A composite particle including a core with at least one carrier material; a fluidizing material layer on the surface of the core; and an outer layer comprising nanoparticles of an ingestible material distributed in at least one matrix-forming material. A process of making the composite particles includes the steps of dry coating carrier particles with a fluidizing material; preparing a suspension of nanoparticles of an ingestible material distributed in a matrix-forming material; and fluid bed coating the carrier particles with the suspension. The process and products provide quick dissolving composite particles which can be used for delivery of poorly water soluble ingestible materials in suitable dosage forms. The process of the invention reduces or prevents particle agglomeration during fabrication of the composite particles to enable delivery and quick redispersion of nanoparticles of the ingestible material from a dosage form.

Provided is method of making an aqueous composition comprising (a) providing a mixer comprising a sealable volume and one or more rotors inside said sealable volume; (b) placing into said sealable volume ingredients comprising ethylcellulose polymer and fatty acid; (c) placing into said sealable volume ingredients comprising water and a water-soluble base; (d) sealing said sealable volume after said steps (b) and (c); (e) then rotating one or more of said rotors while said ingredients are at a temperature above the softening point of said ethylcellulose polymer, to produce said aqueous composition; wherein said step (e) is conducted so that 90% or less of the volume of said ingredients is uncontacted by one or more of said rotors.

This invention relates to amphiphile-polymer particles comprising obtaining a first solution comprising a water-insoluble polymer, a payload and a first amphiphile in a water-miscible solvent; mixing the first solution with an aqueous second solution to form an aqueous composition comprising a particle comprising a water-insoluble polymeric core comprising the water-insoluble polymer; the payload; and the first amphiphile.

A multi-particle dosage form that can deliver phenylephrine in controlled pulsed doses. The dosage form can contain an immediate release form that can contain phenylephrine or a salt thereof and a plurality of delayed release particles with a coating that can contain phenylephrine or salt thereof and a pH sensitive coating.

Opiates, amphetamines, barbiturates and other drugs such as benzodiazepines are extensively abused or misused and are frequently the cause of death by overdosing. These drugs are also prone to oxidation and the final degradation products depend on the reactants and the reaction conditions. This invention describes the use of inactivating agents such as permanganates, peroxides, persulfates, bismuthates, periodates or other oxidants in a dosage form as an approach to minimize abuse and overdose. The product is designed such that the inactivating agent is released if there is an attempt to extract the drug from the formulation or in cases of overdose. Once released, the inactivating agent quickly degrades the drug and converts it into inactive compounds. Since the reactants (drug and inactivating agent) are incompatible in situations of normal drug usage, they are kept separated within the vehicle of the invention, but released for interaction in case of misuse. A catalyst may be included in the formulation to facilitate the reaction.

The present invention relates to, inter alia, safe and effective doses of a beta-lactamase for, e.g. microbiome protection.

GHB drug delivery systems comprising a floating interpenetrating network (IPN) are provided. The pharmaceutical compositions contain at least one IPN forming system, at least GHB drug, and at least one gas generating agent, such that upon oral ingestion of the compositions, a floating IPN is formed in situ. These floating IPN provide extended release of the GHB drug entrapped therein for at least about 3 hours.

Aspects of the disclosure include methods for treating hyperhidrosis in a subject with a composition including a muscarinic antagonist and a muscarinic agonist. In practicing methods according to certain embodiments, a therapeutically effective amount of a composition including a muscarinic antagonist or a pharmaceutically acceptable salt thereof and a muscarinic agonist or a pharmaceutically acceptable salt thereof is administered to a subject and is sufficient to reduce hyperhidrosis in the subject and to reduce a dry mouth side effect of the muscarinic antagonist. Compositions for practicing the subject methods are also described as well as dose units containing one or more of the subject compositions.

The invention discloses a gastric resistant pharmaceutical or nutraceutical composition, comprising a core, comprising a pharmaceutical or nutraceutical active ingredient and a gastric resistant coating layer onto the core, wherein the gastric resistant coating layer comprises at least 30% by weight of a (meth)acrylate copolymer comprising polymerized units of 10 to 40% by weight of acrylic or methacrylic acid, 10 to 80% by weight of a C.sub.4- to C.sub.18-alkyl ester of acrylic or methacrylic acid and optionally 0 to 60% by weight of another vinylic monomer, whereby the release of the pharmaceutical or nutraceutical active ingredient is not more than 10% under in-vitro conditions at pH 1.2 after 2 hours in medium according to USP with and without the addition of 20% (v/v) ethanol.

A controlled extended release composition comprising at least one unit dosage form having at least one active pharmaceutical ingredient (API), wherein said at least one API comprises at least one of pregabalin, a base thereof, a pharmaceutically acceptable prodrug thereof, a pharmaceutically acceptable derivative thereof, a pharmaceutically acceptable complex thereof, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable polymorph thereof, a pharmaceutically acceptable hydrate thereof, a pharmaceutically acceptable solvate thereof, an enantiomer thereof and a racemate thereof. Methods and uses of the composition are provided.