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Liquid pharmaceutical composition containing triptan compound and xylitol

A pharmaceutical composition and composition technology, applied in the field of aqueous liquid pharmaceutical composition, can solve problems such as instability of liquid pharmaceutical composition

Inactive Publication Date: 2011-11-30
ALMIRALL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these sweeteners are not always completely effective in hiding the API's unpalatable taste
[0009] However, some APIs that are unstable to light and / or oxidation ( such as triptans) are particularly unstable when present in liquid pharmaceutical compositions that require long-term storage under unfavorable temperature and humidity conditions

Method used

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  • Liquid pharmaceutical composition containing triptan compound and xylitol
  • Liquid pharmaceutical composition containing triptan compound and xylitol
  • Liquid pharmaceutical composition containing triptan compound and xylitol

Examples

Experimental program
Comparison scheme
Effect test

example 1- 1

[0081] Example 1 - One Week Stress Stability Test

[0082] Aqueous liquid compositions of almotriptan malate in combination with different sweeteners (Table 1 ) were evaluated for physical and chemical stability using a stability screening test at 50°C over a period of one week.

[0083] To prepare each composition, 17.5 mg of almotriptan D, L hydrogen malate was weighed and dissolved in purified water in a 10 ml tubular amber vial. A sweetener or mixture of sweeteners is added to the mixture. After homogenization, the composition was stored at 50°C for 1 week.

[0084] The presence of almotriptan oxidized impurities was followed by High Performance Liquid Chromatography (HPLC) assay. The results are shown in Table 1.

[0085] The total amount of oxidative impurities should be as low as possible, preferably below 0.1% by weight of the amount of almotriptan. In addition, the amount of various impurities (impurity 1 and impurity 2) should also be as low as possible.

[008...

example 2-6

[0094] Example 2-6 months accelerated stability test

[0095] The following composition, Composition 3 (9.5 grams), was prepared and packed into stick packs (polyester 12 microns - Al 9 microns - polyethylene 50 microns):

[0096] -D, L Hydrogen Malate Almotriptan 17.5mg

[0097] - Xylitol 4750mg

[0098] - Fragrance in moderation

[0099] - Pure water added to 100%.

[0100] To prepare the composition, 17.5 mg of almotriptan D,L hydrogen malate were weighed and dissolved in purified water. A fragrance is added to the mixture. After homogenization, xylitol was added. Finally, after homogenization, the composition was stored for 6 months at 40° C. and 75% relative humidity (RH).

[0101] The presence of almotriptan oxidation impurities was followed by HPLC. The results are shown in Table 2.

[0102] Table 2 - Stability of an aqueous liquid composition of D, L hydrogen malate almotriptan combined with xylitol stored at 40°C and 75% RH for 6 months

[0103]

[0104]...

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Abstract

The present invention provides an aqueous liquid pharmaceutical composition comprising a) at least one triptan compound, a pharmaceutically acceptable salt or hydrate thereof, and b) xylitol.

Description

【Technical field】 [0001] The present invention relates to an aqueous liquid pharmaceutical composition comprising at least one triptan compound and xylitol. The compositions do not exhibit the inherent bitterness of triptan compounds and are significantly more stable than compositions comprising other polyols. The invention also relates to a method of preparing said composition and a method of treatment by administering said composition. 【Background technique】 [0002] Migraine is a class of headaches that is a severe, debilitating, and usually unilateral form of episodic headache, the onset of which may be preceded by aura and is often associated with neurological and gastrointestinal symptoms such as Nausea, vomiting, diarrhea, sensitivity to light (photophobia), sound sensitivity (phonophobia), and smell sensitivity (osmophilia); sleep disturbance, and depression. Without treatment, migraine attacks can last from 4 to 72 hours. [0003] Currently, migraine treatment is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K31/4045
CPCA61K9/0095A61K31/4045A61K47/26A61P25/06A61K9/08A61K31/70
Inventor 贝戈尼亚·杜阿尔特·洛佩斯佩雷·吉罗·科利安东尼·马索·卡沃内利
Owner ALMIRALL
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