Abstract: The present invention relates to a dosage form comprising an aqueous solution of a vinca alkaloid drug or its pharmaceutically acceptable salt in a flexible infusion container, and a light protective secondary packaging containing the flexible infusion container, wherein the dosage form is ready-to-infuse and wherein the aqueous solution is stable at room temperature.

Abstract: The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.

Abstract: A method is provided for the acute treatment of migraine headaches with or without aura by injecting dihydroergotamine mesylate into a subject. The method includes storing the dihydroergotamine mesylate in an autoinjector at room temperature in a foil pouch. The method further includes removing the autoinjector from the pouch; removing a cap of the autoinjector; pushing the autoinjector down against an injection site of the subject to depress a safety guard; pressing and releasing an activation button on the autoinjector to start injection; and holding the autoinjector against the injection site for at least 10 seconds irrespective of whether a click is generated. The method further includes confirming that the injection is complete by viewing a change of color in a viewing window of the autoinjector, and lifting the autoinjector up away from the injection site and allowing the guard to drop down and lock over a needle.

Abstract: The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

Abstract: The present invention provides a ready to use stable aqueous dosage form of norepinephrine comprising an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, one or more sulfite antioxidants and an ion chelator. The present invention also provides an infusion container filled with an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, wherein the said solution is stable for a prolonged period of time and can be terminally sterilized by autoclaving.

Abstract: This disclosure relates to methods of treating plaque psoriasis comprising administering an anti-IL-23p19 antibody hum13B8-b to a patient in need thereof. This disclosure also relates to pharmaceutical compositions of an anti-IL-23p19 antibody hum13B8-b or antigen binding fragment thereof for the treatment plaque psoriasis in a patient. This disclosure further relates to the use of an anti-IL-23p19 antibody hum13B8-b or antigen binding fragment thereof for the manufacture of a medicament for treating plaque psoriasis in a patient.

Abstract: The invention relates to an infusion container comprising a sterile, ready-to-use, stable aqueous solution of Midazolam or a pharmaceutically acceptable salt thereof, suitable for direct intravenous infusion to a patient in need thereof. The invention also relates to a novel infusion container having plurality of ports that is suitable for delivering or receiving a sterile fluid, such as the said stable aqueous solution of Midazolam or a pharmaceutically acceptable salt thereof.

Abstract: Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

Abstract: Provided herein are formulations for topical ophthalmic formulations containing 0.087-0.093 wt % of cyclosporine, and methods of making and using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also included herein are methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

Abstract: The present invention relates to a method of treating blepharitis comprising administering to the affected eye of a subject an effective amount of an active ingredient in an ophthalmically acceptable vehicle for a sufficient period of time to treat blepharitis. The active ingredient comprises a glucocorticoid in an ophthalmically acceptable vehicle, such as DuraSite® 2. Additionally, the present invention discloses a kit that includes: (a) a composition comprising about 0.1% by weight dexamethasone in an ophthalmically acceptable vehicle and, optionally, (b) instructions for using the composition for the treatment of blepharitis.

Abstract: The present disclosure pertains to novel Glucagon like Peptide-1 (GLP-1) (7-37) analogs having an amino acid sequence with Leu or Ile at the C-terminal. The new analogs are potent GLP-1 agonists with reduced adverse effect and improved duration of action. The present disclosure further relates to acylated derivatives of the new analogs which have further improved potency and duration of action and are suitable for oral administration. The analogs of present disclosure may be useful in treatment of diabetes and obesity.

Abstract: The present disclosure pertains to novel Glucagon like Peptide-1 (GLP-1) (7-37) analogs having an amino acid sequence with Leu or Ile at the C-terminal. The new analogs are potent GLP-1 agonists with reduced adverse effect and improved duration of action. The present disclosure further relates to acylated derivatives of the new analogs which have further improved potency and duration of action and are suitable for oral administration. The analogs of present disclosure may be useful in treatment of diabetes and obesity.

Abstract: The present invention provides a ready to use stable aqueous dosage form of norepinephrine comprising an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, one or more sulfite antioxidants and an ion chelator. The present invention also provides an infusion container filled with an aqueous solution of norepinephrine or its pharmaceutically acceptable salt, wherein the said solution is stable for a prolonged period of time and can be terminally sterilized by autoclaving.

Abstract: A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C. and 60% relative humidity for at least three months.

Abstract: The present invention relates to a method for enabling hospitals or clinics to administer a dose of a drug to patients in need thereof while avoiding steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration. The present invention further relates to a perfusion system comprising different sets of perfusion containers, each container comprising a ready-to-infuse, stable, sterile, aqueous perfusion solution of a drug, wherein the set of perfusion containers alone or in combination provides for direct intravenous administration of a desired dose of the drug to a patient in need thereof, such that the delivered dose is equal to or within ±5% of the calculated dose.

Abstract: The disclosure relates to an anti-IL-23p19 antibody hum13B8-b or antigen binding fragment thereof and its use in the treatment of plaque psoriasis of the scalp.

Abstract: The present invention discloses an extended release multi-particulate sprinkle composition comprising a plurality of discrete units, each discrete unit comprising quetiapine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

Abstract: A method is provided for the acute treatment of migraine headaches with or without aura by injecting dihydroergotamine mesylate into a subject. The method includes storing the dihydroergotamine mesylate in an autoinjector at room temperature in a foil pouch. The method further includes removing the autoinjector from the pouch; removing a cap of the autoinjector; pushing the autoinjector down against an injection site of the subject to depress a safety guard; pressing and releasing an activation button on the autoinjector to start injection; and holding the autoinjector against the injection site for at least 10 seconds irrespective of whether a click is generated. The method further includes confirming that the injection is complete by viewing a change of color in a viewing window of the autoinjector, and lifting the autoinjector up away from the injection site and allowing the guard to drop down and lock over a needle.

Abstract: The present invention discloses an extended release multi-particulate sprinkle composition comprising a plurality of discrete units, each discrete unit comprising quetiapine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.

Abstract: The disclosure provides compositions and systems for topical ophthalmic application, which include an aqueous mixture of bromfenac and flowable mucoadhesive polymer, for treating inflammation and inflammatory conditions of the eye.