Abstract: A modified release composition comprising cyclosporin A for oral administration. The composition may comprise a core and a modified release coating, wherein the core comprises a hydrogel-forming polymer matrix and cyclosporin A. The composition may be in the form of a minibead. The compositions provide a pharmacokinetic profile and dissolution profile which provides release of cyclosporin A in the lower GI tract whilst minimising systemic exposure. Also disclosed are uses of the composition in the treatment of conditions affecting the lower GI tract, particularly the colon.

Abstract: A composition comprises a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising an active principle. The invention includes embodiments in which the active principle is included in at least some of the oil droplets as well as embodiments in which the oil droplets are released as the matrix containing them dissolves in an aqueous medium. In one embodiment, the oil droplets are substantially immobilized in or by the matrix and the immobilizing feature is lost as the matrix dissolves in aqueous media. In certain embodiments, the oil drops may collectively be referred to as the oil phase of the composition of the invention. The product may be in the form of mini-beads. The oil phase and/or the polymer matrix may each include a surfactant.

Abstract: A method for treating intestinal fibrosis in a subject, comprising enterally administering a steroid to the subject. The steroid may be in a multiple minibead formulation.

Abstract: The present invention relates to a formulation comprising an inhibitor of NFAT activation for use in treating or preventing undesirable effects, more particularly undesirable effects occurring in conjunction with T cell-mediated therapies. The undesirable effects may be cytokine release syndrome (CRS) or symptoms associated with gastrointestinal (GI) inflammation, for example associated with inflammatory bowel diseases, such as ulcerative colitis, optionally caused by activated T cell activity. In addition to ameliorating undesirable effects, the invention is aimed at also maintaining the therapeutic effects of the T-cell mediated therapy.

Abstract: A composition comprises a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising an active principle. The invention includes embodiments in which the active principle is included in at least some of the oil droplets as well as embodiments in which the oil droplets are free of active principle. The oil droplets are released as the matrix containing them dissolves in an aqueous medium. In one embodiment, the oil droplets are substantially immobilized in or by the matrix and the immobilizing feature is lost as the matrix dissolves in aqueous media. In certain embodiments, the oil drops may collectively be referred to as the oil phase of the composition of the invention. The product may be in the form of mini-beads. The oil phase and/or the polymer matrix may each include a surfactant.

Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.

Abstract: A method for treating intestinal fibrosis in a subject, comprising enterally administering a steroid to the subject. The steroid may be in a multiple minibead formulation.

Abstract: This invention relates to compositions for delivering one or more active ingredients, and more particularly to compositions, e.g. beads, comprising a matrix material which matrix material comprises a microorganism. In particular, the invention relates to compositions comprising a microorganism selected from live, killed, attenuated and inactivated microorganisms. The matrix material may also comprise a surfactant and may further comprise an adjuvant. The invention further relates to the manufacture and use of such compositions, and to other subject matter.

Abstract: A pharmaceutical composition comprising a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising at least one immunomodulator selected from an adjuvant, an antigen or a combination thereof. A method of manufacturing shaped compositions comprises mixing an aqueous solution of a water-soluble polymer with an oil-based liquid to form a water-in-oil emulsion, at least one of the aqueous solution and the oil-based liquid comprising an antigen or an adjuvant or a combination thereof, and then causing or allowing the resultant suspension to solidify into one or more beads or other shaped elements.

Abstract: Immunomodulator formulations for use in the treatment of disease of the GI tract. The formulations comprise a hydroxylase inhibitor and/or an immunosuppressant. Exemplary formulations comprise hydralazine as a hydroxylase inhibitor and/or cyclosporin A as an immunosuppressant.

Abstract: A pharmaceutical composition comprising a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising at least one immunomodulator selected from an adjuvant, an antigen or a combination thereof. A method of manufacturing shaped compositions comprises mixing an aqueous solution of a water-soluble polymer with an oil-based liquid to form a water-in-oil emulsion, at least one of the aqueous solution and the oil-based liquid comprising an antigen or an adjuvant or a combination thereof, and then causing or allowing the resultant suspension to solidify into one or more beads or other shaped elements.

Abstract: The present application provides a method for treating or preventing Celiac disease. In one embodiment the method comprises administering to a patient in need thereof a composition comprising minicapsules, wherein the minicapsules comprise a steroid in a liquid, semi-solid or solid core, the minicapsules having release profiles to release the steroid in an active form at one or more sites along the gastrointestinal tract, the one or more sites comprising the proximal small intestine beginning at the duodenum and ending at the ileum. In a related embodiment the method comprises administering budesonide to a patient in need thereof in a pre-solubilized drug delivery format.

Abstract: Immunomodulator formulations for use in the treatment of disease of the GI tract. The formulations comprise a hydroxylase inhibitor and/or an immunosuppressant. Exemplary formulations comprise hydralazine as a hydroxylase inhibitor and/or cyclosporin A as an immunosuppressant.

Abstract: An oral cyclosporin composition comprises minicapsules having a core containing a cyclosporin, especially cyclosporin A in a solubilised liquid form. The minicapsules have a release profile to release the pre-solubilised cyclosporin, at least in the colon. The composition may be used for treating a range of intestinal diseases.

Abstract: An oral composition comprising minicapsules wherein the minicapsules comprise one or more therapeutic prophylactic substances in a liquid, semi-liquid, or solid core. The minicapsules have release profiles to release the substance in an active form at one or more sites along the gastro-intestinal tract to maximise absorption and/or therapeutic efficiency.

Abstract: An oral cyclosporin composition comprises minicapsules having a core containing a cyclosporin, especially cyclosporin A in a solubilised liquid form. The minicapsules have a release profile to release the pre-solubilised cyclosporin, at least in the colon. The composition may be used for treating a range of intestinal diseases.

Abstract: An oral composition comprising minicapsules wherein the minicapsules comprise one or more therapeutic or prophylactic substances in a liquid, semi-liquid, or solid core. The minicapsules have release profiles to release the substance in an active form at one or more sites along the gastro-intestinal tract to maximize absorption and/or therapeutic efficiency.

Abstract: An oral modified release composition comprising cyclosporin, wherein the composition is for use in the treatment of ulcerative colitis in a patient, wherein the composition is for use in the concurrent treatment of the patient with an active agent selected from an aminosalicylate and a steroid, and a fixed or free combination thereof. Also claimed are kits comprising the oral modified release composition and the active agent. Also disclosed are methods for the treatment of ulcerative colitis using the oral modified release composition.

Abstract: A modified release composition comprising cyclosporin A for oral administration. The composition may comprise a core and a modified release coating, wherein the core comprises a hydrogel-forming polymer matrix and cyclosporin A. The composition may be in the form of a minibead. The compositions provide a pharmacokinetic profile and dissolution profile which provides release of cyclosporin A in the lower GI tract whilst minimising systemic exposure. Also disclosed are uses of the composition in the treatment of conditions affecting the lower GI tract, particularly the colon.

Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.