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Preparation method of felodipine sustained release tablets

A felodipine and gentle technology, applied in the field of preparation of felodipine sustained-release tablets, can solve the problems of cumbersome process, difficult industrial production, high production cost, etc., achieve high product yield, easy preparation method, and reduce production cost Effect

Active Publication Date: 2010-09-29
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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  • Preparation method of felodipine sustained release tablets
  • Preparation method of felodipine sustained release tablets
  • Preparation method of felodipine sustained release tablets

Examples

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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] 1000 pieces in total

[0037] Preparation Process:

[0038] 1. Preparation of tablet core: Weigh the prescription amount of felodipine, hypromellose K100LV CR, lactose, mix well, add about 80g of 65% ethanol solution to make soft material, sieve to make wet granules, 50-60 It is dried at °C to a water content of 2 to 3%, granulated, and a prescription amount of hypromellose K4M CR, magnesium stearate is added, and tableted to obtain a tablet core. The content of felodipine is 2.5%.

[0039] 2. Coating: Use Opadry for pan coating, increase the weight by 2 to 3%, and make a sustained-release tablet 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] Polyethylene glycol 6000 29.4g

[0047] Magnesium stearate 0.7g

[0048] Talc 0.7g

[0049] 65% ethanol appropriate amount

[0050] 1000 pieces in total

[0051] Preparation Process:

[0052] 1. Preparation of the tablet core: Weigh the prescription amount of felodipine, hypromellose K100LV CR, mannitol, and polyethylene glycol 6000 and mix them evenly, add about 65g of a 65% ethanol solution to make a soft material, sieving, Make wet granules, dry at 50~60℃ to 2~3% LOD, sizing, add prescription amount of hypromellose K4M CR, hypromellose K15M CR, magnesium stearate and talc, and press , Control the film hardness to 4~7kg to obtain the tablet core. The main drug content is 3.3%.

[0053] 2. Coating: Use Opadry and pan coating until the tablet core increases to 2 to 3% to make a sustained-release tablet containing ...

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] Micro powder silica gel 0.5g

[0063] 70% ethanol appropriate amount

[0064] 1000 pieces in total

[0065] Preparation Process:

[0066] 1. Preparation of tablet core:

[0067] Weigh the prescription amount of felodipine, hypromellose K4M CR, lactose, pregelatinized starch and microcrystalline cellulose, mix them evenly, add about 50g of 70% ethanol solution to make soft material, and sieve to make wet granules , Dried at 50~60℃ until the LOD is 2~3%, sieved and granulated, added the prescribed amount of hypromellose K15M CR, magnesium stearate and finely powdered silica gel, compressed into tablets, controlled the tablet hardness to 3~5kg, Obtain the core. The main drug content is 2.5%.

[0068] 2. Coating: Use Opadry and pan coating until the tablet ...

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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 new type of vascular selective dihydropyridine calcium antagonist. At present, the common tablets that are widely used in clinical practice often need to be taken 2 to 3 times a day, and their drug-time curve has peaks and valleys, 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. It has a significant curative effect, a long-term effect, and a significantly low incidence and degree of adverse reactions It is an ideal preparation for treating hypertension due to its advantages such as common preparations. [0003] Now some patents and patent applications have reported some methods for preparing felodipine sustained-release tab...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4422A61K47/38A61P9/12
Inventor 丁盛殷学治
Owner CHANGZHOU PHARMA FACTORY
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