The present invention relates to solid oral formulations comprising a compound of formula (3Z,5S)-5-(hydroxymethyl)-1-[(2′-methyl-1,1′-biphenyl-4-yl)carbonyl]pyrrolidin-3-one-O-methyloxime, and/or an active metabolite thereof, and the use of said formulations in the treatment and/or prevention of preterm labor, premature birth, dysmenorrhea and embryo implantation failure due to uterine contractions. The present invention is furthermore related to processes for their preparation.

Viral epidemic infections due to influenza, or coronaviruses, particularly influenza A and SARS-CoV-1 and -2 virus cause significant morbidity and mortality. The significant mutation rate of this group of viruses renders existing vaccines or antiviral drugs often useless, creating a need for broad acting, viral DNA or RNA sequence independent antiviral drugs. This invention describes the repurposing of methylene blue and riboflavin, two FDA approved drugs with an excellent safety profile. Using a virus neutralization assay of H1N1 Influenza A and SARS-CoV-2, the significant viricidal activity of both drugs at pharmacological dose and under physiological conditions is demonstrated. In vivo prophylactic and therapeutic use of the drugs for anti-viral application in an animal model is described.

The present disclosure relates to an immediate release tablet of daprodustat having good tensile strength. In other aspects, medical uses of the immediate release tablet and dosage regimens for using the immediate release tablet are disclosed.

The present disclosure relates, in general, to: (a) solid pharmaceutical dosage forms comprising acalabrutinib maleate; (b) methods of using such pharmaceutical dosage forms to treat B-cell malignancies and/or other conditions; (c) kits comprising such pharmaceutical dosage forms and, optionally, a second pharmaceutical dosage form comprising another therapeutic agent; (d) methods for the preparation of such pharmaceutical dosage forms; and (e) pharmaceutical dosage forms prepared by such methods.

The present invention relates to nano-resin particles that are suitable for pharmaceutical use and their use in the pharmaceutical field. The present invention provides nano-sized resin particles having a particle size distribution characterized in that D.sub.90 value is between 200 nanometers to 900 nanometer and D.sub.10 value is not less than 50 nanometers, wherein the nano-resin particles are in pure form and safe for pharmaceutical use. The present invention further relates to pharmaceutical compositions comprising these purified nano-resin particles and their use in the treatment of diseases. The present invention further provides a process for preparing purified, nano-sized resin particles that are suitable for pharmaceutical use, the process comprising steps of: (i) washing an ion exchange resin and suspending in an aqueous liquid, (ii) subjecting the suspension of (i) to wet milling for a period such that the particles have a particle size distribution characterized in that the D.sub.90 value is between 200 nanometers to 900 nanometers and D.sub.10 value is not less than 50 nanometers, (iii) subjecting the suspension of (ii) to purification to remove impurities, (iv) drying the purified suspension to obtain nano-resin particles in the form of dry powder.

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.

Disclosed is a dry powder oral formulation that includes an active pharmaceutical ingredient (API), a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation. Also disclosed are an excipient composition in absence of an API and methods of making and using the formulations and compositions. Also disclosed is a chewable, swallowable, and/or orally disintegrating tablet comprising an API, a lecithin powder, a galactomannan, one or more sweetening agents, one or more flavoring agents and an organic acid in a pharmaceutically acceptable preparation.

Disclosed are methods, materials and devices that pertain to a microstirring pill technology with built-in mixing capability for oral drug delivery that greatly enhances bioavailability of its therapeutic payload. In some aspects, a drug delivery device includes a pill matrix dissolvable in a fluid medium and loaded with a plurality of drug payloads; and a plurality of micro stirrers embedded in the pill matrix and configured to create a local fluid transport upon interacting with a biological fluid surrounding the microstirring pill.

The present disclosure provides epinephrine formulations and methods of treating anaphylaxis, methods for concomitant therapy during a cardiac event, methods for treating hypoglycemia, and a prophylactic method for immunotherapy, using the epinephrine formulations disclosed herein. The epinephrine formulations of the present disclosed are formulated for delivery via the oral mucosa. Epinephrine formulations of the present disclosure may further comprise citric acid to improve delivery of epinephrine through the oral mucosa. The epinephrine formulations of the present disclosure induce a robust, global sympathetic response in a subject that is disproportionate to the serum epinephrine concentration in the subject.

Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor nilotinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer. In particular, the present disclosure provides a pharmaceutical composition in the form of an orally disintegrating tablet. In some embodiments, the pharmaceutical compositions can be administered without regard to food consumption. In other embodiments, the pharmaceutical compositions can be administered at a significantly lower dose as compared to a commercially available immediate-release nilotinib formulation, while providing a comparable therapeutic effect.