A method for treating hyperglycemia and/or diabetes in a subject is provided. In particular, the method is directed for the treatment of patients with type 2 diabetes mellitus who have a fasting blood glucose concentration greater than about 8 mM, wherein the patient is administered a formulation comprising a GLP-1 molecule and a diketopiperazine by pulmonary inhalation with a dry powder inhalation system.

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.

Pharmaceutical formulation comprising centanafadine or a pharmaceutically acceptable salt thereof and an excipient, and related methods of manufacture and use, are disclosed.

A drug delivery system is provided in the form of a controlled release, bioerodible pellet for subdermal implantation. The pellet is bioerodible, and provides for the sustained release of a pharmacologically active agent over an extended time period. As such, the drug delivery system finds significant utility in chronic drug administration. Bioerosion products are water soluble, bioresorbed, or both, obviating the need for surgical removal of the implant. Methods for manufacturing and using the drug delivery system are also provided.

Pharmaceutical compositions of one or more opioid antagonists or phosphodiesterase 5 (PDE5) inhibitors are disclosed.

Dry powder compositions comprising biologically active polynucleotide molecules and methods for the manufacture of such dry powders are provided. In some aspects, dry powders of the embodiment comprise expressible or regulatory (e.g., siRNA) polynucleotide molecules complexed with nanoparticles. Dry powders comprising viable virus and bacteria are also provided.

The composition is formed of a plurality of particles. These particles include nicotine, a sugar, and an amino acid or short peptide.

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.

The present invention relates to a method of manufacturing spray-dried powders. During the process, a solvent is used. The process is done batchwise such that the emulsification mass ratio is low when removal of the solvent is started. Preferred solvents are isopropyl acetate and ethyl acetate. The invention also relates to a set-up to run the inventive process at industrial scale.

Pharmaceutical or food supplement preparation including alpha-lactalbumin and at least one short-chain fatty acid (SCFA) or a precursor or derivative thereof for use in the treatment of disorders of the central nervous system; the SCFA or its precursor or derivative may be contained in at least one first dosage unit together with a carrier acceptable from the pharmaceutical or food standpoint and the alpha-lactalbumin in at least one second dosage unit together with a carrier acceptable from the pharmaceutical or food standpoint, and said dosage units may be distinct units intended for simultaneous or separate administration or the preparation may consist of a pharmaceutical or food supplement composition comprising the at least one short-chain fatty acid or a precursor or derivative thereof and alpha-lactalbumin together with a carrier acceptable from the pharmaceutical or food standpoint.