US 6,555,127 B2 · Multi-spike release formulation for oral drug delivery

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.

Claims20

Dependent claims

A composition comprising a drug to be orally administered to a patient comprising

a first component in a form releasing a first dose of the drug immediately following ingestion of the composition;
and
a second component in a form rapidly releasing a second dose of the drug at a second time after release of the first dose,
wherein the first and second doses provide a multi-splice pharmacokinetic profile of the drug and wherein the rapid release is achieved through the use of reagents that generate a burst of gas upon exposure to water immediately disperse or expose the second dose of the drug so that it can be absorbed through the gastrointestinal tract.

1 more element

Dependencies are inferred from the claim text.

Multi-spike release formulation for oral drug delivery

Life of this patent

Multi-spike release formulation for oral drug delivery

Life of this patent

Abstract

Claims20