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Nifedipine double-layer osmotic pump medicinal composition and preparation technology thereof

An osmotic pump and composition technology, applied in the field of single-chamber double-layer osmotic pump controlled-release pharmaceutical composition and its preparation, can solve the problems of poorly maintained uniformity, slow tablet core hydration rate, and difficult-to-control controlled-release tablets Issues such as batch-to-batch consistency

Active Publication Date: 2015-01-21
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, many methods and ideas have emerged in the field of single-chamber, double-layer osmotic pump core design. The common problem is that the hydration rate of the core prepared by polyoxyethylene polymer material is slow, and the time lag of drug release is relatively slow. Although the tablet core prepared with lower low molecular weight excipients has a faster early hydration rate, it cannot maintain the uniformity of the later release rate and the earlier release rate well, and it is more difficult to control the controlled release in the mass production process Lot-to-lot consistency

Method used

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  • Nifedipine double-layer osmotic pump medicinal composition and preparation technology thereof
  • Nifedipine double-layer osmotic pump medicinal composition and preparation technology thereof
  • Nifedipine double-layer osmotic pump medicinal composition and preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] (1) Drug-containing layer

[0045]

[0046]

[0047] Prepare soft materials with 10% PVPK30 ethanol solution

[0048] (2) booster layer

[0049] Polyoxyethylene (molecular weight 5 million) 60g

[0050] HPMC (K4M) 12.4g

[0051] Sodium chloride 16g

[0052] Iron Oxide Red 1.72g

[0053] Prepare soft materials with 10% PVPK30 ethanol solution

[0054] (3) Prescription of coating solution

[0055] Cellulose acetate (398-10NF) 60g

[0056] PEG 4000 6g

[0057] DEP10%

[0058] Proper amount of acetone

[0059] Preparation:

[0060] 1. Preparation of drug-containing layer particles:

[0061] Grind nifedipine, polyoxyethylene (molecular weight: 200,000) and sodium lauryl sulfate into fine powder, pass through a 100-mesh sieve, mix well, make a soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve Granules, dried at 45°C for 12 hours, added with 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing ...

Embodiment 2

[0071] (1) Drug-containing layer

[0072]

[0073] Prepare soft materials with 10% PVPK30 ethanol solution

[0074] (2) booster layer

[0075] Polyoxyethylene (molecular weight 5 million) 60g

[0076] HPMC (K4M) 12.4g

[0077] Sodium chloride 16g

[0078] Iron Oxide Red 1.72g

[0079] Prepare soft materials with 10% PVPK30 ethanol solution

[0080] (3) Prescription of coating solution

[0081] Cellulose acetate (398-10NF) 60g

[0082] PEG 4000 6g

[0083] DEP10%

[0084] Proper amount of acetone

[0085] Preparation:

[0086] 1. Preparation of drug-containing layer particles:

[0087] Grind nifedipine, polyoxyethylene (molecular weight: 300,000) and sodium lauryl sulfate into fine powder, pass through a 100-mesh sieve, mix well, make a soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve Granules, dried at 45°C for 12 hours, added with 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing layer gran...

Embodiment 3

[0097] (1) Drug-containing layer

[0098]

[0099] Prepare soft materials with 10% PVPK30 ethanol solution

[0100] (2) booster layer

[0101] Polyoxyethylene (molecular weight 5 million) 60g

[0102] HPMC (K4M) 12.4g

[0103] Sodium chloride 16g

[0104] Iron Oxide Red 1.72g

[0105] Prepare soft materials with 10% PVPK30 ethanol solution

[0106] (3) Prescription of coating solution

[0107] Cellulose acetate (398-10NF) 60g

[0108] PEG 4000 6g

[0109] DEP10%

[0110] Proper amount of acetone

[0111] Preparation:

[0112] 1. Preparation of drug-containing layer particles:

[0113] Grind nifedipine, polyoxyethylene (molecular weight: 200,000) and poloxamer 188 into fine powder, pass through a 100-mesh sieve, mix well, make soft material with 10% povidone ethanol solution, pass through a 40-mesh sieve to granulate , dried at 45°C for 12 hours, added 1% magnesium stearate and 0.5% silicon dioxide, and mixed evenly to obtain drug-containing layer granules. The...

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Abstract

The invention provides a nifedipine double-layer osmotic pump medicinal composition and a preparation technology thereof. The composition comprises a double-layer tablet core and a controlled release coating membrane thereof, wherein the double-layer tablet core is composed of pharmaceutically acceptable excipients and comprises one or more than one of a macromolecular suspending aid substance, an osmotic pressure active substance, a permeation enhancer, a dissolving aid substance, a colorant, a macromolecule swelling substance, a lubricant, a flow aid, an adhesive and a solvent; and the controlled release coating membrane is composed of one or more than one of a membrane forming material, a pore-forming agent and a plasticizer. The nifedipine double-layer osmotic pump medicinal composition prepared by the invention can effectively control a medicament to release in a specific time so that the medicament taking time can be decreased.

Description

1. Technical field [0001] The invention relates to a controlled-release pharmaceutical preparation, in particular to a single-chamber double-layer osmotic pump controlled-release pharmaceutical composition of an antihypertensive drug nifedipine and a preparation method thereof. 2. Background technology [0002] Nifedipine (NIFEDIPINE), chemical name: dimethyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate, is calcium One of the ion antagonists, it has the strongest effect on dilating coronary arteries and peripheral arteries, and has a significant effect on inhibiting vasospasm. It is the drug of choice for variant angina pectoris. It also has a good effect on intractable and severe hypertension. Because it can reduce afterload, it also has good curative effect on refractory congestive heart failure and is suitable for long-term use. In addition, it is also suitable for patients with angina pectoris suffering from airway obstructive diseases, and its ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K9/24A61K9/44A61P9/12
Inventor 吴宗好高宇
Owner HEFEI HUAFANG PHARMA SCI & TECH
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