Microporous spongy ondansetron hydrochloride film agent and preparation method thereof

A technology of ondansetron hydrochloride and sponge, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, sheet-like delivery, etc. It can solve the problem of increasing the proportion of plasticizers, unfavorable film formation, Membrane brittle and other problems

Active Publication Date: 2012-09-19
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Not conducive to production, transportation, storage and use
The usual practice is to add a sufficient amount of plasticizer, but while increasing the proportion of plasticizer, the proportion of polymer materials is relatively reduced, which is not conducive to the formation of the film
In order to ensure the strength of the membrane when the proportion of polymer is small, it is necessary to use materials with higher molecular weight and higher viscosity, so that the dissolution of the membrane will be slowed down, and the effect of rapid onset of action will not be achieved.
[0008] And when adopting the technology disclosed by the inventor's prior patent application to prepare ondansetron hydrochloride film, the test found that there was also the defect that the film was brittle and fragile during slitting and packaging, which needed to be improved.

Method used

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  • Microporous spongy ondansetron hydrochloride film agent and preparation method thereof
  • Microporous spongy ondansetron hydrochloride film agent and preparation method thereof
  • Microporous spongy ondansetron hydrochloride film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 80 g of PVA with a molecular weight of 130,000 Daltons and 20 g of HPC with a molecular weight of 600,000 Daltons were dissolved in 500 g of water to form a water slurry.

[0061] Add 100g of pore-forming agent, 10g of ondansetron hydrochloride, 1g of aspartame, 1g of arginine, 5g of glycerin and 3g of titanium dioxide into the above water slurry, stir well and mix evenly.

[0062] The components of the pore-forming agent include chitin with a particle size of 0.5 μm and acetone adsorbed thereon, and the parts by weight of chitin and the parts by weight of the solvent are:

[0063] Chitosan 100 parts

[0064] Acetone 400 parts

[0065] (2) Then use the method reported in the literature of the study of nitroglycerin membranes (Chinese Journal of Pharmaceutical Industry, 1977, 12 (5)) to coat and form membranes to obtain thin film precursors;

[0066] (3) Dry the film precursor obtained in step (2) at 80° C. to obtain the film for the drug film preparation, with a thick...

Embodiment 2

[0074] 16 g of HPMC with a molecular weight of 20,000 Daltons and 64 g of PEO with a molecular weight of 7,000,000 Daltons were dissolved in 500 g of water to form a water slurry.

[0075] Add 200g of pore-forming agent, 50g of ondansetron hydrochloride, 5g of cyclamate and 0.1g of sunset yellow pigment into the above water slurry, fully stir and mix evenly.

[0076] The components of the pore-forming agent include CaCO with a particle size of 50 μm and ethanol adsorbed thereon, and the parts by weight of CaCO and the parts by weight of the solvent are:

[0077] CaCO3 100 parts

[0078] Ethanol 100 parts

[0079] Others are the same as embodiment 1.

[0080] The weight ratio of each component:

[0081] Low molecular weight water-soluble polymer material: high molecular weight water-soluble polymer material=1:4;

[0082] Water-soluble polymer material: water-insoluble micropowder = 1:1.25;

[0083] The diameter of the micropores is 10 nm.

[0084] Performance evaluation: ...

Embodiment 3

[0086] Dissolve 60 g of sodium alginate with a molecular weight of 32,000 Daltons and 120 g of CMC-Na with a molecular weight of 700,000 Daltons in 700 g of water to form a water slurry.

[0087] Add 90g of pore-forming agent, 50g of ondansetron hydrochloride, 5g of sucralose, 5g of triethyl citrate and 3g of titanium oxide into the above water slurry, fully stir and mix evenly.

[0088] The component of described pore-forming agent comprises the sodium polystyrene sulfonate of 10 μ m and the ethanol adsorbed on it, the parts by weight of sodium polystyrene sulfonate and the parts by weight of solvent are:

[0089] Sodium polystyrene sulfonate 100 parts

[0090] Ethanol 100 parts

[0091] Others are the same as embodiment 1.

[0092] The weight ratio of each component:

[0093] Low molecular weight water-soluble polymer material: high molecular weight water-soluble polymer material=1:2;

[0094] Water-soluble polymer material: water-insoluble micropowder = 1:0.25;

[0095...

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Abstract

The invention discloses a microporous spongy ondansetron hydrochloride film agent and a preparation method thereof. The microporous spongy ondansetron hydrochloride film agent comprises ondansetron hydrochloride, water-soluble polymer materials and water insoluble micro powder; according to the film agent, two kinds of polymer materials are matched for used, wherein the molecular weight of one kind of the polymer material is 10,000 to 200,000 Daltons, and the molecular weight of the other kind of the polymer material is 200,000 to 10,000,000 Daltons; and the ratio of one kind of the polymer material to the other kind of the polymer material is (1:4) to (4:1). By the polymer material with the low molecular weight, a film can be dissolved quickly; by the polymer material with the high molecular weight, the physical intensity and toughness of the film can be guaranteed; and the aim of quick release is fulfilled, and the intensity of the film is guaranteed.

Description

technical field [0001] The invention relates to an ondansetron hydrochloride preparation. Background technique [0002] Ondansetron (Ondansetron) is a 5-hydroxytryptamine receptor antagonist, which is mainly used clinically for nausea and vomiting caused by chemotherapy or radiotherapy, and can also be used for nausea and vomiting after surgery. Its antiemetic mechanism has both peripheral and central effects. It exerts its curative effect mainly by inhibiting the 5-hydroxytryptamine receptor in the emetic chemoreceptor area of ​​the medulla oblongata. And it has the function of gastric motility, accelerates gastric emptying, and thus is beneficial to antiemetic. [0003] The clinical application of ondansetron is very suitable for making film. Because the film does not need water to be taken, it is especially suitable for patients with dysphagia; it dissolves immediately on the tongue and is not easy to spit out after sticking. Compared with liquid preparations such as ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4178A61K47/36A61K47/38A61K47/32A61K47/34A61P1/08
Inventor 陈芳侯惠民夏怡然张桦
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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