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Preparation method of felodipine double-layer osmotic pump controlled-release tablet

A technology of felox and drug layer, which is applied in the field of preparation of osmotic pump-type drug delivery preparations, can solve the problems of reducing drug safety, tablet stability, differential thermal stability, and unfavorable drug effect industrialized production.

Active Publication Date: 2016-01-06
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the osmotic pump preparation of felodipine (ZL200610103992.6) uses polyoxyethylene as a carrier, and a relatively large proportion of surfactant is added to the prescription as a solubilizing substance, and the osmotic pump prepared by using polyoxyethylene as a carrier The preparation has a long time lag and poor thermal stability (glass transition temperature is 65 ~ 67 ℃), which is unfavorable to the rapid exertion and industrial production of the drug effect; the addition of a large proportion of surfactants reduces the efficacy of the drug. Safety and tablet stability

Method used

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  • Preparation method of felodipine double-layer osmotic pump controlled-release tablet
  • Preparation method of felodipine double-layer osmotic pump controlled-release tablet
  • Preparation method of felodipine double-layer osmotic pump controlled-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) Drug-containing layer

[0031]

[0032] The soft material was prepared with 10% PVP-K90 ethanol solution.

[0033] (2) booster layer

[0034]

[0035]

[0036] The soft material was prepared with 10% PVP-K30 ethanol solution.

[0037] A total of 1000 pieces were made.

[0038] (3) Prescription of coating solution

[0039] Cellulose acetate 60g

[0040] Polyethylene glycol 5g

[0041] Proper amount of acetone

[0042] (4) Prescription of moisture-proof coating solution

[0043] Opadry xy-type coating solution 3%

[0044] Preparation:

[0045] 1. Preparation of drug-containing layer particles:

[0046] Pass felodipine and PLASDONES630 through a 200-mesh sieve, add iron oxide yellow, mix well, granulate with 10% PVP-K90 ethanol solution, pass through a 40-mesh sieve, dry at 50°C for 12 hours, add magnesium stearate, Micropowder silica gel and mix well to obtain drug-containing layer granules.

[0047] 2. Preparation of booster layer particles:

[0...

Embodiment 2

[0058] (1) Drug-containing layer

[0059]

[0060] The soft material was prepared with 10% PVP-K30 ethanol solution.

[0061] (2) booster layer

[0062]

[0063]

[0064] The soft material was prepared with 10% PVP-K90 ethanol solution.

[0065] A total of 1000 pieces were made.

[0066] (3) Prescription of coating solution

[0067] Cellulose acetate 60g

[0068] Polyethylene glycol 5g

[0069] Proper amount of acetone

[0070] (4) Prescription of moisture-proof coating solution

[0071] Opadry xy-type coating solution 3%

[0072] Preparation:

[0073] 1. Preparation of drug-containing layer particles:

[0074] Pass felodipine and PLASDONES630 through a 200-mesh sieve, add iron oxide yellow, mix well, granulate with 10% PVP-K30 ethanol solution, granulate through a 40-mesh sieve, dry at 50°C for 12 hours, add magnesium stearate, Micropowder silica gel and mix well to obtain drug-containing layer granules.

[0075] 2. Preparation of booster layer particles:

...

Embodiment 3

[0086] (1) Drug-containing layer

[0087]

[0088] Prepare the soft material with 95% ethanol solution.

[0089] (2) booster layer

[0090]

[0091] The soft material was prepared with 10% PVP-K30 ethanol solution.

[0092] A total of 1000 pieces were made.

[0093] (3) Prescription of coating solution

[0094] Cellulose acetate 60g

[0095] Polyethylene glycol 5g

[0096] Proper amount of acetone

[0097] (4) Prescription of moisture-proof coating solution

[0098] Opadry xy-type coating solution 3%

[0099] Preparation:

[0100] 1. Preparation of drug-containing layer particles:

[0101] Pass felodipine, PVP-K90 and PLASDONES630 through a 200-mesh sieve, add iron oxide yellow, mix well, granulate with 95% ethanol solution, granulate through a 40-mesh sieve, dry at 50°C for 12 hours, add magnesium stearate , Micropowder silica gel, and mix well to obtain drug-containing layer particles.

[0102] 2. Preparation of booster layer particles:

[0103] Grind sodiu...

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Abstract

The invention provides a preparation method of felodipine two-layer osmotic pump controlled release tablet, consisting of a two-layer tablet core and a controlled release semipermeable coating film. The tablet core comprises pharmaceutically acceptable excipients including: Sunvidone VA, sodium starch carboxymethyl, sodium chloride, magnesium stearate, ferric oxide red, ferric oxide yellow and the like; the controlled release semipermeable coating film is composed of one or several kinds of film-forming material, porogenic agent and plasticizing agent. The felodipine controlled release tablet prepared by the invention releases felodipine at a controlled speed, so that the purpose of one-time administration for every day when using the tablet can be achieved.

Description

1. Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of an antihypertensive drug felodipine using copovidone and sodium carboxymethyl starch as main carriers and excipients in an osmotic pump type drug delivery preparation. 2. Background technology [0002] Felodipine (Felodipine, chemical name: 4-(2,3 dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3 pyridinedicarboxylate ethyl methyl ester), is an optional Calcium antagonists, mainly inhibit the inflow of extracellular calcium in arteriole smooth muscle, selectively dilate arterioles, have no effect on veins, do not cause orthostatic hypotension, and have no obvious inhibitory effect on myocardium. While reducing renal vascular resistance, felodipine does not affect glomerular filtration rate and creatinine clearance rate, renal blood flow does not change or even slightly increases, and has natriuretic and diuretic effects. It can increase output volum...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K9/24A61K31/4422A61K47/38A61P9/12
Inventor 吴宗好高宇
Owner HEFEI HUAFANG PHARMA SCI & TECH
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