Use of a mixture of two or more enteric materials to regulate drug release via membrance or matrix for systemic therapeutics
AssigneeSupernus Pharmaceuticals, Inc.
InventorsRong-Kun Chang, Niraj Shah
Life of this patent
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Abstract
Disclosed are pharmaceutical compositions, particularly oral dosage forms, which comprise two or more enteric coating materials, either as a coating or as part of a matrix dosage form, and methods of making and using the same. The compositions are characterized by having a sustained release profile at lower pH and an accelerated dissolution profile at higher pH.
Claims22
1-27. (canceled)
A pharmaceutical composition, comprising:
- a core containing one or more pharmaceutically active ingredients selected from one or more of psychotropics, anti-depressants, anti-manics, antiparkinsonian substances agents for the treatment of hyperactivity or attention deficit hyperactivity disorders, stimulants, sedatives, anticonvulsants, and antispasmodics, and
- a coating layer surrounding the core, said coating layer comprising a combination of two or more enteric coating materials, at least two of which enteric coating materials dissolve at different pHs, whereby the active ingredient(s) has a release profile that is pH-dependent.
A process for the preparation of a pharmaceutical composition, which comprises (a) obtaining a membrane-controlled or matrix-controlled oral dosage form that contains an active pharmaceutical ingredient, and (b) coating the dosage form with a mixture of two or more enteric coating materials.
A method of treating a CNS condition in a mammal, comprising administering to such a mammal an oral dosage form comprising a membrane-controlled or matrix-controlled dosage form of a pharmaceutical ingredient which is active against said condition, and which is coated with a combination of two or more enteric coating materials, whereby the oral dosage form has a drug release profile that is pH-dependent.
Dependencies are inferred from the claim text.