Abstract: A biorelevant precursor composition suitable, upon dispersing, dilution or suspension in an aqueous medium, for simulating fed-state gastric fluids of mammalian species, wherein said biorelevant precursor composition comprises a substantially solid/sol-id-like concentrate, a viscous gel-like concentrate, or a liquid fat dispersion/concentrate, comprising at least one primary component selected from each of the following groups of primary components comprising: i) Triglyceride and/or diglyceride and/or monoglyceride or any combinations thereof in an amount of from 1-70% by weight; ii) Lecithin and/or lysolecithin in an amount of from 1-45% by weight; iii) Carbohydrate in an amount of from 15-70% by weight; and iv) Water or other aqueous medium in an amount of from 1-70% by weight; wherein the weight ratio of total fats (one or more primary components from each of groups i) and ii) combined): total carbohydrates (one or more primary components from group iii) combined) is between 20:1 to 1:20; and the weight ra

Abstract: A method for preparing a buffer solution suitable for physiologically relevant in vitro drug dissolution testing, drug solubility testing and/or drug profiling, the method comprising: (a) dispensing from a deformable container into a second container a predetermined quantity of a concentrate of the buffer solution, said deformable container having an orifice or aperture configured to dispense the concentrate in a dropwise manner and/or in a controlled stream, and (b) diluting the predetermined quantity of the concentrate with a predetermined quantity of a solvent to produce the buffer solution. A pack comprising a container and a concentrate of said buffer solution within the container, and a method for preparing the said pack, are also provided.

Abstract: There are described solid compositions or examining drug solubility comprising bile salts and phospholipids, optionally containing buffer components suitable for preparation of intestinal media that simulate the composition of the intestinal fluids in fasted and fed states.

Abstract: This application relates to a homogeneous biorelevant composition for preparing fasted state biorelevant media having a surface tension between 25 mN/m and 50 mN/m for simulating fasted state gastric and fasted state upper small intestinal fluids of mammalian species, especially humans, dogs, etc. comprising at least one bile salt, eg. sodium taurocholate or sodium taurodeoxycholate; at least one phospholipid, especially 60-99 wt % phosphatidylcholine (PC), enzyme digested diacylphospholipids containing 50-90 wt % of monoacyl-PC; or mixtures thereof; and at least one fatty acid or monovalent salt of the fatty acid, such as sodium oleate. The application also relates to an aqueous biorelevant media composed of surfactants occurring in the gastrointestinal tract of mammals, in particular when prepared from above homogeneous biorelevant composition.

Abstract: There are described solid compositions or examining drug solubility comprising bile salts and phospholipids, optionally containing buffer components suitable for preparation of intestinal media that simulate the composition of the intestinal fluids in fasted and fed states.

Abstract: The present disclosure describes a method for the continuous dissolution of e.g. crystalline astaxanthin or canthaxanthin suspension in oil, by applying heat for a predetermined period using an in-line or optionally batch wise-process, followed by cooling the heated solution with an oil phase or heat exchanger. The resulting oil solution may be used as such or added directly to feed components which are turned into feed compositions by extrusion, compaction or granulation. Alternatively the oil solution is spray coated or directly loaded to extruded or compacted pellets and granulates. The disclosure avoids using formulated carotenoids prepared by known multi-step production methods requiring solvents, solvent removal, cooling and emulsification with an aqueous phase or precipitation and recovery steps.

Abstract: Mixtures of specific crystal forms of astaxanthin and the individual crystal forms designated crystal Form I and II and disclosed together with methods for preparing said crystal Forms. Methods for preparing nutritional dosage forms including the disclosed astaxanthin crystal forms for the life science industry are also disclosed.

Abstract: The present disclosure describes a method for the continuous dissolution of e.g. crystalline astaxanthin or canthaxanthin suspension in oil, by applying heat for a predetermined period using an in-line or optionally batch wise-process, followed by cooling the heated solution with an oil phase or heat exchanger. The resulting oil solution may be used as such or added directly to feed components which are turned into feed compositions by extrusion, compaction or granulation. Alternatively the oil solution is spray coated or directly loaded to extruded or compacted pellets and granulates. The disclosure avoids using formulated carotenoids prepared by known multi-step production methods requiring solvents, solvent removal, cooling and emulsification with an aqueous phase or precipitation and recovery steps.

Abstract: Mixtures of specific crystal forms of astaxanthin and the individual crystal forms designated crystal Form I and II and disclosed together with methods for preparing said crystal Forms. Methods for preparing nutritional dosage forms including the disclosed astaxanthin crystal forms for the life science industry are also disclosed.

Abstract: Compositions for forming molecular associates with lipophilic compounds and an improved method of loading lipophilic biologically active compounds into previously formed, aqueous suspensions of lipid particles. A preferred embodiment for injection purposes comprise lipid particles having sizes below 1000 nm in diameter, in a vial or other suitable container are described. The method involves mixing a lipophilic compound either in solution or as an amorphous, preferably lyophilised powder in a first container with an aqueous suspension of lipid particles contained in a second container to form molecular associates. Only minimum agitation is required. The entire procedure may be carried out instantly in situ, in sealed sterile units just prior to use in the hospital ward or by the bedside.

Abstract: A composition in the form of a dry powder and which comprises: a) at least one membrane lipid, and b) at least one biologically active compound comprising a xanthine and/or a carboxylic acid, and which forms structured lipid assemblies when dispersed/dissolved in an aqueous medium. A method of preparing such a composition is also provided, together with a dispersion of structured lipid assemblies suspended in a solution of at least one biologically active compound and a method of preparing the same. The compositions and dispersions are suitable for use in creams and lotions for skin care.

Abstract: Compositions for forming molecular associates with lipophilic compounds and an improved method of loading lipophilic biologically active compounds into previously formed, aqueous suspensions of lipid particles. A preferred embodiment for injection purposes comprise lipid particles having sizes below 1000 nm in diameter, in a vial or other suitable container are described. The method involves mixing a lipophilic compound either in solution or as an amorphous, preferably lyophilised powder in a first container with an aqueous suspension of lipid particles contained in a second container to form molecular associates. Only minimum agitation is required. The entire procedure may be carried out instantly in situ, in sealed sterile units just prior to use in the hospital ward or by the bedside.

Abstract: A substantially homogeneous composition for human administration comprises a biologically active lipophilic compound dissolved in or associated with at least one micelle-forming lipid. For example, cyclosporin A is dissolved or dispersed in the mixture of PC and MAPC. The composition may be made by dissolving the lipid material in ethanol, adding the lipophilic compound to the ethanol and removing the ethanol, after which the composition may be formulated for human oral administration.