The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

This invention relates to high drug load compositions of medium chain triglycerides (MCT), and to methods for treatment with such compositions at amounts effective to elevate ketone body concentrations so as to treat conditions associated with reduced neuronal metabolism, for example Alzheimer’s disease.

One solid preparation of the present invention mainly includes silicon fine particles, and has a capability of generating hydrogen. In addition, one specific example of the solid preparation mainly includes silicon fine particles having a crystallite diameter principally of 1 nm or more and 100 nm or less, and exhibits a capability of generating hydrogen in an amount of 3 ml/g or more when brought into contact with a water-containing liquid having a pH value of 7 or more. In this solid preparation, hydrogen is generated when the silicon fine particles are brought into contact with a water-containing liquid having a pH value of 7 or more. Therefore, taking advantage of the characteristics of the solid preparation, generation of hydrogen is promoted in, for example, a gastrointestinal tract where the pH value is 7 or more due to secretion of pancreatic fluid after passage through the stomach after oral ingestion.

The present invention discloses a spray drying process characterized by continuous preparation and immediate spray drying of a solution comprising at least one active pharmaceutical ingredient and/or at least one excipient, and at least one solvent. The said active pharmaceutical ingredient(s) and solvent(s) are combined, alone or along with one or more excipients to form a first suspension. Said suspension is continuously fed to an intensifier pump that pushes said suspension through at least one micro-reaction chamber and/or at least one micro-channel where the suspension's solid(s) component(s) is(are) dissolved into said solvent(s) by means of high energy mixing I forced contact at micro, nano and molecular level to form a solution stream. The said solution stream is then immediately and continuously fed to the spray dryer through at least one atomization nozzle, drying said atomized stream to obtain solid particles and collecting said solid particles. Single component particles or multi-component particles, particulate amorphous solid dispersion and pharmaceutical compositions are also disclosed. The present invention also discloses amorphous solid dispersions obtained by the method of the invention as well as pharmaceutical compositions containing the same.

Methods are provided for acute treatment of agitation, including agitation in patients with schizophrenia or bipolar disorder, comprising administering to a subject with agitation an effective dose of a dry pharmaceutical composition comprising olanzapine, wherein the dose is administered by an intranasal delivery device that provides, following intranasal administration, (a) a mean peak plasma olanzapine concentration (C.sub.max) of at least 30 ng/mL, with (b) a mean time to C.sub.max (T.sub.max) of olanzapine of less than 0.5 hours. Dry pharmaceutical compositions and devices suitable for intranasal delivery of olanzapine are provided.

An oral composition includes an immediate-release pharmaceutical admixture and an extended-release pharmaceutical admixture. The immediate-release pharmaceutical admixture includes a first portion of an active ingredient and a first portion of a hydrophilic dispersant, in which the active ingredient is substantially insoluble in water. The extended-release pharmaceutical admixture includes a controlled-release material, a second portion of the active ingredient, and a second portion of the hydrophilic dispersant, wherein the second portion of the active ingredient and the second portion of the hydrophilic dispersant are mixed in the controlled-release material, wherein the active ingredient is present as a nanoparticle in the immediate-release pharmaceutical admixture and the extended-release pharmaceutical admixture.

Pharmaceutical compositions suitable for long-term storage at room temperature are described. The pharmaceutical composition comprises the compound of formula (1) ##STR00001##
and can be used for the treatment of steatohepatitis. Also described are methods for preparing the pharmaceutical composition and methods of treatment using the pharmaceutical compositions.

Disclosed are tablet dosage forms and methods for formulating and delivering drugs via lipid-based drug delivery systems. An example tablet dosage form includes a plurality of granules, each granule comprising a pre-concentrate and a carbohydrate sorbent particle, where the pre-concentrate includes a drug having a log P of about −3 to about 10 and a lipid component The disclosed tablet dosage forms can be manufactured through high speed tableting methods with advantageous properties such as high drug release and low friability.

The present invention features pharmaceutical compositions including sepiapterin, or a pharmaceutically acceptable salt and/or co-crystal thereof, and methods for the treatment of tetrahydrobiopterin-related disorders (e.g., tetrahydrobiopterin deficiency or phenylketonuria) with such compositions.

The present invention relates to a process for preparing a solid composition comprising at least one active ingredient and at least one excipient comprising: i) mixing said at least one active ingredient and said at least one excipient in a granulator to obtain wet granules; ii) spreading wet granules on a tray and let stand for 2 to 24 hours between 15 and 25° C.; iii) compressing granules obtained after step ii) with a tablet press; and iv) collecting the solid composition. The invention further relates a solid composition obtained by such process.