Immediate release dosage forms of sodium oxybate
AssigneeJazz Pharmaceuticals, Inc.
InventorsAndrea Rourke, Clark Allphin, Maura Murphy
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Abstract
The present invention provides a pharmaceutical composition, presented as a solid unit dosage form adapted for oral administration of sodium oxybate. The preferred unit dosage form is a tablet comprising a relatively high weight-percentage of sodium oxybate, in combination with a relatively small weight-percentage of total excipients. This permits the tablets to contain/deliver a pharmaceutically effective amount, e.g., about 0.5-1.5 g of sodium oxybate in each tablet with a delivery profile similar to that of the liquid form. The tablets are bioequivalent to the liquid form.
Claims19
A compressed tablet of sodium oxybate for oral delivery of 0.5-1.25 g of sodium oxybate comprising 80-95 wt % sodium oxybate;
- 5-10 wt % compression aid;
- and 1-50% binder;
- wherein the tablet is bioequivalent to sodium oxybate oral solution.
An immediate release unit dosage form comprising an about 0.5-1.5 g compressed tablet comprising 80-95 wt-% sodium oxybate;
- about 2.5-7.5 wt-% microcrystalline cellulose and about 0.25-2.5 wt-% surfactant, wherein at least 90% of the sodium oxybate is released from the tablet within one hour from exposure of the tablet to an aqueous medium.
A compressed tablet of an oxybate salt for oral delivery of 0.5-1.25 g of oxybate salt comprising 80-95 wt % oxybate salt;
- 5-10 wt % compression aid;
- and 1-50% binder;
- wherein the tablet is bioequivalent to sodium oxybate oral solution.
Dependencies are inferred from the claim text.