Efavirenz, lamivudine and tenofovir disoproxil fumarate triple compound tablet middle tablet and preparation method thereof

A technology of tenofovir disoproxil fumarate and efavirenz, which is applied in the field of pharmaceutical preparations, can solve the problems of broken pellets, uncontrollable degree and proportion of broken pellets, and difficult to achieve degradation, so as to prevent degradation, Good dissolution, moderately sized effects

Active Publication Date: 2019-10-11
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process of pellet tableting will inevitably cause some pellets to break during the compression process. The degree and proportion of pellet breakage are very uncontrollable, and it is difficult to achieve contact between tenofovir and the other two main drugs without degradation.
Therefore, developing a new pharmaceutical preparation and its preparation method to solve the degradation caused by the physical contact of the drug is a new topic to be solved urgently.

Method used

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  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triple compound tablet middle tablet and preparation method thereof
  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triple compound tablet middle tablet and preparation method thereof
  • Efavirenz, lamivudine and tenofovir disoproxil fumarate triple compound tablet middle tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Preparation of core part:

[0042] The tenofovir disoproxil fumarate bulk drug is processed through a 40-60 mesh sieve. Tenofovir disoproxil fumarate 150g (50%), anhydrous calcium hydrogen phosphate 127.5g (42.5%), the pregelatinized starch 3g (1%) of adding amount in clean container; Put it into the wet mixing granulator, start stirring and mixing for 3-10 minutes; add an appropriate amount of purified water into the wet mixing granulator, start stirring and shearing granulation, the granulation time is 1.5-3 minutes, until the Soft materials that are suitable for hardness and softness; 18-24 mesh nylon screens are installed on the oscillating granulator, and the soft material prepared in the previous step is slowly added to the oscillating granulator, and wet granules are prepared and put into a drying oven for drying at a temperature of 60°C. Install 18-24 mesh sieves on the swinging granulator, pass the dried granules through the 18-24 mesh swinging granulator for ...

Embodiment 2

[0046] Mix the raw and auxiliary materials according to the ratio of the prescription amount, compress the common tablet and then coat it, and compare it with the sample content of the tablet-in-tablet according to the present invention at 0 o'clock and long-term 3 months respectively under the same conditions. The results showed that there was no significant difference in the content of ordinary tablets and tablets-in-tablets at 0 o'clock, but the content of tenofovir disoproxil fumarate in ordinary tablets decreased significantly in the long-term for 3 months, while the content of tenofovir disoproxil fumarate in tablets-in-tablets The content of fovir dipivoxil remained almost unchanged, the results are shown in Table 1.

[0047] Table 1 Content comparison of tenofovir disoproxil fumarate at 0 hours and long-term for 3 months

[0048] 0 o'clock long term 3 months Triple Compound Ordinary Tablets 98.9％ 90.1％ Triple compound tablet-in-tablet 100.3％ ...

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Abstract

The invention relates to a middle tablet of a triple compound tablet composed of tenofovir disoproxil fumarate, efavirenz and lamivudine in the field of pharmaceutical preparations and a preparation method thereof. The tablet-in-tablet contains a coated tablet core of tenofovir disoproxil fumarate, in which the core is contained by efavirenz, lamivudine and auxiliary materials. The invention solves the problems of degradation and slow dissolution caused by contacting tenofovir disoproxil fumarate with other two raw materials. The tablet-in-tablet preparation method adopted in the present invention can effectively avoid the degradation of tenofovir disoproxil fumarate due to contact with efavirenz and lamivudine, thereby obtaining a good product stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tablet-in-tablet of efavirenz, lamivudine and tenofovir fumarate and a preparation method thereof. Background technique [0002] It has been confirmed by clinical workers and related data that efavirenz, tenofovir disoproxil fumarate and lamivudine preparations have been used in combination in clinical practice, and the combined treatment effect on HIV is better than single use of single preparations One, but in the process of combined use, there will be problems such as difficulty in swallowing and low compliance of patients. [0003] CN103908456A discloses about tenofovir, lamivudine and efavirenz triple compound pellets, in this patent, it is described that tenofovir will be degraded by contacting with other two main ingredients, and the preparation The process prepares the three main drugs into coated pellets and then compresses them into ta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/675A61K31/536A61K31/513A61K9/36A61P31/18
Inventor 宋林邢丹周联波鲍辉李霄曹沛潼陈雅琴王龙李岩那馨竹王金晶
Owner NORTHEAST PHARMA GRP
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