Abiraterone acetate soft capsule and preparation method thereof

A technology of abiraterone acetate and soft capsules, which is applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as low solubility, precipitation of abiraterone, and poor oral bioavailability
CN113616614APending Publication Date: 2021-11-09HANGZHOU HEZE PHARMA TECH +1
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
HANGZHOU HEZE PHARMA TECH
Publication Date
2021-11-09

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Abstract

The invention discloses an abiraterone acetate soft capsule and a preparation method thereof. The abiraterone acetate soft capsule consists of a content and a capsule shell, wherein the content comprises abiraterone acetate, caprylic / capric acid mono / diglyceride, Tween 80, Span 80 and butylated hydroxyanisole; and the capsule shell is made of soft capsule materials and comprises gelatin, water, glycerol and a sorbitol and sorbitan solution, wherein the ratio of the gelatin to the water to the glycerol to the sorbitol and sorbitan solution is 1: 0.74: 0.35: 0.35. After the abiraterone acetate soft capsule provided by the invention is orally taken on the empty stomach, compared with an original research medicine Zytiga (the specification is 250mg), the step of dissolving out the original research medicine Zytiga in the digestive tract is not required, the oral bioavailability is improved to 12.5 times, variability among individuals is low, and the phenomenon that the exposure quantity of abiraterone is obviously increased due to postprandial administration of the original research medicine Zytiga is eliminated.
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Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, in particular to an abiraterone acetate soft capsule and a preparation method thereof. Background technique

[0002] Abiraterone Acetate is a white to off-white, non-hygroscopic crystalline powder. Abiraterone acetate is a prodrug of abiraterone, a selective irreversible inhibitor of 17α-hydroxylase / C17,20-lyase (CYP17). The enzyme is expressed in testis and adrenal gland tissues and catalyzes the conversion of pregnene and nandrolone and progesterone to testosterone precursors, DHEA and androstenedione, respectively, through 17α hydroxylation and cleavage of C17,20 bonds. Abiraterone can inhibit the activity of CYP17 to prevent testosterone synthesis in testes, adrenal glands and tumors. Prostate cancer is an androgen-dependent disease, and testosterone suppression is a key pharmacological tool in controlling prostate cancer development. The chemical structure of abiraterone acetate...

Claims

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