Abstract: A pharmaceutical formulation comprising a single population of IR/XR particles of viloxazine, wherein each IR/XR particle of the single population of IR/XR particles comprising an extended-release region (XR) of the viloxazine; and an immediate-release region (IR) of the viloxazine, wherein the immediate-release region (IR) of the viloxazine is coated surrounding the extended-release region (XR) of the viloxazine, wherein the extended-release region (XR) is formed as an extended-release particle and the immediate-release region (IR) is formed as a coat surrounding the extended-release particle. A process for making the single population of IR/XR particles of viloxazine comprising the steps in the sequence of: (a) making the extended-release (XR) particles of the viloxazine; and (b) making the immediate-release (IR) coat of the viloxazine surrounding the extended-release (XR) particles of the viloxazine.

Abstract: A controlled release pharmaceutical dosage form that improve tolerability by reducing incidence of side effect associated with a Selexipag or its active metabolite contained in the dosage form comprising a release rate controlling ingredient in addition to the Selexipag or its active metabolite that govern a release of the Selexipag or its active metabolite from the dosage form, wherein the dosage form after administration to a mammal in fasting condition providing a. a mean or median Tmax of at least greater than 2 hours for the Selexipag and/or at least greater than 3.5 hours for the active metabolite of the Selexipag, and/or b. at least 20% lower Cmax for Selexipag and/or it's active metabolite compared to Cmax obtained after administration of the same amount of an immediate release dosage form of Selexipag or its active metabolite in fasting condition.

Abstract: A pharmaceutical abuse deterrent composition and method of making the same is described in the present invention. A pharmaceutical abuse deterrent composition is constructed in one strength or more than one strength, wherein each strength in alone or in combination with another strength has a unique overdose prevention features. A pharmaceutical abuse deterrent composition is constructed in one strength or more than one strength, wherein each strength has resistant to physical tampering and chemical tampering.

Abstract: The present invention provides an extended release osmotic tablet dosage form comprising methylphenidate hydrochloride (MPH). The dosage form comprises a core tablet comprising methylphenidate hydrochloride in an amount of more than 8% by weight of the core tablet; a semi-permeable membrane surrounding the core tablet, and an immediate release drug coat comprising methylphenidate hydrochloride surrounding the semipermeable membrane.

Abstract: Tamper resistant pharmaceutical composition and a process for the production of tamper resistant pharmaceutical composition are described herein. Tamper resistant pharmaceutical composition comprising drug substance and water soluble ingredient having cloud point greater than about 90° C., wherein the cloud point of the water soluble ingredient inhibit extraction of the drug substance from the pharmaceutical composition by hot water having temperature greater than about 90° C. Tamper resistant pharmaceutical composition comprising (a) drug substance; (b) water soluble ingredient; and (c) cloud point modifier, wherein the cloud point modifier increase the cloud point of the water soluble ingredient till at least about 90° C.; wherein the water soluble ingredient and the cloud point modifier inhibit extraction of the drug substance from the pharmaceutical composition by hot water having temperature greater than about 90° C.

Abstract: A novel pulsatile drug delivery system composition, methods of administration, method of treating disease condition and methods of making the same are provided. Novel pulsatile drug delivery systems provide adjustable lag time of release of drug from dosage form before administration. Novel pulsatile drug delivery systems provide administration of dosage form after modifying lag time of drug release while patient miss the administration of dosage form at particular time.

Abstract: An abuse deterrent pharmaceutical composition comprising: (a) an active ingredient; (b) deterrent agent; (c) pH dependent soluble ingredient; and (d) pH modifying agent; wherein deterrent agent is not release in effective amount to produce its intended aversive effect upon correct administration but it release in effective amount to produce its intended aversive effect upon incorrect administration.