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Oseltamivir phosphate micro-tablet as well as preparation method and preparation thereof

A technology of oseltamivir phosphate and oseltamivir phosphate, applied in pill delivery, antiviral agents, pharmaceutical formulations, etc., can solve problems such as good compliance, and achieve improved dissolution rate, uniformity of active ingredient content, and good dissolution rate , the effect of taking medicine conveniently

Active Publication Date: 2022-03-11
BEIJING VAGARY PHARM TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to overcome the above technical problems, the present invention provides a kind of oseltamivir phosphate microtablet, which can realize the precise administration of the minimum dose without the need for post-dispersion It is used in small quantities, and the microtablets are small in size, which can be directly administered to children and elderly patients, without difficulty in swallowing, and good compliance

Method used

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  • Oseltamivir phosphate micro-tablet as well as preparation method and preparation thereof
  • Oseltamivir phosphate micro-tablet as well as preparation method and preparation thereof
  • Oseltamivir phosphate micro-tablet as well as preparation method and preparation thereof

Examples

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Effect test

Embodiment 1

[0058] A preparation method of oseltamivir phosphate microchips, the composition of the microchips is as follows:

[0059] The composition of table 1 embodiment 1

[0060] prescription composition Parts by weight (parts) Oseltamivir Phosphate 20 Silicified microcrystalline cellulose 34 Mannitol 30 soybean polysaccharide 7 Alginic acid 6 Magnesium stearate 1 silica 2

[0061] Preparation Process:

[0062] (1) Dissolve oseltamivir phosphate and mannitol in water and spray dry;

[0063] (2) mixing (1) with silicified microcrystalline cellulose, soybean polysaccharide, and alginic acid;

[0064] (3) mixing (2) with magnesium stearate and silicon dioxide;

[0065] (4) Made into microtablets with a diameter of 2 mm and a tablet weight of 10 mg, each containing 1.5 mg of oseltamivir.

Embodiment 2

[0067] A preparation method of oseltamivir phosphate microchips, the composition of the microchips is as follows:

[0068] The composition of table 2 embodiment 2

[0069] prescription composition Parts by weight (parts) Oseltamivir Phosphate 10 Silicified microcrystalline cellulose 46 Mannitol 34 Carboxymethyl Starch Sodium 5 Sodium stearyl fumarate 3 silica 2

[0070] Preparation Process:

[0071] (1) Dissolve oseltamivir phosphate and mannitol in water, spray dry, the spray pressure is 0.25MPa, and the spray temperature is 50-60°C to prepare oseltamivir phosphate mixed powder;

[0072] (2) Mix (1) with silicified microcrystalline cellulose, sodium carboxymethyl starch, sodium stearyl fumarate, and silicon dioxide in a mixer with a rotating speed of 18 rpm and a time of 10 min. D90 = 126.92 μm;

[0073] (3) Tablets were pressed with a tablet machine at a rotating speed of 15rpm to make microtablets with a diameter of 3mm ...

Embodiment 3

[0075] A preparation method of oseltamivir phosphate microchips, the composition of the microchips is as follows:

[0076] The composition of table 3 embodiment 3

[0077] prescription composition Parts by weight (parts) Oseltamivir Phosphate 39.5 Silicified microcrystalline cellulose 28 β-cyclodextrin 18 Carboxymethyl Starch Sodium 6 Sodium stearyl fumarate 2.5 silica 6

[0078] Preparation Process:

[0079] (1) Mix oseltamivir phosphate with D90=103.69 μm and β-cyclodextrin, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, and silicon dioxide;

[0080] (2) Made into microtablets with a diameter of 3 mm and a tablet weight of 20 mg, each containing 6 mg of oseltamivir.

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to an oseltamivir phosphate micro-tablet as well as a preparation method and a preparation thereof. The oseltamivir phosphate micro-tablet comprises oseltamivir phosphate and / or auxiliary materials, the diameter of the micro-tablet is 1-5 mm, the weight of the micro-tablet is 1-50 mg, and each micro-tablet contains 1-15 mg of oseltamivir. The number of the micro-tablets in the preparation is one or more. The invention also provides a preparation method of the micro-tablet. According to the micro-tablet, small-dose direct administration can be realized, the dosage is accurate, the use is convenient, and the medication compliance is improved; the micro-tablet does not contain preservatives and flavoring agents, so that the medication safety is improved. The preparation process is simple and controllable, the prepared microtablet has good stability, good content uniformity and good dissolution rate, and the bioavailability can be remarkably improved.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an oseltamivir phosphate microtablet and a preparation method and preparation thereof. Background technique [0002] Oseltamivir Phosphate, English name Oseltamivir Phosphate, its structural formula is: [0003] [0004] Oseltamivir phosphate is white or off-white crystalline powder, easily soluble in water or methanol, slightly soluble in N,N-dimethylformamide, almost insoluble in ether. Unstable to humidity, heat and light. [0005] Oseltamivir phosphate was first developed and launched by the Swiss company Roche. Oseltamivir phosphate has a strong neuraminidase inhibitory activity and is effective against influenza A and B viruses. Its properties and preparation methods are disclosed in in WO1998007685A1 and WO1996026933A1. [0006] At present, the commercially available dosage forms of oseltamivir phosphate include capsules, dry suspensions, and granules. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/40A61K47/26A61K47/36A61K47/04A61K31/215A61P31/16
CPCA61K9/2072A61K9/2054A61K9/205A61K9/2018A61K9/2009A61K9/2095A61K31/215A61P31/16Y02A50/30
Inventor 张蓓
Owner BEIJING VAGARY PHARM TECH LTD