Described herein are formulations of a somatostatin modulator, methods of making such formulations, and methods of using such formulations in the treatment of conditions, diseases, or disorders that would benefit from modulation of somatostatin activity.

The disclosure provides a tebipenem pivoxil HBr formulation in the form of a tablet core comprising at least 70% (w/w) tebipenem pivoxil HBr, and in certain embodiment more than 80% (w/w) tebipenem pivoxil HBr. The disclosure provides a tebipenem pivoxil HBr tablet core comprising at least 70% w/w tebipenem pivoxil HBr, 5-25% w/w of a diluent, 0.5 to 5% w/w of a glidant, 0.5 to 5% w/w of a lubricant, and optionally 0.5 to 5% w/w of disintegrant. The disclosure provides methods of treating a patient who has a bacterial infection such as complicated urinary tract infection (cUTI), acute and chronic pyelonephritis, an upper or lower respiratory infection, or bacteremia by administering a formulation of the disclosure to the patient.

Praziquantel may be formulated to enhance its pharmacokinetic, toxicity, and palatability properties. It can be stored and/or dispensed as a liquid, powder, or tablet. Reduction in the most common side effects improves patient compliance and satisfaction. Altered taste profile improves patient compliance and satisfaction. Once formulated it can be used to treat a variety of blood flukes and worms in human and veterinary subjects.

The present invention relates to solid dispersions including, but not limited to, co-processed carbohydrates with different solubilities and concentrations, which have a microcrystalline plate structure. The solid dispersions, excipient systems and formulations of the present invention are highly compactable and durable and when compressed into solid dosage forms demonstrate uniform densification, low friability at low pressures, and and/or relatively constant low disintegration times at various hardnesses. The solid dosage forms of the present invention demonstrate superior organoleptics, disintegration, and/or robustness.

Intravesical drug delivery devices that include a device body, a number of solid drug tablets, and a retention frame. The device body includes a drug reservoir lumen and a retention frame lumen. The drug tablets is positioned in the drug reservoir lumen, and the retention frame is positioned in the retention frame lumen.

The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.

The present invention addresses the problem of providing a tablet that contains a high concentration of acetaminophen, satisfies an acetaminophen dissolution rate from the tablet of at least 80% in 15 minutes, and can be manufactured by dry direct compression. The present invention provides a tablet including: acetaminophen that has a median particle diameter in a range from 100 to 350 .Math.m; crystalline cellulose that has a bulk density in a range from 0.10 to 0.23 g/cm.sup.3; and at least two types of disintegrants. The at least two types of disintegrants are (a) at least one disintegrant selected from the group consisting of crospovidone, croscarmellose sodium, and sodium starch glycolate, and (b) a disintegrant that is a low-substituted hydroxypropyl cellulose. The acetaminophen content per tablet is at least 86 weight%.

The present invention provides a pharmaceutical composition comprising (S)—N-(1-(2-((4-amino-3-nitrophenyl)amino)-6-propylpyrimidin-4-yl)pyrrolidin-3-yl)acetamide or a pharmaceutically acceptable salt thereof having an activity as a 5-HT.sub.4 receptor agonist and an acidifying agent; and a process for preparing the same.

A method of making a magnesium salt of an alpha keto acid of the amino acid comprising valine, leucine, and/or isoleucine: 1) combining ingredients comprising: a calcium salt of an amino acid valine, leucine, or isoleucine; water; hydrochloric acid; and methyl tert-butyl ether; 2) stirring for about thirty minutes; 3) allowing the composition to settle into two layers, and collecting the top organic layer, and adding water and magnesium carbonate to the top organic layer; 4) heating the composition for one hour to 60-65° Celsius; 5) removing the solvent, cooling, and adding methyl-tert-butyl ether; 6) stirring the composition for one hour at 25-30° Celsius; 7) filtering, washing, drying under vacuum, and storing the composition as a powder; and 8) wherein the powder is a safe consumable low nitrogen product orally administered within a food, a beverage, or a tablet to treat kidney disease.

Provided is a rapid release tablet excellent in binding capability and disintegrability and also excellent in storage stability and the like. More specifically, provided are a granulated composite comprising low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight and D-mannitol, wherein the D-mannitol contains 0.9% by weight or less of D-sorbitol; a rapid release tablet comprising the granulated composite and a drug; and a method for producing a granulated composite comprising the steps of: mixing low-substituted hydroxypropyl cellulose having a degree of hydroxypropoxy substitution of from 5 to 16% by weight, first D-mannitol, and water to obtain an aqueous dispersion, and granulating while adding the aqueous dispersion to second D-mannitol, wherein the first D-mannitol and the second D-mannitol contain 0.9% by weight or less of D-sorbitol in total.