Tap Pharmaceuticals Ag

Other

Watson Laboratories Inc.

Famygen Life Sciences, Inc.

Nilesh Parikh

William Hite

William Crawford Hite

Teshome Melaku

Kapil Swain

Jonathan Moreno

Bhavesh R Patel

Kartik Shah

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.

Liquid pharmaceutical formulations of apixaban

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.

Syringes

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.

Topical Ciprofloxacin compositions

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.

Liquid levothyroxine formulations

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.

Saccharide free, storage stable thyroid hormone active drug formulations and methods for their production

A pharmaceutical formulation having a geometric configuration that affects the release characteristics of active agents contained therein and associated methods are provided. In one aspect, a sustained release oral dosage pharmaceutical tablet may include a first layer having a first active agent, where the first layer is disposed between two adjacent controlled release layers, at least one of the adjacent layers including at least one second active agent. The two adjacent layers are arranged such that they cover a portion of the first layer. The two adjacent layers may be separate layers or they may be joined into a single continuous layer, depending on the overall configuration and geometric design of the oral dosage form.

Controlled release formulations and associated methods

A divisible pharmaceutical tablet comprises an upper portion and a lower portion, the upper portion including at least one upper convex surface bordering at least one dividing notch. A ridgeline is formed between the at least one dividing notch and the at least one upper convex surface. The upper convex surface includes an apex defined at a location along the ridgeline.

Growing community of inventors

Irvine, CA, United States of America

Nilesh Parikh