The present invention relates to a sustained release microsphere for long-lasting injectable formulations comprising one or more active ingredients selected from the group consisting of rivastigmine and pharmaceutically acceptable poorly soluble salts thereof and a biodegradable polymer, and a long-lasting injectable formulation for preventing or treating Alzheimer's disease comprising the same and a method for preparing the microsphere, and it can reduce side effects of the patient's gastrointestinal tract, which are frequently seen in conventional oral administration agents, and increase the adaptability of taking medicine, thereby maximizing the therapeutic effect, by providing a long-lasting injectable formulation comprising a rivastigmine sustained release microsphere, which has a high content while effectively controlling the initial burst drug release.

Provided herein are particles comprising compounds having a steroid core structure, or salts or esters thereof, and transition metal nanoparticles. Also provided herein are compositions comprising the particles, and methods of using the particles, for example in methods of treating liver disorders or for fat reduction.

The present disclosure provides a dry powder composition of treprostinil prodrugs and a method of treating pulmonary hypertension (e.g., pulmonary arterial hypertension), portopulmonary hypertension, or pulmonary fibrosis in a patient in need thereof. The dry powder composition includes (a) from about 0.1 wt % to about 3 wt % of a compound of Formula (I): ##STR00001##
or an enantiomer, diastereomer, or a pharmaceutically acceptable salt thereof, (b) from about 0.01 wt % to about 3 wt % of DSPE-PEG2000, (c) from about 10 wt % to about 50 wt % of leucine, and the balance being (d) a sugar selected from the group consisting of trehalose and mannitol. The entirety of (a), (b), (c), and (d) is 100 wt %, and R.sup.1 is tetradecyl, pentadecyl, hexadecyl, heptadecyl, or octadecyl. The method includes administering an effective amount of the dry powder composition to the lungs of the patient by inhalation via a dry powder inhaler. In certain compositions and methods provided herein, R.sup.1 is hexadecyl, e.g., linear hexadecyl.

Microparticles containing a core of therapeutic protein and a cortex of a biocompatible and biodegradable polymer, and methods of making and using the microparticles are provided. The extended release of a therapeutic protein from the microparticles in a physiological solution is demonstrated over an extended period of time.

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.

A simple, self-propelling particle system is disclosed that can deliver a cargo through flowing aqueous solutions. This disclosure provides a non-aqueous composition comprising: (i) particles formed of a carbonate salt and having an average diameter of about 100 μm or less; and (ii) an acid in solid form. The particles may be associated with a cargo molecule or particle. In mouse models of severe hemorrhage, the propelled particles are able to deliver a procoagulant enzyme and halt bleeding.

This invention is directed to reduction of flake-like aggregation in nanoparticulate compositions. Also encompassed by the invention are compositions comprising a nanoparticulate active agent, at least one surface stabilizer and a flake-like aggregation reducing agent, such as a buffer and a sugar. The nanoparticulate active agent compositions comprise particles of the active agent having an effective average particle size of less than about 2000 nm.

The invention provides a method of inducing satiety in a subject comprising a step of orally administering a composition comprising an effective amount of a first agent capable of inducing satiety and of a second agent capable of augmenting the satiety-inducing effect of the first agent. Also disclosed are compositions for carrying out the method, and a body weight management system comprising such compositions in combination with a device configured for the collection, storage and/or display of information relating to a subject's response to a predefined therapeutic regimen of orally administering the composition.

Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses is provide. The composition contains, at a minimum, (a) at least one GHB drug in a first pulse release which releases in less than about 3 hours; (b) at least one GHB drug in a delayed trigger release form; (c) at least one non-toxic gas generating agent; and (d) a RAFT system, wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one GHB drug in the stomach for at least about 3 hours.