The preparation method of felodipine slow-release tablet

A kind of gentle and lodipine technology, which is applied in the field of preparation of felodipine sustained-release tablets, can solve the problems of difficult industrialized production, cumbersome process, and high production cost, and achieves the advantages of easy preparation method, high product yield and reduced production cost. Effect

Active Publication Date: 2015-10-07
CHANGZHOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above-mentioned documents, some adopt powder direct compression technology to prepare felodipine sustained-release tablets. Although the process is relatively simple, it will encounter poor fluidity of the powder during large-scale production and affect the content uniformity of the tablet; tablet hardness and Unsatisfactory friability will increase the difficulty of the subsequent coating process
[0004] Some documents have adopted melt granulation technology to prepare felodipine sustained-release tablets. This method has a complicated process and requires special equipment. The production cost is high and it is difficult to realize industrial production.
[0005] The above documents are all applied to the wet granulation process, but they all mix and granulate polymer materials with different viscosities, which makes it difficult to select a suitable binder for wet granulation in large-scale production, and the production cost is high
[0006] At present, there is no patent on the preparation method of Felodipine Sustained-release Tablets using the main drug and some polymer materials to mix and granulate

Method used

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  • The preparation method of felodipine slow-release tablet
  • The preparation method of felodipine slow-release tablet
  • The preparation method of felodipine slow-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of Felodipine Sustained-release Tablets

[0029] prescription:

[0030] Felodipine 5g

[0031] Hypromellose K100LV CR 50g

[0032] Hypromellose K4M CR 28g

[0033] Lactose 115g

[0034] Magnesium Stearate 2g

[0035] 65% ethanol appropriate amount

[0036] A total of 1000 pieces were made

[0037] Preparation Process:

[0038] 1. Preparation of tablet cores: Take felodipine, hypromellose K100LV CR and lactose in the prescribed amount, mix them evenly, add about 80 g of 65% ethanol solution to make soft material, sieve to make wet granules, 50-60 ℃ drying to a water content of 2-3%, granulation, adding the prescribed amount of hypromellose K4M CR, magnesium stearate, tableting, to obtain tablet cores. The content of felodipine is 2.5%.

[0039] 2. Coating: pan-coat with Opadry, increase the weight by 2 to 3%, and make slow-release tablets containing 5 mg of felodipine.

Embodiment 2

[0041] Felodipine 5g

[0042] Hypromellose K100LV CR 29.4g

[0043] Hypromellose K4MCR 10.3g

[0044] Hypromellose K15M CR 11.8g

[0045] Mannitol 59.7g

[0046] Macrogol 6000 29.4g

[0047] Magnesium stearate 0.7g

[0048] Talc powder 0.7g

[0049] 65% ethanol appropriate amount

[0050] A total of 1000 pieces were made

[0051] Preparation Process:

[0052] 1. Preparation of tablet cores: take by weighing felodipine, hypromellose K100LV CR, mannitol, and polyethylene glycol 6000 of the prescribed amount, mix evenly, add about 65g of 65% ethanol solution to make soft material, sieve, Make wet granules, dry at 50-60°C until the L.O.D is 2-3%, granulate, add the prescribed amount of hypromellose K4M CR, hypromellose K15M CR, magnesium stearate and talc, and press into tablets , controlling the tablet hardness to 4-7kg to obtain tablet cores. The main drug content is 3.3%.

[0053] 2. Coating: use Opadry, pan-coat until the tablet core increases in wei...

Embodiment 3

[0055] Felodipine 2.5g

[0056] Hypromellose K4M CR 15g

[0057] Hypromellose K15M CR 5g

[0058] Lactose 16g

[0059] Pregelatinized starch 33g

[0060] Microcrystalline Cellulose 27.5g

[0061] Magnesium stearate 0.5g

[0062] Micronized silica gel 0.5g

[0063] 70% ethanol appropriate amount

[0064] A total of 1000 pieces were made

[0065] Preparation Process:

[0066] 1. Preparation of tablet cores:

[0067] Weigh the prescribed amount of felodipine, hypromellose K4M CR, lactose, pregelatinized starch and microcrystalline cellulose, mix well, add about 50g of 70% ethanol solution to make soft material, and sieve to make wet granules , dried at 50-60°C until the L.O.D is 2-3%, sieved and granulated, added hypromellose K15M CR, magnesium stearate and micro-powdered silica gel in the prescribed amount, and pressed into tablets to control the hardness of the tablets to 3-5kg. Obtain the core. The main drug content is 2.5%.

[0068] 2. Coating: use O...

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Abstract

The invention discloses a preparation method of felodipine sustained release tablets. The method is characterized by comprising the following steps of: mixing felodipine accounting for 1-10 percent of the total component weight, a part of hydroxypropyl methylcellulose accounting for 20-55 percent of the total component weight and a filler; and wetting by using a wetting agent to carry out wet granulation; after wet granules are dried at low temperature, mixing the dried granules with residual hydroxypropyl methylcellulose; adding a lubricating agent and then tabletting to prepare cores containing main drugs; and coating by using a coating material to obtain the felodipine sustained release tablets. The preparation method is easy to control and suitable for industrial scale production, has high product yield and reduces the production cost. Compared with merchant like preparations, the felodipine sustained release tablets obtained by using the preparation method has similar in vitro release curve.

Description

technical field [0001] The invention discloses a preparation method of felodipine sustained-release tablets. Background technique [0002] Felodipine is a novel vascular selective dihydropyridine calcium antagonist. At present, ordinary tablets, which are widely used clinically, often need to be taken 2 to 3 times a day, and there are peaks and valleys in the drug time curve, and the blood drug concentration is too high, resulting in K + Outflow, leading to hypokalemia, felodipine sustained-release tablets only need to be taken once a day, which can effectively control blood pressure without affecting the function of the heart. Compared with ordinary preparations, it is an ideal preparation for the treatment of hypertension. [0003] Now some patents and patent applications have reported some methods for preparing felodipine sustained-release tablets: the publication numbers are CN101103964A, CN 1640400A and CN 101292962A Chinese invention patent application and U.S. Paten...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K9/28A61K31/4422A61P9/12
Inventor 丁盛殷学治
Owner CHANGZHOU PHARMA FACTORY
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