Tap Pharmaceuticals Ag

Famygen Life Sciences, Inc.

William Hite

Nilesh Parikh

Kapil Swain

Kartik Shah

Jonathan Moreno

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).

Aqueous formulations of topiramate

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.

Aqueous pharmaceutical compositions of prostaglandins

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.

Liquid pharmaceutical formulations of topiramate

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.

Pharmaceutical formulations of quinolines

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.

Topical otic, ophthalmic, and nasal corticosteroid formulations

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.

Liquid pharmaceutical formulations of tafamidis

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.

Pharmaceutical formulations of tafamidis

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.

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Winchester, CA, United States of America

William Hite