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Irbesartan dispersible tablet and preparation method thereof

A technology for dispersible tablets and prescriptions, applied in the field of irbesartan dispersible tablets and their preparation, can solve the problem that the combination of auxiliary materials does not well solve the solubility problem of irbesartan, the dissolution rate and stability of irbesartan dispersible tablets problems such as poor tablet weight and related substances increase, to achieve the effect of improving bioavailability, good quality stability, disintegration rate and dissolution rate

Active Publication Date: 2014-04-02
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the hardness of the dispersible tablets we prepared according to this scheme is moderate, the dissolution test is not good, and the tablet weight and related substances have increased greatly during long-term storage. This may be due to the poor combination of excipients in this experimental scheme. Solve the solubility problem of irbesartan, and at the same time, the use of too much lubricant makes it difficult to dissolve the main drug, while povidone is easy to absorb water during storage, and it is easy to increase the weight of the tablet and related substances
In addition, talcum powder is used as a lubricant in this solution, and talc powder has been restricted in the United States because of its potential carcinogenic factors.
[0006] In view of the slow disintegration of the existing irbesartan preparations, the dissolution rate and stability of the irbesartan dispersible tablets prepared by the existing technology are not good, and there are large safety hazards at the same time

Method used

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  • Irbesartan dispersible tablet and preparation method thereof
  • Irbesartan dispersible tablet and preparation method thereof
  • Irbesartan dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1, a kind of irbesartan dispersible tablet, the composition of every 1000 is as follows:

[0047]

[0048] The preparation method is as follows:

[0049] (1) Ingredients, pulverization and sieving: fully mix the prescribed amount of irbesartan, hydroxypropyl cellulose, aspartame, lactose, and microcrystalline cellulose, and pulverize through a 120-mesh sieve to obtain adjuvant mixed powder;

[0050] (2) Granulation: add an appropriate amount of 8% starch slurry to the auxiliary material mixed powder to obtain a soft material, and pass through a 20-mesh sieve to obtain wet granules;

[0051] (3) Drying and granulation blending: dry the wet granules at 50°C-80°C; pass the dried granules through a 30-mesh sieve for granulation, add the prescribed amount of sodium carboxymethyl starch, micropowder silica gel and Polyethylene glycol, after mixing evenly, tableting can obtain the irbesartan dispersible tablet of the present invention;

Embodiment 2

[0052] Embodiment 2, a kind of irbesartan dispersible tablet, the composition of every 1000 is as follows:

[0053]

[0054] The preparation method is as follows:

[0055] (1) Ingredients and crushing and sieving: Weigh the prescribed amount of irbesartan, hydroxypropyl cellulose, aspartame, lactose, and microcrystalline cellulose and fully mix them, and pass through a 120-mesh sieve after crushing to obtain adjuvant mixed powder;

[0056] (2) Granulation: add an appropriate amount of 8% starch slurry to the auxiliary material mixed powder to obtain a soft material, and pass through a 20-mesh sieve to obtain wet granules;

[0057] (3) Drying and granulation blending: dry the wet granules at 50°C-80°C; pass the dried granules through a 30-mesh sieve for granulation, add the prescribed amount of sodium carboxymethyl starch, micropowder silica gel and Polyethylene glycol, after mixing evenly, tableting can obtain the irbesartan dispersible tablet of the present invention;

Embodiment 3

[0058] Embodiment 3, a kind of irbesartan dispersible tablet, the composition of every 1000 is as follows:

[0059]

[0060]

[0061] The preparation method is as follows:

[0062] (1) Ingredients and crushing and sieving: Weigh the prescribed amount of irbesartan, hydroxypropyl cellulose, aspartame, lactose, and microcrystalline cellulose and fully mix them, and pass through a 120-mesh sieve after crushing to obtain adjuvant mixed powder;

[0063] (2) Granulation: add an appropriate amount of 8% starch slurry to the auxiliary material mixed powder to obtain a soft material, and pass through a 20-mesh sieve to obtain wet granules;

[0064] (3) Drying and granulation blending: dry the wet granules at 50°C-80°C; pass the dried granules through a 30-mesh sieve for granulation, add the prescribed amount of sodium carboxymethyl starch, micropowder silica gel and Polyethylene glycol, after mixing evenly, tableting can obtain the irbesartan dispersible tablet of the present in...

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Abstract

The invention belongs to the field of pharmaceutic preparation and in particular relates to an irbesartan dispersible tablet and a preparation method thereof. To overcome the technical defects of the conventional irbesartan preparation, such as poor dissolution rate and low bioavailability, the invention provides the irbesartan dispersible tablet and the preparation method thereof. The irbesartan dispersible tablet is prepared mainly by taking microcrystalline cellulose and lactose as fillers, hydroxypropylcellulose and sodium carboxymethyl starch as a disintegrating agent, aspartame as the favoring agent, 8% starch slurry as a wetting agent, and polyethylene glycol and superfine silica powder as lubricants; and the composition proportion of the components is further optimized. When used for hypertension treatment, the dispersible tablet is high in disintegration speed and high in bioavailability, the production cost is greatly lowered, the stability is high after long-term storage, and therefore the dispersible tablet has good industrial application values and medical application prospects.

Description

technical field [0001] The invention relates to an irbesartan dispersible tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Hypertension has become a major killer of human health. According to the latest estimates, the number of hypertensive people in the world has reached 1.2 billion. About one-third of adults in the United States, or about 80 million people, have high blood pressure. In my country, the number of hypertensive patients has exceeded 300 million, and there is a trend of younger age. With the deepening of people's understanding of hypertension, the development of antihypertensive drugs has also made significant progress. In my country's antihypertensive drug market, there are nearly 100 kinds of clinical hypertension treatment drugs, and the number is still increasing. At present, there are mainly six categories of drugs that have antihypertensive effects internationally recognized: ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4184A61K47/38A61P9/12
Inventor 曹悦兴刘新宁马德重滕学厚
Owner JINAN LIMIN PHARMA
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