after in-depth investigation and research. The preparation can be in the form of an aqueous suspension solution or a lyophilized preparation. The latter is mixed with matching sterile water for injection to form a suspension aqueous solution, and is used by intramuscular injection or subcutaneous injection. Compared with oral cariprazine hydrochloride capsules, the advantages of the invention include:

[0024] (1) Cariprazine hydrochloride exists in the granules with low solubility in the aqueous suspension solution, and the drug can be continuously released after injection, which can significantly reduce the number of administrations and avoid peak-to-trough fluctuations, thereby improving the patient's treatment compliance and safety;

[0025] (2) The drug loading of this preparation is relatively high, and a sustained release of at least 1 w...

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Abstract

The invention provides a cariprazine hydrochloride injection preparation, and a preparation method and a use thereof. The injection preparation is an aqueous suspension when used, cariprazine hydrochloride has a high concentration and a good stability, a high dosage can be obtained within a limited injection volume, the dosage can be flexibly adjusted according to the long-acting administration time, the particle size distribution and the injection dosage are controlled to achieve the long-acting effect, the cariprazine hydrochloride is continuously released in at least one week after the preparation is injected, and the preparation is administrated every one week or more to increase the compliance of patients. The invention also provides the preparation method of the cariprazine hydrochloride injection preparation. The injection preparation prepared by the method has the advantages of good stability and high safety, and the method is simple, is easy to implement, 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 a preparation method and application thereof. Background technique [0002] Cariprazine is an atypical antipsychotic drug, which is a partial agonist of dopamine D2 and D3 receptors, and is mainly used for the treatment of adult schizophrenia and bipolar mania. [0003] At present, only Cariprazine Hydrochloride Capsules from Forest Lab is on the market. This product is an oral preparation and needs to be administered daily 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, researches are mainly aimed at improving the bioavailability and stability of oral administration of cariprazine hydrochloride. However, there is currently a lack of research on parenteral formulations of cariprazine and its salts in th...

Claims

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Application Information

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Patent Type & Authority Applications(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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