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Nasal dosage forms of dihydroergotamine

A dihydroergotamine and ergotamine nasal technology, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, aerosol delivery, etc., can solve the problem that there is no dihydroergotamine nasal dosage form available And other issues

Pending Publication Date: 2020-02-21
DR REDDYS LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Currently, there is no nasal dosage form of dihydroergotamine available that provides quick and easy administration to provide an effective dose

Method used

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  • Nasal dosage forms of dihydroergotamine
  • Nasal dosage forms of dihydroergotamine
  • Nasal dosage forms of dihydroergotamine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0404] Compositions of dihydroergotamine mesylate (DHE) were prepared as outlined below.

[0405] The time to precipitation (PPT) of the prepared compositions was evaluated.

[0406] Table 1

[0407]

[0408] Preparation:

[0409] The WFI was bubbled with carbon dioxide and the caffeine, DHE and dextrose were dissolved to obtain a clear solution. The volume of the solution was adjusted to the desired level, then filtered. Store the filtered solution in glass vials and close with rubber stoppers and aluminum seals.

Embodiment 4-5

[0411] A composition of dihydroergotamine mesylate was prepared as outlined below. The time to precipitation of the prepared compositions was evaluated.

[0412] Table 2

[0413]

[0414]

[0415] Preparation:

[0416] Add sufficient methanesulfonic acid to the WFI to bring the pH to 3.6 ± 0.2. Dissolve ethanol, glycerol and DHE in WFI to obtain a clear solution. The volume of the solution was adjusted to the desired level, then filtered. Store the filtered solution in glass vials and close with rubber stoppers and aluminum seals.

Embodiment 6-12

[0418] Compositions of dihydroergotamine mesylate containing various stabilizers were prepared as outlined below. The time to precipitation of the prepared compositions was evaluated.

[0419] table 3

[0420]

[0421]

[0422] Preparation:

[0423] Bubble the WFI with nitrogen and dissolve the caffeine, DHE and dextrose to obtain a clear solution. Stabilizers such as methanesulfonic acid, citric acid monohydrate, ammonium acetate, lysine acetate, lysine hydrochloride, ascorbic acid as indicated in the table above are then added. Adjust the volume of the solution to the desired level. The formulation was filtered and the solution was stored in glass vials and closed with rubber stoppers and aluminum seals.

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PUM

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Abstract

The present application relates to a nasal dosage form of dihydroergotamine, wherein the dosage form requires less than about 15 minutes for administration and requires less than four sprays to administer effective dose of dihydroergotamine for treating migraine in human subjects.

Description

technical field [0001] The present application relates to a nasal dosage form of dihydroergotamine, wherein said dosage form requires an administration time of less than 15 minutes and requires less than four sprays to administer an effective dose of dihydroergotamine for the treatment of migraine in a human individual Ergotamine. Background technique [0002] Migraine is a type of headache that is an intense, severely debilitating and often unilateral episodic headache that may be accompanied by aura and is usually associated with neurologic and gastrointestinal symptoms such as nausea, vomiting, Diarrhea, sensitivity to light (photophobia), sound (phonophobia), and smell (osmophilia); sleep disruption and depression. Without treatment, migraines can last anywhere from 4 to 72 hours. [0003] Dihydroergot alkaloid mesylate (DHE) has long been used in the treatment of migraine. For patients with migraine attacks, DHE is administered parenterally. Dihydroergotamine has be...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K47/12
CPCA61K9/0043A61K31/4985A61K47/02A61K47/10A61K47/12A61K47/183A61K47/186A61K47/20A61K47/26A61K47/32A61K47/34A61K9/12A61K47/22A61K31/519A61P25/06
Inventor 阿迪蒂亚·纳拉辛哈·穆尔蒂皮尤什·古普塔阿伦·亚娜维沙尔·瓦拉哈达萨·拉蒂吉里什·卡伦斯拉杰夫·辛格·拉古凡什
Owner DR REDDYS LAB LTD
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