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Palonosetron oral cavity film agent and preparation method thereof

一种帕洛诺司琼、口腔膜剂的技术，应用在医药配方、非有效成分的医用配制品、含有效成分的医用配制品等方向，能够解决无法使用、药效减弱、吞咽困难等问题，达到起效快、药物吸收快的效果

Active Publication Date: 2016-10-12
LP PHARM (XIAMEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite the many clinical benefits and advantages of injectables, injectables clearly present special issues regarding the stability and shelf life of active drugs
Injectables are inconvenient for patients to self-medicate and increase the risk of contamination and human error
When capsules are used, patients may vomit the contents of the stomach, chemotherapy drugs due to vomiting or nausea induced by these drugs, which will reduce the effectiveness of the drugs
Some patients may not be able to use capsules due to difficulty swallowing

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 palonosetron hydrochloride oral film (comparative example)

[0034] Preparation method: dissolve peppermint oil, sucralose, glycerin, palonosetron hydrochloride, hyaluronic acid and hydroxypropyl methylcellulose in 30% ethanol aqueous solution, and stir until completely dissolved. The percentage by weight of each component in each film is shown in the table below. Stand still or vacuumize to eliminate air bubbles; apply the film-forming liquid evenly on the substrate, and then dry at 55-80°C, the ethanol solution will evaporate during the drying process, after the film is formed, take out the film and cut it into a suitable size and shape, and pack immediately.

[0035] Prepared film preparation every film weight 32mg, contains following composition in every film, and prepared film-forming liquid is that following composition is dissolved in the 30% ethanol aqueous solution of 288mg:

[0036]

[0037] The palonosetron hydrochloride oral film preparatio...

Embodiment 2

[0038] Embodiment 2 palonosetron hydrochloride oral film

[0039] Preparation method: dissolve peppermint oil, sucralose, Tween 80, palonosetron hydrochloride, hyaluronic acid and hydroxypropyl methylcellulose in 30% ethanol aqueous solution, and stir until completely dissolved. The percentage by weight of each component in each film is shown in the table below. Stand still or vacuumize to eliminate air bubbles; apply the film-forming liquid evenly on the substrate, and then dry at 55-80°C, the ethanol solution evaporates during the drying process, after the film is formed, take out the film and cut it into a suitable size and shape, and pack immediately.

[0040] Prepared film preparation every film weight 32mg, contains following composition in every film, and prepared film-forming liquid is that following composition is dissolved in the 30% ethanol aqueous solution of 288mg:

[0041]

[0042] The palonosetron hydrochloride oral film prepared according to the above pres...

Embodiment 3

[0043] Embodiment 3 palonosetron hydrochloride oral film

[0044] Preparation method: dissolve peppermint oil, sucralose, Tween 80, palonosetron hydrochloride, hyaluronic acid and hydroxypropyl cellulose in 30% ethanol aqueous solution, and stir until completely dissolved. The percentage by weight of each component in each film is shown in the table below. Stand still or vacuumize to eliminate air bubbles; apply the film-forming liquid evenly on the substrate, and then dry at 55-80°C, the ethanol solution evaporates during the drying process, after the film is formed, take out the film and cut it into a suitable size and shape, and pack immediately.

[0045] Prepared film preparation every film weight 32mg, contains following composition in every film, and prepared film-forming liquid is that following composition is dissolved in the 30% ethanol aqueous solution of 288mg:

[0046]

[0047] Palonosetron hydrochloride oral film preparation according to above-mentioned presc...

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Abstract

The invention discloses a pharmaceutical preparation for carrying out palonosetron dosing through the oral mucosa or the sublingual mucosa. The pharmaceutical preparation is prepared from 0.1-25% (w / w) of active ingredient palonosetron hydrochloride, 50-86.9% (w / w) of film-forming materials, 1-8% (w / w) of plasticizer, 5-25% (w / w) adhesive and 0.5-2% (w / w) of absorption accelerant. The plasticizer is preferably polysorbate, the adhesive is preferably polyvinylpyrrolidone or sodium carboxymethylcellulose, and the absorption accelerant is preferably oleum menthae or menthol.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to a pharmaceutical preparation that releases palonosetron through oral mucosa or sublingual mucosa in the form of a thin film and a preparation method thereof. Background technique [0002] Tumor has become the number one killer threatening human health. Chemotherapy is the main means of treating tumor diseases. Nausea and vomiting caused by chemotherapy are one of the most common adverse reactions in cancer patients. Severe vomiting can lead to dehydration, electrolyte imbalance, debilitating, and even the patient's refusal to re-treat. The main antiemetic granisetron currently used is a serotonin antagonist. [0003] Palonosetron Hydrochloride is a highly efficient and highly selective 5-HT3 receptor antagonist. Compared with traditional 5-HT3 receptor antagonists, it has high curative effect, long acting time, small dosage and less adverse effects. The ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/473A61K47/38A61K47/26A61K47/44A61P1/08
CPCA61K9/006A61K31/473A61K47/26A61K47/38A61K47/44A61K9/7007A61K47/10A61K47/32A61P1/08A61K47/36A61K47/46
Inventor 朱海健凌榕镔罗晴叶英
Owner LP PHARM (XIAMEN) CO LTD
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