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 Elsidding, 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.
Claims33
A tablet, comprising 25-hydroxyvitamin D3, microcrystalline cellulose, starch, magnesium stearate, crospovidone, sucrose, medium chain triglycerides, and silicon dioxide.
A tablet, comprising 25-hydroxyvitamin D3 and an excipient, 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 excipient comprises a filler present in the tablet in an amount of at least 70 wt %, based on the total weight of the tablet, a disintegrant, a lubricant 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 an absorption enhancer 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.
A tablet comprising a spray-dried 25-hydroxyvitamin D3 composition comprising microcrystalline cellulose, starch, magnesium stearate, crospovidone, sucrose, medium chain triglycerides, and silicon dioxide.
Dependencies are inferred from the claim text.