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Nitroglycerin sublingual tablet and preparation method thereof

A technology of nitroglycerin and sublingual tablets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, oil/fat/wax non-active ingredients, etc., and can solve the difficult to meet the requirements of powder direct compression, dependence, fluidity no problem

Pending Publication Date: 2021-11-23
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, PVP K30 and PEG400 also have fatal disadvantages: on the one hand, both PVP K30 and PEG400 are easy to absorb moisture, and nitroglycerin sublingual tablets are not coated, so it is easy to absorb moisture from the air and deteriorate; on the other hand, PVP K30 and PEG400 The fluidity of the powder is not good, and it cannot meet the requirements of the powder direct pressing process in the industrial production process.
The powder properties of glyceryl monostearate from different sources vary greatly. The quality of glyceryl monostearate produced by German IOI company is generally good, it is granular, and its fluidity is relatively good, which can meet the requirements of powder direct compression. requirements; glyceryl monostearate produced by GATTEFOSSé in France is in the form of flakes, and after crushing and sieving, its fluidity is not good, and it is difficult to meet the requirements of powder direct compression
That is to say, the patent US06500456B1 adopts powder direct compression technology, which largely depends on the quality and powder properties of glyceryl monostearate, which has certain limitations

Method used

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  • Nitroglycerin sublingual tablet and preparation method thereof
  • Nitroglycerin sublingual tablet and preparation method thereof
  • Nitroglycerin sublingual tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0028] The production of embodiment 1 nitroglycerin sublingual tablet (former prescription)

[0029]Weigh 18.65kg of lactose and put it into a wet granulator. The stirring speed is 120rpm, the cutting speed is 1200rpm, add 3kg 10% nitroglycerin ethanol solution to the liquid addition device, start the liquid addition and finish adding within 90s, and continue to run for 30~60s; the stirring speed is 150rpm, the cutting speed is 1500rpm, and the cutting speed is 30~ 60s, stop and discharge. Spread the granules prepared by the above wet granulation evenly on the baking trays, control the thickness of each tray to no more than 2cm, draw lines horizontally and vertically, turn on the heating, set the heating temperature to 40°C (the control range is 40±5°C), and dry each Turn the material once in about 30 minutes, spread the particles evenly, draw lines horizontally and vertically, and put them back into the oven. Record the temperature about every 30 minutes. After drying for 2 ...

Embodiment 2

[0031] Production of Example 2 Nitroglycerin Sublingual Tablets (Prescription 1)

[0032] Weigh 3 kg of 10% nitroglycerin ethanol solution, add 0.3 kg of polyoxyethylene 40 hydrogenated castor oil to it under stirring, and stir fully to prepare a clear and transparent mixed solution. Weigh 18.15kg of lactose and put it into a wet granulator. The stirring speed is 120rpm, the cutting speed is 1200rpm, add the above mixed solution into the liquid addition device, start the liquid addition and finish adding within 90s, continue to run for 30-60s; material. Spread the granules prepared by the above wet granulation evenly on the baking trays, control the thickness of each tray to no more than 2cm, draw lines horizontally and vertically, turn on the heating, set the heating temperature to 40°C (the control range is 40±5°C), and dry each Turn the material once in about 30 minutes, spread the particles evenly, draw lines horizontally and vertically, and put them back into the oven. ...

Embodiment 3

[0033] Example 3 Production of Nitroglycerin Sublingual Tablets (Prescription 2)

[0034] Weigh 18 kg of 10% nitroglycerin ethanol solution, add 6 kg of polyoxyethylene 40 hydrogenated castor oil to it under stirring, and stir fully to prepare a clear and transparent mixed solution. Weigh 88.2kg of lactose and put it into a wet granulator. The stirring speed is 120rpm, the cutting speed is 1200rpm, the above mixed solution is added to the dosing device, the dosing is started within 200s, and the operation is continued for 60-90s; material. Spread the granules prepared by the above wet granulation evenly on the baking trays, control the thickness of each tray to no more than 2cm, draw lines horizontally and vertically, turn on the heating, set the heating temperature to 40°C (the control range is 40±5°C), and dry each Turn the material once in about 30 minutes, spread the particles evenly, draw lines horizontally and vertically, and put them back into the oven. Record the tem...

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Abstract

The invention discloses a nitroglycerin sublingual tablet and a preparation method thereof, and the preparation method comprises the following steps: dissolving a stabilizer in a 10% nitroglycerin ethanol solution, adding a filler for wet granulation, drying, size stabilization, mixing with a disintegrating agent, a glidant and a lubricant, and directly pressing powder to prepare the nitroglycerin sublingual tablet. Compared with the traditional wet granulation preparation method, the nitroglycerin sublingual tablet prepared by the method has the advantages that the stability of the product is greatly improved, the problem that the nitroglycerin sublingual tablet is easy to volatilize in the storage process is solved, and the safety problems of explosion and the like in the industrial production process are also solved. The product is suitable for preventing and rapidly relieving angina pectoris attack caused by coronary artery diseases.

Description

technical field [0001] The invention relates to a method for improving the stability of a nitroglycerin sublingual tablet. Background technique [0002] Nitroglycerin is a powerful vasodilator for peripheral circulation and coronary arteries, and is a representative drug of nitrates. After nitroglycerin is absorbed in the body, it produces nitric oxide free radicals, activates guanylate cyclase, increases cyclic guanosine monophosphate in smooth muscle and other tissues, and dephosphorylates the myosin light chain that regulates the contraction state of smooth muscle, thereby Causes vasodilation and improves blood supply to the ischemic area. Since Sahreron was first synthesized in 1846, it has been widely used as a common anti-myocardial ischemia and heart failure drug. Nitroglycerin has been used to treat angina pectoris for over a hundred years. Because of its advantages of fast onset of action, definite curative effect, convenient use, and economy, it is still one of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/21A61K47/44A61K47/32A61K47/10A61K47/38A61P9/10
CPCA61K9/2031A61K9/2027A61K9/2054A61K9/006A61K31/21A61P9/10
Inventor 谢斌陈新民刘杰刘彦杉杨冬吴晓斐关东王晓翠焦慎超
Owner 珠海润都制药股份有限公司
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