Abstract: The present invention relates to pharmaceutical tablet compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are tablet compositions containing niraparib formed by the disclosed methods, and therapeutic uses of such tablet compositions for treating various disorders and conditions.

Abstract: A drill guide handle configured to engage a variable angle drill guide, including: a handle grip; a first cannula extending from a proximal end of the drill guide handle to a distal end of the drill guide handle, wherein the first cannula is configured to provide a zero degree insertion angle for a drill bit; and a body including: a first tab and a second tab wherein the first and second tabs include a first and second tab protrusion, respectively, wherein each of the first tab and the second is configured to flex so that the first and second tab protrusions engage a horizontal groove on a variable angle drill guide; and a body protrusion on an inner surface of the body, wherein the body protrusion is configured to engage a vertical grove on the variable angle drill guide.

Abstract: The present invention relates to pharmaceutical tablet compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are tablet compositions containing niraparib formed by the disclosed methods, and therapeutic uses of such tablet compositions for treating various disorders and conditions.

Abstract: The present invention relates to pharmaceutical capsule compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are capsule formulations containing niraparib formed by the disclosed methods, and therapeutic uses of such capsule formulations for treating various disorders and conditions. The niraparib is distributed with substantial uniformity throughout a pharmaceutically acceptable carrier of the capsule formulations and exhibit good long-term stability and dissolution properties.

Abstract: The present invention relates to methods of treating cancer in pediatric subjects comprising administration of compound niraparib in a suitable oral dosage form and optionally in combination with a second therapeutic agent such as a PD-1 inhibitor.

Abstract: The present invention relates to pharmaceutical tablet compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are tablet compositions containing niraparib formed by the disclosed methods, and therapeutic uses of such tablet compositions for treating various disorders and conditions.

Abstract: The present invention relates to pharmaceutical capsule compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are capsule formulations containing niraparib formed by the disclosed methods, and therapeutic uses of such capsule formulations for treating various disorders and conditions. The niraparib is distributed with substantial uniformity throughout a pharmaceutically acceptable carrier of the capsule formulations and exhibit good long-term stability and dissolution properties.

Abstract: Bioadhesive nanoparticulate compositions, comprising active agent particles and one or more cationic surface stabilizers, are described. The cationic surface stabilizers prevent aggregation of the nanoparticles and increase bioadhesion of the nanoparticles to biological substrates, such as an insect, teeth, bone, nails, chitin, feathers, scales, mucous, skin, hair, plant tissue, etc. The particles may consist of pharmacologically active compounds (e.g., drug compounds for human or veterinary use), agricultural chemicals (pesticides, herbicides, fertilizers, and the like), cosmetic agents, consumer products (coloring agents, flavors, or fragrances), or other materials which function by interacting with biological substrates. In addition, the invention relates to methods of preparing and using such bioadhesive nanoparticulate compositions.

Abstract: Nanoparticulate insulin compositions having effective an average particle size of less than about 5 microns are described. The compositions exhibit retention of insulin bioactivity, increased bioavailability, and increased consistency of bioavailability as compared to prior macro-sized insulin compositions. Methods of making nanoparticulate insulin compositions, dosage forms containing them, and the use of such formulations in insulin therapy are also described.

Abstract: Disclosed is a solid or semi-solid gelatin nanoparticulate active agent dosage form comprising at least one nanoparticulate active agent and at least one gel forming substance which exhibits gelation sufficient to retain excess water in the solid or semi-solid gelatin form. The active agent particles have an effective average diameter prior to inclusion in the dosage form of less than about 2000 nm. The dosage form of the invention has the advantages of easy administration combined with rapid dissolution of the active agent following administration.

Abstract: Nanoparticulate insulin compositions having effective an average particle size of less than about 5 microns are described. The compositions exhibit retention of insulin bioactivity, increased bioavailability, and increased consistency of bioavailability as compared to prior macro-sized insulin compositions. Methods of making nanoparticulate insulin compositions, dosage forms containing them, and the use of such formulations in insulin therapy are also described.