The invention provides a method for the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject, said method comprising administering an effective amount of an alginate oligomer to a subject in need thereof. Also provided is an alginate oligomer for use in the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject and a product containing an alginate oligomer and further pharmaceutical for the treatment of intestinal microbial overgrowth and/or a CFTR modulator as a combined preparation for separate, simultaneous or sequential use in the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject.

A method of treating focal segmental glomerulosclerosis with a compound of Formula I is provided. FSGS may be primary (no known cause) or secondary. The secondary FSGS may be associated with infections or viruses such as HIV, diseases such as sickle cell disease or lupus, toxins or drugs such as anabolic steroids, heroin or pamidronate, nephron loss and hyperfiltration, such as with chronic pyelonephritis and reflux, morbid obesity, or diabetes mellitus.

A method of treating focal segmental glomerulosclerosis with a compound of Formula I is provided. FSGS may be primary (no known cause) or secondary. The secondary FSGS may be associated with infections or viruses such as HIV, diseases such as sickle cell disease or lupus, toxins or drugs such as anabolic steroids, heroin or pamidronate, nephron loss and hyperfiltration, such as with chronic pyelonephritis and reflux, morbid obesity, or diabetes mellitus.

The present invention relates to a melt extrusion process for preparing a solid dispersion comprising a pharmaceutically active ingredient, a polymeric binder, and, optionally, one or more auxiliary agents, comprising a) in a batch-wise operation, placing a pre-determined amount of the polymeric binder, a pre-determined amount of the active ingredient, and, optionally, a pre-determined amount of the auxiliary agent(s) in a melting vessel; melting the polymeric binder with agitation to disperse the active ingredient in the polymeric binder to obtain a molten pre-dispersion; b) feeding the pre-dispersion into an extruder to homogenize the pre-dispersion and release a melt through a die; and c) allowing the melt to solidify.

The present invention relates to a melt extrusion process for preparing a solid dispersion comprising a pharmaceutically active ingredient, a polymeric binder, and, optionally, one or more auxiliary agents, comprising a) in a batch-wise operation, placing a pre-determined amount of the polymeric binder, a pre-determined amount of the active ingredient, and, optionally, a pre-determined amount of the auxiliary agent(s) in a melting vessel; melting the polymeric binder with agitation to disperse the active ingredient in the polymeric binder to obtain a molten pre-dispersion; b) feeding the pre-dispersion into an extruder to homogenize the pre-dispersion and release a melt through a die; and c) allowing the melt to solidify.

A microneedle with very high drug loading is described, and comprises a base and a penetrating tip, the tip having a dimension ranging from about 50 nm to about 50 μm, wherein at least 80% of the microneedle by volume consists of heat-meltable active pharmaceutical ingredient (v/v). The meltable active pharmaceutical ingredient is characterised by being heat-meltable (i.e. it can be heated to a molten form), is solid at 25° C., and has an ability to form a glassy, amorphous form following melting by heating and cooling with a glass transition temperature greater than 25° C. A method of fabricating a microneedle comprises the steps of providing a microneedle micromold comprising a micromold substrate and one or more holes in the upper surface of the micromold substrate, wherein the interior surface of the hole in the micromold substrate defines an exterior surface of the microneedle, moulding a meltable drug in the microneedle micromold to form a microneedle, and separating the microneedle from the microneedle micromold. Microneedles of the invention may incorporate up to 99% drug or more.

A microneedle with very high drug loading is described, and comprises a base and a penetrating tip, the tip having a dimension ranging from about 50 nm to about 50 μm, wherein at least 80% of the microneedle by volume consists of heat-meltable active pharmaceutical ingredient (v/v). The meltable active pharmaceutical ingredient is characterised by being heat-meltable (i.e. it can be heated to a molten form), is solid at 25° C., and has an ability to form a glassy, amorphous form following melting by heating and cooling with a glass transition temperature greater than 25° C. A method of fabricating a microneedle comprises the steps of providing a microneedle micromold comprising a micromold substrate and one or more holes in the upper surface of the micromold substrate, wherein the interior surface of the hole in the micromold substrate defines an exterior surface of the microneedle, moulding a meltable drug in the microneedle micromold to form a microneedle, and separating the microneedle from the microneedle micromold. Microneedles of the invention may incorporate up to 99% drug or more.

Provided is a pharmaceutical composition in which the solubility and/or dissolution properties of a poorly-soluble drug can be improved. The pharmaceutical composition comprises a poorly-soluble drug, and polyvinyl alcohol having a saponification degree of 63 mol % or more and 67 mol % or less.

Provided is a pharmaceutical composition in which the solubility and/or dissolution properties of a poorly-soluble drug can be improved. The pharmaceutical composition comprises a poorly-soluble drug, and polyvinyl alcohol having a saponification degree of 63 mol % or more and 67 mol % or less.

A method is provided for lowering blood pressure in a subject in need thereof by administering a dihydropyridine-type calcium channel blocker pharmaceutical composition to a subject qualified for over-the-counter access to the dihydropyridine-type calcium channel blocker pharmaceutical composition. In some embodiments, the dihydropyridine-type calcium channel blocker pharmaceutical composition includes isradipine, nifedipine, or nisoldipine. In some embodiments, the dihydropyridine-type calcium channel blocker pharmaceutical composition includes 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate or a pharmaceutically acceptable salt thereof.