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Multi-spike release formulation for oral drug delivery



Multi-spike release formulation for oral drug delivery



Official Gazette of the United States Patent & Trademark Office Patents 1269(5), Apr 29



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.

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Accession: 035349562

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