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 pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of one or more of a monosaccharide, a disaccharide, and an oligosaccharide sufficient to stabilize the levothyroxine sodium; and two or more of a filler, a binder, and a lubricant.

Abstract: The present invention provides devices for dispensing topical pharmaceutical compositions. In some embodiments, the dispensing device possesses a reservoir for storing the composition and means for metering the composition. In some embodiments, such reservoirs are: i. made from, or substantially lined with, a material that opaque and/or substantially nondepleting of at least one component of the composition; ii. optionally, volumetrically compressible; and iii. fitted with the means for metering the composition. And the means for metering are adapted to measure a fixed amount of the composition for application to a dermal region of a user of the device. In some embodiments, the compositions has a specific gravity in the range of from about 0.85 to about 1.20 at about room temperature and comprises a medicament; a thickening agent; and a solvent, and optionally a skin penetration enhancer and/or a deodorant.

Abstract: Embodiments of the present invention provide pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of one or more of a monosaccharide, a disaccharide, and an oligosaccharide sufficient to stabilize the levothyroxine sodium; and two or more of a filler, a binder, and a lubricant.

Abstract: Embodiments of the invention provide pharmaceutical compositions of ciprofloxacin formulated for topical application to a body surface and for having at least localized antibacterial activity. In some embodiments, the compositions are further formulated for localized anti-inflammatory activity, anti-fungal activity, anti-viral activity, or combinations thereof. Such compositions possess a therapeutically effective amount of a non-betaine form ciprofloxacin (e.g., ciprofloxacin hydrochloride monohydrate); one of a pH adjusting agent and a preservative; water; and a pH from about 5.5 to about 10. In some embodiments, such compositions may be free or free of added skin permeation enhancer and/or contain a betaine form ciprofloxacin.

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 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.

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 present invention provide pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of one or more of a monosaccharide, a disaccharide, and an oligosaccharide sufficient to stabilize the levothyroxine sodium; and two or more of a filler, a binder, and a lubricant.

Abstract: Embodiments of the present invention provide pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of an alditol sufficient to stabilize the levothyroxine sodium; and at least two excipients selected from a filler, a binder, and a lubricant. Such compositions are free of added monosaccharide, disaccharide, and an oligosaccharide and are storage stable.