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Eplerenone dispersible tablet

A technology of eplerenone and dispersible tablets, applied in the field of medicine, can solve the problems of poor stability of liquid preparations, low bioavailability, slow disintegration of solid preparations, etc., and achieves reduction of adverse reactions, avoidance of high drug concentration, and fast absorption. Effect

Active Publication Date: 2016-03-02
HEFEI JIUNUO MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Dispersible tablets refer to tablets that can quickly disintegrate in contact with water to form a uniform aqueous dispersion. They are designed to solve the problems of slow disintegration of solid preparations, poor dissolution, low bioavailability or poor stability of liquid preparations, and inconvenient packaging, transportation, and storage. A new formulation developed by

Method used

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  • Eplerenone dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] 1. Prescription 1: (prescription quantity is 1000 tablets)

[0041]

[0042] 2. Preparation process:

[0043] 1) Pass the active ingredient eplerenone through a 200-mesh sieve;

[0044] 2) Weigh the prescribed amount of eplerenone, and add the prescribed amount of lactose, microcrystalline cellulose, croscarmellose sodium, low-substituted hydroxypropyl cellulose and lauryl Sodium sulfate, mixed evenly; add purified water to moisten the soft material, and granulate with a 24 mesh sieve;

[0045] 3) Wet granules are air-dried at 50-70°C, and sieved with 20 meshes;

[0046] 4) add the lubricant talcum powder and magnesium stearate of prescription quantity, mix homogeneously;

[0047] 5) Tablets.

[0048] The dispersion time limit of the dispersible tablet prepared in this embodiment is 48 seconds, and the dissolution rate is 99.85%.

Embodiment 2

[0050] 1. Prescription 2: (prescription quantity is 1000 tablets)

[0051]

[0052] 2. Preparation process:

[0053] 1) Pass the active ingredient eplerenone through a 200-mesh sieve;

[0054] 2) Weigh the prescribed amount of eplerenone, and add the prescribed amount of lactose, microcrystalline cellulose, croscarmellose sodium, low-substituted hydroxypropyl cellulose and lauryl Sodium sulfate, mixed evenly; add purified water to moisten the soft material, and granulate with a 24 mesh sieve;

[0055] 3) Wet granules are air-dried at 50-70°C, and sieved with 20 meshes;

[0056] 4) add the lubricant talcum powder and magnesium stearate of prescription quantity, mix homogeneously;

[0057] 5) Tablets.

[0058] The dispersion time limit of the dispersible tablets prepared in this example is 1 minute and 19 seconds, and the dissolution rate is 98.34%.

Embodiment 3

[0060] 1. Prescription 3: (prescription quantity is 1000 tablets)

[0061]

[0062]

[0063] 2. Preparation process:

[0064] 1) Pass the active ingredient eplerenone through a 200-mesh sieve;

[0065] 2) Weigh the prescribed amount of eplerenone, and add the prescribed amount of lactose, microcrystalline cellulose, croscarmellose sodium, low-substituted hydroxypropyl cellulose and lauryl Sodium sulfate, mixed evenly; add purified water to moisten the soft material, and granulate with a 24 mesh sieve;

[0066] 3) Wet granules are air-dried at 50-70°C, and sieved with 20 meshes;

[0067] 4) add the lubricant talcum powder and magnesium stearate of prescription quantity, mix homogeneously;

[0068] 5) Tablets.

[0069] The dispersion time limit of the dispersible tablets prepared in this example is 1 minute and 54 seconds, and the dissolution rate is 98.88%.

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Abstract

The invention discloses an eplerenone dispersible tablet, which takes eplerenone as an active drug ingredient and uses a disintegrating agent, a cosolvent and an auxiliary additive as non-active ingredients, wherein the disintegrating agent, the cosolvent and the auxiliary additive are common medicinal dispersible tablet dosage adjuvant materials for preparing the dosage form of the dispersible tablet. The eplerenone dispersible tablet disclosed by the invention can overcome the shortcomings of a conventional eplerenone tablet which, due to slow disintegration, is slow in dissolution, insufficient in absorption, not high in bioavailability and the like; the dispersible tablet can rapidly disintegrate in water so as to form a uniform suspension, and the dispersible tablet can rapidly disintegrate and disperse in gastrointestinal tract; a drug distribution area is enlarged, absorption points are increased and absorption is accelerated, and bioavailability is significantly higher than that of the conventional tablet; and the preparation is stable, more convenient to take, low in adverse reactions and is more suitable for patients of hypertension at various ages.

Description

1. Technical field [0001] The invention relates to a pharmaceutical dosage form, in particular to an eplerenone dispersible tablet, which belongs to the technical field of medicine. 2. Background technology [0002] Eplerenone (Eplerenone, I) is a new generation of selective aldosterone antagonist developed by Pfizer / Pharmacia. It is used to treat patients with stage 1 and stage 2 hypertension. The magnitude was similar to that of enalapril. Eplerenone also has a good antihypertensive effect on patients with essential hypertension with low renin levels who are ineffective by angiotensin-converting enzyme inhibitors and angiotensin II receptor inhibitors. It has a good antihypertensive effect on isolated systolic hypertension, and has a good antihypertensive effect on diet-induced obesity-related hypertension. [0003] [0004] Eplerenone ordinary tablets were first launched in the United States in 2002, under the trade name: For the treatment of hypertension, heart fa...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/585A61K47/38A61K47/36A61K47/32A61K47/20A61K47/26A61P9/12A61P9/04A61P9/10
CPCA61K9/0056A61K9/0095A61K9/2013A61K9/2054A61K31/585
Inventor 吴标柳郁崔红晓施伶俐王章姐
Owner HEFEI JIUNUO MEDICAL TECH
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