Abstract: The invention relates to a drug delivery system, particularly to a liposomal drug delivery system. Most particularly the invention relates to a liposomal drug delivery system for the release of at least one drug compound at a target site within a human or animal body. The invention extends to a method of manufacturing the drug delivery system.

Abstract: This invention relates to pharmaceutical dosage forms, particularly to pH dependent pharmaceutical dosage forms with enhanced and/or prolonged distribution of a pharmaceutical compound at a target site. More specifically, this invention relates to a controlled release intravaginal pharmaceutical dosage form and, more particularly, to a pharmaceutical dosage form which comprises microspheres encapsulated and/or embedded within a bioerodible polymeric matrix, together the microspheres and the matrix are formed into a caplet and/or tablet.

Abstract: This invention relates to an orally administrable, gastroretentive pharmaceutical dosage form which contains at least one pharmaceutically active ingredient and at least one polymeric adjuvant. The adjuvant serves to retain the dosage form in a selected region of the gastrointestinal tract for sufficient time for the pharmaceutically active ingredient to be released and absorbed. Ideally the dosage form will contain two or more pharmaceutically active ingredients which are delivered to different regions of the gastrointestinal tract.

Abstract: An improved monolithic drug delivery dosage form releases a pharmaceutically active agent at a predetermined rate. The dosage form comprises a salted-out or crosslinked polymer and a pharmaceutically active agent. The salted-out or crosslinked polymer functions to polymerically entangle the pharmaceutically active agent but, progressively relaxes on contact with an aqueous medium in use to release the pharmaceutically active agent at a predetermined rate.

Abstract: The invention provides a pharmaceutical composition for oral administration of a pharmaceutically active agent to a subject, including the pharmaceutically active agent and an inhibitor of CYP3A4. Administration of the inhibitor and the pharmaceutically active agent reduces pre-systemic degradation of the pharmaceutically active agent by CYP3A4. The inhibitor can be poly(ethylene glycol), methoxy poly(ethylene glycol), aminated poly(ethylene glycol), O-(2-aminoethyl)-O-methoxy poly(ethylene glycol), polyoxyethylene glycol, branched poly(ethylene glycol), 3-arm poly(ethylene glycol), 4-arm poly(ethylene glycol), 8-arm-poly(ethylene glycol)polyamine, poly(L-lysine), poly(L-arginine), poly(L-alanine), poly(L-valine), poly(L-serine), poly(L-histidine), poly(L-isoleucine), poly(L-leucine), poly(L-glutamic acid), poly(L-glutamine), poly(L-guanidine), poly(methyl methacrylate), polyvinyl acetate, polyacrylate, poly(lactic-co-glycolic acid) and derivatives thereof. A method of treatment is also described.

Abstract: The invention provides an inflammation-responsive implantable device for the in situ delivery of one or more pharmaceutically active agents to a human or animal. The device comprises two differential release bioresponsive polymeric matrices (BPMs): an outer polymetric matrix and an inner polymeric matrix, both of which contain at least one pharmaceutically active agent or drug, typically an antibiotic and an anti-inflammatory agent, respectively. The therapeutically effective agent may be embedded in nanoparticles or nanobubbles. In response to inflammation, the pharmaceutically active agents are released, but at different rates: the rate of drug release from the inner polymeric matrix is lower than the rate of drug release from the outer polymeric matrix. Suitable polymers for forming the outer and inner polymeric matrices are hyaluronic acid and chitosan, respectively. A method of making the device and a method of treatment are also described.

Abstract: A pharmaceutical composition or dosage form is described for the delivery of at least one pharmaceutically active agent or drug in a sustained and controlled manner. The pharmaceutical composition is an injectable formulation which is capable of responding to local stimuli at the site of injection, such as pH and temperature, and comprises a thermoresponsive polymer composition with a suspension of pH responsive micro- or nano-particles which contain the at least one pharmaceutically active agent or drug. The thermoresponsive polymer composition is formed from poly(methyl vinyl ether) (PMVE), and an inorganic salt, and the micro- or nano-particles are formed from chitosan and eudragit. The composition can be used to treat any disease or condition which results in a decrease in pH, such as for treating a solid tumour, gout, acidosis, ketosis and the like.

Abstract: A pharmaceutical composition for intraperitoneal delivery of an anti-neoplastic agent is provided for treating cancers associated with aberrant mucin expression, preferably ovarian cancer and pancreatic, prostate, metastatic breast, bladder and lung cancers. The composition comprises nanomicelles loaded with the anti-neoplastic agent, and antibodies such as anti-MUC16, anti-MUC1 or anti-MUC4 are conjugated to these nanomicelles. The antibody-bound nanomicelles are optionally embedded in a biodegradable pH- and thermo-responsive hydrogel capable of sol-gel transition at body temperature. The pharmaceutical composition is implantable in the peritoneum, where it transforms into a semi-solid gel at the body's core temperature. In response to pH, the hydrogel swells and releases the antibody-bound nanomicelles. The nanomicelles specifically target mucin antigens on cancer cells.

Abstract: A pharmaceutical dosage form for the release of at least one pharmaceutically active ingredient is claimed. The pharmaceutical dosage form includes a polymer matrix, polymer-lipid nanoparticles incorporated within the matrix and the pharmaceutically active ingredient(s). The polymer matrix is formed from at least two crosslinked cationic and anionic polymers, such as Eudragit® E100 and sodium carboxymethlycellulose. It can also include a neutral polymer, such as one derived from locust bean. The polymer-lipid nanoparticles are formed from at least one polymer, such as Eudragit® E100 and/or chitosan, and at least one phospholipid, such as lecithin. The polymer(s) and phospholipid are crosslinking with a chelating agent, such as sodium tripolyphosphate. The active ingredient or ingredients can be any pharmaceutically active compound(s), and in particular poorly absorbed compounds such as levodopa for the treatment of Parkinson's disease.

Abstract: The invention provides an implantable intracranial device for the site-specific delivery of a pharmaceutically active agent to a human or animal for treating a mental or neurological disorder, such as Alzheimer's disease, schizophrenia or other psychoses. The biodegradable device includes a pharmaceutically active agent for treating the disorder, polymeric nano-lipoparticles into or onto which the pharmaceutically active agent is embedded; and a polymeric matrix or scaffold incorporating the nano-lipoparticles. The nano-lipoparticles can be in the form of nano-liposhells or nano-lipobubbles. The nano-liposhells or nano-lipobubbles can include an essential fatty acid or can be conjugated to a peptide ligand which targets the device to a specific cell into which the therapeutic agent can be delivered. The device can be implanted in the sub-arachnoid space in the region of the frontal lobe of the brain.

Abstract: A polymeric hydrogel composition is described for the delivery of a pharmaceutically active agent when an electrical stimulus is applied to the composition. The composition comprises a polymer which forms the hydrogel, such as poly vinyl alcohol (PVA) cross-linked with diethyl acetamidomalonate (DAA), an electroactive polymer such as polyaniline and a pharmaceutically active agent such as an analgesic, and in particular, indomethacin. The composition can be subcutaneously implanted at a targeted site and under normal conditions, the active agent will be entrapped in the hydrogel itself. However, upon the application of an electric current to the hydrogel, the active agent will be released. When the electric current is removed, the change is reversed and the active agent will cease to be released. In one embodiment of the invention, the hydrogel composition is for use in alleviating chronic pain.

Abstract: A pH responsive and mucoadhesive pharmaceutical dosage form for the release of a pharmaceutically active agent is described. The dosage form includes a mucoadhesive layer for site-specific mucoadhesion, a water-insoluble outer layer, and an intermediate layer including one or more pharmaceutically active agents for site-specific delivery. The different membranous layers perform different functions in order to create a drug delivery system which is able to deliver a drug to a specific site, for a particular period of time and with a specific drug release pattern. The dosage form can have two or more intermediate layers, each layer comprising an active agent. The mucoadhesive layer can also include an active agents. The dosage form is preferably an oral or buccal delivery form for release of the active agent into the gastro intestinal tract. The intermediate layer can be an electrospun fibrous membrane layer containing the active agent.

Abstract: This invention relates to a polyamide rate-modulated monolithic drug delivery system comprising at least one active compound and a biodegradable and biocompatible polyamide polymer. The polymer is selected for delivering, in use, the active compound, within a predetermined time frame depending on the biodegradable properties of the polymer, to a target organism or organisms. In one embodiment of the invention the polymer is modified by salting-out or crosslinking the polymeric material to achieve the desired biodegradability characteristics and, consequently, to control the release of the active compound.

Abstract: This invention relates to a polymeric pharmaceutical dosage form for the delivery, in use, of at least one pharmaceutical composition in a rate-modulated and site-specific manner. The dosage form comprises a biodegradable, polymeric, scaffold incorporating loaded with at least one active pharmaceutical ingredient (API). The polymer or polymers making up the scaffold degrade in a human or animal body in response to or in the absence of specific biological stimuli and, on degradation, release the API or APIs in an area where said stimuli are encountered. Preferably the polymeric scaffold is formed from poly (D1L-lactide) (PLA) and polymethacrylate (Eudragit S100/ES100) polymers.

Abstract: This invention relates to a multi-configured, transmucosal pharmaceutical dosage form and, more particularly, to a pharmaceutical dosage form which has a single monolithic/heterogeneous layer or a plurality of such layers. The dosage form is suitable for the delivery of one or more pharmaceutical compositions via the buccal, sublingual, rectal, vaginal or transmucosal delivery route in a human or animal body. It provides for selected delivery profiles resulting from, but not limited to, a porosity-enabled composite matrix of one or more layers/components of the pharmaceutical composition/s. The invention also provides for a method of manufacturing said transmucosal pharmaceutical dosage form in a plurality of configurations.

Abstract: The invention relates to biodegradable and implantable devices for the in situ delivery of a pharmaceutical composition to a human or animal that comprise a generally discoid body, having at least one aperture through which the body is anchorable by suture, and that are formed from biodegradable polymeric compositions. The invention relates to methods of manufacturing devices for the in situ delivery of a pharmaceutical composition to a human or animal that comprise a generally discoid body, having at least one aperture through which the body is anchorable by suture, and that are formed from biodegradable polymeric compositions. The invention relates to a therapeutic method that comprises inserting a biodegradable and implantable device that comprises a generally discoid body, having at least one aperture through which the body is anchorable by suture, and that is formed from a biodegradable polymeric composition, into a body cavity of a human or animal.

Abstract: This invention relates to a pharmaceutical dosage form for the phase-controlled and chronotherapeutic delivery of at least one and, preferably, several pharmaceutically active ingredients. The dosage form has a carrier platform which,—preferably, is a polymer having known biodegradable characteristics. The platform may include a pharmaceutically active ingredient'which is released over a predetermined period of time as the platform polymer degrades. At least one pharmaceutically active ingredient in the form of a disc is embedded in the platform and, once the polymer of the platform has degraded, the disc is released and releases its ingredient in the same location as that of the platform or it travels to another region of the body where it releases its ingredient.

Abstract: This invention relates to a pharmaceutical dosage form for the delivery of at least one active pharmaceutical ingredient (API) or the pharmaceutically active salts and isomers thereof, to a desired absorption location of the human or animal body, preferably the gastrointestinal tract, in a predetermined rate-modulated manner. The dosage form is orally ingestible and is in the form of a multi-layered tablet preferably three layers and each layer includes an API or capsule containing a multiplicity of multi-layered granules. Each layer contains one or more APIs mixed or blended with at least one and preferably a matrix of polymers and, where appropriate, excipients, which, in use, inhibit release of an API in a region of the gastrointestinal tract other than the desired absorption location and, thus, facilitate release of the API in a rate controlled manner when in the desired absorption location. Methods of manufacturing said dosage form are further disclosed.

Abstract: This invention relates to a pharmaceutical dosage form for the site specific delivery of more than one active pharmaceutical ingredient to different sites in the human or animal body in the gastrointestinal tract. The dosage form has an outer polymeric layer incorporating a first active pharmaceutical ingredient which reacts to stimuli specific in the stomach, degrades, and releases the first active pharmaceutical ingredient in the stomach for absorption. The dosage form also has at least one inner polymeric layer incorporating a second active pharmaceutical ingredient which, once the outer layer has degraded, passes into the intestine where the polymers of the second layer degrade to release the second active pharmaceutical ingredient. The dosage form may have additional layers each incorporating active pharmaceutical ingredients for release in different portions of the intestine depending on the nature of the polymers.

Abstract: This invention relates to an orally administrable, gastroretentive pharmaceutical dosage form which contains at least one pharmaceutically active ingredient and at least one polymeric adjuvant. The adjuvant serves to retain the dosage form in a selected region of the gastrointestinal tract for sufficient time for the pharmaceutically active ingredient to be released and absorbed. Ideally the dosage form will contain two or more pharmaceutically active ingredients which are delivered to different regions of the gastrointestinal tract.