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 other 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 gastro intestinal secretions and having a fill volume inside containing a weighting agent in the form of a tablet comprising dibasic calcium phosphate which is retained at one end of the fill volume, the dosage form being coated with a coating material comprising a drug substance.
2. The dosage form of claim 1 , wherein the coating material is in direct contact with the external surface of the dosage form.
3. The dosage form of claim 1 , wherein the coating material is in direct contact with a pre-coating material, the pre-coating material being in direct contact with the external surface of the dosage form.
4. The dosage form of claim 3 , wherein the pre-coating material is an enteric coating material.
5. The dosage form of claim 2 , wherein the coating material further comprises a binder or a release rate controlling agent, or both.
6. The dosage form of claim 3 , wherein the coating material further comprises a binder or a release rate controlling agent, or both.
7. The dosage form of claim 4 , wherein the coating material further comprises a binder or a release rate controlling agent, or both.
8. The dosage form of claim 5 , wherein the binder is selected from a hydroxypropyl cellulose (HPC) and a hydroxypropyl methylcellulose (HPMC).
9. The dosage form of claim 6 , wherein the binder is selected from a hydroxypropyl cellulose (HPC) and a hydroxypropyl methylcellulose (HPMC).
10. The dosage form of claim 7 , wherein the binder is selected from a hydroxypropyl cellulose (HPC) and a hydroxypropyl methylcellulose (HPMC).
11. The dosage form of claim 5 , wherein the release rate controlling agent is in the form of a hydrophilic polymer, a hydrophobic polymer, or mixtures thereof, or copolymers thereof, or mixtures of these polymers and copolymers.
12. The dosage form of claim 6 , wherein the release rate controlling agent is in the form of a hydrophilic polymer, a hydrophobic polymer, or mixtures thereof, or copolymers thereof, or mixtures of these polymers and copolymers.
13. The dosage form of claim 7 , wherein the release rate controlling agent is in the form of a hydrophilic polymer, a hydrophobic polymer, or mixtures thereof, or copolymers thereof, or mixtures of these polymers and copolymers.
14. The dosage form of claim 11 , wherein the release rate controlling agent includes a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl cellulose (HPC), a poly(ethylene oxide), an ethylcellulose, or a combination thereof.
15. The dosage form of claim 12 , wherein the release rate controlling agent includes polyethylene glycol, ethycellulose, cellulose acetate phthalate, or a combination thereof.
16. The dosage form of claim 13 , wherein the release rate controlling agent includes a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl cellulose (HPC), a poly(ethylene oxide), an ethylcellulose, or a combination thereof.
17. The dosage form of claim 11 , wherein the release rate controlling agent includes polyethylene glycol, ethycellulose, cellulose acetate phthalate, or a combination thereof.
18. The dosage form of claim 12 , wherein the release rate controlling agent includes a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl cellulose (HPC), a poly(ethylene oxide), an ethylcellulose, or a combination thereof.
19. The dosage form of claim 13 , wherein the release rate controlling agent includes polyethylene glycol, ethycellulose, cellulose acetate phthalate, or a combination thereof.
20. The dosage form of claim 1 , which is formed of two parts sealed together prior to coating with the coating material comprising a drug substance.
21. The dosage form of claim 1 , wherein the fill volume includes a wadding, a plug of waxy material, or a second capsule.
22. The dosage form of claim 1 , wherein the dosage form has a length of 15mm or greater along its long axis.
23. The dosage form of claim 22 , wherein the length is not longer than 30 or 31 mm.
24. An elongate dosage form of cylindrical shape in the form of a hollow capsule which is impermeable to gastro intestinal secretions and having a fill volume inside containing a weighting agent in the form of a tablet comprising dibasic calcium phosphate which is retained at one end of the fill volume, the fill volume further comprising a wadding, a plug of waxy material, or a second capsule, and the dosage form being coated with a coating material comprising a drug substance.
25. An elongate dosage form of cylindrical shape in the form of a hollow capsule which is impermeable to gastro intestinal secretions and having a fill volume inside containing a weighting agent in the form of a tablet comprising dibasic calcium phosphate which is retained at one end of the fill volume, the dosage form having a length of 15 mm or greater, and the dosage form being coated with a coating material comprising a drug substance.
26. The dosage form of claim 25 , wherein the length is not longer than 30 or 31 mm.