Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: A formulation for injection moulding of a pharmaceutical carrier comprising 27-85% (w/w) of polyvinyl alcohol, and 10-60% (w/w) of a disintegration aid selected from maize starch, wheat starch, and combinations thereof; and optionally one or more excipients.

Abstract: The present invention relates to methods of preparing pharmaceutical products, involving filling active pharmaceutical ingredient powders into pharmaceutical carriers with a vacuum assisted metering and filling device. The methods disclosed herein can be used in a continuous process, such as in a high-throughput process for producing a pharmaceutical product. The present invention further relates to a particular quality of the neat active pharmaceutical ingredient (API) HDM201, i.e. siremadlin, present as succinic acid co-crystal, which can be used in the methods of preparation of the present invention.

Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: A formulation for injection molding of a pharmaceutical carrier comprises 43.5-97% (w/w) of one or more polyethylene oxide polymer having a weight average molecular weight of MW 94,000-188,000; and optionally one or more excipients.

Abstract: A pharmaceutical carrier (20) comprises a lid part (22) and a bottom part (24), wherein at least one of the lid part (22) and the bottom part (24) has a first wall section (26, 30) with a thickness of 180-250 ?m, preferably 185-225 ?m, even more preferably 190-220 ?m, and most preferably about 215 ?m, and a second wall section (28, 32) with a thickness of 350-450 ?m, preferably 375-425 ?m, more preferably 390-410 ?m, and most preferably about 400 ?m. The first wall section (26) of the lid part (22) defines an entire top portion of the lid part (22). Alternatively or additionally thereto, the first wall section (30) of the bottom part (24) defines an entire bottom portion of the bottom part (24).

Abstract: Materials containing pharmaceutically active species in solid (e.g., crystal) form, and related methods, are provided, allowing for improved stability, solubility, bioavailability, and/or dissolution rates for pharmaceutically active species having poor aqueous solubility.

Abstract: The invention relates to a method for producing a micronized, virtually anhydrous form of (1?,2?,4?,5?,7?)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide, said form per se, and the use thereof for producing a medicament, especially a medicament having an anticholinergic effect.

Abstract: A process of preparing a particulate and substantially crystalline drug substance. The process involves suspending a substantially crystalline drug substance in an anti-solvent to give a suspension, homogenising the suspension at elevated pressure to give drug particles that have a mean particle size of less than about 10 ?m, and drying the drug particles to remove any residual anti-solvent.

Abstract: A process for reducing the tendency of a drug substance to aggregate and/or agglomerate during storage. The process involves micronising the drug substance to give a mean particle size of less than about 10 ?m, and exposing the micronised drug substance to a dry environment at an elevated temperature between 40° C. and 120° C. for at least six hours.

Abstract: The invention relates to a method for producing a micronized, virtually anhydrous form of (1?,2?,4?,5?,7?)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide, said form per se, and the use thereof for producing a medicament, especially a medicament having an anticholinergic effect.

Abstract: The present invention relates to an aqueous pharmaceutical composition comprising 1-(2-dimethylaminoethyl)-3-((2R,4aS,5R,10bS)-5-phenyl-9-trifluoromethyl-3,4,4a,5,6,10b-hexahydro-2H-pyrano[3,2-c]quinolin-2-ylmethyl)urea as active compound, to a liquid pharmaceutical composition which is suitable for the preparation of the aqueous pharmaceutical composition, and to a process for the preparation of the compositions.

Abstract: The invention relates to a method for producing microparticles and/or nanoparticles of a substance, wherein particles are formed from molecularly distributed substances which simultaneously stabilized in suspension. The substance is dissolved in a solvent system and subsequently a non-solvent for said substance is added whereby said non-solvent can be mixed with the solvent system for this substance. One or several crystal growth inhibitors are added and a rapid merging of solvents and non-solvents take place. The substance is precipitated by forming a dispersion of particles whose size lies in the micrometer or nanometer range.

Abstract: The present invention relates to a process for the formation of profen crystals, which comprises carrying out the formation of solids by displacement precipitation, cooling crystallization, evaporative crystallization or a combination thereof in the presence of one or more additives, and the use of the profens thus prepared for pharmaceutical formulations.