Abstract: The present invention relates to a method for preparing immediate and sustained release solid dosage forms, comprising antibodies and functional fragments thereof, by solution/suspension layering, optionally coated with a delayed release coating; the solid dosage forms prepared by the method; and the use of the solid dosage forms in the topical treatment in the gastrointestinal tract of a patient.

Abstract: The present invention relates to a method for preparing immediate and sustained release solid dosage forms, comprising antibodies and functional fragments thereof, by solution/suspension layering, optionally coated with a delayed release coating; the solid dosage forms prepared by the method; and the use of the solid dosage forms in the topical treatment in the gastrointestinal tract of a patient.

Abstract: The present invention relates to the therapeutic topical use of compositions containing antibody molecules or functional fragments or derivatives specific to tumour necrosis factor alpha (TNF?), for treating or preventing immune checkpoint (ICP) inhibitor-induced adverse events.

Abstract: A method produces a coatable core for a delayed release drug formulation for oral administration, to deliver a drug to the colon. The method involves forming a core containing a drug. An outer layer coating preparation is formed by combining a first aqueous preparation of an enzymatically degradable polymer, which is degradable by colonic bacterial enzymes; a second aqueous preparation of a film-forming enteric polymer having a pH threshold of about pH 6 or above; and an organic anti-tack agent. The core is then coated with the outer layer coating preparation to form an outer layer coated core.

Abstract: A delayed release drug formulation contains a core containing a drug and a delayed release coating for intestinal release, where release of the drug in the colon is not hindered by the absence of an alkaline middle layer between the core and the outer layer. The delayed release coating contains an outer coating, and optionally, an isolation layer. The outer coating contains a mixture of an enzymatically degradable polysaccharide which is degradable by colonic enzymes selected from the group of starch, amylose, amylopectin, chitosan, chondroitin sulfate, cyclodextrin, dextran, ptallulan, carrageenan, scleroglucan, curdulan, and levan and a film-forming enteric polymer having a pH threshold at about pH 6 or above. The enzymatically degradable polysaccharide and the enteric polymer are present in the outer coating in a ratio of more than 60:40.

Abstract: A delayed release drug formulation for oral administration delivers a drug to the colon of a subject. The formulation includes a core containing a drug and a coating for the core. The coating contains an outer layer and an inner layer. The outer layer contains a film-forming enteric polymer having a pH threshold at about pH 6 or above, and the inner layer contains a film-forming non-ionic polymer that is soluble in intestinal or gastrointestinal fluid and a buffer agent in an amount from more than 20 wt % to about 60 wt % based on the dry weight of the non-ionic polymer.

Abstract: The present invention relates to a method for preparing immediate and sustained release solid dosage forms, comprising antibodies and functional fragments thereof, by solution/suspension layering,optionally coated with a delayed release coating; the solid dosage forms prepared by the method; and the use of the solid dosage forms in the topical treatment in the gastrointestinal tract of a patient.

Abstract: The present invention relates to a method for preparing immediate and sustained release solid dosage forms, comprising antibodies and functional fragments thereof, by wet granulation, extrusion and spheronization,optionally coated with a delayed release coating the solid dosage forms prepared by the method and the use of the solid dosage forms in the topical treatment in the gastrointestinal tract of a patient.

Abstract: The present invention relates to a multiple unit dosage form comprising a core, wherein the core comprises a plurality of individual units, each unit comprising a pharmaceutically active ingredient and each unit being covered with a mucoadhesive material, and wherein the multiple unit dosage form further comprises an enteric core coating layer. The invention furthermore relates to the use of said multiple unit dosage form in the treatment of inflammatory disorders, especially for the gastrointestinal tract.