Abstract: Certain embodiments of the present disclosure provide storage-stable, aqueous pharmaceutical formulations, suitable for oral administration, that contain a therapeutically effective amount of that is from 2% w/v to 7.5% w/v topiramate, from 45% w/v to 75% w/v PEG 400, from 6% w/v to 12% w/v water, balance glycerol. In some embodiments, such formulations further comprise a sweetener (e.g., sucralose) and/or a flavorant (e.g., berry flavor).

Abstract: Aqueous pharmaceutical compositions, suitable for topical ophthalmic administration to a mammal, that comprise a therapeutically effective amount of a prostaglandin, less than 0.3% w/v, and no added benzalkonium chloride, are provided. Such compositions are useful in methods comprising their topical administration to mammalian subjects, e.g., humans and reducing intraocular pressure and/or ocular hyperemia in the patient. Such compositions are also useful in methods comprising their topical administration to mammalian subjects, e.g., humans and promoting eyelash growth in the patient.

Abstract: Certain embodiments of the present disclosure provide storage-stable, aqueous pharmaceutical formulations, suitable for oral administration, that contain a therapeutically effective amount of that is from 2% w/v to 7.5% w/v topiramate, from 45% w/v to 75% w/v PEG 400, from 6% w/v to 12% w/v water, balance glycerol. In some embodiments, such formulations further comprise a sweetener (e.g., sucralose) and/or a flavorant (e.g., berry flavor).

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain a therapeutically effective amount of topiramate that is from 50 mg/ml to 100 mg/ml and amounts of polyethylene glycol (“PEG”) 400 and glycerol sufficient to result in a greater than a prior art taught calculated maximum amount of the topiramate being in the solution phase of the formulation, at room temperature.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain a therapeutically effective amount of topiramate that is from 50 mg/ml to 100 mg/ml and amounts of polyethylene glycol (“PEG”) 400 and glycerol sufficient to result in a greater than a prior art taught calculated maximum amount of the topiramate being in the solution phase of the formulation, at room temperature.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain from 10 mg/ml to 100 mg/ml of a cinchona alkaloid or a quinolone compound, e.g. chloroquine or hydroxychloroquine, a solvent that is at least one of a glycerin, a propylene glycol (PG), and a polyethylene glycol (PEG); and a carbonate. In such formulations, the solvent and the carbonate are present in amounts sufficient to promote resistance to hydrogen peroxide mediated degradation of the cinchona alkaloid or quinoline.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain from 10 mg/ml to 100 mg/ml of a cinchona alkaloid or a quinolone compound, e.g. chloroquine or hydroxychloroquine, a solvent that is at least one of a glycerin, a propylene glycol (PG), and a polyethylene glycol (PEG); and a carbonate. In such formulations, the solvent and the carbonate are present in amounts sufficient to promote resistance to hydrogen peroxide mediated degradation of the cinchona alkaloid or quinoline.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain from 1 mg/ml to 300 mg/ml of chloroquine, hydroxychloroquine, or pharmaceutically acceptable salt(s) thereof and a solvent that is one or more of a glycerin, a propylene glycol, and a polyethylene glycol. Such formulations are free of added water and contain an amount of the the solvent is present sufficient to result in the chloroquine, hydroxychloroquine, or pharmaceutically acceptable salt thereof being in the solution phase of the formulation.

Abstract: The disclosure provides pharmaceutical topical otic, ophthalmic, or nasal aqueous suspension formulations that comprise a corticosteroid; a chelating agent; a xanthan gum; an ionic tonicity agent; a pH from 5 to 6; and balance water. Such formulations comprise amounts of each of the xanthan gum and the ionic tonicity agent that together result in the formulation having: (i) a viscosity of from 4000 centipoises (“cps”) to 8000 centipoises (“cps”), and (ii) an osmolality of from 250 milliosmoles (“mOsm”) to 350 mOsm, and (iii) are readily redispersible.

Abstract: Aqueous pharmaceutical compositions, suitable for topical ophthalmic administration to a mammal, that comprise a therapeutically effective amount of a prostaglandin, less than 0.3% w/v, and no added benzalkonium chloride, are provided. Such compositions are useful in methods comprising their topical administration to mammalian subjects, e.g., humans and reducing intraocular pressure and/or ocular hyperemia in the patient. Such compositions are also useful in methods comprising their topical administration to mammalian subjects, e.g., humans and promoting eyelash growth in the patient.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain an amount of a tafamidis of from 0.5 mg/ml to 20 mg/ml, water, and an amount of an alkaline pH modifier that yields a content of the tafamidis solubilized in the water of from 0.5 mg/ml to 19.8 mg/ml.

Abstract: Certain embodiments of the present disclosure provide pharmaceutical, unit-dose formulations, suitable for oral administration, that contain from 1% w/w to 20% w/w of a tafamidis-organic acid (such as adipic acid, glutaric acid, or fumaric acid) co-crystal; from 0.25% w/w to 2.5% w/w of an organic acid dissolution enhancer. Such formulations release, within 15 minutes in ¾ strength FeSSIF pH 5.8 or in FaSSIF+0.1% polysorbate 80 pH 6.5, at least 85% of the total tafamidis of the formulation.

Abstract: The disclosure provides pharmaceutical topical otic, ophthalmic, or nasal aqueous suspension formulations that comprise a corticosteroid; a chelating agent; a xanthan gum; an ionic tonicity agent; a pH from 5 to 6; and balance water. Such formulations comprise amounts of each of the xanthan gum and the ionic tonicity agent that together result in the formulation having: (i) a viscosity of from 4000 centipoises (“cps”) to 8000 centipoises (“cps”), and (ii) an osmolality of from 250 milliosmoles (“mOsm”) to 350 mOsm, and (iii) are readily redispersible.

Abstract: Certain embodiments of the present disclosure provide liquid pharmaceutical formulations, suitable for oral administration, that contain glycerol and an amount of apixaban in the solution phase of the formulations of from 0.5 mg/ml to 6 mg/ml.

Abstract: Embodiments of this invention provide syringes calibrated for use with a predetermined liquid medication having an active pharmaceutical ingredient (API) at a particular weight per unit volume (w/v) concentration. Such syringes comprising a plunger and a barrel are configured such that the plunger, and/or an end portion of the plunger, is sealingly receivable through an opening at one end the barrel and within the barrel and slidingly moveable lengthwise within the barrel. This configuration allows formation of a reservoir inside the barrel into which the liquid medication may be loaded through an intake opening for the liquid medication at the other end of the barrel. Syringe barrels according to this invention possess line increments that form two or more graduated scales of API weight dosages extending lengthwise along the barrels. The increment lines provide for highly precise and accurate measurement of fine-increment weight dosages of the API.

Abstract: Embodiments of this invention provide syringes calibrated for use with a predetermined liquid medication having an active pharmaceutical ingredient (API) at a particular weight per unit volume (w/v) concentration. Such syringes comprising a plunger and a barrel are configured such that the plunger, and/or an end portion of the plunger, is sealingly receivable through an opening at one end the barrel and within the barrel and slidingly moveable lengthwise within the barrel. This configuration allows formation of a reservoir inside the barrel into which the liquid medication may be loaded through an intake opening for the liquid medication at the other end of the barrel. Syringe barrels according to this invention possess line increments that form two or more graduated scales of API weight dosages extending lengthwise along the barrels. The increment lines provide for highly precise and accurate measurement of fine-increment weight dosages of the API.

Abstract: Embodiments of the present invention provide levothyroxine solutions that consist of from about 0.001% w/v to about 0.01% w/v of a levothyroxine; at least 70% w/w of a glycerol; less than 30% w/w of a water; and from about 0.01% w/w to about 1.5% w/w of an ethylenediaminetetraacetic acid (EDTA). Such levothyroxine solutions are characterized by exhibiting levothyroxine storage stability.

Abstract: Embodiments of he invention provide aqueous pharmaceutical compositions suitable for topical administration to otic tissue, ocular tissue, nasal tissue, or a combination thereof that contain 0.02%-0.40% w/w of a ciprofloxacin, 0.01%-1.0% w/w of a surfactant, 0.05%-2.5% w/w of an acetic acid-acetate salt buffer, an amount of a tonicity agent sufficient to cause the composition to have an osmolality of about 275-325 mOsm, and water. In such embodiments, the compositions have a pH of from 5.0 to 5.2 and at least about 97% of the ciprofloxacin is in solution at a temperature of 5° C.

Abstract: Embodiments of the present invention provide pharmaceutical compositions in unit dosage form that possess a therapeutically effective amount of a levothyroxine sodium; an antioxidant in an amount sufficient to inhibit oxidation of the levothyroxine sodium in the unit dosage form; an amount of a calcium phosphate sufficient to facilitate a processing of the levothyroxine into the unit dosage form, and two or more excipients selected from the group consisting of a filler, a binder, a glidant, a lubricant, a disintegrant, and a surfactant. In such embodiments, the compositions are free of added alditol, added monosaccharide, added disaccharide, and added oligosaccharide and are storage stable.

Abstract: Embodiments of the invention provide aqueous pharmaceutical compositions suitable for topical administration to otic tissue, ocular tissue, nasal tissue, or a combination thereof that contain 0.02%-0.40% w/w of a ciprofloxacin, 0.01%-1.0% w/w of a surfactant, 0.05%-2.5% w/w of an acetic acid-acetate salt buffer, an amount of a tonicity agent sufficient to cause the composition to have an osmolality of about 275-325 mOsm, and water. In such embodiments, the compositions have a pH of from 5.0 to 5.3 and at least about 95% of the ciprofloxacin is in solution at room temperature.