Dilute ready to use large volume containers of phenylephrine
AssigneeSintetica S.A.
InventorsNicola Caronzolo, Elisabetta Donati, Clara Bianchi
Life of this patent
Estimating the term…
Abstract
Ready to use large volume containers (intravenous drip bags) of dilute solutions of phenylephrine having excellent shelf stability, suitable for continuous intravenous infusion without further dilution prior to administration, are provided. Further provided are plastic packaging systems suitable for such containers and solutions, and methods of manufacturing such products and phenylephrine solutions are provided.
Claims47
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;
- b) the bag defines an interior volume;
- c) the interior volume comprises:
- i) a liquid volume comprising from 75 to 550 ml or from 100 to 350 ml or from 250 to 325 ml of a liquid formulation;
- ii) a gaseous headspace occupying from 0 to 25% or from 2 to 15% 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 or from 0.01 to 0.8 mg/ml;
- ii) a tonicity agent;
- iii) an acidic pH adjusting agent;
- and
- iv) water;
- e) the liquid formulation has a pH of from 2.8 to 4.5;
- and
- f) the liquid formulation excludes antioxidants and chelating agents.
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
A drug product in a hermetically sealed intravenous ready to use collapsible drip bag, wherein:
- a) the bag defines an interior volume;
- b) the interior volume comprises:
- i) a liquid volume comprising from 75 to 550 ml or from 100 to 350 ml or from 250 to 325 ml of a liquid formulation;
- ii) a gaseous headspace occupying from 0 to 25% or from 2 to 15% of the interior volume;
- c) the liquid formulation comprises:
- i) phenylephrine or a pharmaceutically acceptable salt thereof at a concentration of from 0.001 to 2.0 mg/ml or from 0.01 to 0.8 mg/ml;
- ii) a tonicity agent;
- iii) an acidic pH adjusting agent;
- and
- iv) water;
- d) the liquid formulation has a pH of from 2.8 to 4.5;
- and
- e) the liquid formulation excludes antioxidants, chelating agents, and pH buffers.
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
A method of making a phenylephrine drug product in an intravenous ready to use collapsible drip bag comprising:
- a) dissolving phenylephrine or a pharmaceutically acceptable salt thereof, a tonicity agent, and an acidic pH adjusting agent in water to produce a phenylephrine liquid formulation at a concentration of from 0.001 to 2.0 mg/ml or from 0.01 to 0.8 mg/ml;
- b) distributing from 75 to 550 ml or from 100 to 350 ml or from 250 to 325 ml of the phenylephrine liquid formulation and an inert gas into the bag, such that the percentage of the bag's volume occupied by the headspace is from 0 to 25% or from 2 to 15%;
- and
- c) hermetically sealing the bag;
- wherein:
- i) the liquid formulation excludes antioxidants and chelating agents;
- and
- ii) the liquid formulation has a pH of from 2.8 to 4.5.
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
(canceled)
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 without any additional external protection from oxygen;
- b) the bag defines an interior volume;
- c) the interior volume comprises:
- iii) a liquid volume comprising from 75 to 550 ml or from 100 to 350 ml or from 250 to 325 ml of a liquid formulation;
- iv) a gaseous headspace occupying from 0 to 25% or from 2 to 15% of the interior volume;
- d) the liquid formulation comprises:
- v) phenylephrine or a pharmaceutically acceptable salt thereof at a concentration of from 0.001 to 2.0 mg/ml or from 0.01 to 0.8 mg/ml;
- vi) a tonicity agent;
- vii) an acidic pH adjusting agent;
- and
- viii) water;
- e) the liquid formulation has a pH of from 2.8 to 4.5;
- and
Dependencies are inferred from the claim text.