Abstract: The present invention includes a controlled-release composition having a matrix. The matrix contains a pharmaceutically effective amount of an active agent or a pharmaceutically acceptable salt, solvate, ester, and/or prodrug thereof, an ionic non-gelling matrix polymer, and a pH modifier. The ionic non-gelling matrix polymer is practically insoluble and unswellable at a first aqueous fluid pH and is soluble at a second aqueous fluid pH. The pH modifier is present in an amount to control the release of the active agent from the composition. The controlled-release composition is substantially free of a gelling or swellable excipient. The present invention also provides methods of making and using the controlled-release compositions.

Abstract: Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed herein are solid oral dosage forms which can be administered as a capsule or tablet, or alternatively as a sprinkle form with the patient experiencing little or no bitter taste. The dosage forms provide immediate release in vitro and in vivo.

Abstract: Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed herein are solid oral dosage forms which can be administered as a capsule or tablet, or alternatively as a sprinkle form with the patient experiencing little or no bitter taste. The dosage forms provide immediate release in vitro and in vivo.

Abstract: Disclosed herein are quinine formulations and methods of using quinine formulations. Specifically disclosed herein are solid oral dosage forms which can be administered as a capsule or tablet, or alternatively as a sprinkle form with the patient experiencing little or no bitter taste. The dosage forms provide immediate release in vitro and in vivo.

Abstract: The present invention includes a controlled-release composition having a matrix. The matrix contains a pharmaceutically effective amount of an active agent or a pharmaceutically acceptable salt or solvate thereof, an ionic non-gelling matrix polymer, and a pH modifier. The ionic non-gelling matrix polymer is practically insoluble and unswellable at a first aqueous fluid pH and is soluble at a second aqueous fluid pH. The pH modifier is present in an amount to control the release of the active agent from the composition. The controlled-release composition is substantially free of a gelling or swellable excipient and does not contain a functional coating or a lipophilic component. The present invention also provides methods of making and using the controlled-release compositions.

Abstract: Disclosed herein are systems and methods to promote patient compliance with a dosage regimen of a prescribed pharmaceutical agent.

Abstract: Disclosed herein are controlled-release formulations of a core comprising a core active agent (e.g., alfuzosin) and a wax excipient substantially coated with an extended-release coating.

Abstract: Disclosed herein are controlled-release formulations containing a core comprising a core active agent (e.g., levetiracetam) and a wax excipient, where the core is substantially coated with an extended-release coating.

Abstract: Disclosed herein are extended-release levetiracetam formulations having a matrix comprising levetiracetam and a hydrophobic excipient or an acrylic polymer excipient.

Abstract: Alfuzosin compositions comprising a tablet core of alfuzosin and a release-retarding matrix comprising about 40 to about 80% (by weight) hydroxypropyl methyl cellulose with a maximum apparent viscosity of about 5600 cP, based on the total weight of the tablet core; and an extended-release coating substantially surrounding the tablet core comprising a release-retarding coating material, wherein the compositions are bioequivalent to the reference dosage form of NDA #021287 (UROXATRAL) are disclosed. Methods of making and using the alfuzosin compositions are also disclosed.

Abstract: The present invention includes a controlled-release composition having a matrix. The matrix contains a pharmaceutically effective amount of an active agent or a pharmaceutically acceptable salt or solvate thereof, an ionic non-gelling matrix polymer, and a pH modifier. The ionic non-gelling matrix polymer is practically insoluble and unswellable at a first aqueous fluid pH and is soluble at a second aqueous fluid pH. The pH modifier is present in an amount to control the release of the active agent from the composition. The controlled-release composition is substantially free of a gelling or swellable excipient and does not contain a functional coating or a lipophilic component. The present invention also provides methods of making and using the controlled-release compositions.

Abstract: The present invention includes a controlled-release composition having a matrix. The matrix contains a pharmaceutically effective amount of an active agent or a pharmaceutically acceptable salt, solvate, ester, and/or prodrug thereof, an ionic non-gelling matrix polymer, and a pH modifier. The ionic non-gelling matrix polymer is practically insoluble and unswellable at a first aqueous fluid pH and is soluble at a second aqueous fluid pH. The pH modifier is present in an amount to control the release of the active agent from the composition. The controlled-release composition is substantially free of a gelling or swellable excipient. The present invention also provides methods of making and using the controlled-release compositions.

Abstract: Disclosed are amorphous carvedilol salt forms, controlled-release carvedilol compositions, and methods of preparing the forms and compositions.

Abstract: Disclosed are amorphous carvedilol salt forms, controlled-release carvedilol compositions, and methods of preparing the forms and compositions.

Abstract: Disclosed are amorphous carvedilol salt forms, controlled-release carvedilol compositions, and methods of preparing the forms and compositions.

Abstract: Alfuzosin compositions comprising alfuzosin and a release-retarding matrix comprising about 40 to about 80% (by weight) hydroxypropyl methyl cellulose with a maximum apparent viscosity of about 5600 cP, wherein the compositions are bioequivalent to the reference dosage form of NDA #021287 are disclosed. Alfuzosin compositions comprising alfuzosin and a release-retarding matrix comprising about 40 to about 80% (by weight) hydroxypropyl methyl cellulose (HPMC) with a maximum apparent viscosity of about 5600 cP, wherein the dissolution profile of the compositions are substantially identical to the dissolution profile of the reference dosage form of NDA #021287 are also disclosed. Methods of making and using the alfuzosin compositions are also disclosed.

Abstract: Disclosed herein are controlled-release formulations which exhibit substantially zero-order release kinetics. The formulations include a core comprising a core active agent and a wax excipient substantially coated with an extended-release coating. The formulation optionally includes an immediate-release portion comprising an immediate-release active agent in the form of, for example, a coating disposed on at least a portion of the core. Further disclosed are fexofenadine/pseudoephedrine combination formulations, which exhibit substantially no food effect.

Abstract: Active agent compositions comprising active agent particles having an effective average particle size of less than 2000 nm, wherein the compositions comprise a particle sequestrant are disclosed. Compositions having an effective average particle size of less than 2000 nm, wherein the compositions comprise no added surfactants, phospholipids, or combinations thereof, are also disclosed. In some embodiments, the active agent is fenofibrate. In other embodiments, the fenofibrate compositions are in a treatment form that that is bioequivalent to TriCor® 145 mg or 48 mg.

Abstract: Disclosed herein are systems and methods to promote patient compliance with a dosage regimen of a prescribed pharmaceutical agent.

Abstract: Disclosed herein are controlled-release quinine formulations and methods of preparing the same. Also disclosed are methods of preventing or treating malaria, leg cramps, or babesiosis by administering the controlled-release quinine formulations. The controlled-release quinine formulations may help to reduce or eliminate adverse side effects typically associated with the dosing of quinine.