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Oral gatifloxacin disintegrant and its preparing process

A technology for oral disintegrating tablets and gatifloxacin, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., to achieve the effects of good taste, rapid disintegration, and improved bioavailability

Inactive Publication Date: 2006-11-08
SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the domestic marketed dosage forms mainly include ordinary tablets, capsules, eye drops, water for injection injections, powder injections for injections and other dosage forms, and there are no reports or literature on the dosage forms of orally disintegrating tablets at home and abroad.

Method used

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  • Oral gatifloxacin disintegrant and its preparing process
  • Oral gatifloxacin disintegrant and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1 composition weight percent content

[0031] Gatifloxacin Hydrochloride 20%

[0032] Acrylic resin E 100 2%

[0033] Acetone 0.5%

[0034] Industrial ethanol 0.5%

[0035] Lactose 6%

[0036] Citric acid 2%

[0037] Sodium Hydroxymethyl Cellulose 20%

[0038] Microcrystalline Cellulose 37%

[0039] Low Substituted Hydroxypropyl Cellulose 7%

[0040] 10% aqueous solution of polyvinylpyrrolidone 3% (calculated as polyvinylpyrrolidone)

[0041] Talc 2%

[0042] Preparation method: powder-coated tablet method: firstly, the above-mentioned excipients are respectively crushed through a 150-mesh sieve, and gatifloxacin hydrochloride is passed through a 200-mesh sieve. Weigh 4g of gatifloxacin hydrochloride fine powder, put it in a fluidized bed to make it boil, coat with a 10% solution of 100mg of acrylic resin E 100 and 100ml of acetone...

Embodiment 2

[0043] Embodiment 2 composition weight percentage content

[0044] Gatifloxacin Hydrochloride 40%

[0045] Hydroxypropyl methylcellulose 7% aqueous solution 7% (calculated as hydroxypropyl methylcellulose)

[0046] Lactose 5.5%

[0047] Aspartame 0.5%

[0048] Sodium Hydroxymethyl Cellulose 10%

[0049] Microcrystalline Cellulose 25%

[0050] Low Substituted Hydroxypropyl Cellulose 7%

[0051] Polyvinylpyrrolidone 10% aqueous solution 4% (calculated as polyvinylpyrrolidone)

[0052] Talc 1%

[0053] Preparation method: powder-coated tablet method: firstly, the above-mentioned excipients are respectively crushed through a 150-mesh sieve, and gatifloxacin hydrochloride is passed through a 200-mesh sieve. Weigh 12g of gatifloxacin hydrochloride fine powder, put it in a fluidized bed to make it boil, dissolve 2.1g of hydroxypropyl methylcellulose into a 7% aqueous solution as ...

Embodiment 3

[0054] Embodiment 3 composition weight percent content

[0055] Gatifloxacin Hydrochloride 50%

[0056] Glyceryl Behenate 5%

[0057] Sorbitol 15%

[0058] Lactose 15%

[0059] Sodium Starch Carboxymethyl 12%

[0060] Vanillin 1%

[0061] Magnesium Stearate 2%

[0062] Preparation method: powder-coated tablet method: crush gatifloxacin hydrochloride through a 200-mesh sieve, weigh 17.5g of fine powder, put it in a fluidized bed to make it boil, and coat it with 1.75g ​​of behenic acid glyceride. 10% weight gain of the main ingredient, coating the drug through a 120-mesh sieve, weighing 5.25g of sorbitol, 5.25g of lactose, 4.2g of sodium carboxymethyl starch and mixing with the coated drug. Granulate with an 80-mesh sieve, dry, mix the dry granules with 350 mg of vanillin and 700 mg of magnesium stearate, control the tablet weight to 350 mg, and press into tablets to obtain 100 gatifloxacin orally disintegrating tablets.

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Abstract

The present invention provides an oral gatifloxacin disintegrant and its preparation process. The oral gatifloxacin disintegrant contains gatifloxacin in 20-75 wt% and medicinal supplementary material in 25-80 wt%, and the medicinal supplementary material includes one or several of disintegrating agent, stuffing, wetting adhesive, lubricant and coating material. The preparation process of the oral gatifloxacin disintegrant includes coating medicine powder or medicine carrying micro pill and tabletting. The oral gatifloxacin disintegrant of the present invention has the advantages of fast medicine release, increased absorbing points and less local excitation on gastrointestinal tract and is suitable for taking without using water and by patient with dysphagia.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an oral dosage form of antibacterial drug gatifloxacin—gatifloxacin orally disintegrating tablet and a preparation method thereof. Background technique [0002] Orally disintegrating tablet is a new drug preparation, the English name is "Orally disintegrating tables", the US FDA has approved this dosage form for marketing, the reason is: it is convenient for some people to take medicine, such as the elderly, children with difficulty swallowing or patients in special circumstances. [0003] Definition of orally disintegrating tablet: A tablet that disintegrates or dissolves in the oral cavity without the need for water. It should meet the requirements of the technical quality standard: ①Disintegrate rapidly in the oral cavity, without gritty feeling, good taste, easy to swallow, and non-irritating to the oral mucosa. ②Establish a suitable measurement method and limit of disintegra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P31/04
Inventor 郑白水李显林苏显英刘宏飞
Owner SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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