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Glonoin Orally disintegrating tablets preparation of and preparing method thereof

A technology of nitroglycerin and disintegrating tablets, which can be used in medical preparations of non-active ingredients, pill delivery, and pharmaceutical formulations, etc. It can solve problems such as poor quality, difficulty in swallowing by patients, and low bioavailability, and achieve rapid disintegration and dissolution rate, relieve the symptoms of angina pectoris, and improve the effect of drug stability

Inactive Publication Date: 2008-07-30
TIANJIN MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of medicine is currently administered in oral tablets, and its disadvantages are: it is difficult for some patients (such as the elderly and children) to swallow, and the medication is restricted by some special conditions (such as lack of drinking water), which affects the The compliance of drug therapy; second, the disintegration of ordinary tablets is slow, the bioavailability is low, and the process of taking medicine needs to be completed by drinking water and swallowing action, so the existing ordinary nitroglycerin tablets cannot meet the medication requirements of all patients need
Nitroglycerin is highly volatile and is easily affected by factors such as temperature, humidity, and packaging, so nitroglycerin sublingual tablets are quite unstable, and its quality is worrying
In addition, due to the long disintegration time of sublingual tablets, it seriously affects the efficacy of nitroglycerin.

Method used

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  • Glonoin Orally disintegrating tablets preparation of and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription 1:

[0045] The main drug is nitroglycerin solution, and its main drug content is determined according to the weight of the mixture of lactose and xylitol as the auxiliary material in the prescription. The content of the main drug is 0.85ml per 10g of the mixture of lactose and xylitol;

[0046] Excipients and their component weight ratios (excipients and their components weight in g, PVP 30 Alcohol solution in ml)

[0047] Microcrystalline Cellulose 101 40

[0048] Low-substituted hydroxypropyl cellulose 10

[0049] Crospovidone (disintegrant) 6

[0050] Lactose 33

[0051] Xylitol 10

[0052] pvp 30 Alcoholic solution 7.5

[0053] Magnesium Stearate 1

[0054] The main ingredient of this embodiment is glycerol absolute ethanol solution (content 10%), binder PVP 30 Alcoholic solution, is 3g PVP 30 Dissolve in 100ml of 50% ethanol as a binder. Cross-linked povidone is selected as the disintegrant; the ratio of microcrystalline cellulose 101 to lo...

Embodiment 2

[0060] Embodiment 2: the preferred polyvinylpolypyrrolidone of present embodiment is as disintegrating agent, is based on following experiment:

[0061] The coordination of the main drug and the auxiliary materials in the prescription 1 of the above-mentioned embodiment 1 is constant, and the cross-linked povidone, sodium carboxymethyl starch and cross-linked carboxymethyl Sodium cellulose was used as a disintegrant respectively, and three kinds of disintegrating tablets were prepared according to the preparation process of the above-mentioned Example 1, and the disintegration time of the obtained tablets was measured. Table 1 is the experimental data of disintegration time, and Table 2 is the result of mathematical statistics.

[0062] The experimental data of table 1 disintegration time

[0063] group

[0064] Table 2 One-way analysis of variance (disintegration time)

[0065] sum of squares

[0066] The results of variance analysis showed that the di...

Embodiment 3

[0068] According to embodiment 1 prescription 1, the coordination of main ingredient and auxiliary material remains unchanged, and the binder in the auxiliary material prepared by it by weight ratio is made into 3% PVP respectively with 75% ethanol, 50% ethanol, and 0% ethanol 30 Alcoholic solution and 3% PVP 30 Aqueous solution, respectively prepare three kinds of orally disintegrating tablets according to the preparation process of the above-mentioned Example 1. The disintegration time (s) is measured, and Table 3 is the experimental data obtained. Table 4 is the result of mathematical statistics.

[0069] Table 3 Experimental data

[0070] group

[0071] Table 4 One-way analysis of variance (disintegration time)

[0072] sum of squares

[0073] Between groups

[0074] The results of variance analysis showed that the disintegration time of the orally disintegrating tablets made with three different binders was statistically different. Aft...

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Abstract

The invention relates to a nitroglycerin cavity (hypoglossis) disintegrating tablet and a preparation method which mainly adopts water-soluble excipient. When coming across saliva, a disintegrating tablet can be disintegrated rapidly and most of the excipient is dissolved, which can be absorbed into body to recycle by hypoglossis mucosa. The main indigent of the invention is nitroglycerin ethanol solution occupying 10 percent in weight, and the containing weight uses the mixture of lactose and xylitol in every 10g is 0.8 to 0.9ml. The excipient comprises microcrystalline cellulose 101, low-substituted hydroxypropyl cellulose, disintegrant, lactose, xylitol, alcoholic solution of PVP30 and magnesium stearate. The invention adopts a wet method of preparing particle and tablet, combines with blank particle method to mix the blank particles and the particles containing medicine after being made into particles, which changes the traditional method of spraying medicine layer to blank particles and raises the stability of medicine. The pressure of a tabletting machine is adjusted to 1 to 3kg and the disintegration of the pressed tablets is speeded up.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation for treating cardiovascular diseases and a preparation method thereof, in particular to a nitroglycerin orally (sublingual) disintegrating tablet preparation and a preparation method thereof. Background technique: [0002] Heart disease is a common human disease and an important killer of human health. The early manifestation of its onset is angina pectoris. Angina pectoris is a paroxysmal attack, and the pain often gradually increases after it appears, and gradually disappears within 3 to 5 minutes, and rarely exceeds 15 minutes. If it exceeds 15 minutes, the possibility of acute myocardial infarction should be considered. Typical symptoms are squeeze-like or constriction-like pain, accounting for about 60% of angina pectoris patients, often accompanied by anxiety or fear of dying. Atypical symptoms describe the pain as burning or dull pain, but rarely described as needle-like or knife-like pain...

Claims

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Application Information

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IPC IPC(8): A61K31/21A61K9/20A61K47/38A61P9/10
Inventor 房志仲李晓华刘群杨金荣
Owner TIANJIN MEDICAL UNIV
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