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US 12,564,561 B2Granted
Dilute ready to use large volume containers of phenylephrine
AssigneeSintetica S.A.
InventorsNicola Caronzolo, Elisabetta Donati, Clara Bianchi
Life of this patent
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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.
Claims4
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.
11 more elements
Dependencies are inferred from the claim text.