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|Title:||Capsule and powder formulations containing lanthanum compounds|
|Abstract:||The present invention includes an oral pharmaceutical capsule comprising a shell, lanthanum carbonate or lanthanum carbonate hydrate, and a lubricant such as talc, wherein the shell encapsulates the lanthanum carbonate or its hydrate and the lubricant. Capsule shells comprise, for example, gelatin. The present invention also includes an oral pharmaceutical powder comprising lanthanum carbonate or lanthanum carbonate hydrate and a pharmaceutically acceptable excipient. The oral pharmaceutical capsules and powders of the present invention can be administered to treat a patient at risk of or suffering from hyperphosphatemia, at risk of or suffering from chronic kidney disease (CKD), at risk of or suffering from soft tissue calcification associated with CKD, or at risk of or suffering from secondary hyperparathyroidism.|
|Inventor(s):||Pierce; David (Hertfordshire, GB), Ferdinando; Josephine Christine (Tadley, GB), Davies; Peter Neil (Basingstoke, GB)|
|Assignee:||Shire LLC (Florence, KY)|
1. An oral pharmaceutical powder comprising: (1) lanthanum carbonate, lanthanum carbonate hydrate, or a combination thereof, wherein the lanthanum carbonate or
lanthanum carbonate hydrate comprises elemental lanthanum, and the elemental lanthanum is in an amount of about 26% by weight to about 50% by weight; (2) dextrates in an amount from about 5% to about 50% by weight; (3) one or more flow aids; and (4)
one or more lubricants; wherein the weight % of elemental lanthanum is greater than the weight % of the dextrates.
2. The powder of claim 1, wherein the lanthanum carbonate or lanthanum carbonate hydrate has the formula: La.sub.2(CO.sub.3).sub.3.nH.sub.2O wherein n has a value from 0 to 10.
3. The powder of claim 2, wherein n has a value from 3 to 6.
4. The powder of claim 1, wherein the one or more flow aids is in an amount from about 0.1% to about 4% by weight.
5. The powder of claim 1, wherein the one or more flow aids is selected from the group consisting of silica, colloidal anhydrous silica, colloidal silicon dioxide, and a combination thereof.
6. The powder of claim 5, wherein the one or more flow aids is colloidal silicon dioxide.
7. The powder of claim 1, wherein the one or more lubricants is selected from the group consisting of magnesium stearate, talc, mineral oil, polyethylene glycol, silica, colloidal anhydrous silica, colloidal silicon dioxide, hydrogenated vegetable oil, glyceryl behenate, L-leucine, L-leucine/polyethylene glycol 6000, polyethylene glycol 6000, glyceryl monostearate, and a combination thereof.
8. The powder of claim 7, wherein the one or more lubricants is magnesium stearate.
9. The oral pharmaceutical powder of claim 1, wherein the powder is in an amount of about 750 mg or about 1000 mg elemental lanthanum.
10. The oral pharmaceutical powder of claim 1, wherein the powder is filled into one or more sachets, stick packs, or rigid containers.
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