Abstract: The present disclosure relates to ultra-pure forms, polymorphs, amorphous forms, and formulations of N-[(1r,4r)-4-(3-chloro-4-cyanophenoxy)cyclohexyl]-6-[4-({4-[2-(2,6-dioxopiperidin-3-yl)-6-fluoro-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl]piperazin-1-yl}methyl)piperidin-1-yl]pyridazine-3-carboxamide, referred to herein as Compound A: The present disclosure also relates methods of manufacturing and purifying the same, as well as intermediates useful in the synthesis of Compound A. The ultra-pure forms, polymorphs, amorphous forms, and formulations of Compound A can be used as therapeutic agents for the treatment of various diseases and conditions such as cancer.

Abstract: A concentrated poly(ethylene glycol) solution that has good stability for extended storage is provided for use as a laxative. The concentrated solution comprises water, sodium benzoate, poly(ethylene glycol), and enough acid to yield a solution having a pH at 25° C. in the range 3.0-5.0. It is prepared and packaged to minimize the accumulation of degradation products.

Abstract: The invention discloses a pharmaceutical composition comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is for oral administration wherein the composition delivers phenylephrine or a pharmaceutically acceptable salt thereof via absorption in the colon. The pharmaceutical composition comprises a core comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is in a time-dependent, pH-dependent, or colon-specific enzyme-dependent erodible layer that degrades to expose the core to release phenylephrine in the colon. In one preferred embodiment, the erodible layer encases the core. The composition optionally further comprises phenylephrine in the erodible layer or other additional layer(s).

Abstract: The invention discloses a pharmaceutical composition comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is for oral administration wherein the composition delivers phenylephrine or a pharmaceutically acceptable salt thereof via absorption in the colon. The pharmaceutical composition comprises a core comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is in a time-dependent, pH-dependent, or colon-specific enzyme-dependent erodible layer that degrades to expose the core to release phenylephrine in the colon. In one preferred embodiment, the erodible layer encases the core. The composition optionally further comprises phenylephrine in the erodible layer or other additional layer(s).

Abstract: A concentrated poly(ethylene glycol) solution that has good stability for extended storage is provided for use as a laxative. The concentrated solution comprises water, sodium benzoate, poly(ethylene glycol), and enough acid to yield a solution having a pH at 25° C. in the range 3.0-5.0. It is prepared and packaged to minimize the accumulation of degradation products.

Abstract: A concentrated poly(ethylene glycol) solution that has good stability for extended storage is provided for use as a laxative. The concentrated solution comprises water, sodium benzoate, poly(ethylene glycol), and enough acid to yield a solution having a pH at 25° C. in the range 3.0-5.0. It is prepared and packaged to minimize the accumulation of degradation products.

Abstract: A pharmaceutical composition comprises multiparticulates comprising a drug, a matrix material, and swelling agent. In one aspect, the multiparticulates comprise a core comprising a drug, and a coating surrounding the core. The coating is selected from the group consisting of (i) a water-permeable, substantially drug-impermeable coating, and (ii) an anti-enteric coating.

Abstract: Pharmaceutical compositions comprising phenylephrine or a pharmaceutically acceptable salt thereof and methods for administering the pharmaceutical compositions wherein the composition is formulated for systemic absorption of phenylephrine that avoids first pass metabolism. The compositions of the invention are formulated to be applied to oral mucosa of an animal to allow for enhanced systemic delivery of therapeutically active form of phenylephrine.

Abstract: A sustained-release pharmaceutical composition in a form of an orally deliverable tablet containing reboxetine, or a pharmaceutically acceptable salt thereof, dispersed in a matrix containing a hydrophilic polymer and a starch, wherein the starch has a tensile strength of at least 0.15 kN cm?2 at a solid fraction of 0.75 to 0.85.

Abstract: Compositions of matter containing an active agent, and methods of manufacturing thereof, wherein the method comprises the step of coating a substrate with a coating composition comprising the active agent formulated for immediate release, wherein the coating composition does not contain an appreciable amount of cellulosic materials and preferably comprises polyvinyl alcohol or a polyvinyl alcohol derived copolymer.

Abstract: A pharmaceutical composition in a form of an orally deliverable liquid comprises water having in solution therein a pharmaceutically acceptable water-soluble salt of a tolterodine related compound at a therapeutically effective concentration in the composition. The composition has a pH of about 2 to about 6 and further comprises a sweetening agent and an antimicrobial agent at a concentration that is antimicrobially effective at the pH of the composition. The composition is useful for treating a muscarinic receptor mediated disorder, more particularly overactive bladder, in a subject by orally administering to the subject a therapeutically effective amount of the composition.

Abstract: The present invention is directed to dry formulations of coated oxazolidinone particles, such as coated linezolid particles, which, when suspended in an aqueous solution, mask the taste of the oxazolidinone in the resulting suspension vehicle. Specifically, a mixture of sugars in the formulation, comprising sorbitol and sucrose, inhibit mass transport of the oxazolidinone from the particles into the suspension vehicle. Dry formulations of the coated oxazolidinone particles, suspensions of the same, and methods of using the same to treat or prevent infections from gram positive bacteria are all disclosed.

Abstract: The present invention is directed to a suspension vehicle for coated drug particles. The coated drug particles are suitable for use in taste masking. The suspension vehicle disclosed enables the maintenance of coated drug particles with an average particle size of about 50 &mgr;m to about 600 &mgr;m in suspension for an extended period of time, without sedimentation or floating, even after shaking in the presence of air. The suspension vehicle of the present invention makes it possible to produce multidose oral suspensions of coated drugs, from which consistent dosages can be dispensed over time. The dry formulations, methods, and suspension vehicles of the present invention are particularly well suited for the delivery of objectionable tasting drugs, such as linezolid.

Abstract: Orally disintegrating valdecoxib fast-melt tablets and processes for preparing such dosage forms are provided.

Abstract: A rapid-onset pharmaceutical composition is provided, useful for treatment of sexual dysfunction, stimulation of sexual activity and enhancement of sexual desire, interest and performance in men and women. The composition is a dosage form comprising (a) a therapeutically or sexual-stimulatorily effective amount of a therapeutic agent having a molecular weight, excluding counterions, not greater than 250, and (b) at least one pharmaceutically acceptable excipient; and is adapted for delivery by a route of administration that entails interaction with the organs of taste yet has acceptable organoleptic properties.

Abstract: A process for producing granules by rotomelt granulation comprising mixing at least one powdered pharmaceutically active material and a powdered excipient material within a zone wherein both powdered materials are maintained in a fluidized state by a rising stream of gas in an apparatus having a rapidly rotating horizontal-disk located within a vertical vessel wherein said gas is at a temperature sufficient to cause at least one powdered material to at least partially melt thereby causing said powdered materials to aggregate and form granules.

Abstract: Chewable medicament tablets are made from coated rotogranules of a medicament wherein the rotogranules are formed from a granulation mixture of medicament, e.g. ibuprofen, polyvinylpyrrolidone, sodium starch glycolate and sodium lauryl sulfate and the rotogranules are coated with hydroxyethyl cellulose or a mixture of hydroxyethyl cellulose and hydroxypropyl methylcellulose and a process for making such tablets and a method of providing taste masking of medicaments utilizing such coated rotogranules in a tablet.

Abstract: Chewable medicament tablets are made from coated rotogranules of a medicament wherein the rotogranules are formed from a granulation mixture of medicament, e.g. ibuprofen, polyvinylpyrrolidone, sodium starch glycolate and sodium lauryl sulfate and the rotogranules are coated with hydroxyethyl cellulose or a mixture of hydroxyethyl cellulose and hydroxypropyl methylcellulose and a process for making such tablets and a method of providing taste masking of medicaments utilizing such coated rotogranules in a tablet.