Zolmitriptan nasal spray

A technology of zolmitriptan and nasal spray, which is applied in the field of zolmitriptan nasal spray, can solve the problems of drug overdose, multiple economic burdens for patients, and high price, and achieve the prevention of drug overdose and drug abuse, The effect of reducing the requirements of filling equipment and mature processing technology

Inactive Publication Date: 2013-09-11
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages: 1, slow onset, migraine can be relieved 45 minutes after administration; 2, poor oral absorption, low bioavailability (40%)
But there are following defects: 1, the small-capacity spray bottle and the supporting special spray head that zolmitriptan nasal spray adopts are all specially customized, and the precision requirement is high, and the cost of the device itself is relatively high
2. The inner and outer diameters of the small-capacity spray bottles used are very small (less than 1cm), which leads to high precision requirements for equipment in the large-scale industrial production of sprays in pharmaceutical factories. The production line requires high-precision transmission devices and filling equipment, which is expensive
3. Zolmitriptan nasal spray is disposable, and each device can only be sprayed once, and it will be discarded after use, causing a lot of waste and causing too much economic burden to patients
4. The spray bottle used for zolmitriptan nasal spray has a dead volume, and the liquid medicine cannot be completely absorbed. The liquid medicine must be filled according to the volume of 120% to 130% of the theoretical amount to ensure the effective dose, which further increases increased the cost and increased the financial burden on patients
[0006] If adopt the device of conventional multi-dose nasal spray, such as existing commercially available 10ml common spray bottle and spray head, fill into the medicinal liquid of multi-dose, although can reduce cost, because dose in the bottle is more (commercially available) 10ml ordinary spray bottle can hold at least 50 sprays), which can easily lead to overdose of the drug, so the zolmitriptan nasal spray Zomig marketed by AstraZeneca is a single dose of 5mg / support, and each medicine box contains Only 6 sticks are placed, and the drug instructions clearly state that the maximum daily dose is 10mg (ie 2 sticks), and some studies have shown that a dose of 50mg (ie 10 sticks) can produce a sedative effect, so the existing commercially available 10ml Although the way of ordinary spray bottles reduces the cost, it brings hidden dangers of drug overdose and drug abuse

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 1. Prescription (1000 bottles, 0.1ml / spray, 5mg / spray)

[0045]

[0046] Second, the preparation process:

[0047] 1. Liquid preparation: Weigh the raw and auxiliary materials of the prescription amount, add them to 95% of the prescription amount of water, stir to dissolve them, add 1.0mol / L sodium hydroxide solution to adjust the pH value to 5.0, add water to make up the volume, and get .

[0048] 2. Filling: Fill the zolmitriptan aqueous solution prepared above into the attached image 3 In the spray bottle shown, fill each bottle with 0.7ml, tighten the spray head (0.1ml / spray, 5mg / spray), and the final product is attached Figure 5 .

[0049] 3. Tests of effective spray times, spray uniformity and spray residual rate

[0050] The content of main medicine per spray:

[0051] Take a self-made zolmitriptan nasal spray, hold it upright, press the nozzle for a test spray 4 times to activate it, wipe the nozzle, and then spray several times until the amount of spr...

Embodiment 2

[0070] 1. Prescription (1000 bottles, 0.1ml / spray, 5mg / spray)

[0071]

[0072] Second, the preparation process:

[0073] 1. Liquid preparation: Weigh the raw and auxiliary materials of the prescription amount, add them to 95% of the prescription amount of water, stir to dissolve them, add 1.0mol / L sodium hydroxide solution to adjust the pH value to 5.0, add water to make up the volume, and get .

[0074] 2. Filling: Fill the zolmitriptan aqueous solution prepared above into the attached Figure 4 In the spray bottle shown, fill each bottle with 0.7ml, tighten the spray head (0.1ml / spray, 5mg / spray), and the final product is attached Figure 6 .

[0075] 3. Tests of effective spray times, spray uniformity and spray residual rate

[0076] Every spray main ingredient content: with embodiment 1

[0077] Reference substance solution preparation: with comparative example

[0078] Residual main drug content in the bottle:

[0079] Take out all the residual liquid in the sp...

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PUM

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Abstract

The invention provides a zolmitriptan nasal spray which comprises a spray bottle and a spray head and is characterized in that the spray bottle comprises a casing (1) and a liner (2) with the volume of 1.2 ml; the liner shape of the spray bottle is in a shape of a cylinder, the combination of a cylinder and a cylinder plus cone, or the combination of a cylinder plus, a cone and a plug cylinder with a smaller diameter; the casing of the spray bottle has the same shape, size and interface parts with the conventional 10-ml spray device sold in the market; and the spray head adopts the spray head of the conventional 10-ml spray device sold in the market. The zolmitriptan nasal spray has the advantages of few residues, high safety, many effective liquid spraying times, can reduce the production cost, and eliminate medicine waste.

Description

Technical field: [0001] The invention relates to a zolmitriptan nasal spray, in particular to a zolmitriptan nasal spray using a spray bottle with a volume of 1.2ml. Background technique: [0002] Zolmitriptan is a second-generation triptan drug, which is a highly selective and potent 5-HT1B / 1D receptor agonist, which stimulates intracranial blood vessels (including arteriovenous anastomosis) and trigeminal nervous system The 5-HT1B / 1D receptors of sensory nerves can constrict intracranial arteries and inhibit the release of neuropeptides after inflammation, thereby alleviating the onset of migraine. It is currently one of the most ideal drugs for treating migraine. [0003] Zolmitriptan was first marketed abroad (1997) in the form of tablets, the original manufacturer: AstraZeneca, specifications: 2.5mg, 5mg, trade name: Zomig. Advantages of the tablet: the curative effect is clear, and 73% of the patients' migraine can be relieved after 4 hours of administration. Disadva...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M11/00A61J1/05
Inventor 姜庆伟衣伟锋吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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