Multi-spike release formulation for oral drug delivery
US6555127B2 · kind B2 · utility
Assignee
Inventor
Key dates
| Filing date | Jan 19, 2001 |
| Grant date | Apr 29, 2003 |
| Priority date | — |
| Expiry date | Jan 26, 2021 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K9/0056
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Methylphenidate or other drugs are provided in a formulation for oral administration that releases the drug in two or more pharmacokinetic spikes, by combining different release forms in a single formulation. In a preferred embodiment for methylphenidate, the first pharmacokinetic spike is achieved by the release of taste-masked methylphenidate which is not enterically coated, while a second pharmacokinetic spike is achieved by the release of methylphenidate in a finely divided form from enterically coated pellets or microparticles formulated for rapid release following dissolution of the enteric coating. A critical aspect of the formulation is the inclusion of excipients that create a burst release following the initial rapid release and uptake. The formulation can be administered as a paste, jelly, suspension, or fast dissolving wafer. To manipulate the dose, the formulation can be provided, for example, as a paste packaged in a tube similar to those used to dispense toothpaste.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.