The present invention concerns pharmaceutical formulations of ARN-509, which can be administered to a mammal, in particular a human, suffering from an androgen receptor (AR)-related disease or condition, in particular cancer, more in particular prostate cancer, including but not limited to castration-resistant prostate cancer, metastatic castration resistant prostate cancer, chemotherapy-naive metastatic castration resistant prostate cancer, biochemically relapsed hormone sensitive prostate cancer, or high-risk, non-metastatic castration-resistant prostate cancer. In one aspect, these formulations comprise a solid dispersion of ARN-509, a poly(meth)acrylate copolymer and HPMCAS. In one aspect, the solid dispersion of ARN-509, a poly(meth)acrylate copolymer and HPMCAS is obtainable, in particular is obtained, by melt-extruding a mixture comprising ARN-509, a poly(meth)acrylate copolymer and HPMCAS and optionally subsequently milling said melt-extruded mixture. In one aspect, the solid dispersion of ARN-509, a poly(meth)acrylate copolymer and HPMCAS is obtainable, in particular is obtained, by spray drying a mixture comprising ARN-509, a poly(meth)acrylate copolymer and HPMCAS in a suitable solvent.

The present invention concerns pharmaceutical formulations of ARN-509, which can be administered to a mammal, in particular a human, suffering from an androgen receptor (AR)-related disease or condition, in particular cancer, more in particular prostate cancer, including but not limited to castration-resistant prostate cancer, metastatic castration resistant prostate cancer, chemotherapy-naive metastatic castration resistant prostate cancer, biochemically relapsed hormone sensitive prostate cancer, or high-risk, non-metastatic castration-resistant prostate cancer. In one aspect, these formulations comprise a solid dispersion of ARN-509 and HPMCAS. In one aspect, the solid dispersion of ARN-509 and HPMCAS is obtainable, in particular is obtained, by melt-extruding a mixture comprising ARN-509 and HPMCAS and optionally subsequently milling said melt-extruded mixture. In one aspect, the solid dispersion of ARN-509 and HPMCAS is obtainable, in particular is obtained, by spray drying a mixture comprising ARN-509 and HPMCAS in a suitable solvent.

A method and system of forming a pharmaceutical dosage form within a portion of a blister packaging. The method includes the steps of providing a blister packaging for the dosage form with depressions. A predetermined amount of a drug-containing powder material comprising drug-containing particles is deposited into a substantially uniform powder layer within the depressions. A binding liquid is then deposited in a pattern on the powder layer within the depressions, to bind the particles of the powder layer and form an incremental wetted powder layer. Excess solvent in the binding material can be removed to form an incremental bound layer. These steps are repeated in sequence at least one or more times to form the pharmaceutical dosage form within the blister packaging.

The present invention provides a method, wherein the method forms a biofilm, wherein the biofilm comprises a population of at least one bacterial strain attached to particles, wherein the biofilm is configured to colonize a gut of a subject in need thereof for at least five days, when ingested by the subject, the method comprising: a. obtaining a population comprising at least one strain of bacteria; b. inoculating a growth medium containing particles with the population comprising at least one strain of bacteria; c. incubating the particles with the population comprising at least one bacterial strain for a time sufficient for the population of at least one strain of bacteria to attach to the particles; and d. culturing the population comprising at least one strain of bacteria attached to the particles in a growth medium, for a time sufficient to form a biofilm.

The particle (1) is suitable for the manufacture of an implantable soft tissue engineering material and comprises a three-dimensionally warped and branched sheet (2) where:

(i) the three-dimensionally warped and branched sheet (2) is made from a biocompatible material having a Young's modulus of 1 kPa to 1 GPa;

(ii) the three-dimensionally warped and branched sheet (2) has an irregular shape which is encompassed in a virtual three-dimensional envelope (3) having a volume VE;

(iii) the three-dimensionally warped and branched sheet (2) has a mean sheet thickness T;

(iv) the three-dimensionally warped and branched sheet (2) has a volume VS;

(v) the particle (1) has a Young's modulus of 100 Pa to 15 kPa; and

(vi) the particle (1) further comprises a number of protrusions (4) where the three-dimensionally warped and branched sheet (2) reaches the envelope (3);

(vii) the particle (1) has a number of interconnected channel-type conduits (5) defined by the branching of the sheet (2) and/or by voids in the sheet (2); and

(viii) where the conduits (5) have (a) a mean diameter DC; and (b) an anisotropicity index of 1.01 to 5.00.

The present invention is directed to multiparticulate granulate compositions comprising particles of insulin and particles of an infant nutritional excipient, wherein the multiparticulate granulate is substantially free of layers of insulin and excipient, methods of making thereof, and methods of use thereof.

The present invention relates to extended release liquid compositions of guaifenesin. The extended release liquid compositions are in the form of suspensions which are ready-to-use or suspensions which are reconstituted from powder. It also relates to processes for the preparation of said extended release liquid compositions.

A composition in the form of a thermoformed extrudate includes at least one protoberberine alkaloid and at least one polymer of natural and/or synthetic origin chosen from the group consisting of proteins of natural and/or synthetic origin, amino acids, peptides and polypeptides of natural and/or synthetic origin, lipids of natural and/or synthetic origin, dextrins of natural and/or synthetic origin, alginates of natural and/or synthetic origin, oligosaccharides of natural and/or synthetic origin, cyclodextrins of natural and/or synthetic origin, hyaluronates of natural and/or synthetic origin, carrageenans of natural and/or synthetic origin, and derivatives and mixtures thereof.

The present invention relates to a process for producing an oral thin film comprising microparticles, comprising the steps of: a) producing a solution comprising a hydrophobic polymer, a hydrophobic pharmaceutically active ingredient and hydrophobic solvent, b1) providing a hydrophilic polymer and providing a hydrophilic solvent immiscible with the solvent from a), or b2) providing a solution comprising a hydrophilic polymer and a hydrophilic solvent immiscible with the solvent from a), c1) mixing the solution from a) with the hydrophilic polymer from b1) followed by the addition of the hydrophilic solvent from b1) immiscible with the solvent from a) to obtain an emulsion, or c2) mixing the solution from a) and the solution from b2) to obtain an emulsion, and d) spreading and drying the emulsion from c1) or c2) to obtain an oral thin film comprising microparticles.

A composite particle including a core with at least one carrier material; a fluidizing material layer on the surface of the core; and an outer layer comprising nanoparticles of an ingestible material distributed in at least one matrix-forming material. A process of making the composite particles includes the steps of dry coating carrier particles with a fluidizing material; preparing a suspension of nanoparticles of an ingestible material distributed in a matrix-forming material; and fluid bed coating the carrier particles with the suspension. The process and products provide quick dissolving composite particles which can be used for delivery of poorly water soluble ingestible materials in suitable dosage forms. The process of the invention reduces or prevents particle agglomeration during fabrication of the composite particles to enable delivery and quick redispersion of nanoparticles of the ingestible material from a dosage form.