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|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)|
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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