An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

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.

Zwitterionic phosphatidylserione (ZPS) monomers, ZPS polymers and ZPS copolymers, methods for making the ZPS monomers, ZPS polymers, and ZPS copolymers, compositions and materials that include ZPS polymers and ZPS copolymers, and methods for using the ZPS monomers, ZPS polymers, and ZPS copolymers.

Drug delivery systems comprising a floating interpenetrating network (IPN) are provided. The pharmaceutical compositions contain at least one IPN forming system, at least one 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 drug entrapped therein 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.

An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

The present invention relates to oral extended release composition, comprising memantine or its pharmaceutically acceptable salt as an active ingredient, resin complexation ingredient, release retardant, extended release coating system and the composition further comprising diluents, viscosity increasing agents, glidants, sweeteners, stabilizing agents, preservatives and other pharmaceutically acceptable excipients, wherein the drug-resin complex and drug-resin complex matrix particulates and coated drug-resin complex particulates have the specific particle size range. The present invention also relates to a process for the preparation of memantine or its salt oral extended release composition comprising the steps of drug-resin complexation, matrix resinate/particulates preparation process followed by extended release coating. The present invention also relates to oral extended release composition comprising memantine or its pharmaceutically acceptable salt as an active ingredient and pharmaceutically acceptable excipients using extended release resin-complexation technology, further comprising additional active ingredient is in its immediate release form.

A chewing gum composition comprising cannabinoids or derivatives thereof and nicotine in the form of nicotine polacrilex is provided. The chewing gum composition is formulated to provide rapid and controlled release of cannabinoids and nicotine during chewing. Methods to provide tobacco and/or cannabis smoking cessation using the chewing gum composition according to this invention are also provided.

The present invention relates to particles comprising protamine, RNA and at least one endosome destabilizing agent, to methods of their production and to pharmaceutical compositions or kits containing the particles. It further relates to particles comprising protamine and RNA for use in methods of treatment or prevention of diseases and to kits comprising such particles together with at least one endosome destabilizing agent.