A61K9/1617

RILUZOLE PRODRUGS AND THEIR USE

Pharmaceutical compositions of the invention include substituted riluzole prodrugs useful for the treatment of cancers including melanoma, breast cancer, brain cancer, and prostate cancer through the release of riluzole. Prodrugs of riluzole have enhanced stability to hepatic metabolism and are delivered into systemic circulation by oral administration, and then cleaved to release riluzole in the plasma via either an enzymatic or general biophysical release process.

Lipid nanoparticle compositions and methods of formulating the same

Provided herein are compositions and methods of reducing adduct formation.

SOLID DELTA9-TETRAHYDROCANNABINOL (DELTA9-THC) COMPOSITIONS

The invention relates to a solid Δ.sup.9-THC composition containing Δ.sup.9-THC and a powder former and having a molar ratio of Δ.sup.9-THC to powder former to form a flowable Δ.sup.9-THC powder. The powder former is selected from the group consisting of adenine, aspartame, caffeine, lactose, mannitol, nicotinamide, β-nicotinamide adenine dinucleotide, pipecolic acid, saccharin, aspartic acid, glutamic acid, glutamine, histidine, leucine, methionine, phenylalanine, proline, serine, tryptophan, valine, Epigallocatechin Gallate (EGCG), 2-Hydroxypropyl-beta-cyclodextrin (HPbCD), and Trimethyl-beta-cyclodextrin (TOMBC) and mixtures thereof. The invention also relates to methods of making a solid Δ.sup.9-THC composition of the invention. The Δ.sup.9-THC may be synthetic Δ.sup.9-THC or may be extracted Δ.sup.9-THC. The invention provides pharmaceutical or nutraceutical composition containing a solid Δ.sup.9-THC composition of the invention and a pharmaceutically- or nutraceutically-acceptable carrier where Δ.sup.9-THC is present in a pharmaceutically or nutraceutically effective amount. The invention also provides methods of treating a disease, disorder, or condition by administering to a patient in need thereof a therapeutically effective amount of a solid Δ.sup.9-THC composition. A solid Δ.sup.9-THC composition of the invention may also be incorporated into food and beverage products.

COMPOSITIONS AND METHODS FOR TRANSPLANTATION OF COLON MICROBIOTA

The present invention provides compositions that include an extract of human feces, and methods for using such compositions, including methods for replacing or supplementing or modifying a subject's colon microbiota, and methods for treating a disease, pathological condition, and/or iatrogenic condition of the colon.

LIPID NANOPARTICLE COMPOSITIONS AND METHODS OF FORMULATING THE SAME

Provided herein are compositions and methods of reducing adduct formation.

Solid Δ.SUP.9.-tetrahydrocannabinol (Δ.SUP.9.-THC) compositions

The invention relates to a solid Δ.sup.9-THC composition containing Δ.sup.9-THC and a powder former and having a molar ratio of Δ.sup.9-THC to powder former to form a flowable Δ.sup.9-THC powder. The powder former is selected from the group consisting of adenine, aspartame, caffeine, lactose, mannitol, nicotinamide, β-nicotinamide adenine dinucleotide, pipecolic acid, saccharin, aspartic acid, glutamic acid, glutamine, histidine, leucine, methionine, phenylalanine, proline, serine, tryptophan, valine, Epigallocatechin Gallate (EGCG), 2-Hydroxypropyl-beta-cyclodextrin (HPbCD), and Trimethyl-beta-cyclodextrin (TOMBC) and mixtures thereof. The invention also relates to methods of making a solid Δ.sup.9-THC composition of the invention. The Δ.sup.9-THC may be synthetic Δ.sup.9-THC or may be extracted Δ.sup.9-THC. The invention provides pharmaceutical or nutraceutical composition containing a solid Δ.sup.9-THC composition of the invention and a pharmaceutically- or nutraceutically-acceptable carrier where Δ.sup.9-THC is present in a pharmaceutically or nutraceutically effective amount. The invention also provides methods of treating a disease, disorder, or condition by administering to a patient in need thereof a therapeutically effective amount of a solid Δ.sup.9-THC composition. A solid Δ.sup.9-THC composition of the invention may also be incorporated into food and beverage products.

Extended release compositions comprising trihexyphenidyl

The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced C.sub.max, a C.sub.min:C.sub.max ratio of ≥0.4, Fluctuation Index of ≤1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.

Pharmaceutical compositions of amorphous solid dispersions and methods of preparation thereof

Provided are amorphous solid dispersions comprising an active pharmaceutical ingredient and pharmaceutical compositions comprising the amorphous solid dispersions. Also described herein are methods for preparing and using such compositions. In some embodiments, an amorphous solid dispersion comprises an active pharmaceutical ingredient such as palbociclib or neratinib, one or more acids, and a high-molecular weight material.

Composition of a Spray-Dried Powder for Pulmonary Delivery of a Long Acting Neuraminidase Inhibitor (LANI)

The present invention is related to pharmaceutical formulations and methods of treating a subject afflicted with the influenza virus, the method includes administering to the respiratory tract of the patient particles that include more than about 5% to about 50% weight percent (wt %) of a neuraminidase inhibitor. The particles are delivered to the patient's pulmonary system, including the upper airways, central airways and deep lung.

PULMONARY PHARMACEUTICAL FORMULATIONS

The present invention provides improved pharmaceutical formulations for pulmonary delivery having improved chemical and physical stability of the therapeutic, prophylactic or diagnostic agent as compared to formulations known in the art. The improved pharmaceutical formulations of the invention for administration to the respiratory system of a patient for the treatment of a variety of disease conditions comprise a mass of biocompatible particles comprising an active agent, and a hydrogenated starch hydrosylate (HSH). The improvement over the prior art comprises the presence of HSH in the pharmaceutical formulation. The invention further relates to a method of treating diseases comprising administering the pharmaceutical formulations of the present invention to the respiratory system of a patient in need of treatment.