Slayback Pharma LLC

The present invention relates to liquid pharmaceutical compositions of tofacitinib or its pharmaceutically acceptable salts thereof, suitable for oral administration, that are stable under varying storage conditions for extended periods of time. The present invention also relates to methods of treating auto-immune disorders using the stable liquid pharmaceutical compositions of tofacitinib. A stable liquid pharmaceutical composition of tofacitinib according to the invention comprises of (a) tofacitinib at a concentration of about 1 mg/mL or more; (b) a pharmaceutically acceptable liquid vehicle; (c) at least one anti-oxidant; and (d) optionally one or more other pharmaceutically acceptable excipients.

The present invention provides stable, ready-to-use injectable pharmaceutical compositions, comprising the combination of neostigmine, glycopyrrolate, a stabilizing amount of one or more aminopolycarboxylic acids, and a pharmaceutically acceptable liquid vehicle. Other aspects of the invention relate to methods for making such compositions and methods of using such compositions for reversing the effects of non-depolarizing neuromuscular blocking agents. Preferably, the composition comprises neostigmine methylsulfate, glycopyrronium bromide, ethylenediaminetetraacetic acid (EDTA) and a pharmaceutically acceptable liquid vehicle, and is provided in a pre-filled, ready-to-use sealed container, such as a pre-filled syringe, suitable for intravenous administration.

Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., T max , C max , AUC 0-t and/or AUC 0-infinity ) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., T max , C max , AUC 0-t and/or AUC 0-infinity ) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

The present invention relates to storage stable emulsion formulations of meloxicam or its pharmaceutically acceptable salts, solvates and hydrates thereof suitable for parenteral administration.

The present application relates to stable pharmaceutical compositions for oral administration comprising a progesterone alone, or optionally in combination with an estradiol. The pharmaceutical compositions may further include a solubilizing agent, a surfactant and optionally other pharmaceutical acceptable excipients. Preferably, the estradiol does not precipitate for at least 12 months, and the pharmaceutical compositions are stable for at least 12 months under normal storage conditions at room temperature. Also, when the pharmaceutical compositions are stored for 6 months at 40° C./75% relative humidity (RH), the level of Impurity-M in the composition is less than about 0.2% (w/w) as measured by HPLC. The pharmaceutical compositions may be used for the treatment of moderate to severe vasomotor symptoms due to menopause in post-menopausal women.

The present invention relates to stable pharmaceutical compositions of dihydroergotamine mesylate or other pharmaceutically acceptable salts thereof and methods for preparing the compositions particularly for the treatment of migraine headaches. The invention further relates to stable injectable composition comprising dihydroergotamine or its pharmaceutically acceptable salts thereof, wherein the composition has a pH from about 5.0 to about 6.0. Further, the present invention relates to a method of treating migraine comprising providing a stable pharmaceutical composition for parenteral administration comprising dihydroergotamine mesylate, wherein the pH of the composition ranges from 5.0 to 6.0 and, wherein the composition comprises no greater than 3% of total impurities as determined by HPLC.

The present invention relates to liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof. More specifically, stable liquid pharmaceutical compositions of baclofen at concentrations of 5 mg/mL or more are provided. Preferably, the liquid pharmaceutical compositions are suitable for oral administration, and stable at pH ranges of 5-8 over a variety of storage conditions, including long-term storage for extended periods of time.

Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., C max , AUC 0-t and/or AUC 0-infinity ) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.