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Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof

An instant film, taste-masking technology, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of unsatisfactory taste, etc. The effect of improving compliance

Inactive Publication Date: 2013-01-09
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Ondansetron has a strong bitter taste, and it is technically difficult to completely cover this bitter taste. The oral preparations currently on the market include tablets, capsules and orally disintegrating tablets, and the taste is not ideal. The majority of patients, especially children Patients urgently need preparations that taste good and can effectively mask the bad taste of drugs

Method used

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  • Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof
  • Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof
  • Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Each tablet contains ondansetron hydrochloride 4mg, and the composition of 1000 tablets of ondansetron hydrochloride oral instant film is:

[0034]

[0035] The specific operation process is as follows:

[0036]Weigh ondansetron hydrochloride, sucralose, microcrystalline cellulose, and mannitol, disperse with 30% glycerin solution, add 3% hydroxypropyl methylcellulose solution, stir while adding, and stir for about 15 minutes , add carboxymethylcellulose sodium to swell for 1 hour, then stir and mix with 0.3% pigment solution for 5 minutes, degas, apply the above-mentioned ondansetron hydrochloride suspension glue evenly on the flat plate, blast, heat and dry , the heating temperature is 60° C., and cutting (2 cm × 2 cm) obtains ondansetron hydrochloride oral instant film.

[0037] The film has good appearance, good flexibility, slow dissolution in the mouth, bitter taste, and the dissolution time limit is 35s.

Embodiment 2

[0039] Each tablet contains ondansetron hydrochloride 4mg, and the composition of 1000 tablets of ondansetron hydrochloride oral instant film is:

[0040]

[0041] The specific operation process is as follows:

[0042] Weigh ondansetron hydrochloride, sucralose, microcrystalline cellulose, disperse with 30% glycerin solution, add 10% pullulan aqueous solution, stir while adding, after stirring for about 15 minutes, add carboxymethyl cellulose Swell with plain sodium for 1 hour, add 0.3% pigment solution, stir and mix for 5 minutes, degas, apply the above-mentioned suspension of ondansetron hydrochloride evenly on the flat plate, blow air, heat and dry, and the heating temperature is 60°C , cut (2cm × 2cm), to obtain ondansetron hydrochloride oral instant film.

[0043] The film has a good appearance, average flexibility, improved dissolution at the entrance, bitter taste, and a melting time limit of 25s.

Embodiment 3

[0045] Each tablet contains ondansetron hydrochloride 4mg, and the composition of 1000 tablets of ondansetron hydrochloride oral instant film is:

[0046]

[0047] Specific operation process:

[0048] Weigh 4 g of ondansetron hydrochloride, dissolve in 500 ml of water, stir and dissolve at room temperature, add 4 g of polacrilin potassium resin, and continue stirring for ion exchange for 1 hour to obtain ondansetron hydrochloride drug resin solution, then add sucralose , microcrystalline cellulose, mannitol, stir to make it evenly dispersed, add xanthan gum solution, stir while adding, after stirring for about 15 minutes, add glycerin, stir and mix the pigment solution for 5 minutes, degas, and mix the above hydrochloric acid The ondansetron suspension is evenly coated on the flat plate, blasted, heated and dried at a heating temperature of 60°C, and cut (2cm×2cm) to obtain the ondansetron hydrochloride oral instant film.

[0049] The film has good appearance, good toughne...

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Abstract

The invention provides an ondansetron oral cavity instant membrane capable of sheltering bad medicine taste and a preparation method thereof. The oral cavity instant membrane comprises active pharmaceutical ingredients for sheltering the bad taste and auxiliary materials suitable for pharmacy, the active pharmaceutical ingredients include ondansetron or salts acceptable in the pharmacy, and the auxiliary materials suitable for the pharmacy comprise a membrane-forming material, a sweetening agent and a filling agent. The oral cavity instant membrane has the advantages that the taste is good, the oral cavity instant membrane can be rapidly dissolved in the oral cavity without water, the bioavailability is high, the usage is convenient, the processing technology is simple, convenient and practical, the related auxiliary materials suitable for the pharmacy are easy to purchase, and good social and economic benefits are achieved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ondansetron oral instant film capable of masking bad taste of medicines and a preparation method thereof. Background technique [0002] The oral instant film belongs to the film in the pharmaceutical dosage form, and it is also an oral solid immediate release preparation. It is evolved from the breath freshening film in the sugar paste and oral care market. It has been used in non-prescription drugs and prescription drugs in foreign countries. middle. Oral instant film is a safe and effective dosage form. Generally, the product is designed to be the size of a postage stamp. It can be quickly dissolved on the tongue and swallowed with normal swallowing movements. Patients can take it without drinking water, so as to achieve Rapid release of one or several active ingredients of a drug. Oral instant film can realize convenient, fast and accurate medication when it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4178A61K47/32A61K47/34A61K47/36A61K47/38A61K47/40A61P1/08
Inventor 赵伟康静王红霞李化淋
Owner 天津市聚星康华医药科技有限公司
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