The present invention relates to solid oral pharmaceutical compositions for chronotropic administration of mesalazine, the salts or derivatives thereof, consisting of a complex monolithic matrix core comprising at least one low/medium viscosity hydroxypropyl methylcellulose, at least one medium/high viscosity hydroxypropyl methylcellulose, one or more methacrylic polymers or copolymers and/or cellulose acetate phthalate and/or hydroxypropyl methylcellulose acetate succinate or shellac, and an outer coating of said core consisting of a layer comprising ethylcellulose, or of a gastroresistant layer or of a layer comprising ethylcellulose coated in turn with gastroresistant polymers.

The present invention provides compositions and methods for treating Sjogren's syndrome (SS), including primary or secondary SS, as well as methods for preventing clinical disease in patients at risk of developing clinical SS. In various embodiments, the invention relates to administering a regimen of larazotide (or derivative) and/or 4-APAA compounds or 5-ASA compounds (e.g., 5-ASA, 4-ASA, 4-Ac APAA, and 4-APAA) to a patient in need thereof.

The present invention provides compositions and methods for treating Sjogren's syndrome (SS), including primary or secondary SS, as well as methods for preventing clinical disease in patients at risk of developing clinical SS. In various embodiments, the invention relates to administering a regimen of larazotide (or derivative) and/or 4-APAA compounds or 5-ASA compounds (e.g., 5-ASA, 4-ASA, 4-Ac APAA, and 4-APAA) to a patient in need thereof.

The present invention provides compositions and methods for treating Sjogren's syndrome (SS), including primary or secondary SS, as well as methods for preventing clinical disease in patients at risk of developing clinical SS. In various embodiments, the invention relates to administering a regimen of larazotide (or derivative) and/or 4-APAA compounds or 5-ASA compounds (e.g., 5-ASA, 4-ASA, 4-Ac APAA, and 4-APAA) to a patient in need thereof.

The present invention provides rebamipide for use in a method of prevention and/or treatment of Crohn's disease. In particular, rebamipide is used in prevention and/or treatment of Crohn's disease in a person suffering from increased intestinal permeability or in a person who is at risk of increased intestinal permeability.

The present invention provides rebamipide for use in a method of prevention and/or treatment of Crohn's disease. In particular, rebamipide is used in prevention and/or treatment of Crohn's disease in a person suffering from increased intestinal permeability or in a person who is at risk of increased intestinal permeability.

In alternative embodiments, the invention provides compositions and methods for treating various disorders and conditions in mammals, including chronic disorders in which there is a presence of an abnormal microbiota or an abnormal distribution of microflora in the gastrointestinal tract. In alternative embodiments, the invention provides liquid preparations or formulations derived from a human fecal material (e.g., a stool) processed, e.g., filtered and/or centrifuged, such that all bacteria, fungal spores and viruses are removed, but retaining the native biologically active molecules from the fecal material and bacteriophages. In alternative embodiments, the invention provides a “rough-”, “incomplete-” or medium-filtered microbiota which still comprises native physiological components or nutritive agents for the bacteria, e.g., retains native biologically and nutritionally active components. In alternative embodiments, the invention provides a highly filtered or substantially purified microbiota in combination with, or having added back, a liquid preparation or formulation of the invention. In alternative embodiments, the invention provides compositions or formulations where the bacteria, or microbiota, component has been cultured, or cultured under anaerobic conditions, or harvested, stored and/or cultured under anaerobic conditions. In alternative embodiments, the invention provides various additives, compositions and donor restrictions for treating these disorders and conditions.

In alternative embodiments, the invention provides compositions and methods for treating various disorders and conditions in mammals, including chronic disorders in which there is a presence of an abnormal microbiota or an abnormal distribution of microflora in the gastrointestinal tract. In alternative embodiments, the invention provides liquid preparations or formulations derived from a human fecal material (e.g., a stool) processed, e.g., filtered and/or centrifuged, such that all bacteria, fungal spores and viruses are removed, but retaining the native biologically active molecules from the fecal material and bacteriophages. In alternative embodiments, the invention provides a “rough-”, “incomplete-” or medium-filtered microbiota which still comprises native physiological components or nutritive agents for the bacteria, e.g., retains native biologically and nutritionally active components. In alternative embodiments, the invention provides a highly filtered or substantially purified microbiota in combination with, or having added back, a liquid preparation or formulation of the invention. In alternative embodiments, the invention provides compositions or formulations where the bacteria, or microbiota, component has been cultured, or cultured under anaerobic conditions, or harvested, stored and/or cultured under anaerobic conditions. In alternative embodiments, the invention provides various additives, compositions and donor restrictions for treating these disorders and conditions.

In alternative embodiments, the invention provides compositions and methods for treating various disorders and conditions in mammals, including chronic disorders in which there is a presence of an abnormal microbiota or an abnormal distribution of microflora in the gastrointestinal tract. In alternative embodiments, the invention provides liquid preparations or formulations derived from a human fecal material (e.g., a stool) processed, e.g., filtered and/or centrifuged, such that all bacteria, fungal spores and viruses are removed, but retaining the native biologically active molecules from the fecal material and bacteriophages. In alternative embodiments, the invention provides a “rough-”, “incomplete-” or medium-filtered microbiota which still comprises native physiological components or nutritive agents for the bacteria, e.g., retains native biologically and nutritionally active components. In alternative embodiments, the invention provides a highly filtered or substantially purified microbiota in combination with, or having added back, a liquid preparation or formulation of the invention. In alternative embodiments, the invention provides compositions or formulations where the bacteria, or microbiota, component has been cultured, or cultured under anaerobic conditions, or harvested, stored and/or cultured under anaerobic conditions. In alternative embodiments, the invention provides various additives, compositions and donor restrictions for treating these disorders and conditions.

A mesalamine pharmaceutical composition with reduced delivery variability for delivery of mesalamine to the colon that includes multiple dosage elements, and each dosage element includes mesalamine and an enteric coating. The enteric coating of each different dosage element differs so the release point of the mesalamine in the GI tract is varied. In one embodiment, a first dosage element releases about 30% to about 60% by weight of the total mesalamine in the composition after 60 minutes at a pH of about 6.6 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm and a second dosage element releases about 40% to about 70% by weight of the total mesalamine after 60 minutes at a pH of about 7.2 in an aqueous phosphate buffer using a paddle apparatus 2 with a paddle speed of 100 rpm.