Claims for Patent: 12,564,561

Summary for Patent: 12,564,561

Title:	Dilute ready to use large volume containers of phenylephrine
Abstract:	Ready to use semi-naked dilute solutions of phenylephrine, resistant to oxidative degradation when packaged in transparent or translucent collapsible polypropylene bags and terminally sterilized, without the need for an aluminum over-wrap, oxygen scavengers, oxygen impermeable polypropylene, antioxidants, or chelating agents.
Inventor(s):	Nicola Caronzolo, Elisabetta Donati, Clara Bianchi
Assignee:	Sintetica SA
Application Number:	US17/670,620
Patent Claims:	1. A drug product in a hermetically sealed intravenous ready to use collapsible drip bag, wherein: a) the bag comprises two opposed walls sealed around their peripheries comprising an inner ply of translucent or transparent polypropylene; b) the bag defines an interior volume; c) the interior volume comprises: i) a liquid volume comprising from 75 to 550 ml of a liquid formulation; ii) a gaseous headspace occupying from 0 to 25% of the interior volume; d) the liquid formulation comprises: i) phenylephrine or a pharmaceutically acceptable salt thereof at a concentration of from 0.001 to 2.0 mg/ml; ii) a tonicity agent; iii) an acidic pH adjusting agent; and iv) water; e) the liquid formulation has a pH of from 3.0 to 3.4; and f) the liquid formulation excludes antioxidants and chelating agents and contains no more than 1% degradants or impurities after three months storage at 40° C. and 75% relative humidity. 2. The drug product of claim 1, comprising phenylephrine hydrochloride at a concentration of 0.08 mg/ml or 0.4 mg/ml based on the weight of the hydrochloride salt. 3. The drug product of claim 1, in the absence of an antimicrobial preservative. 4. The drug product of claim 1, wherein the bag wall has an oxygen transmission rate greater than 100 cm3·20 μm/m2·day atm at room temperature and atmospheric pressure.