Syringe Products and Related Methods and Uses
A syringe product comprises a syringe barrel having a fluid-containment wall made using a polymer composition comprising a metallocene polypropylene polymer and an oganophosphate clarifier. The syringe product may be prefilled with an injectable medical formulation prior to use. The syringe product may be used to administer an injectable medical formulation to a patient.
1 . A syringe product, comprising:
a syringe barrel comprising a fluid-containment wall and an internal volume defined at least in part by the wall;
a syringe plunger movably disposed within the internal volume and movable within the internal volume to accomplish at least one of creating fluid suction within at least a portion of the internal volume and creating fluid pressure within at least a portion of the internal volume;
the wall of the syringe barrel consisting essentially of a polymer composition comprising a metallocene polypropylene polymer and an organophosphate clarifier;
wherein:
the polymer composition comprises at least 98 weight percent of the metallocene polypropylene polymer; and
the metallocene polypropylene polymer is polypropylene homopolymer.
2 . A syringe product according to claim 1 , wherein the polymer composition comprises at least 99 weight percent of the metallocene polypropylene polymer and from 0.1 weight percent to 0.25 weight percent of the organophosphate clarifier.
3 . A syringe product according to claim 1 , wherein the wall has a transparency of at least 48%.
4 . A syringe product according to claim 1 , wherein the syringe barrel has a resistance to failure by burst from internal pressure of greater than 200 psi (1.38 MPa).
5 . A syringe product according to claim 1 , wherein the wall has an impact resistance of at least 0.1 foot-pounds-force (0.0138 kg-force meter).
6 . A syringe product according to claim 1 , wherein the syringe barrel has a low extractability indicated by extraction test absorbance for an ultraviolet wavelength spectrum of 220 to 240 nanometers of not greater than 0.08 and absorbance for an ultraviolet wavelength spectrum of 241 to 350 nanometers of not greater than 0.05, determined as specified in the Japanese pharmacopeia.
7 . A syringe product according to claim 1 , wherein the syringe barrel is made substantially entirely of the polymer composition.
8 . A syringe product according to claim 1 , wherein the wall is tubular and the internal volume is cylindrical.
9 . A syringe product according to claim 1 , wherein the syringe product is a prefilled syringe comprising a volume of an injectable medical formulation sealed within the internal volume.
10 . A syringe product according to claim 9 , wherein the syringe barrel comprises a fluid exit port opposite the plunger with the injectable medical formulation disposed between the plunger and the fluid exit port, wherein the fluid exit port is sealed to prevent the injectable medical formulation from exiting through the fluid exit port.
11 . A syringe product according to claim 9 , wherein the fluid exit port is not in fluid communication with a hypodermic needle.
12 . A syringe product according to claim 9 , wherein the injectable medical formulation comprises a member selected from the group consisting of x-ray contrast media, magnetic resonance contrast media, ultrasound imaging agents, optical imaging agents, saline, heparin and analgesics.
13 . A syringe product according to claim 9 , wherein the injectable medical formulation comprises x-ray contrast media.
14 . A syringe product according to claim 9 , wherein the injectable medical formulation comprises magnetic resonance contrast media.
15 . A syringe product according to claim 9 , wherein the injectable medical formulation comprises ultrasound imaging agent.
16 . A syringe product according to claim 9 , wherein the injectable medical formulation comprises optical imaging agent.
17 . A method for preparing a filled syringe, comprising introducing a volume of an injectable medical formulation into the internal volume of the syringe product according to claim 1 ;
the injectable medical formulation comprising x-ray contrast media, magnetic resonance contrast media, ultrasound imaging agent or optical imaging agent.
18 . A method according to claim 17 , comprising after the introducing, sealing the volume of injectable medical formulation in the internal volume.
19 . A method for administering an injectable medical formulation to a patient, comprising injecting a volume of the injectable medical formulation into the patient from the syringe product of claim 1 .
20 . A method for administering an injectable medical formulation to a patient, comprising:
unsealing the volume of the injectable medical formulation within the internal volume of the syringe product of claim 9 ; and
injecting at least a portion of the volume of the injectable medical formulation into the patient.
21 . Use of a polymer composition comprising at least 98 weight percent of a metallocene polypropylene homopolymer and an organophosphate clarifier for a fluid-containment wall of a syringe barrel.