Pediatric dosage forms, methods of making and using
AssigneeEirgen Pharma Ltd.
InventorsPraful Balavant Deshpande, Stephen James Quinlan, Marta Golec, John Gerard O'Brien, James Joseph McDonald, Reem Elamein Elsiddig, Ken O'Shea
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Abstract
Pediatric and modified release dosage forms of vitamin D compounds, and methods of making and using the dosage forms, are disclosed.
Claims30
A tablet, consisting of:
- a mixture of 25-hydroxyvitamin D3, microcrystalline cellulose, starch, magnesium stearate, crospovidone, sucrose, medium chain triglycerides, and silicon dioxide, or
- a mixture of 25-hydroxyvitamin D, microcrystalline cellulose, starch, magnesium stearate, crospovidone, sucrose, medium chain triglycerides, silicon dioxide and a disintegrant,
- wherein the 25-hydroxyvitamin D3 is the sole active agent in the tablet.
A tablet, consisting of a mixture of 25-hydroxyvitamin D3 and an excipient, the excipient consisting of:
- a filler, a disintegrant, a lubricant, and an absorption enhancer, or
- a filler, a disintegrant, a lubricant, an absorption enhancer, and a release modifier,
- wherein the 25-hydroxyvitamin D3 is present in the tablet in an amount in a range of about 0.01 wt. % to about 0.06 wt. %, based on the total weight of the tablet, and wherein the filler is present in the tablet in an amount of at least 70 wt %, based on the total weight of the tablet, the lubricant is present in the tablet in an amount in a range of about 0.1 wt. % to about 5 wt. %, based on the total weight of the tablet, and the absorption enhancer is present in the tablet in an amount in a range of about 1 wt. % to about 15 wt. %, based on the total weight of the tablet,
- wherein the filler is selected from the group consisting of lactose, saccharose, glucose, starch, microcrystalline cellulose, microfine cellulose, mannitol, sorbitol, calcium hydrogen phosphate, aluminum silicate, amorphous silica, sodium chloride, dibasic calcium phosphate dihydrate, crospovidone, carrageenan, chitosan, pectinic acid, glycerides, beta-cyclodextrine, cellulose derivatives, powdered cellulose, polyplasdone crospovidone, polyethylene oxide, and combinations thereof,
- wherein the lubricant is selected from the group consisting of stearic acid, magnesium stearate, calcium stearate, aluminum stearate, talc, siliconized talc, and combinations thereof,
- wherein the absorption enhancer is selected from the group consisting of capryolcaproyl macrogolglcyerides, triglycerides, and combinations thereof,
- wherein the release modifier is a pore former and is a sugar, and
- wherein the 25-hydroxyvitamin D3 is the sole active agent in the tablet.
A tablet consisting of a spray-dried 25-hydroxyvitamin D3 composition consisting of a mixture of 25-hydroxyvitamin D3, microcrystalline cellulose, starch, magnesium stearate, crospovidone, sucrose, medium chain triglycerides, and silicon dioxide, wherein the 25-hydroxyvitamin D3 is the sole active agent in the tablet.
Dependencies are inferred from the claim text.