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Nifedipine controlled release tablet and preparation method thereof

A technology of nifedipine and tablet cores, applied in the field of nifedipine controlled-release tablets and its preparation, can solve problems such as hindering industrial production and complicated preparation process

Active Publication Date: 2016-03-23
XINAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, in these osmotic pump preparations, in addition to functional excipients such as permeation enhancers and permeation-promoting polymers, other materials are added to control the drug release behavior in the drug-containing layer. For example, the patent CN101869555A adds functional excipients In addition to polyoxyethylene, the diluent hypromellose is also added; although some studies have used new excipients instead of polyoxyethylene, in order to achieve the effect of polyoxyethylene, it is necessary to use a mixture of two or more excipients , these excessive auxiliary materials make the preparation process too complicated, hindering its industrial production

Method used

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  • Nifedipine controlled release tablet and preparation method thereof
  • Nifedipine controlled release tablet and preparation method thereof
  • Nifedipine controlled release tablet and preparation method thereof

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preparation example Construction

[0082] The present invention also provides a preparation method of nifedipine controlled-release tablets, comprising the following steps:

[0083] A) mixing 5-45% of nifedipine, 25%-85% of suspending agent, 1-25% of penetration enhancer and 0.5-10% of lubricant to obtain the drug-containing layer material;

[0084] Mixing 45-90% of permeation-enhancing polymer, 5-45% of permeation-enhancing agent, 0.1-4% of coloring agent and 0.1-10% of lubricant to obtain the booster layer material;

[0085] B) compressing the drug-containing layer material and the booster layer material in the step A) to obtain a double-layer tablet core;

[0086] C) Mix the film-forming material, the porogen and the solvent to obtain a coating solution, and use the coating solution to coat the double-layer tablet core obtained in the step B) to obtain a coated tablet. The film-forming The mass ratio of material and porogen is 100: (5-30);

[0087] D) perforating one side of the drug-containing layer of th...

Embodiment 1

[0100] Drug-containing layer prescription (amount per tablet):

[0101]

[0102] Booster layer prescription (amount per tablet):

[0103]

[0104] Controlled release coat prescription (1000 tablets):

[0105]

[0106] Shading layer prescription (1000 tablets):

[0107] Opadry 85G689189g;

[0108] 200g of water.

[0109] According to the above formula, each component of the drug-containing layer and each component of the booster layer were mixed separately for 10 minutes without adding a lubricant, and then mixed separately for 3 minutes after adding a lubricant, and the uniformly mixed drug-containing layer and booster layer were taken. Push layer material, use 9.0mm shallow concave abrasive tool to press double-layer tablet, tablet core hardness is 4kg / mm 2 ;

[0110] The compressed double-layer tablet core is covered with a semi-permeable film, the solid content of the controlled-release coating coating solution is 5%, the tablet bed temperature is 20° C., and ...

Embodiment 2

[0115] Drug-containing layer prescription (amount per tablet):

[0116]

[0117] Booster layer prescription (amount per tablet):

[0118]

[0119] Controlled release coat prescription (1000 tablets):

[0120] Opadry 19000430g;

[0121] Acetone 1000g;

[0122] 90g of water;

[0123] Shading layer prescription (1000 tablets):

[0124] Opadry 85G689188.5g;

[0125] 190g of water.

[0126] According to the above formula, the components of the drug-containing layer and the components of the booster layer were mixed for 15 minutes without adding lubricant, and then mixed for 5 minutes after adding lubricant, and the uniformly mixed drug-containing layer and booster layer were taken. Push layer material, use 9.0mm shallow concave abrasive tool to press double-layer tablet, tablet core hardness is 6kg / mm 2 ;

[0127] The compressed double-layer tablet core is coated with a semi-permeable film, the solid content of the coating solution of the controlled-release coating ...

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Abstract

The invention provides a nifedipine controlled release tablet. The nifedipine controlled release tablet comprises a tablet core and a coating wrapping the tablet core, wherein the tablet core comprises a medicated layer and a booster layer compounded with the medicated layer; a drug release hole is formed in the coating on the medicated side; the medicated layer comprises the following ingredients by mass percent: 5-45 percent of nifedipine, 25-85 percent of a suspending agent, 1-25 percent of a penetration enhancer and 0.5-10 percent of a lubricant; the booster layer comprises the following ingredients by mass percent: 45-90 percent of a penetration enhancing polymer, 5-45 percent of a penetration enhancer, 0.1-4 percent of a coloring agent and 0.1-10 percent of a lubricant; the coating comprises a film forming material and a pore-foaming agent, and the mass ratio of the film forming material to the pore-foaming agent is 100:(5-30). The nifedipine controlled release tablet is simple in composition and good in controlled release effect. The invention further provides a preparation method of the nifedipine controlled release tablet.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a nifedipine controlled-release tablet and a preparation method thereof. Background technique [0002] Nifedipine was first developed and marketed by German Bayer Company in the 1970s. After years of clinical application and in-depth research, nifedipine has become one of the first-selected drugs for the clinical treatment of hypertension and angina pectoris. Nifedipine has strong photosensitivity, and a disproportionation reaction will occur in the molecule when it sees light to generate nitro or nitrosophenylpyridine derivatives. Common preparations of nifedipine reflexively cause increased heart rate, activation of the sympathetic nervous system, adverse reactions such as unfavorable control of myocardial ischemia and heart failure, and require frequent administration, making it difficult to meet the medication needs of patients. Therefore, the common prep...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/22A61K31/4422A61P9/12A61P9/10
CPCA61K9/0002A61K9/2086A61K9/2866A61K31/4422
Inventor 蒲道俊李标余春梅白镇亚赵强邱晓丽向俭吴强
Owner XINAN PHARMA
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