Floating gastric retentive dosage form
An elongate dosage form of generally cylindrical shape having two opposing ends, the dosage form being buoyant in. gastric fluid, wherein the dosage form is weight biased such that. one end is heavier than the ether end. The dosage form is adapted to float on gastric fluid with its long axis substantially perpendicular to the surface of the: fluid with its heavier end pointing: generally; downwards and into the fluid.
1. An elongate dosage form of cylindrical shape in the form of a hollow capsule which is impermeable to gastric fluid and having a fill volume inside containing a weighting agent which is retained at one end of the fill volume, the dosage form being buoyant and self-orientating in an aqueous fluid such that it floats in the aqueous fluid with its long axis perpendicular to the surface of the aqueous fluid.
2. A dosage form according to claim 1 that has a length of at least 12 mm along its longest length.
3. A dosage form according to claim 1 wherein the weighting agent is in the form of a tablet.
4. A dosage form according to claim 1 wherein the weighting agent comprises an ingredient selected from the group consisting of barium sulphate, dibasic calcium phosphate, iron oxide, iron, titanium dioxide, calcium carbonate having a density of 1.3 or greater and calcium sulphate.
5. A dosage form according to claim 1 wherein a second capsule, smaller than the hollow capsule is disposed within the fill volume of the hollow capsule, the dimensions of the second capsule being such as to leave a space in the fill volume of the hollow capsule to receive the weighting agent and retain it at one end of the hollow capsule.
6. The dosage form of claim 5 , wherein the second capsule is hollow.
7. A dosage form according to claim 1 wherein the weighting agent is retained within the hollow capsule at one end thereof by means of a plug of waxy material that is formed around the weighting agent.
8. A dosage form according to claim 7 wherein the waxy material is macrogol or natural or semi synthetic lipidic waxes.
9. A dosage form according to claim 7 wherein the waxy material has a melting point above 37° C.
10. A dosage form according to claim 1 wherein the dosage form is coated with a coating material comprising a drug substance.
11. The dosage form of claim 1 , wherein the weight of the weighting agent ranges from 10 up to 500 mg.
12. The dosage form of claim 1 , wherein (1) the dosage form comprises a coating applied to the dosage form, the coating selected from (i) an enteric-coating, or (ii) a partly or wholly insoluble coating.
13. The dosage form of claim 1 , wherein the weight of the weighting agent ranges from 10 to 400 mg.
14. The dosage form of claim 1 , wherein the weight of the weighting agent ranges from 100 and 350 mg.
15. The dosage form of claim 1 , wherein the weight of the weighting agent ranges from 50 to 250 mg.