Provided herein are compositions and methods for generating an immunogenic response in humans. Such compositions include an immunogenic biological agent encompassed by (ii) an agent that directs delivery of the immunogenic biological agent to the ileum of the human, wherein agent (ii) is an enteric coating (e.g., Eudragit®) that has a threshold pH 5.8-6.8. Further provided are methods for designing such compositions, e.g., for vaccines.

The invention provides a solid composition of the peripheral mu opioid antagonist axelopran and a combination dosage form of the mu opioid antagonist axelopran sulfate in an immediate release form and an opioid analgesic agent which may be in an extended release, sustained release, modified release, or controlled release form and methods of preparing such a combination dosage form.

Methods for improving the gastrointestinal tolerability of biguanide compounds and for treating metabolic disorders and/or inducing weight loss in patients in need thereof, particularly in individuals having a contraindication for treatment with biguanide compounds, are provided comprising administering delayed release formulations of such biguanide compounds, including metformin, targeted to the small intestine.

Compositions for reducing the frequency of urination and methods of manufacturing the compositions are disclosed. The compositions comprises a first component having an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents.

The present invention relates to a pharmaceutical preparation comprising omeprazole, an enantiomer thereof or a pharmaceutically acceptable salt thereof, and sodium bicarbonate, and a method for preparing the same. Specifically, the present invention relates to a pharmaceutical preparation in which sodium bicarbonate is first disintegrated so as to raise pH, and then omeprazole is dissolved such that the release properties of an active ingredient are improved, and thus the dissolution pattern and bioavailability of a drug can be enhanced.

Compositions and procedures for applying pharmaceutical tablet coatings, recognized as film coating wherein it is possible to obtain a final product coated with brightness superior to that achievable with typical compositions. The main difference in the composition is in the inclusion of the product derived from isomaltulose, which is a mixture of 6-O-α-D-glucopyranosyl-D-mannitol dihydrate with 6-O-α-D-glucopyranosyl-D-sorbitol, known as Isomalt, combined with a variety of film-forming polymers such as ethylene glycol and polyvinyl alcohol copolymer, copovidone, polyvinyl alcohol, and cellulosic derivatives, wherein the process conditions are advantageous as it is possible to handle high concentrations of solids in their preparation and wider applying temperature ranges than normally recommended for film coatings.

The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

A method of chemically tagging tablet coatings and readout of the tag includes addition of the specific mass of the tagging substance to the coating and preparation of coatings with the tagging substance. The method additionally includes extraction of the compounds present in the tablet coating and chromatographic analysis of the compounds present in the coating. Further, the method includes comparison of the absolute, non-unitary concentration values and paraben mass to authenticate the results.

The invention relates to a kinase inhibitor, in particular an inhibitor of protein kinases including the protein-tyrosine kinases LCK, ABL, SRC, KIT, SIK-family and/or their mutants. Although structurally similar to dasatinib, the kinase inhibitor of the invention displays, eg functional and ADMET properties distinct to dasatinib. Also, the invention relates to pharmaceutical compositions that comprise the kinase inhibitor, including those formulated for oral administration, such as in unit dose form that comprise particular ranges or amounts of the kinase inhibitor. The kinase inhibitor or pharmaceutical composition may be used in the treatment of a proliferative disorder, such as a leukaemia or solid tumour. The kinase inhibitor or pharmaceutical composition may be used in a treatment regimen that corresponds to, is similar to or is distinct from that used with dasatinib for a corresponding disorder, and in particular may be used in a combination treatment regimen together with one or more additional therapeutic agents, such as immune-checkpoint inhibitors.

A film coating composition comprising a cellulosic polymer, an opacifying agent, and a fatty acid is disclosed herein. Also disclosed is a film coating composition comprising a cellulosic polymer, an opacifying agent, a plasticizing agent, and a polyol. The disclosed film coating compositions may be mixed with a solvent to produce a film coating suspension. The film coating suspension can be applied to a substrate, such as a nutritional supplement, pharmaceutical, tablet, capsule, softgel, granule, particle, food confectionary form, agricultural seed, and the like to form a film coating on the substrate. Methods of coating a substrate with the film coating suspensions are also provided.