Oral quick-release film agent containing ondansetron hydrochloride solid dispersion

A technology of ondansetron hydrochloride and solid dispersion, which is applied in the field of oral immediate-release films, can solve the problems of frequent administration, poor patient compliance, and low bioavailability, so as to improve bioavailability and patient compliance, The effect of rapid drug release and convenient application

Active Publication Date: 2014-08-27
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ondansetron is affected by the hepatic first-pass effect, and its bioavailability is low. However, conventional clinical oral dosage forms such as capsules and tablets all have the problems of frequent administration and poor patient compliance.

Method used

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  • Oral quick-release film agent containing ondansetron hydrochloride solid dispersion
  • Oral quick-release film agent containing ondansetron hydrochloride solid dispersion
  • Oral quick-release film agent containing ondansetron hydrochloride solid dispersion

Examples

Experimental program
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Embodiment 1

[0030] Embodiment 1 prepares the oral immediate-release film containing ondansetron hydrochloride solid dispersion

[0031] Prepare 100 tablets, each containing 8 mg of ondansetron hydrochloride, the amount of raw materials and auxiliary materials is:

[0032] Ondansetron hydrochloride 0.8g, PVPK300.8g, hydroxypropyl methylcellulose 1.8g, methylcellulose 0.6g, xanthan gum 0.04g, PEG4000.9g, erythritol 0.1g.

[0033] The preparation method steps are as follows:

[0034] (1) Preparation of ondansetron hydrochloride solid dispersion: get ondansetron hydrochloride and polyvinylpyrrolidone, mix, place in a mortar and grind evenly, add appropriate amount of methanol (make the concentration of ondansetron hydrochloride be 4%, w / v, unit g / ml), stir evenly to make it dissolve, put it on a 40°C constant temperature water bath and stir for 1h, evaporate the solvent methanol to dryness under reduced pressure, put the product in a vacuum oven at 45°C, and dry it for 48h (to remove residu...

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Abstract

The invention discloses an oral quick-release film agent containing ondansetron hydrochloride solid dispersion, which is prepared from the following bulk drugs and accessories in parts by weight: 8.0-16.0 parts of ondansetron hydrochloride, 8.0-16.0 parts of polyvinylpyrrolidone, 24.0-48.0 parts of hydroxypropyl methyl cellulose, 8.0-16.0 parts of methylcellulose, 0.4-1.0 part of xanthan gum, 9.0-36.0 parts of plasticizer and 1.0-5.0 parts of erythritol. The oral quick-release film agent containing ondansetron hydrochloride solid dispersion can be conveniently applied to patients suffering from dysphagia; drugs are released quickly; the bioavailability and the patient compliance are increased; drugs exist in the preparation in the amorphous form; the retention time of drugs can be prolonged; the oral quick-release film agent containing ondansetron hydrochloride solid dispersion disclosed by the invention also has the effect of disguising bad taste of drugs.

Description

technical field [0001] The invention relates to an oral immediate-release film comprising ondansetron hydrochloride solid dispersion. Background technique [0002] At present, radiotherapy and chemotherapy are mostly used to treat cancer, but cancer patients who receive radiotherapy and chemotherapy will experience nausea and vomiting symptoms to varying degrees. Nausea and vomiting caused by chemotherapy refer to a toxic reaction caused by chemotherapy drugs during chemotherapy. Nausea and vomiting symptoms occur in about 60% of chemotherapy patients, which can be divided into acute nausea and vomiting, delayed vomiting and anticipatory vomiting. Nausea and vomiting caused by chemotherapy drugs are mainly caused by the following aspects: ① Chemotherapy drugs stimulate the gastrointestinal mucosa, causing chromaffin cells on the mucosa to release 5-HT 3 and other neurotransmitters, 5-HT 3 with 5-HT 3 Nerve impulses generated by receptor binding are transmitted to the vom...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4178A61K47/32A61P35/00A61P1/08
Inventor 赵忠熙魏婷董爱梅张芳林贵梅
Owner SHANDONG UNIV
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