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Dutasteride oral cavity film agent and preparation method thereof

A technology of dutasteride and oral film, applied in the field of dutasteride oral film and preparation thereof

Inactive Publication Date: 2014-05-28
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, the dosage form of dutasteride on the market is soft capsule. The preparation process of tasteride oral film is simple, low in cost, accurate in dosage, good in taste, convenient to take, and has good compliance to patients

Method used

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  • Dutasteride oral cavity film agent and preparation method thereof
  • Dutasteride oral cavity film agent and preparation method thereof
  • Dutasteride oral cavity film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035]

[0036] Preparation Process:

[0037] (1) Dissolve pullulan in 20ml of purified water, and fully stir until dissolved in a water bath at 90°C to make it a uniform viscous liquid;

[0038] (2) Disperse L-HPC in 12ml purified water to form a dispersion;

[0039] (3) Dissolve orange essence, acesulfame potassium and citric acid in 8ml purified water to form a solution;

[0040] (4) Add the dispersion and solution formed by (2) and (3) into (1) in sequence under stirring, and continue to stir evenly; and add dutasteride under stirring to make it evenly disperse in the viscous liquid, then add propylene glycol and epoxidized iron to obtain the viscous liquid of dutasteride;

[0041] (5) After stirring for 20 minutes, let it stand still, and drain the air bubbles in the viscous liquid;

[0042] (6) Apply the above-mentioned degassed viscous dutasteride solution evenly on the mold, heat and dry at 50°C, cool, peel off the film, and cut to prepare the dutasteride oral film...

Embodiment 2-4

[0044] See Table 2 for prescription

[0045]

[0046] Preparation Process:

[0047] The preparation method of embodiment 2-4 is the same as the preparation process of embodiment 1.

Embodiment 5-7

[0049] See Table 3 for prescription

[0050]

[0051] Preparation Process:

[0052] (1) Dissolve HPMC and HPC in 20ml of purified water, stir well until dissolved, and make it into a uniform viscous liquid;

[0053] (2) Disperse the pregelatinized starch in 12ml of purified water to form a dispersion;

[0054] (3) Dissolve orange essence, acesulfame potassium, and citric acid in 8ml of purified water to form a solution;

[0055] (4) Add the dispersion and solution formed by (2) and (3) into (1) in sequence under stirring, and continue to stir evenly; and add dutasteride under stirring to make it evenly disperse in the viscous liquid, then add glycerin and epoxidized iron to obtain the viscous liquid of dutasteride;

[0056] (5) After stirring for 20 minutes, let it stand still, and drain the air bubbles in the viscous liquid;

[0057] (6) Apply the above-mentioned degassed viscous dutasteride solution evenly on the mold, heat and dry at 50°C, cool, peel off the film,...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/58A61K47/38A61K47/36A61P13/08
Inventor 张涛刘丽张雁翎王立邓杰
Owner CHONGQING PHARMA RES INST
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