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Oseltamivir phosphate dispersible tablet and preparation method thereof

A technology of oseltamivir phosphate and dispersible tablets, which is applied in the direction of dispersion liquid delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of inability to ensure drug safety and high cost of granules , Difficulty in accurate drug administration and other issues, to achieve the effect of high application value, simple process conditions and equipment requirements, and low production cost

Inactive Publication Date: 2017-06-27
SHANGHAI SUNTECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cost of granules is high, deliquescent, and palatability is slightly poor; multi-dose dry suspensions have high requirements for storage conditions and packaging materials; the dosage of capsules is too large, and it is difficult to accurately administer the drug to children, especially young children. Cannot be administered safely and is not suitable for children and the elderly who have trouble swallowing

Method used

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  • Oseltamivir phosphate dispersible tablet and preparation method thereof
  • Oseltamivir phosphate dispersible tablet and preparation method thereof
  • Oseltamivir phosphate dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] 1) Grind oseltamivir phosphate through 80 meshes, dissolve the prescribed amount of polyvinylpyrrolidone K30 in 50% ethanol water, prepare 5% soft material, and set aside;

[0025] 2) Weigh the raw materials, fillers, disintegrants and sweeteners according to the formula in the table, and mix them evenly in the granulator. Pour into the granulator, during the process of adding liquid and granulating, the stirring speed of the granulator is 200rpm, the speed of the shearing knife is 1800rpm, and the wet mixing time is controlled at 10 minutes in total;

[0026] 3) Pass the soft material through a 20-mesh sieve, dry in a fluidized bed (Glatt, GPCG2) (inlet air temperature 60°C, dry for 2 hours), 24-mesh granulation, add lubricant and lemon essence during the granulation process, Type mixer (Yali Machinery, DGN-II) after mixing and tableting to obtain 1000 oseltamivir phosphate dispersible tablets.

[0027] The hardness of the tablets was measured with a hardness tester (...

Embodiment 2

[0037] The preparation method is the same as in Example 1, and the components and detection results of the oseltamivir phosphate dispersible tablet are as follows:

[0038] Formula and test results:

[0039]

[0040]

Embodiment 3

[0042] The preparation method is the same as in Example 1, and the components and detection results of the oseltamivir phosphate dispersible tablet are as follows:

[0043] Formula and test results:

[0044]

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Abstract

The invention provides an oseltamivir phosphate dispersible tablet and a preparation method thereof. The dispersible tablet is composed of the following components in percentage by weight: 30-50% of oseltamivir phosphate and 50-70% of medicinal excipient. The preparation method provided by the invention comprises the following steps: stirring and mixing oseltamivir phosphate and the proper auxiliary material, granulating, finishing, and tabletting to obtain the oseltamivir phosphate dispersible tablet. The dispersible tablet can be quickly disintegrated and uniformly dispersed in water, and is suitable for children, old people, bed-ridden patients and severely disabled patients; and the dispersible tablet can be prepared into a uniform dispersion solution, and the uniform dispersion solution can be measured by an appropriate measuring vessel to satisfy the application demands of children with different weights. The method is easy to implement and simple for preparation, is suitable for industrial production, and has great application value.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a preparation of a pharmaceutical preparation, in particular to an oseltamivir phosphate dispersible tablet and a preparation method thereof. Background technique [0002] Oseltamivir is a class of neuraminidase inhibitors, the chemical name is (3R,4R,5S) 4-acetamide-5-amino-3-(1-propoxyethyl ester)-1-cyclohexane- 1 Ethyl carboxylate phosphate, trade name; molecular formula C16H28N2O4·H3PO4; relative molecular weight 410.4. The trade name Tamiflu (tamiflu) is oseltamivir phosphate (oseltamivir, OS) capsule preparation, developed and produced by Roche, Switzerland, approved by the US Food and Drug Administration (FDA) in 1999, and approved by WHO as the first choice for anti-avian flu drug. It is used for the treatment of influenza A and B for adults and children over 1 year old, and for the prevention of influenza A and B for adults and adolescents aged 13 and over. Oseltamivir ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/215A61K47/36A61K47/38A61P31/16
CPCA61K9/2059A61K9/0095A61K9/2054A61K31/215
Inventor 刘学军鲁西强王洪静牛国琴
Owner SHANGHAI SUNTECH PHARMA
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