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Claims for Patent: 4,879,303

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Claims for Patent: 4,879,303

Title: Pharmaceutically acceptable salts
Abstract:Improved pharmaceutical salts of amlodipine, particularly the besylate salt, and pharmaceutical compositions thereof. These salts find utility as anti-ischaemic and anti-hypertensive agents.
Inventor(s): Davison; Edward (Margate, GB2), Wells; James I. (Canterbury, GB2)
Assignee: Pfizer Inc. (New York, NY)
Application Number:07/256,938
Patent Claims: 1. The besylate salt of amlodipine.

2. A pharmaceutical composition comprising an antihypertensive, antiischaemic or angina - alleviating effective amount of the besylate salt of amlodipine as claimed in claim 1 together with a pharmaceutically acceptable diluent or carrier.

3. A tablet formulation comprising an anti-hypertensive, antiischaemic or angina - alleviating effective amount of the besylate salt of amlodipine as claimed in claim 1 in admixture with excipients.

4. A tablet formulation as claimed in claim 3 wherein the excipients comprise a compression and, an additive to provide sheen to the tablet, a disintegrant and a lubricant.

5. A tablet formulation as claimed in claim 4 wherein the excipients comprise microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycollate and magnesium stearate.

6. A capsule formulation comprising an antihypertensive, antiischaemic or angina - alleviating effective amount of the besylate salt of amlodipine as claimed in claim 1 in admixture with excipients.

7. A capsule formulation as claimed in claim 6 wherein the excipients comprise an inert diluent, a dried disintegrant and a lubricant.

8. A capsule formulation as claimed in claim 7 wherein the excipients comprise microcrystalline cellulose, dried maize starch and magnesium stearate.

9. A sterile aqueous solution comprising an antihypertensive, antiischaemic or angina - alleviating effective amount of the besylate salt of amlodipine for parenteral administration.

10. A sterile aqueous solution as claimed in claim 9 comprising from 10 to 40% w/v of propylene glycol.

11. A sterile aqueous solution as claimed in claim 9 or claim 10 comprising about 1% w/v sodium chloride.
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