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Details for Patent: 5,580,580

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Details for Patent: 5,580,580

Title: Formulations and their use in the treatment of neurological diseases
Abstract:Pharmaceutical formulations comprise a mono- or di-aminopyridine active agent for administration on a once- or twice-daily basis for use in the treatment of neurological diseases, in particular multiple sclerosis and Alzheimer's disease. The formulations, which are suitable for oral or percutaneous administration of the active agent, include the active agent in a carrier effective to permit release of the mono- or di-aminopyridine at a rate allowing controlled absorption thereof over, on the average, not less than a 12 hour period and at a rate sufficient to achieve therapeutically effective blood levels over a period of 12-24 hours following administration.
Inventor(s): Masterson; Joseph G. (London, GB), Myers; Michael (Athlone, IE)
Assignee: Elan Corporation, plc (Athlone, IE)
Filing Date:Jun 07, 1995
Application Number:08/479,506
Claims:1. A pharmaceutical formulation for the once-daily, percutaneous administration of a mono- or di-aminopyridine active agent for improving nerve conduction, which formulation comprises said mono- or di-aminopyridine uniformly distributed in a solid, semi-solid or mucilaginous medium which can be placed in intimate contact with the skin of a patient in need thereof, the release of said mono- or di-aminopyridine from said formulation being at a rate allowing controlled absorption thereof over a 24 hour period following topical application of said preparation, said rate being measured in vivo and having a Tmax between 2 and 16 hours.

2. A pharmaceutical formulation according to claim 1, which contains from 10-100 mg of mono- or di-aminopyridine active agent.

3. A pharmaceutical formulation according to claim 1, which contains from 25-75 mg of mono- or di-aminopyridine active agent.

4. A pharmaceutical formulation according to claim 1, wherein the solid, semi-solid or mucilaginous medium comprises a gum selected from the group consisting of guar gum, acacia gum, ghatti gum, karaya gum, tragacanth gum, xanthan gum and mixtures thereof.

5. A pharmaceutical formulation according to claim 1, wherein the solid, semi-solid or mucilaginous medium comprises a synthetic or natural polysaccharide selected from the group consisting of alkylcelluloses, hydroxyalkylcelluloses, cellulose ethers, cellulose esters, nitrocelluloses, dextrin, agar, carrageenan, pectin, furcellaran and starch and starch derivative and mixtures thereof.

6. A pharmaceutical formulation according to claim 1, wherein the solid, semi-solid or mucilaginous medium comprises a polypeptide selected from the group consisting of zein, gelatin, collagen, polygeline and mixtures thereof.

7. A pharmaceutical formulation according to claim 1, wherein the solid, semi-solid or mucilaginous medium comprises and alginate selected from the group consisting of alginic acid, propylene glycol alginate, sodium alginate and mixtures thereof.

8. A pharmaceutical formulation according to claim 1, which includes one or more auxiliary agent(s) selected from the group consisting of an antimicrobial agent, a preservative, an antioxidant, a pH-controlling agent, a plasticizer, a surfactant, an enhancer, a humectant, a local anaesthetic, an anti-irritant agent, rubefacient and mixtures thereof.
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