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|Title:||Effervescent compositions comprising bisphosphonates and methods related thereto|
|Abstract:||The invention provides effervescent composition comprising a bisphosphonate, an acidic compound, an alkaline effervescing component, and optionally an anti-ulcer agent and methods of treating osteoporosis in a mammal using the effervescent compositions.|
|Inventor(s):||Rosen; Christer (Tequesta, FL)|
1. An effervescent composition comprising: (a) 50 mg to 120 mg alendronate (b) citric acid, and (c) an alkaline effervescing component which is a carbonate salt or a
bicarbonate salt, wherein the composition has a total weight of 3500 mg to about 6000 mg and when dissolved in water produces a solution having a buffered pH of about 4 to about 6.5 and has buffering capacity sufficient to mediate the pH of a patient's
stomach for at least 15 minutes.
2. The composition of claim 1, wherein the alkaline effervescing component comprises a carbonate salt and a bicarbonate salt.
3. The composition of claim 1, wherein the acid component and the alkaline effervescing component are at least partially reacted with each other during granulation with the bisphosphonate.
4. The composition of claim 1, further comprising a sweetener or flavorant.
5. The composition of claim 1, further comprising a solubilizing agent.
6. The composition of claim 5, wherein the solubilizing agent is selected from the group consisting of polyvinylpyrrolidones, polyethylene glycols, dextrans, and combinations thereof.