The invention also relates to pharmaceutical compositions comprising highly pure amphetamine and amphetamine-class compounds resulting from the synthesis of chiral and racemic amphetamine derivatives by stereospecific, regioselective cuprate addition reaction with aziridine phosphoramidate compounds, and to methods of manufacturing, delivering, and using the amphetamine compounds resulting from the synthesis of chiral and racemic amphetamine derivatives by stereospecific, regioselective cuprate addition reaction with aziridine phosphoramidate compounds.

There are provided an enteric coating composition having an excellent film-forming property, being capable of forming a film at a lower temperature than conventional compositions, and/or being capable of avoiding decomposition of a drug due to a high temperature and operational troubles due to or nozzle clogging; and others. More specifically, there are provided an enteric coating composition containing hypromellose acetate succinate having a molar substitution of hydroxypropoxy groups of 0.40 or more, and water; a method for producing a solid preparation including steps of coating a drug-containing core with the enteric coating composition to obtain a coating layer, and drying the coating layer; and a solid preparation containing a drug-containing core, and a coating layer directly or indirectly on the core, the coating layer containing a hypromellose acetate succinate having a molar substitution of hydroxypropoxy groups of 0.40 or more.

The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

A pharmaceutical preparation, comprising: A) A plurality of particles, each particle comprising: 1) a core comprising at least one agent that increases oxygen tension and/or redox potential and/or pH in the colon of a subject following administration to the subject, and 2) an enteric coating encasing the core; and B) a capsule or sachet encasing the plurality of particles. Methods of weight management for a subject, comprising administering the pharmaceutical preparation to a subject in need thereof.

Provided is a manufacturing method of particles coated with coatable microparticles. The method is a manufacturing method of particles coated with coatable microparticles, comprising the step of adding the coatable microparticles to an inner core comprising a component of interest and a macromolecule, and, while rolling the mixture, coating the mixture while spraying a solvent that can dissolve the macromolecule, wherein the particles coated with the coatable microparticles are coated, component of interest-containing hollow particles.

Provided herein are oral pharmaceutical compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and which have a low level of organic solvent. Provided are also methods of orally administrating a composition comprising amantadine, or a pharmaceutically acceptable salt thereof, to a subject, which has reduced gastrointestinal side effects or sleep disturbances. Further provided are extended release oral compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, that are suitable for once daily administration.

The invention provides a pharmaceutical composition comprising activated carbon particles, for oral administration. The pharmaceutical composition may be for (use in) the treatment of gastrointestinal fistula.

The disclosure provides compositions and dosage forms for promoting healthy microbial flora in a mammal, for example, a human. The disclosure further provides compositions and dosage forms for disrupting biofilm or preventing formation of biofilm containing pathogenic bacteria and/or pathogenic fungi in a particular region of a subject. The dosage forms contain (i) an isolated non-pathogenic fungal strain that is viable in the region of the subject, (ii) an isolated non-pathogenic bacterial strain that is viable in the region of the subject, and optionally (iii) an enzyme capable of disrupting the biofilm. The present disclosure also provides methods of disrupting a biofilm or preventing formation of a biofilm with such a composition or dosage form, methods of identifying a subject suitable for treatment with such a composition or dosage form, and methods of improving nutrient absorption using such a composition or dosage form.

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

The present invention provides for a method of treatment of IgA nephropathy, which method comprises: (i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711>/Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test; (a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.2; (b) the composition fulfils the requirement that no more than about 10% of the budesonide is released into a pharmaceutically-relevant dissolution medium within about 30 minutes; and (c) the composition fulfils the requirement that at least about 70% of the budesonide is released into the pharmaceutically-relevant dissolution medium within about 120 minutes; (ii) wherein the method comprises the step of administering said composition to a patient with IgA nephropathy in need of said treatment.