Abstract: Ammonia is used as a processing aid in a method for forming a sprayed solid dispersion comprising an active agent, wherein the active agent, in a free acid form, has a pKa?7 and a solubility?40 mg/mL in the spray solvent. Ammonia is subsequently removed from the sprayed solid dispersion. Sprayed solid dispersions formed by the disclosed method are also disclosed.

Abstract: An aqueous composition for making dip-molded comestible hard capsules comprising a film forming capsule base material and one or more colorants each consisting of a hydrophilic coloring foodstuff concentrate.

Abstract: Disclosed are various embodiments of lipid multiparticulate compositions comprising at least one active agent, a low flow point excipient, and a high flow point excipient.

Abstract: The instant disclosure provides a process for making pullulan.

Abstract: The present disclosure relates to acid resistant banding solutions for two piece hard capsules endowed with acid resistant properties, and methods of making and using acid resistant banding solutions. The present disclosure also relates, in part, to methods for banding such acid resistant capsules which provides an acid resistant seal between the capsule parts and achieves acid resistance in vitro.

Abstract: [Technical Problem] A problem of the present invention is, in one aspect, to provide a capsule formulation including an active ingredient and the like that may deteriorate upon contacting an acid, wherein the capsule formulation makes it possible not to deteriorate the active ingredient and the like by a gastric acid which enters into a capsule film. [Technical Solution] A capsule formulation comprising an active ingredient and oil, wherein said capsule of said formulation is an enteric capsule comprising a water soluble film forming polymer and gellan gum; said oil is an oil acceptable for pharmaceuticals or foods; and said active ingredient is encapsulated in said capsule together with said oil, and the production method thereof, are provided.

Abstract: This disclosure concerns oral pharmaceutical compositions comprising a solid dosage form (SDF). The SDF comprises (i) a solid amorphous dispersion (SAD) comprising a poorly water soluble active agent and a matrix material comprising poly[(methyl methacrylate)-co-(methacrylic acid)] (PMMAMA), and (ii) a concentration-sustaining polymer (CSP), wherein the CSP is not dispersed in the SAD, and the SAD is at least 35 wt % of the SDF. The SAD and CSP together may be at least 50 wt % of the SDF. The SDF may be, for example, a tablet, a caplet, or a capsule.

Abstract: [Problem] Providing a whitened capsule and a whitened film without using any white pigment such as titanium dioxide. [Solution] Provided is a film, a capsule, and a film forming composition, characterized by comprising: a film-forming polymer; and a whitening agent including either a surfactant or both a surfactant and a salt, and characterized in that the surfactant is selected from a fatty acid ester of polyhydric alcohol, a polyethylene glycol, a polypropylene glycol, a polyalkylene oxide derivative, an alkyl sulfate ester salt, and a saponin.

Abstract: An acid resistant capsule comprises at least one hard capsule shell, said shell comprising: an enteric polymer having acid groups; a film-forming aid; and an alkaline material, wherein said alkaline material is present in an amount such that said carboxylic acid groups of said enteric polymer have a degree of ionization of less than 15%.

Abstract: The present disclosure relates to aqueous composition comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water, wherein the dispersed polymer is partially neutralized with at least one alkaline material. The instant disclosure also relates to compositions for use in methods of making capsule shells endowed with bulk enteric properties. The present disclosure also relates to capsules made according with the compositions and methods of the present disclosure.

Abstract: Embodiments of a spray-drying process for producing low aspect ratio particles of poly[(methyl methacrylate)-co-(methacrylic acid)] (PMMAMA) are disclosed. In some examples, at least 95% of PMMAMA-containing particles made by the process have an aspect ratio <10. The particles may further include an active ingredient and/or an excipient.

Abstract: The present disclosure relates to aqueous composition comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water, wherein the dispersed polymer is partially neutralized with at least one alkaline material. The instant disclosure also relates to compositions for use in methods of making capsule shells endowed with bulk enteric properties. The present disclosure also relates to capsules made according with the compositions and methods of the present disclosure.

Abstract: The present invention relates to new acid resistant hard pharmaceutical capsules, a process for their manufacture and use of such capsules particularly but not exclusively for oral administration of pharmaceuticals, veterinary products, food and dietary supplements to humans or animals. The capsules of the invention are obtained by aqueous compositions comprising a water soluble film forming polymer and gellan gum in a mutual weight ratio of 4 to 15 weight parts of gellan gum for 100 weight parts of film forming polymer.

Abstract: An apparatus for dosing solid particulate material into one or more receptacles, the apparatus comprising: a reservoir for containing an amount of solid particulate material; a dosing unit comprising a dose collection position for collecting a predetermined dose of solid particulate material from the reservoir, and a dose release position for releasing the solid particulate material into the one or more receptacles; a receptacle handling unit for retaining the one or more receptacles, arranged to at least periodically align at least one of the one or more receptacles with the dosing unit when in the dose release position; and optionally a receptacle closing unit for closing the one or more receptacles once filled with the solid particulate material; wherein the dosing unit comprises one or more dosing chambers arranged to displace relative to said reservoir, and/or vice versa, along a perpendicular axis Y such that at least a portion of the chamber(s) is capable of being immerged into, and emerged out of, the

Abstract: The present disclosure relates to delivery systems and methods for increasing the bioavailability and increasing the absorption rate by monolithic enteric capsule administration to humans of active ingredients compared to the bioavailability of active ingredients enterically coated for modified release or gastric protection, particularly acid sensitive active ingredients such as esomeprazole, omeprazole, and other proton pump inhibitors, systems for delivering active pharmaceutical ingredients to humans or animals via monolithic enteric capsules, and improved methods of treating gastrointestinal disorders with such methods and delivery systems.

Abstract: Multiparticulate compositions including an active agent and a gelling agent are disclosed. The multiparticulate compositions are prepared by an aqueous-based spray and congeal process.

Abstract: Abiraterone acetate lipid formulations.

Abstract: The instant disclosure provides a process for making pullulan.

Abstract: The instant disclosure provides a capsule composition comprising pullulan, a setting system and a surfactant system that is a sucroglyceride or a sugar fatty acid ester, and methods for making such capsules.

Abstract: An apparatus for aseptic sealing a capsule having coaxial parts that at least partly overlap when telescopically joined, certain embodiments of the apparatus comprising: a capsule carrier assembly provided with at least one cavity for accommodating a respective capsule therein; a clamping member comprising a first half and a second half disposed on either side of the cavity at a capsule processing station, and each half arranged to linearly displace towards the cavity containing the capsule to a clamped position over and/or around at least a portion of the capsule; wherein the clamping member comprises a sealing means adapted to apply a sealing fluid uniformly to a circumferential gap around the capsule to be sealed when in the clamped position, and wherein the clamping member further comprises a suction means adapted to provide an area of low pressure around the capsule after application of the sealing fluid so as to remove any excess sealing fluid from the capsule when in the same clamped position.