Orally disintegrating Nifedipine prepn and its recipe

A technology of dipine prescription and nifedipine, applied in the field of pharmaceutical preparations and orally disintegrating tablet dosage forms

Inactive Publication Date: 2003-03-19
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

O / W nifedipine cream can also achieve the same effect with the help of transdermal enhancer, but because nifedipine has light instability, so the cream must be protected from light during preparation and use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Prescription 1

[0022] Nifedipine (NFDP) 3.1%

[0023] Polyethylene glycol 6000 (PEG6000) 6.2%

[0024] Starch 62.1%

[0025] Dextrin 15.52%

[0026] Low-substituted hydroxypropylmethylcellulose (L-HPC) 8.69%

[0027] Mannitol 3.1%

[0028] Talc 1.24%

[0029] Preparation: Weigh each component. First heat and melt PEG6000, add NFDP powder that has been crushed through an 80-mesh sieve in advance, stir and mix, then quench the melt at low temperature to solidify, crush and sieve. Add starch, dextrin, L-HPC, mannitol, wet granulate, add talcum powder to compress.

[0030] The disintegration time limit is 0.5h, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30 minutes is 38.7%.

Embodiment 2

[0032] Prescription 2

[0033] Nifedipine (NFDP) 3.97%

[0034] Polyethylene glycol 6000 (PEG6000) 9.93%

[0035] Polyethylene glycol 4000 (PEG4000) 1.98%

[0036] Microcrystalline Cellulose (MCC) 63.49%

[0037] Low-substituted hydroxypropylmethylcellulose (L-HPC) 15.87%

[0038] Mannitol 3.97%

[0039] Magnesium Stearate 0.79%

[0040] Preparation: Weigh each component. First heat and melt PEG6000 and PEG4000, add NFDP powder that has been crushed through an 80-mesh sieve, stir and mix well, then quench and solidify the melt at low temperature, crush and sieve, add MCC, L-HPC, and mannitol for wet granulation, add Lubricant magnesium stearate for tableting.

[0041] The disintegration time limit is greater than 2min, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30min is 58.47%.

Embodiment 3

[0043] Prescription 3

[0044] Nifedipine (NFDP) 3.74%

[0045] Polyethylene glycol 6000 (PEG6000) 7.49%

[0046] Microcrystalline Cellulose (MCC) 59.93%

[0047] Low-substituted hydroxypropylmethylcellulose (L-HPC) 14.98%

[0048] Cross-linked polyvinylpyrrolidone (PPVP) 9.36%

[0049] Mannitol 3.75%

[0050] Magnesium Stearate 0.75%

[0051] Preparation: Weigh each component. First heat and melt PEG6000, add NFDP powder that has been crushed through an 80-mesh sieve in advance, stir and mix, then quench and solidify the melt at low temperature, crush and sieve, add MCC, L-HPC, PPVP, mannitol for wet granulation, add Lubricant magnesium stearate for tableting.

[0052] The disintegration time limit is greater than 30s, and the dissolution rate of 1% sodium dodecylsulfonate solution at 37°C in 30 minutes is 80.41%.

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PUM

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Abstract

The recipe of orally disintegrating Nifedipine preparation includes Nifedipine, solid dispersing carrier, stuffing, disintegrating agent, corrective, lubricant, etc. The present invention aims at providing one kind of orally disintegrating Nifedipine preparation with simple preparation process, easy administration, quick effect and obvious treating effect. The present invention reaches the said aim via the synergetic effect of solid dispersing carrier and disintegrating agent. After being taken, the preparation of the present invention is disintegrated in oral cavity into fine powder and this is favorable to the resolution and absorption of the medicine. The preparation is easy to take, especially for special patient with dysphagia.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to a dosage form of orally disintegrating tablets, in particular to an orally disintegrating tablet of nifedipine with quick-release effect. Background technique [0002] Nifedipine (nifedipine NFDT), the chemical name is 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate dimethyl Hydropyridine calcium channel blockers are first-line drugs for the treatment of cardiovascular system diseases. Colic, duodenal ulcer, acute pancreatitis, acute diarrhea, gastrointestinal spasmodic colic, severe pneumonia in children with heart failure, bronchial asthma, threatened abortion, threatened premature delivery, pregnancy-induced hypertension, dysmenorrhea, vascular headache, Hemorrhagic stroke, cerebral infarction, etc. At present, considering the needs of the condition and treatment, nifedipine has been made into various dosage forms and administered in various ways. Because ni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4422A61P9/10A61P9/12
Inventor 梁文权邱利焱
Owner ZHEJIANG UNIV
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