Disclosed is a pharmaceutical unit dosage composition including a plurality of enteric coated micro pellets. Each enteric coated micro pellet includes a core bead, an optional first sealing layer, an API layer including a Compound (I) having the following structure or a pharmaceutically acceptable salt thereof, an optional second sealing layer, and an enteric coating layer. Also disclosed is a method for the treatment and prophylaxis of RSV diseases including providing a Compound (I) and administering to a patient in need thereof a therapeutically effective amount of the Compound (I) so that t½ of the Compound (I) is about 6 to 13 hours.

##STR00001##

This invention provides, in part, various compositions and methods for protecting the gastrointestinal microbiome from antibiotic disruption from orally administered antibiotics.

The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

There is provided acid-resistant capsules, and in particular acid-resistant, vegetarian-based, and/or gelatin-based soft gel capsules and method of manufacturing the soft gel capsule. The soft gel capsule has 30% wt. to 45% wt. water; 15% wt. to 19% wt. glycerol; and a gel mass composition comprising a gelling agent and an alkaline agent. The method of manufacturing the capsule involves: dissolving a gelling polymer into water to form an enteric polymer solution; mixing an acid insoluble polymer with an alkali agent to form a film forming polymer; and adding the film forming polymer to the enteric polymer solution while mixing and heating at 70° C. until a gel mass forms.

The invention provides ingestible particles comprising a water-swellable or water-soluble polymeric component, a lipid component, and optionally an amino acid, a vitamin and/or a micro-nutrient. The polymeric component may be embedded in the lipid component. The particle may further comprise an inert core and/or an outer layer which rapidly disintegrates after oral ingestion. The invention further provides methods for preparing the ingestible particles and uses thereof.

The present invention relates a microcapsule that comprises an active pharmaceutical ingredient and a polymeric shell comprised of polymeric materials such as polyether, polyester, polyamine, polyamide, polyurea, polyurethane, polythiocarbamate, and polythiocarbonate. The outer surface of shell comprises surface functional groups such as hydroxide, primary amine, carboxylic acid, or protected forms thereof. These surface functional groups may be reacted further with reactants to place specific organic groups on the surface of the microcapsule. Such microcapsules are prepared by a modified interfacial condensation polymerization.

The invention provides methods of making microparticle and nanoparticle ocular implants from a compositions comprising: 99 to 60% (w/w) of a photopolymerizable composition selected from the group of fragments or monomers consisting of polyalkylene glycol diacrylate and polyalkylene glycol dimethacrylate, wherein the photopolymerizable composition has a molecular weight in the range of 100 to 20,000 Dalton; a biodegradable polymer selected from the group consisting of aliphatic polyester-based polyurethanes, polylactides, polycaprolactones, polyorthoesters and mixtures, copolymers, and block copolymers thereof; a photoinitiator; and a therapeutic agent.

The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

A spherical core containing an esomeprazole compound as an active ingredient and having a median particle diameter (d.sub.50) of 50 μm or more is coated with a coat containing a controlled release layer to prepare a controlled release granule containing a controlled release granule with a median particle diameter (d.sub.50) of 350 μm or less. The spherical core may contain the esomeprazole compound at a proportion of 50% by mass or more relative to the spherical core. The spherical core may be a spherical particle containing the esomeprazole compound as a drug. The spherical core has a median particle diameter (d.sub.50) of 50 μm or more. The spherical core may have a sphericity of 0.6 or more. The coat may be in a multilayer free from an esomeprazole compound as an active ingredient. The controlled release layer may be an enteric coating layer. The proportion of the coat may be 80% by mass or more relative to the whole amount of the preparation. The oral preparation may be an orally disintegrating tablet containing a disintegrator in addition to the controlled release granule. The oral preparation has an excellent controlled release ability and an excellent formulation designability such as miniaturization.