An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses is provided. The composition contains, at a minimum, (a) at least one drug in an immediate release pulse release form; (b) at least one drug in a delayed trigger release form; (c) at least one non-toxic gas generating agent and (d) a RAFT system, wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one drug in the stomach for at least about 3 hours, provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.

The present invention relates to a nicotine delivery product comprising, or even consisting essentially of, a population of nicotine-loaded cation exchange resin particles, said population comprises at least 50% (w/w) particles having a size in the range of 90-300 micron which provides an improved nicotine stability to oral dosage forms comprising the nicotine delivery product. The invention furthermore relates to methods of producing the nicotine delivery product and the oral dosage forms and to the use of the nicotine delivery product.

An orally dissolvable film includes at least one layer comprising a first pharmaceutically active ingredient; a resinate comprising an ion exchange resin and a second pharmaceutically active ingredient; and a matrix and/or binder. The provision of a first pharmaceutically active ingredient, e.g., dispersed or dissolved in the film, and of a resinate comprising an ion exchange resin and a second pharmaceutically active ingredient, may allow immediate release of the first active ingredient, and controlled, sustained and/el or delayed release of the second active ingredient.

An oral pharmaceutical composition is provided that can comprise a rho kinase inhibitor, for example, fasudil, a pharmaceutically acceptable salt thereof, a hydrate thereof, a prodrug thereof, a substituted derivative thereof, or a metabolite thereof, or any combination thereof, the rho kinase inhibitor having a bitter taste; and an ion exchange resin. The ion exchange resin can partially or fully mask the bitter taste of the rho kinase inhibitor, making the composition more palatable. The composition can comprise a solid dosage form, and/or a liquid dosage form. The solid dosage form can comprise a powder, granules, a tablet, or a capsule, or any combination thereof. The composition can be present, for example, in a unit dose, in an amount sufficient to treat a neurodegenerative disease. A method of treating the neurodegenerative disease with the oral pharmaceutical composition is provided. The method can ameliorate a symptom of a neurodegenerative disease.

The invention provides a complex comprising at least one proteinaceous agent, an ionic polymer comprising a repetitive unit of formula (I):

##STR00001##

wherein R.sup.1 represents a hydrogen atom or a straight or branched chain alkyl group, preferably a straight or branched chain alkyl group comprising from 1 to 6 carbon atoms, for example a methyl group; R.sup.2 represents a straight or branched chain alkyl group which is substituted by a group which may have a positive charge at a physiological pH; and optionally a surfactant; a complex for use in a method of medical treatment; a pharmaceutical composition

The present invention includes a compositions and methods comprising: one or more thyroid hormones in or on a micro-multi-particulate having a mean particle size of 150 uM or smaller and a Span (D90−D10)/(D50) of less than 2.0, wherein the total thyroid hormone(s) are less than 10% weight-to-weight (w/w) of the micro-multi-particulate; and a polymer release coating on the micro-multi-particulate that is greater than a 5:1 ratio w/w, on a dry weight basis, to a dry weight of the thyroid hormone(s), wherein a total tablet weight exceeds a micro-multi-particulate weight by a ratio of 5:1 or greater.

The present technology relates to the field of drug delivery. For example, the present technology provides methods of delivering a therapeutic to a cell where the method includes administering to a cancer cell a drug delivery composition. In this exemplary method, the drug deliver composition includes a (super)paramagnetic iron oxide nanoparticle core, where the nanoparticle core includes a coat non-covalently attached to a therapeutic, and the coat includes at least one of poly(acrylic acid), carboxymethyl dextran, and polyglucose sorbitol carboxymethylether.

An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses is provide. The composition contains, at a minimum, (a) at least one GHB drug in a first pulse release which releases in less than about 3 hours; (b) at least one GHB drug in a delayed trigger release form; (c) at least one non-toxic gas generating agent; and (d) a RAFT system, wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one GHB drug in the stomach for at least about 3 hours.

An orally administrable drug powder composition which forms a gastro-retentive RAFT having at least two trigger pulses is provided. The composition contains, at a minimum, (a) at least one drug in an immediate release pulse release form; (b) at least one drug in a delayed trigger release form; (c) at least one non-toxic gas generating agent and (d) a RAFT system, wherein following oral ingestion, the composition provides a self-assembling gastro-retentive RAFT having entrapped therein, the at least one drug of (a) and (b) and the gas generated in situ by the non-toxic gas generating agent, thereby providing a floating gastro-retentive RAFT having a dual pulse system wherein at least the second pulse is a trigger pulse and which retains the at least one drug in the stomach for at least about 3 hours, provided that the composition does not include a gamma hydroxybutyrate and its salts, hydrates, tautomers, or solvates, or complexes thereof.

This disclosure provides a pharmaceutical composition for oral administration, which comprises micronized ion-exchange resin particles having particle sizes less than 50 pm and at least one therapeutic agent releasably bound to the micronized resin particles through ionic interaction to form resin-therapeutic agent complexes. The resin-therapeutic agent complexes have particle sizes less than 50 pm, and the pharmaceutical composition is formulated as a dosage form providing uniform dispersion of the resin-therapeutic agent complexes with a substantially masked taste of the therapeutic agent, and a reduced gritty mouthfeel for geriatric patients and pediatric patients.