Abstract: A solid amorphous dispersion comprises a cholesteryl ester transfer protein (CETP) inhibitor, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMG-CoA reductase inhibitor), and a concentration enhancing polymer. At least a major portion of the CETP inhibitor in the dispersion is amorphous. The solid amorphous dispersion provides concentration-enhancement of the CETP inhibitor when administered to an aqueous use environment.

Abstract: Pharmaceutical compositions of a low-solubility drug and lower alkanoate-, phthalate- and trimellitate esters of hydroxypropyl methyl cellulose and lower alkanoate- and succinate esters of cellulose and methyl cellulose are disclosed that provide enhanced concentrations of the drug in a use environment.

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: Multiparticulates of low-solubility drugs and carriers that result in rapid release of the drug are disclosed.

Abstract: The present invention provides methods, dosage forms and kits for treating with an effective amount of ziprasidone a CNS disorder in a human when the human is in a fasted state. In one embodiment, the invention relates to a method for treating a CNS disorder in a human, which method comprises administering to the human in a fasted state, a solid oral dosage form comprising an amount of ziprasidone effective to treat said CNS disorder, wherein the area under the serum concentration versus time curve (AUC0-inf) of the ziprasidone in the human subsequent to said administering is from 70% to 140% of the mean area under the ziprasidone serum concentration versus time curve (AUC0-inf) resulting from administration of a control ziprasidone immediate release oral capsule containing the same amount of ziprasidone to a cohort of humans in a fed state.

Abstract: A pharmaceutical dosage form comprising celecoxib and a pharmaceutically acceptable carrier, the dosage form when initially administered to at least 12 human patients in the fasted state in a crossover study providing: (a) a mean blood plasma concentration of celecoxib within 0.5 hour after administration (C0.5) of at least about 0.9 ng/ml per mg of celecoxib dosed; (b) a mean blood plasma concentration of celecoxib 12 hours after administration (Ci2) of at least about 0.6 ng/ml per mg of celecoxib dosed; (c) a mean area under the blood plasma concentration versus time curve for the 12 hour period following administration (AUC12) of at least 19 ng-hr/mL per mg of celecoxib dosed; and (d) a mean maximum blood plasma concentration (Cmax) of celecoxib of less than about 4.9 ng/ml per mg of celecoxib dosed.

Abstract: A process is described for producing drug-containing multiparticulates with improved stability, characterized by an improvement in one or more of chemical stability, physical stability, or dissolution stability.

Abstract: A pharmaceutical composition comprises nanoparticles comprising a core of non-crystalline drug and surface stabilizers consisting of a phospholipid and a bile salt.

Abstract: A membrane-permeation test for evaluating pharmaceutical compositions is described. The method comprises the following steps: (1) providing a microporous membrane having a plurality of pores, the membrane having a feed side and a permeate side, wherein the feed side of the membrane is in fluid communication with the feed solution, and wherein the permeate side of the membrane is in fluid communication with a permeate solution; (2) administering a pharmaceutical composition to an aqueous solution to form a feed solution; and (3) measuring the concentration of drug in the permeate solution; wherein the feed side of the membrane is hydrophilic, and/or wherein the permeate solution comprises an organic fluid.

Abstract: A pharmaceutical composition comprises multiparticulates comprising a melt-congeal core and a solid amorphous dispersion layer of a poorly water soluble drug and polymer. The multiparticulates are suitable for improving bioavailability of poorly water soluble drugs. The melt-congeal cores facilitate application of the solid amorphous dispersion layer, and allow incorporation of additional optional components to the core so as to adjust the release of drug from the multiparticulate.

Abstract: A pharmaceutical composition comprises nanoparticles comprising a poorly water-soluble drug and an enteric polymer, and casein.

Abstract: A sustained release solid oral dosage form for treatment of a psychotic disorder, for example schizophrenia, in a mammal is provided, which oral dosage form comprises ziprasidone in an amount effective in treating said psychotic disorder and a pharmaceutically acceptable carrier.

Abstract: A membrane-permeation test for evaluating pharmaceutical compositions is described. The method comprises the following steps: (1) providing a microporous membrane having a plurality of pores, the membrane having a feed side and a permeate side, wherein the feed side of the membrane is in fluid communication with the feed solution, and wherein the permeate side of the membrane is in fluid communication with a permeate solution; (2) administering a pharmaceutical composition to an aqueous solution to form a feed solution; and (3) measuring the concentration of drug in the permeate solution; wherein the feed side of the membrane is hydrophilic, and/or wherein the permeate solution comprises an organic fluid.

Abstract: Multiparticulates of low-solubility drugs and carriers that result in rapid release of the drug are disclosed.

Abstract: A solid amorphous dispersion comprises a cholesteryl ester transfer protein (CETP) inhibitor, an inhibitor of 3-hydroxy-3-methylglutaryl-conenzyme A reductase (HMG-CoA reductase inhibitor), and a concentration enhancing polymer. At least a major portion of the CETP inhibitor in the dispersion is amorphous. The solid amorphous dispersion provides concentration-enhancement of the CETP inhibitor when administered to an aqueous use environment.

Abstract: A pharmaceutical composition comprising the compound 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyl]indazole, or a pharmaceutically acceptable salt or solvate thereof, in an amorphous form.

Abstract: A highly porous, fast-disintegrating binder suitable for pharmaceutical applications and methods of making the same are disclosed, the binder comprising microporous particles of an aqueous-soluble cellulosic polymer and a wicking agent. Pharmaceutical compositions and fast-disintegrating dosage forms containing the binder are also disclosed.

Abstract: Improved taste masking of pharmaceutical compositions of unpleasant-tasting drugs and cyclodextrin is achieved by forming a mixture of drug and cyclodextrin wherein the drug's dissolution rate has been retarded, or the the cyclodextrin's dissolution rate has been enhanced, or by both.

Abstract: The present invention is related to an oral dosage form comprising an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a glyceride which comprises glyceryl monobehenate, glyceryl dibehenate, glyceryl tribehenate, or a mixture thereof and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule.

Abstract: Compositions of matter comprising sertraline and a solubilizing agent which increases the solubility of sertraline in aqueous chloride ion-containing use environments.