US20070187405A1 - Container for compositions containing cefdinir - Google Patents

Container for compositions containing cefdinir Download PDF

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Publication number
US20070187405A1
US20070187405A1 US11/621,440 US62144007A US2007187405A1 US 20070187405 A1 US20070187405 A1 US 20070187405A1 US 62144007 A US62144007 A US 62144007A US 2007187405 A1 US2007187405 A1 US 2007187405A1
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Prior art keywords
cefdinir
sodium benzoate
container
remains
theoretical amount
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US11/621,440
Inventor
Chetan Pujara
Daniel Kim
Shyamala Jayaraman
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Abbott Laboratories
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Abbott Laboratories
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Priority to US11/621,440 priority Critical patent/US20070187405A1/en
Assigned to ABBOTT LABORATORIES reassignment ABBOTT LABORATORIES ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: JAYARAMAN, SHYAMALA C., KIM, DANIEL W., PUJARA, CHETAN P.
Publication of US20070187405A1 publication Critical patent/US20070187405A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Plastic containers for storage and preservation of compositions comprising cefdinir are disclosed.

Description

  • This application claims priority to U.S. Provisional Patent Application No. 60/761,199, filed Jan. 23, 2006.
  • FIELD OF THE INVENTION
  • This invention pertains to plastic containers for storage and preservation of compositions comprising cefdinir.
  • BACKGROUND OF THE INVENTION
  • Cefdinir, an antibiotic available as capsules and powder for reconstituted suspension, is transported and stored in glass containers. To improve safety and handling of cefdinir, there is an existing need in the therapeutic arts for a less breakable container in which the cefdinir may be transported and stored.
  • BRIEF DESCRIPTION OF THE FIGURES
  • FIG. 1 shows the effect of plastic type on cefdinir amount over time.
  • FIG. 2 shows the effect of plastic type on sodium benzoate amount over time.
  • FIG. 3 shows a preferred shape for a plastic container.
  • SUMMARY OF THE INVENTION
  • One embodiment of this invention pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate or the cefdinir remains substantially unchanged over time.
  • Another embodiment pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate and the cefdinir remains substantially unchanged over time.
  • DETAILED DESCRIPTION OF THE INVENTION
  • This invention pertains to plastic containers for storage and preservation of compositions comprising cefdinir.
  • One embodiment of this invention pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate or the cefdinir remains substantially unchanged over time.
  • Another embodiment pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a plastic container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate and the cefdinir remains substantially unchanged over time.
  • Still another embodiment pertains to a plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a plastic container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • Still another embodiment pertains to a cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
  • The term “substantially unchanged,” as used herein in reference to cefdinir, means remains at least at about 90% of its original theoretical amount, preferably at least at about 95% of its original theoretical amount, more preferably at least at about 98% of its original theoretical amount, most preferably at least at about 99% of its original theoretical amount.
  • The term “substantially unchanged,” as used herein in reference to sodium benzoate, means remains at least at about 80% of its original theoretical amount, preferably at least at about 90% of its original theoretical amount, more preferably at least at about 95% of its original theoretical amount, most preferably at least at about 99% of its original theoretical amount.
  • The cefdinir of this invention may be in a physical form such as powders, pellets or granules. In a preferred embodiment for the practice of this invention the cefdinir is in powder form for reconstitution in suspension.
  • The amount of cefdinir in a sample removed from a container, based on a formula composition for its label indication (its original theoretical amount), is typically between about 90% and 100% of its original theoretical amount.
  • For example, for a teaspoon of a composition comprising cefdinir powder for reconstituted suspension with a label indication that claims that 250 mg of cefdinir will be in that teaspoon, the amount of cefdinir in that teaspoon may be about 90% to about 100% of the 250 mg.
  • FIG. 3 shows a plastic container 1, provided with a conventional closure device 2, that is useful for storing and preserving compositions comprising sodium benzoate and cefdinir 3. It is meant to be understood that the container 1 shown in FIG. 3 is a preferred embodiment for the practice of this invention and that a container of any shape for storing and preserving pharmaceutical compositions comprising cefdinir can be made from a plastic in which the percentage of the cefdinir in the compositions remains substantially constant over time.
  • In a study with HDPE and triple layer bottles (PET/COC/PET), it was noted that a substantial reduction in the amount of sodium benzoate and original theoretical amounts of cefdinir occurred over time. It was also noted that the reduction of the original theoretical amounts of cefdinir in the composition accelerated when the amount of sodium benzoate in the same composition dropped to below about 90% of its original amount.
  • A rapid screening study was designed to evaluate plastics that might cause reduction in the amount of sodium benzoate. The plastics tested are shown in TABLE 1.
    TABLE 1
    Plastic Abbreviation
    Cyclic Olefin Copolymer 8007 D-61 COC
    Ethylene Chlorotrifluoroethylene E-CTFE
    Fluorinated ethylenepropylene FEP
    High-density Polyethylene 5502 BN HDPE
    Polyethylene naphthylate 75-3177 PEN
    Polyethylene terphthalate 79921 PET
    Polyphenylenesulfide Fotran 9320C0 PPS
    Polypropylene FT120WB PP
    Polystyrene 3510 PS
    Polyvinyl chloride PVC
  • Based on the results of this study, shown in TABLE 2, PEN and COC were chosen for further evaluation.
    TABLE 2
    Plastic Beads % Loss After 1 Week % Loss After 2 Weeks
    PEN 6.5 13.8
    PPS 4.0 17.7
    polystyrene 11.9 18.0
    COC 11.5 19.8
    PET 10.2 20.3
    polypropylene 14.4 20.3
    HDPE 22.9 22.3
    PVC 15.9 24.9
    control (1) −1.3 0.4
    control (2) 7.8 17.4

    % loss are w/w percentages

    (1) without beads and without salt solution and

    (2) without beads and with salt solution
  • Bottles made from PEN and COC were charged with active granulation and placed on an accelerated stability study at 25° C./60% relative humidity for 24 months along with glass bottles that served as controls. The contents of the bottles were tested at pre-determined time points for cefdinir and sodium benzoate concentration.
  • As shown in FIG. 1, results from the stability study indicate that the assay values of cefdinir were greater than 90% for the glass, PEN and COC bottles. The sodium benzoate values for the glass, PEN and COC bottles also remained substantially constant over the duration of the study.
  • Additionally, bottles made from E-CTFE and FEP were charged with active granulation and placed on an accelerated stability study at 40° C./75% relative humidity for 6 months along with glass bottles that served as controls. The contents of the bottles were tested at pre-determined time points for cefdinir and sodium benzoate concentration. Results from this stability study indicated that the assay values for the glass, E-CTFE and FEP bottles remained substantially constant over the duration of the study.
  • The foregoing is meant to illustrate the invention but not to limit it. Variations and changes obvious to one skilled in the art are intended to be within the scope of the invention as defined in the claims.

Claims (36)

1. A plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate or the cefdinir remains substantially unchanged over time.
2. The plastic container of claim 1, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
3. A plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
4. The plastic container of claim 3, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
5. A plastic container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
6. The plastic container of claim 5, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
7. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
8. The plastic container of claim 7, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
9. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
10. The polyethylene naphthylate container of claim 9, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
11. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
12. The polyethylene naphthylate container of claim 11, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
13. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
14. The cyclic olefin copolymer container of claim 13, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
15. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
16. The cyclic olefin copolymer container of claim 15, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
17. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount or the sodium benzoate remains at least at about 80% of its original theoretical amount.
18. The cyclic olefin copolymer container of claim 17, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
19. A plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the percentage of the sodium benzoate and the cefdinir remains substantially unchanged over time.
20. The plastic container of claim 19, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
21. A plastic container having a closure device for storing and preserving compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
22. The plastic container of claim 21, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
23. A plastic container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
24. The plastic container of claim 23, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
25. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
26. The polyethylene naphthylate container of claim 25, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
27. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
28. The polyethylene naphthylate container of claim 27, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
29. A polyethylene naphthylate container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
30. The polyethylene naphthylate container of claim 29, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
31. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir.
32. The cyclic olefin copolymer container of claim 31, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
33. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
34. The cyclic olefin copolymer container of claim 33, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
35. A cyclic olefin copolymer container having a closure device for storing and preserving pharmaceutical compositions comprising sodium benzoate and cefdinir, wherein, after 24 months, the cefdinir remains at least at about 90% of its original theoretical amount and the sodium benzoate remains at least at about 80% of its original theoretical amount.
36. The cyclic olefin copolymer container of claim 35, wherein the cefdinir therein is cefdinir powder for reconstituted suspension.
US11/621,440 2006-01-23 2007-01-09 Container for compositions containing cefdinir Abandoned US20070187405A1 (en)

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DE10161077A1 (en) 2001-12-12 2003-06-18 Boehringer Ingelheim Vetmed Highly concentrated stable meloxicam solutions for needleless injection
US8992980B2 (en) 2002-10-25 2015-03-31 Boehringer Ingelheim Vetmedica Gmbh Water-soluble meloxicam granules
EP1568369A1 (en) 2004-02-23 2005-08-31 Boehringer Ingelheim Vetmedica Gmbh Use of meloxicam for the treatment of respiratory diseases in pigs
WO2011046853A1 (en) 2009-10-12 2011-04-21 Boehringer Ingelheim Vetmedica Gmbh Containers for compositions comprising meloxicam
SG183846A1 (en) 2010-03-03 2012-10-30 Boehringer Ingelheim Vetmed Use of meloxicam for the long-term treatment of musculoskeletal disorders in cats
US9795568B2 (en) 2010-05-05 2017-10-24 Boehringer Ingelheim Vetmedica Gmbh Low concentration meloxicam tablets

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KR0169505B1 (en) * 1992-09-11 1999-01-15 오오쓰끼 아끼히꼬 Drug packing polyolefinic material, process for producing the same and container for drug packing
JP2007532416A (en) * 2004-04-08 2007-11-15 アイディーディー−イール マニュファクチャリング カンパニー リミテッド Container for preparing liquid formulations

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Owner name: ABBOTT LABORATORIES, ILLINOIS

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PUJARA, CHETAN P.;KIM, DANIEL W.;JAYARAMAN, SHYAMALA C.;REEL/FRAME:019087/0573

Effective date: 20070329

STCB Information on status: application discontinuation

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