A nimodipine injection concentrate and diluted formulation comprises nimodipine (base or salt), an effective amount of a hydrophilic surfactant, and a pharmaceutically acceptable carrier for injection which is an aqueous solution, an organic solvent, an oil, or a cyclodextrin, such that the nimodipine is substantially contained in a concentrated injection solution, suspension, emulsion or complex as a micelle or a colloidal particle or an inclusion complex and the formulation is stable and clear. In certain embodiments, the hydrophilic surfactant is polysorbate 80.

A nimodipine injection concentrate and diluted formulation comprises nimodipine (base or salt), an effective amount of a hydrophilic surfactant, and a pharmaceutically acceptable carrier for injection which is an aqueous solution, an organic solvent, an oil, or a cyclodextrin, such that the nimodipine is substantially contained in a concentrated injection solution, suspension, emulsion or complex as a micelle or a colloidal particle or an inclusion complex and the formulation is stable and clear. In certain embodiments, the hydrophilic surfactant is polysorbate 80.

Provided herein is a celecoxib and amlodipine composition and method of making the same. The composition contains granules containing celecoxib. The amlodipine is incorporated into the composition as an extragranulate.

The present invention is directed to pharmaceutical compositions and dosage forms comprising TPR beads, wherein said TPR beads comprise a solid dispersion of at least one active pharmaceutical ingredient in at least one solubility-enhancing polymer, and a TPR coating comprising a water insoluble polymer and an enteric polymer, wherein the active pharmaceutical ingredient comprises a weakly basic active pharmaceutical ingredient having a solubility of not more than 100 g/mL at pH 6.8.

The present invention is directed to pharmaceutical compositions and dosage forms comprising TPR beads, wherein said TPR beads comprise a solid dispersion of at least one active pharmaceutical ingredient in at least one solubility-enhancing polymer, and a TPR coating comprising a water insoluble polymer and an enteric polymer, wherein the active pharmaceutical ingredient comprises a weakly basic active pharmaceutical ingredient having a solubility of not more than 100 g/mL at pH 6.8.

Provided herewith is a compound that reacts with a reactive lipid species to form a non-toxic product or an active product. Also provided is a method of reducing a reactive lipid species. Additionally provided is a method of treating a mitochondrion in a patient comprising a mitochondrial dysfunction. In other embodiments, a compound is provided that reacts with an activating agent present at a mitochondrion to form an active product that inhibits or enhances the opening of a mitochondrial permeability transition pore (MPTP). In additional embodiments, a method of inhibiting or enhancing the opening of an MPTP is provided. Further provided is a nonpolar compound capable of crossing the blood-brain barrier (BBB) into the central nervous system (CNS).

Provided herewith is a compound that reacts with a reactive lipid species to form a non-toxic product or an active product. Also provided is a method of reducing a reactive lipid species. Additionally provided is a method of treating a mitochondrion in a patient comprising a mitochondrial dysfunction. In other embodiments, a compound is provided that reacts with an activating agent present at a mitochondrion to form an active product that inhibits or enhances the opening of a mitochondrial permeability transition pore (MPTP). In additional embodiments, a method of inhibiting or enhancing the opening of an MPTP is provided. Further provided is a nonpolar compound capable of crossing the blood-brain barrier (BBB) into the central nervous system (CNS).

Provided are methods for treatment of chronic systemic hypoxia. The method comprises administration of an inhibitor of mitochondrial complex II (MTCII). An example of an MTCII inhibitor is Atpenin 5.

The present invention relates to a melt extrusion process for preparing a solid dispersion comprising a pharmaceutically active ingredient, a polymeric binder, and, optionally, one or more auxiliary agents, comprising a) in a batch-wise operation, placing a pre-determined amount of the polymeric binder, a pre-determined amount of the active ingredient, and, optionally, a pre-determined amount of the auxiliary agent(s) in a melting vessel; melting the polymeric binder with agitation to disperse the active ingredient in the polymeric binder to obtain a molten pre-dispersion; b) feeding the pre-dispersion into an extruder to homogenize the pre-dispersion and release a melt through a die; and c) allowing the melt to solidify.

The present invention relates to a melt extrusion process for preparing a solid dispersion comprising a pharmaceutically active ingredient, a polymeric binder, and, optionally, one or more auxiliary agents, comprising a) in a batch-wise operation, placing a pre-determined amount of the polymeric binder, a pre-determined amount of the active ingredient, and, optionally, a pre-determined amount of the auxiliary agent(s) in a melting vessel; melting the polymeric binder with agitation to disperse the active ingredient in the polymeric binder to obtain a molten pre-dispersion; b) feeding the pre-dispersion into an extruder to homogenize the pre-dispersion and release a melt through a die; and c) allowing the melt to solidify.