SUN PHARMACEUTICAL INDUSTRIES LIMITED

The present invention relates to long acting glucagon-like peptide-1 and human glucose-dependent insulinotropic polypeptide (GIP) dual agonist polypeptide which may be useful for treating type 2 diabetes mellitus (T2D), diabetes with obesity, obesity and hyperlipidemia.

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.

The present invention provides a parenteral dosage form consisting essentially of a solution filled in a container, the solution comprising amiodarone or its pharmaceutically acceptable salt and a sulfo-alkyl ether beta-cyclodextrin in an aqueous vehicle, wherein the solution has a pH in the range of about 2.4 to 3.9 and further wherein the dosage form is sterilized by subjecting the filled container to autoclaving.

A parenteral dosage form having an infusion container filled with an aqueous solution in volumes ranging from 40 ml to 500 ml comprising 1 mg/ml to 2 mg/ml of carboplatin, wherein the solution contains known impurity of 1, 1-cyclobutanedicarboxylic acid in an amount of not more than 1.0% by weight of carboplatin and the solution remains physically stable when stored at room temperature.

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.

The present invention refers to an intravenous infusion dosage form comprising a composition containing pemetrexed or its pharmaceutically acceptable salt, an osmagent and an aquous vehicle. The composition is present in a flexible infusion container containing an inert gas in the headspace. Additionally, a second container may be present surrounding the flexible infusion container.

A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter. The injector is configured to provide at least one audible feedback during the rotation. The method further includes operating the actuator to deliver the octreotide acetate from the cartridge through the needle to treat the subject. The injector is provided with multiple surface portions.

The present disclosure relates to a stable multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof, with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the level of nitrosamine drug substance-related impurities (NDSRIs) in the drug product during shelf life of the product.

The present disclosure relates to a combination of the anti-IL-23 antibody tildrakizumab in combination with a corticosteroid for use in the treatment of plaque psoriasis.

A method of preparing patients for cataract surgery includes topical administration of a cyclosporine solution. The administration may occur twice daily and may occur over the course of 28 days. The method results in an improved error prediction for 1-month spherical equivalent refractive outcome and improved ocular surface irregularity.