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A kind of composition, the technology of medicine, be used in the preparation field that comprises triptan compound
Active Publication Date: 2015-10-07
DR REDDYS LAB LTD
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Abstract
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Problems solved by technology
[0013] The onset time of existing triptan preparations on the market is less than 30 minutes
Method used
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Embodiment 1
[0192] Embodiment 1: Preparation of "sumatriptan citrate" composition
[0193] process:
[0194] Step i: Preparation of Phosphate Buffer:
[0195] Dissolve 0.2 g disodium hydrogen phosphate and 10.0 g potassium dihydrogen phosphate in enough water to produce 1000 mL of phosphate buffer.
[0196] Step ii: Preparation of 1N NaOH:
[0197] Dissolve 1.0 g of sodium hydroxide in sufficient water to yield 25 mL of 1 N sodium hydroxide.
[0198] Step iii: Preparation of 5N citric acid monohydrate:
[0199] Dissolve 70.04 g of citric acid monohydrate in a sufficient amount of purified water, and make up its volume to 200 mL with purified water.
[0200] Step iv: Add required amount of citric acid monohydrate (5N) solution to required amount of water and mix well to obtain a homogeneous mixture. To this solution is added the required amount of sumatriptan and the mixture is stirred to dissolve the drug.
[0201] Step v: To check the pH of the solution obtained in step iv, add the...
Embodiment 2
[0210] Embodiment 2: Preparation of "sumatriptan phosphate" composition
[0211] By a similar procedure as described in Example 1, a pharmaceutical composition comprising sumatriptan phosphate was prepared using the following amounts of reaction materials.
[0212] Ingredients / Conditions
Embodiment 3-5
[0213] Embodiment 3-5: Preparation of "sumatriptan formate, acetate and maleate" composition
[0214] Compositions of sumatriptan formate, acetate and maleate can be prepared by following the procedure described in Example 1, using appropriate amounts of the reactants and maintaining appropriate pH conditions.
[0215]
[0216] * Used as a solution of (10N) formic acid in water.
[0217] ** Used as a solution of (10N) acetic acid in water.
[0218] *** Used as a solution of (5N) maleic acid in water.
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Abstract
The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described. The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a Tmax substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
Description
technical field [0001] The present invention provides a pharmaceutical composition, which comprises a salt of sumatriptan (sumatriptan) or a pharmaceutically acceptable solvate thereof and a mucosal penetration enhancer (mucosal permeation enhancer); also provides The pharmaceutical composition is used for treating diseases related to cephalic pain. Background technique [0002] Current treatments for migraine headaches include the administration of serotonin 5HT, known collectively as triptans 1B / 1D Agonists, triptans are chemically tryptamine-based drugs. Sumatriptan, the first of its kind to be developed, offers improved potency and tolerability compared to ergot-derived compounds. Following the development of sumatriptan, a large number of second-generation triptans were developed, including zolmitriptan, naratriptan, and rizatriptan. A recent study of migraineurs (those who suffer from two or more migraines per month) showed that sumatriptan nasal spray (IMITREX ) ...
Claims
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Application Information
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