Colour Stability Testing for Pantoprazole Formulations: Can Blinding be Maintained in a Randomized Trial?
CCCF ePoster library. Zytaruk N. Oct 4, 2017; 198157; 103
Nicole Zytaruk
Nicole Zytaruk
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Colour Stability Testing for Pantoprazole Formulations: Can Blinding be Maintained in a Randomized Trial?

Zytaruk, N1; Wallace, C2; Copland, M3; Al-Hazzani, W4; Kanji, S5; Muscedere, J6; Lauzier, F7; Deane, A8; Barletta, J9; Cook, D10; for the REVISE Investigators, CCCTG and ANZICS-CTG

1 Critical Care Trial Coordinator, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.

2 Pharmacy Department, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.

3 Department of Critical Care Research, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.

4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

5 Department of Clinical Epidemiology, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

6 Department of Critical Care, Queens University, Kingston, Ontario, Canada.

7 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

8 Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.

9 Department of Pharmacy Practice, Midwestern University, College of Pharmacy-Glendale, Glendale, Arizona, USA.

10 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.

 




 

Background:
REVISE is a randomized, blinded, placebo-controlled trial examining the effect of intravenous (IV) pantoprazole compared to placebo (0.9% sodium chloride; normal saline [NS]) on rates of upper gastrointestinal bleeding, pneumonia and Clostridium difficile infection in the ICU. Pantoprazole is chemically stable, retaining its potency at 0.8mg/ml when mixed in NS for up to 28 days in the fridge (2-8°C)1,2.    However, some studies evaluating pantoprazole in solution have observed a change in colour over time, which may affect the integrity of blinding in a clinical trial.  We previously documented colour stability for 5 days3. The objective of this study was to extend these observations to 10 days by evaluating any change in colour under refrigerated conditions (2-8°C) for 2 different pantoprazole parenteral formulations  currently marketed in Canada.

Methods: 
Under sterile conditions (laminar flow hood), Pharmacy Research Personnel prepared 5 sample minibags for each of the 2 parenteral pantoprazole products (10 x 50mL) (Table).  The final concentration of pantoprazole was 40mg/50mL (0.8mg/mL). Each mini-bag was labeled and stored protected from light and refrigerated at 2-8°Celcius. A continuous temperature measurement device was in the refrigerator throughout the testing period, recording the minimum and maximum temperature daily for 10 consecutive days.
On each of the 10 study days, one 50mL minibag of each product formulation was selected. Using a transparent 10 ml syringe, 5 x 10 mL of reconstituted pantoprazole was withdrawn from the minibag, and compared with 10 mL of NS in an identical syringe (placebo). Syringes were placed on bright white paper for 20 minutes (the duration of typical study drug administration) under room light at room temperature, and daily photos were taken. The same 2 research coordinators performed all assessments. In duplicate but independently, they inspected the syringes, comparing each pantoprazole-containing syringe with the placebo syringe, seeking any colour change. This was repeated for a total of 10 days. 
 



















Product Name Product Description Manufacturer
Pantoprazole for Injection 40mg/vial (lyophilized powder) Fresenius Kabi
Pantoprazole Sodium for Injection 40mg/vial (lyophilized powder) Sandoz Canada Inc

 
 


Results:
Duplicate independent observation by visual inspection and using daily photographs of syringes of each reconstituted pantoprazole solution (0.8mg/mL) compared to syringes of placebo (NS) revealed no colour change over 10 days in either of the products at any time. Within the limitations of visual inspection, there was 100% crude agreement between 2 Research Coordinators.  These findings suggest that the REVISE study drug can be prepared by Pharmacy Research Personnel and stored in the pharmacy or ICU up to 10 days under refrigerated conditions (2-8°) without jeopardizing its identity.
 
Conclusions: 
This colour stability study confirms that pantoprazole can be stored for 10 days without risking unblinding on the grounds of colour change, facilitating cost-effective study drug batching in the international REVISE Trial.
 
Funding: Canadian Institutes of Health Research

 

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