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Oseltamivir phosphate tablet and preparation method thereof

A technology of oseltamivir phosphate and oseltamivir phosphate, which is applied in the fields of pill delivery, antiviral agents, and pharmaceutical formulations

Inactive Publication Date: 2016-12-21
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The tablet can effectively enhance the drug compliance of children and the elderly, and solve the problem of drug administration in special cases (such as under water shortage conditions and patients with dysphagia)

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment approach

[0069] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further describe the present invention in detail.

[0070] The reagents used in the present invention can be purchased from the market or can be prepared by the methods described in the present invention.

Embodiment 1

[0071] Example 1 Effect of different sweeteners on the stability and mouthfeel of oseltamivir phosphate orally disintegrating tablets

[0072] Prescription

[0073]

[0074]

[0075] Preparation:

[0076] Add oseltamivir phosphate, mannitol, sorbitol, microcrystalline cellulose, croscarmellose sodium and povidone into the granulation pot and pre-mix evenly in the prescription amount, and the blade speed of the granulator is 150rpm. The cutter speed is 1500rpm. A peristaltic pump is used to add 17% to 23% by weight of purified water to the premix for granulation. The peristaltic pump speed is 100rpm, the nozzle aperture is 1.0mm, the blade speed of the granulator during the liquid addition and granulation process is 150rpm, and the cutter speed is 3000rpm. Fluidized bed drying is adopted, and the inlet air temperature is 55°C; the dried granules are granulated through a 045R sieve with a comil granulator. In dry granules, add sucralose or sodium saccharin or aspartame ...

Embodiment 2

[0103] Example 2 Research on prescriptions of different specifications of oseltamivir phosphate orally disintegrating tablets

[0104] Prescription

[0105]

[0106] Preparation method with reference to the preparation method of embodiment 1

[0107] The above-mentioned gained oseltamivir phosphate orally disintegrating tablet is carried out mouthfeel investigation, and investigation result and method are as follows:

[0108] Recruit 20 volunteers, take an orally disintegrating tablet orally, without chewing, hold it in the mouth for 30 seconds, and then spit it out. The interval between individual trials is greater than or equal to 1 day; then let the volunteers answer the questions in the questionnaire; evaluate the key issues.

[0109]

[0110]

[0111] The disintegration time and friability of the oseltamivir phosphate orally disintegrating tablets prepared by prescriptions 1 and 6-9 described in Example 2 were carried out.

[0112] Disintegration time and friab...

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Abstract

The invention provides an oseltamivir phosphate tablet and a preparation method thereof. The oseltamivir phosphate tablet contains sucralose, Aspartame or a mixture of sucralose and Aspartame as a sweetening agent, and also contains pharmaceutically acceptable auxiliary materials. The oseltamivir phosphate tablet has good mouthfeel and good stability and is convenient to carry and take. On the other hand, the invention also provides a preparation method of the oseltamivir phosphate tablet. The method is simple and low-cost, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an oseltamivir phosphate tablet and a preparation method thereof. Background technique [0002] Oseltamivir phosphate, chemical name (-)-(3R,4R,5S)-4-acetamide-5-amino-3-(1-ethylpropoxy)cyclohexene-1-carboxylate ethyl ester phosphate. The chemical structural formula is as follows: [0003] [0004] Oseltamivir phosphate has a strong neuraminidase inhibitory activity and is effective against influenza A and B viruses. Information on its properties and preparation methods are disclosed in WO 1998007685 A1 and WO 1996026933 A1. [0005] The currently marketed dosage forms of oseltamivir phosphate include granules, capsules, and dry suspensions. Granules or dry suspensions are suitable for preparation into liquid preparations before use, which is convenient for the elderly, children and people who are not suitable for swallowing. However, oseltamivir phosphate is a ki...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/26A61K47/18A61K47/38A61K31/215A61P31/16
CPCA61K9/0056A61K9/2013A61K9/2018A61K31/215
Inventor 黄心王小芹黄芳芳曾剑游劲松
Owner SUNSHINE LAKE PHARM CO LTD
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