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Dry granulation method of dry suspension

A dry suspension and granule technology, applied in the field of medicine, can solve the problems of uniform granule molding of unfavorable materials, short production time, material bonding, etc. Effect

Active Publication Date: 2021-05-14
北京阳光诺和药物研究股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Since the raw material of oseltamivir phosphate has viscosity itself, and the excipients xanthan gum and sorbitol used in the prescription have a relatively high viscosity when exposed to water, when wet granulation is used, it is easy to cause material sticking after adding water. It is not conducive to the uniformity of materials and particle forming, etc.
And through the investigation of the influencing factors of the raw materials, it can be known that the raw materials have poor stability under conditions such as humidity and heat, so it is necessary to provide a dry granulation process to avoid the addition of water and drying during the preparation process, and the dry granulation process is easy to operate and short production time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1, dry preparation oseltamivir phosphate dry suspension

[0035] The present embodiment provides the prescription and preparation method of preparing 10,000 bags of oseltamivir dry suspension (specification 15mg), as follows:

[0036] The formulation composition is shown in Table 1:

[0037] Table 1 Composition of Oseltamivir Phosphate Dry Suspension

[0038]

[0039] A dry granulation process was used, as shown in Table 2:

[0040] Table 2 dry granulation process steps

[0041]

[0042]

[0043] Table 3 dry granulation process conditions

[0044] Feeding screw speed 20rpm Roller speed 8rpm Roller pressure 15bar Granulator speed 100rpm Whole sieve aperture 1.5mm

Embodiment 2

[0045] Embodiment 2, dry preparation oseltamivir phosphate dry suspension

[0046] The present embodiment provides the prescription and preparation method of preparing 10,000 bags of oseltamivir dry suspension (specification 15mg), as follows:

[0047] The formulation composition is shown in Table 4:

[0048] Table 4 Composition of Oseltamivir Phosphate Dry Suspension

[0049]

[0050] A dry granulation process was used, as shown in Table 5:

[0051] Table 5 dry granulation process steps

[0052]

[0053]

[0054] The samples prepared according to this process were investigated for different xanthan gum dosages, and the results of the dissolution assay were as shown in Table 6:

[0055] The dissolution results of the oseltamivir phosphate dry suspension of the prescriptions 1-3 of table 6

[0056] Dissolution Results (%) 5min 10min 15min 20min 30min prescription 1 95 99 99 99 99 prescription 2 97 98 99 99 99 prescriptio...

Embodiment 3

[0058] Embodiment 3, dry preparation oseltamivir phosphate dry suspension

[0059] The present embodiment provides a recipe and a preparation method for preparing 10,000 bags of oseltamivir dry suspension (specification 15mg). Since the amount of xanthan gum in the recipe is small, the xanthan gum in the recipe is dried to a moisture content of less than 1 %,details as follows:

[0060] The formulation composition is shown in Table 7:

[0061] The composition of table 7 oseltamivir phosphate dry suspension

[0062]

[0063] A dry granulation process was used, as shown in Table 8:

[0064] Table 8 dry granulation process steps

[0065]

[0066]

[0067] The prepared xanthan gum is not subjected to the sample of drying treatment method for dissolution investigation and the results are as follows:

[0068] Table 10 Dissolution results of the oseltamivir phosphate dry suspensions of formulation 4 and formulation 5

[0069] Dissolution Results (%) 5min 10m...

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Abstract

The invention discloses a dry suspension and a dry granulation method thereof. The oseltamivir phosphate dry suspension is prepared from the following components: oseltamivir phosphate, xanthan gum, sorbitol, sodium dihydrogen citrate, essence, titanium dioxide and aspartame, the oseltamivir phosphate dry suspension is prepared from the following components in parts by mass: 4 parts of oseltamivir phosphate, 1 to 3 parts of xanthan gum, 70 to 90 parts of sorbitol, 3 to 8 parts of sodium dihydrogen citrate, 1 to 3 parts of essence, 1 to 3 parts of titanium dioxide and 0.1 to 0.5 part of aspartame. According to the invention, sorbitol is divided into two parts to be added, so that the dry granulation time is shortened, and the product can be quickly dissolved. According to the invention, a dry granulation process is adopted, so that the influence of water addition and heating drying required by wet granulation on the stability of the product is avoided, the stability of the product is improved, the production time is shortened, the production efficiency is improved, and large-scale production is facilitated.

Description

technical field [0001] The invention relates to a dry granulation method of a dry suspension, belonging to the technical field of medicine. Background technique [0002] Because the raw material of oseltamivir phosphate itself has viscosity, and the excipients xanthan gum and sorbitol used in the prescription have high viscosity when exposed to water, so when wet granulation is used, it is easy to cause material adhesion after adding water. It is not conducive to the uniformity of materials and particle formation. And through the investigation of the influencing factors of the raw materials, it can be seen that the stability of the raw materials is poor under conditions such as humidity and heat, so it is necessary to provide a dry granulation process, which avoids adding water and drying in the preparation process, and is easy to operate using the dry granulation process. And the production time is short. SUMMARY OF THE INVENTION [0003] The purpose of the present inve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/215A61K9/10A61K47/26
CPCA61K31/215A61K9/1623A61K9/1682A61K9/10
Inventor 郑柏松韩琳琳刘宇晶佟德全罗桓谌宗永
Owner 北京阳光诺和药物研究股份有限公司
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