Preparation method of oseltamivir phosphate capsule

A technology of oseltamivir phosphate and capsules, which is applied in the field of preparation of oseltamivir phosphate capsules, can solve problems such as poor dissolution uniformity, and achieve the effects of ensuring uniformity and ensuring dissolution uniformity.

Active Publication Date: 2020-06-19
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the problem of poor dissolution uniformity in the existing oseltamivir phosphate capsule preparation technology, and reduce the influence of drug dissolution rate changes on drug onset time

Method used

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  • Preparation method of oseltamivir phosphate capsule
  • Preparation method of oseltamivir phosphate capsule
  • Preparation method of oseltamivir phosphate capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: The influence of same prescription, different preparation methods on dissolution uniformity

[0051] 1. Prescription information

[0052]

[0053] 2. Different preparation methods

[0054] Adopt different preparation methods to prepare respectively the capsules of 2500 grain amounts, concrete method is as follows:

[0055] Method A:

[0056] (1) Weigh the prescription amount of oseltamivir phosphate, pregelatinized starch, povidone K30, croscarmellose sodium and prescription amount of talcum powder and place them in the wet mixing granulator, mix at 100rpm 5min.

[0057] (2) Weigh an appropriate amount of purified water as a wetting agent.

[0058] (3) Add the wetting agent described in step (2) into the wet mixing granulator, mix at 150rpm for 2min, and granulate.

[0059] (4) After drying the granules obtained in step (3), add the prescribed amount of sodium stearyl fumarate, and mix for 5 minutes to obtain a mixture.

[0060] (5) Fill capsules ...

Embodiment 2

[0080] Embodiment 2: The impact of the proportion of glidants added in batches on the uniformity of dissolution

[0081] Adopt the prescription of Example 1 and the preparation method of method C, only change the addition ratio of the glidant twice (see Table 3 for the specific ratio, the percentage of the prescription), and other conditions are exactly the same, and prepare 2500 capsules. Each group took 12 capsules respectively, and adopted the same method as in Example 1 to detect the dissolution rate, and the results are shown in Table 4.

[0082] Table 3 Different proportions of glidants

[0083] Example Glidant for mixing in step (1) Glidant for mixing in step (4) 2-1 30％ 70％ 2-2 40％ 60％ 2-3 50％ 50％ 2-4 60％ 40％ 2-5 70％ 30％

[0084] Table 4 Dissolution Data

[0085]

[0086]

[0087] As can be seen from Table 3 and Table 4, first mix 30%-70% glidant with bulk drug, filler, binder, and disintegrant, then add water to g...

Embodiment 3

[0088] Embodiment 3: the influence of different excipients on dissolution uniformity

[0089] According to the following prescription, the preparation process of Example 2-3 was used to prepare 2500 tablets. And the method in Example 1 was adopted to detect the content uniformity and dissolution rate of the following prescriptions, and the results are shown in Table 5.

[0090] prescribing information

[0091]

[0092] Table 5 Dissolution Data

[0093]

[0094]

[0095] As can be seen from Table 5, changing the type of adjuvant in the prescription, using the method C of the present invention can also control the RSD of the dissolution rate at each detection time point within 10%, and the dissolution uniformity of the preparation is better. It is suggested that the way of adding glidant is the key factor to improve the dissolution uniformity of oseltamivir phosphate capsules.

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Abstract

The invention provides a preparation method of an oseltamivir phosphate capsule. By controlling the adding manner and adding amount of a flow aid, the dissolution uniformity of medicines is effectively improved, and the effects of the change of the dissolution speed of the medicines on the effect taking time of the medicines are reduced.

Description

technical field [0001] This patent relates to the field of pharmaceutical preparations, in particular to a preparation method of oseltamivir phosphate capsules. Background technique [0002] Oseltamivir phosphate is a prodrug of oseltamivir carboxylate, and its active metabolite (oseltamivir carboxylate) is a potent and selective influenza virus neuraminidase inhibitor. The compound is active against the neuraminidases of both influenza A and B viruses. Oseltamivir phosphate has high efficacy in the treatment of influenza A and B in adults and children aged 1 and over, and in the prevention of influenza A and B in adults and adolescents aged 13 and over, and is very well developed value. [0003] Oseltamivir Phosphate is a drug developed by Roche for the treatment and prevention of influenza A and B viruses. The inventors of the present application investigated the dissolution behavior of commercially available oseltamivir phosphate capsules, and found that the dissolutio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/215A61P31/16
CPCA61K9/1652A61K31/215A61P31/16
Inventor 张丹丹杨敏路新新宗娜刘晓争李漫
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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