Dutasteride oral cavity film agent and preparation method thereof

Abstract

The invention relates to a dutasteride oral cavity film agent and a preparation method thereof. The film agent mainly comprises 1-16% (w / w) of dutasteride, 30-70% (w / w) of water-soluble medicinal high molecular material, 5-18% (w / w) of a plasticizer, 10-40% (w / w) of a filling agent and a proper amount of an additive. The dutasteride oral cavity film agent is uniform in appearance, does not stick a tooth, and is completely disintegrated within 30 s. The film agent is used for treating moderate and severe benign prostatic hyperplasia.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dutasteride oral film and a preparation method thereof. Background technique:

[0002] Dutasteride was researched and developed by Glaxo, and approved by the US Food and Drug Administration (FDA) for listing in the United States. Its trade name is Avodart, and its trade name in the European market is AvolveT". It belongs to intracellular enzymes and is currently the only marketed drug that simultaneously inhibits type I and type II 5α reductase and is used for the treatment of moderate to severe benign prostatic hyperplasia.

[0003] Benign prostatic hyperplasia (BPH) is a common disease in male elderly patients. BPH can cause varying degrees of bladder output obstruction, and lead to progressive urinary frequency and urgency due to poor urination and rapid bladder filling, and the incidence of nocturnal enuresis in patients increases . The cause is mai...

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