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Felodipine sustained-release tablets

A gentle and long-lasting technology, which is applied in the directions of non-active ingredient medical preparations, pill delivery, cardiovascular system diseases, etc., can solve the problems of incomplete drug release, long plasma half-life, increased dosage, etc., to achieve effective The effect of blood drug concentration, stable blood pressure and blood pressure control

Active Publication Date: 2012-07-11
北京罡吉医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The slow-release material and production process selected in this patent make the drug release incomplete
To make felodipine continue to release for 24 hours under the optimal process, it is necessary to increase the dosage (embodiment 5 is 25mg felodipine) to achieve effective blood drug concentration at the initial stage of administration, and to continue to release for 24 hours, considering Felodipine has a long plasma half-life, which can easily cause drug accumulation, and the prescription has a relatively high risk in clinical application

Method used

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  • Felodipine sustained-release tablets
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] prescription

[0034] Raw materials Prescription amount (g) Felodipine 2.5g Hypromellose (K4M) 50g Hypromellose (E50) 30g lactose 100g Povidone K30 12g Magnesium stearate 2g Colored film coating agent 6g co-production 1000 pieces

[0035] craft

[0036] (1) Sieve felodipine, hypromellose (K4M), hypromellose (E50) and lactose and set aside.

[0037] (2) Prepare povidone K30 ethanol solution as an adhesive and set aside.

[0038] (3) Weigh the prescribed amount of felodipine, hypromellose (K4M), hypromellose (E50), and lactose, mix them, add binder to granulate, add the prescribed amount of magnesium stearate after drying and mix well .

[0039] (4) Tablets.

[0040] (5) Coating: Take the prescribed amount of colored film coating agent to prepare a coating solution (oxygen barrier, light protection). The plain tablets are placed in a coating pan, sprayed with a film coat, and dried....

Embodiment 2

[0043] prescription:

[0044] Raw materials Prescription amount (g) Felodipine 5g Hypromellose (K4M) 50g Hypromellose (E50) 30g lactose 100g Povidone K30 12g Magnesium stearate 2g Colored film coating agent 6g co-production 1000 pieces

[0045] Process:

[0046] (1) Sieve felodipine, hypromellose (K4M), hypromellose (E50) and lactose and set aside.

[0047] (2) Prepare povidone K30 ethanol solution as an adhesive and set aside.

[0048] (3) Weigh the prescribed amount of felodipine, hypromellose (K4M), hypromellose (E50), and lactose, mix them, add binder to granulate, add the prescribed amount of magnesium stearate after drying and mix well .

[0049] (4) Tablets.

[0050] (5) Coating: Take the prescribed amount of colored film coating agent to prepare a coating solution (oxygen barrier, light protection). The plain tablets are placed in a coating pan, sprayed with a film coat, and dri...

Embodiment 3

[0052] prescription:

[0053] Raw materials Prescription amount Felodipine 10g Hypromellose (K4M) 50g Hypromellose (E50) 30g lactose 100g Povidone K30 10g Magnesium stearate 2g Colored film coating agent 6g co-production 1000 pieces

[0054] Process:

[0055] (1) Sieve felodipine, hypromellose (K4M), hypromellose (E50) and lactose and set aside.

[0056] (2) Prepare povidone K30 ethanol solution as an adhesive and set aside.

[0057] (3) Weigh the prescribed amount of felodipine, hypromellose (K4M), hypromellose (E50), and lactose, mix them, add binder to granulate, add the prescribed amount of magnesium stearate after drying and mix well .

[0058] (4) Tablets.

[0059] (5) Coating: Take the prescribed amount of colored film coating agent to make a coating solution (oxygen barrier, light protection). The plain tablets are placed in a coating pan, sprayed with a film coat, and dried.

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Abstract

The invention discloses felodipine sustained-release tablets. The felodipine sustained-release tablets contain felodipine, high-viscosity hydroxypropyl methylcellulose, low-viscosity hydroxypropyl methylcellulose, a water-soluble filling agent, and other pharmaceutical excipients. The invention also discloses a preparation method for the felodipine sustained-release tablets.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to drug slow-release solid preparations. Background technique [0002] Felodipine is a third-generation dihydropyridine calcium antagonist, which is used to treat hypertension by inhibiting the influx of extracellular calcium in arteriolar smooth muscle and reducing peripheral vascular resistance. [0003] Felodipine is white to pale yellow crystal or crystalline powder, odorless and tasteless; unstable when exposed to light. Soluble in acetone, methanol or ethanol, almost insoluble in water. Its chemical name is methylethyl 2,6-dimethyl-4-(2,3-dichlorophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate, and its structural formula is shown in the figure below. [0004] [0005] Felodipine is a dihydropyridine calcium channel antagonist, which was first launched in Denmark in 1988. It is an efficient, safe and well-tolerated drug for treating hypertension. Patients with...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/28A61K31/4422A61K47/38A61P9/12
Inventor 刘超郭艳丽赵婧汪飞高辉
Owner 北京罡吉医药科技有限公司