PMID- 12506681
OWN - NLM
STAT- MEDLINE
DCOM- 20030319
LR  - 20191106
IS  - 0043-5341 (Print)
IS  - 0043-5341 (Linking)
VI  - 152
IP  - 21-22
DP  - 2002
TI  - [Visual documentation of the stability of intravenous solutions of omeprazole 
      (Losec) and pantoprazole (Pantoloc)].
PG  - 568-73
AB  - Patients with complications of peptic ulcers, high grade reflux oesophagitis, or 
      Zollinger Ellison syndrome need a sufficient permanent acid suppression. In 
      appropriate indications they receive proton pump inhibitors (PPI) intravenously 
      or via perfusion over a longer period, if an oral application is not possible. 
      PPIs are prodrugs, which should be converted into the active principle in the 
      acidic canaliculus at pH 1 of the parietal cell. Otherwise they would be 
      activated prematurely. Immediate chemical degradation causes discolouration. Aim 
      of the study was to compare pH stabilities of the intravenous formulations of 
      Omeprazole (different solutions for infusion and injection) and Pantoprazole (one 
      solution for injection and infusion). The solutions prepared accordingly to the 
      official instructions, were exposed to four different light conditions. Both 
      manufacturers (AstraZeneca Osterreich GmbH, Byk Osterreich Pharma Ges.m.b.H.) 
      state reference solutions for acceptable discolouration. Those were prepared 
      according to the European Pharmacopeia. Discolouration of solutions were 
      evaluated as criterion for stability of the PPI prodrugs. If change of colour is 
      at least of the extent of the corresponding reference solution, further use is no 
      longer permitted. Optical alterations under different light conditions were 
      compared and documented photographically with standardized illumination. 
      Intensity and spectral composition of light as well as temperature had only minor 
      influence on discolouration as measure of degradation of the prodrugs. Both 
      formulations for injection fulfill the specifications for pH stability within the 
      stated time frames mentioned in the summaries of product characteristics (SPC). 
      Comparing both products, after a short period (1 hour) Omeprazole injectable 
      formulation showed a substantial optical discolouration. After 6 hours these 
      changes were more intense than the reference solution BG5 allows. Pantoprazole 
      showed optical alteration to a notable later time point. After 24 hours 
      discolouration reached the reference colour B6. Injectable formulation of 
      Pantoprazole is about three times more stable than that of Omeprazole. Infusion 
      solution of Omeprazole shows no optical alteration within the stated time frame 
      due to high dilution and pH value. Assuming that 100 ml of the infusion solution 
      contains 40 mg Omeprazole. It takes 5 hours for the volume to be infused at a 
      dose regimen of 8 mg/h. Therefor 5 x 100 ml/24 h are needed.
FAU - Leitner, A
AU  - Leitner A
AD  - Institut fur Analytische Chemie, Universitat Wien, Wahringer Strasse 38, A-1090 
      Wien. leitner@anc.univie.ac.at
FAU - Zollner, P
AU  - Zollner P
LA  - ger
PT  - Comparative Study
PT  - Journal Article
TT  - Visuelle Dokumentation der Stabilitat der intravenosen Losungen von Omeprazol 
      (Losec) und Pantoprazol (Pantoloc).
PL  - Austria
TA  - Wien Med Wochenschr
JT  - Wiener medizinische Wochenschrift (1946)
JID - 8708475
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Anti-Ulcer Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (Sulfoxides)
RN  - D8TST4O562 (Pantoprazole)
RN  - KG60484QX9 (Omeprazole)
SB  - IM
CIN - Wien Med Wochenschr. 2003;153(15-16):365; author reply 365. PMID: 13677260
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles
MH  - Anti-Ulcer Agents/administration & dosage/*chemistry
MH  - Benzimidazoles/administration & dosage/*chemistry
MH  - Drug Stability
MH  - Drug Storage
MH  - Esophagitis, Peptic/*drug therapy
MH  - Humans
MH  - Hydrogen-Ion Concentration
MH  - Infusions, Intravenous
MH  - Omeprazole/administration & dosage/*chemistry
MH  - Pantoprazole
MH  - Peptic Ulcer/*drug therapy
MH  - *Proton Pump Inhibitors
MH  - Structure-Activity Relationship
MH  - Sulfoxides/administration & dosage/*chemistry
MH  - Zollinger-Ellison Syndrome/*drug therapy
EDAT- 2003/01/01 04:00
MHDA- 2003/03/20 04:00
CRDT- 2003/01/01 04:00
PHST- 2003/01/01 04:00 [pubmed]
PHST- 2003/03/20 04:00 [medline]
PHST- 2003/01/01 04:00 [entrez]
AID - 10.1046/j.1563-258x.2002.02114.x [doi]
PST - ppublish
SO  - Wien Med Wochenschr. 2002;152(21-22):568-73. doi: 
      10.1046/j.1563-258x.2002.02114.x.