Nevakar Inc.

Nevakar Injectables Inc.

Vyluma Inc.

Innopharma, Inc.

Endo Operations Limited

Endo Ventures Limited

Western University of Health Sciences

Innopharma Licensing, LLC

Kumaresh Soppimath

Milan Indu Patel

Tao Zhang

Tushar Hingorani

Prem Sagar Akasapu

Sunil Agnihotri

Iouri V Ilitchev

Irfan A Mohammed

Navneet Puri

Satish K Pejaver

Reema Ajitkumar Puri

Pooja H Tendulkar

Jack Martin Lipman

Lakkaraju Dasaradhi

Hari Desu

Rama Sodum

Kanaiyalal R Patel

Vivek Yadav

Ronald Domalaon

Varun Khurana

Jinjiang Li

Harshil H Jain

Guru V Betageri

Sriramya Garapati

Udaya Toti

Sunil A Agnihotri

Anant Patel

Hari A Attluri

Shyamprasad Mukundan

Ketan Hippalgaonkar

Rekha Nayak

Sasank Chaitanya Kunadharaju

Satish Pejaver

Guru Betageri

A ready-to-administer epinephrine composition having between about 0.005 and about 0.07 mg/mL epinephrine, at least about 0.9 wt % sodium chloride; between about 1 and about 50 ug/mL ethylenediaminetetraacetic acid; 0.005 wt % or less sodium metabisulfite, and water. Also included are systems having the composition contained in a container.

Epinephrine compositions and containers

The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.

Norepinephrine compositions and methods therefor

A ready-to-administer antioxidant free phenylephrine compositions has improved stability and is optionally free of metal chelating agents. Contemplated compositions are preferably packaged into a flexible polymer bag and maintain degradation of the phenylephrine at remarkably low levels, even over extended storage periods.

Phenylephrine hydrochloride compositions and containers

Pre-filled syringes, pharmaceutical compositions, and kits and methods relating to same allow for emergency administration of one or more drugs from prefilled glass syringes to a patient via a needleless connector. In preferred embodiments, the prefilled glass syringe has a drug volume of at least 5 mL, has a Luer-lock, and has a syringe tip with an internal channel that has a diameter of about 1.7 mm. Such syringes advantageously allow storage of emergency drugs without leaching of plastic materials and degradation, and substantially improve the safety profile where the syringe is attached to an IV line via a needleless connector.

Succinylcholine prefilled syringe, compositions and methods

The inventive subject matter provides ready-to-administer, preferably anti-oxidant free, epinephrine compositions with improved stability, and methods for preparing the same. Contemplated compositions can be packaged using blow-fill-seal technology or packaged into flexible IV bags and maintain degradation of the epinephrine at a level of less than 5 wt % when stored over at least one months at between 2-40° C.

Storage stable sterile ready-to-administer formulations comprising N-acetylcysteine are presented with desirable stability characteristics. In preferred aspects, formulations comprise low quantities of one or more chelating agents, contain N-acetylcysteine at a concentration of 25 mg/mL or 50 mg/mL, and are packaged in a suitable format, such as a polymeric bag with a metalized overwrap and a non-contact oxygen scavenger.

-acetylcysteine compositions and methods

A sterile, ready-to-use pharmaceutical composition having hydralazine and/or a salt thereof at a concentration of less than about 20 mg/mL and a solvent comprising an organic co-solvent, wherein the hydralazine and/or salt thereof and the organic co-solvent are provided at a first weight ratio sufficient for the hydralazine and/or salt thereof to have a change in concentration of no more than about 10% after 2 months of storage at 60° C. Also described are methods of making and using the composition.

Hydralazine compositions and methods

The inventive subject matter is directed to compositions and methods for sterile and storage stable low-dose atropine formulations with improved stability. Most preferably, the compositions presented herein are substantially preservative free and exhibit less than 0.35% tropic acid from degradation of atropine. Advantageously, contemplated formulations are also substantially free of preservatives.

Atropine pharmaceutical compositions

Disclosed herein are storage-stable ephedrine single-phase solution compositions, comprising 4 mg/mL to 6 mg/mL of ephedrine, a pH adjuster comprising acetic acid, and water, wherein the composition has a pH between 4.5 and 5.0; and wherein the pH drift of the composition is less than 0.5 after storage over at least two months at 25° C. and 60% relative humidity. Also disclosed herein are methods of making and using the same.

Ephedrine compositions and methods

Storage stable aqueous ready-to-administer formulations comprising isoproterenol are presented with desirable stability characteristics. In preferred aspects, formulations are terminally sterilized and packaged in a suitable format, such as a polymeric bag with metalized overwrap and include a non-contact oxygen scavenger.

Isoproterenol compositions and methods

N-acetylcysteine compositions and methods

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Skillman, NJ, United States of America

Kumaresh Soppimath