Hyoscyamine dosage form
AssigneeSovereign Pharmaceuticals, Ltd.
InventorsViswanathan Srinivasan, Ralph Brown, David Brown, Himanshu Patel, Juan Carlos Menendez, Somphet Peter Suphasawud
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Abstract
A pharmaceutical dosage form which comprises two or more different hyoscyamine formulations, at least one of the formulations being an immediate release hyoscyamine formulation and at least one other one being a controlled release hyoscyamine formulation. This abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.
Claims51
A pharmaceutical dosage form which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof, wherein the dosage form comprises two or more hyoscyamine formulations and at least one of the formulations is an immediate release formulation and at least one other one of the formulations is a controlled release formulation and the at least one immediate release formulation is capable of providing a hyoscyamine plasma concentration within a therapeutic range for a first period and the at least one controlled release formulation is capable of providing a hyoscyamine plasma concentration within a therapeutic range for a second period, and wherein the dosage form is capable of providing a hyoscyamine plasma concentration within the therapeutic range for a period which is longer than the combined first and second periods.
A pharmaceutical dosage form which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof, wherein the dosage form comprises two or more hyoscyamine formulations and at least one of the formulations is an immediate release formulation and at least one other one of the formulations is a controlled release formulation and the at least one immediate release formulation is capable of releasing the at least one of hyoscyamine and a pharmaceutically acceptable salt thereof for a first period and the at least one controlled release formulation is capable of releasing the at least one of hyoscyamine and a pharmaceutically acceptable salt thereof for a second period, and wherein the first and second periods overlap to provide a hyoscyamine plasma concentration within a therapeutic range during a period within which neither the immediate release formulation by itself nor the controlled release formulation by itself is capable of providing a hyoscyamine plasma concentration within a therapeutic range.
A bi-layered hyoscyamine tablet, wherein the tablet comprises a first layer and a second layer, the first layer comprising an immediate release formulation which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof and being capable of providing a hyoscyamine plasma concentration within a therapeutic range for a first period, and the second layer comprising a controlled release formulation which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof and being capable of providing a hyoscyamine plasma concentration within a therapeutic range for a second period, and wherein the tablet is capable of providing a hyoscyamine plasma concentration within the therapeutic range for a period which is longer than the combined first and second periods.
A bi-layered hyoscyamine tablet, wherein the tablet comprises a first layer and a second layer, the first layer comprising an immediate release formulation which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof and being capable of releasing the at least one of hyoscyamine and a pharmaceutically acceptable salt thereof for a first period, and the second layer comprising a controlled release formulation which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof and being capable of releasing the at least one of hyoscyamine and a pharmaceutically acceptable salt thereof for a second period, and wherein the first and second periods overlap to provide a hyoscyamine plasma concentration within a therapeutic range during a period within which neither the immediate release formulation by itself nor the controlled release formulation by itself is capable of providing a hyoscyamine plasma concentration within a therapeutic range.
Dependencies are inferred from the claim text.