Medicated syringe preparation

• US 5,653,693 A
• Filed: 09/24/1993
• Issued: 08/05/1997
• Est. Priority Date: 09/10/1991
• Status: Expired due to Term

• Current Assignee: Daiichi Sankyo Company Limited
• Original Assignee: Daiichi Pharmaceutical Company Limited (Daiichi Sankyo Company Limited)
• Inventors: Abe, Masaru, Yokote, Sachio, Miwa, Akira, Kikuchi, Masahiko
• Primary Examiner(s): Michl, Paul R.
• Assistant Examiner(s): RAJGURU, UMAKANT K
• Application Number:
  US08/050,136
• Time in Patent Office: 1,411 Days
• Field of Search: 524/83, 524/117, 524/118, 524/119, 524/136, 524/140, 524/145, 128/654, 128/653.4, 604/181, 604/187, 604/218
• US Class Current: 604/187
• CPC Class Codes: A61J 1/06 Ampoules or carpules syringe ampoules or carpules A61M5/28
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: C08K 5/527 Cyclic esters
• CPC Class Codes: C08K 5/5357 cyclic
• CPC Class Codes: C08L 23/10 Homopolymers or copolymers of propene

Abstract

This invention relates to a preparation comprising a transparent syringe body or container, which has been obtained by molding a resin comprising, as a base material, a propylene polymer, and as a nucleating agent, a phosphoric ester represented by the following general formula (1): ##STR1## and a drug solution charged into the syringe body or container. The preparation is excellent in transparency, free from the dissolution of additives for the resin into the drug solution charged therein even when the drug solution remains charged for a long period of time and hence high in safety. The preparation is useful, in particular, as a syringe preparation charged with a drug solution therein.

Claims

1. A transparent syringe prefilled with a drug solution, said transparent syringe having been obtained by molding a resin composition comprising, as a base material, a propylene polymer, and as a nucleating agent, a phosphoric ester represented by the following general formula (1):

##STR4## wherein R¹, R², R³ and R⁴ mean individually a hydrogen atom or a straight-chain, branched or cyclic alkyl which may be substituted, R denotes a direct bond, sulfur atom or alkylidene group, x and y stand individually for 0 or 1, M denotes a metal atom, and n means a valence of the metal, said transparent syringe, prefilled with a drug maintaining its transparency and being free Of contamination upon prolonged storage of at least 6 months at 40°

C.

2. The transparent syringe as claimed in claim 1, wherein the drug solution is a contrast medium.

3. The transparent syringe as claimed in claim 1, wherein the drug solution is a solution comprising, as a principal ingredient, iohexol.

4. The transparent syringe as claimed in claim 1, wherein the propylene polymer is selected from the group consisting of (i) propylene homopolymers, (ii) crystalline copolymers with other monomers which are composed mainly of propylene, and (iii) blends of crystalline polypropylene as a principal component and other polymers, said homopolymers, copolymers and blends having a melt flow index of 0.5-100 g/10 min as measured in accordance with ASTM D-1238.

5. A transparent syringe body as claimed in claim 1, wherein said nucleating agent is methylene bis(2,4-di-tert-butylphenol)-phosphate.

6. The transparent syringe as claimed in claim 1, wherein said phosphoric ester represented by formula (1) is the sole nucleating agent.

7. The transparent syringe as claimed in claim 1, wherein said resin composition consists essentially of said base material and said nucleating agent.

8. The transparent syringe as claimed in claim 1, wherein said resin composition consists of said base material and said nucleating agent.