Colour Stability Testing in Pantoprazole Formulations
CCCF ePoster library. Zytaruk N. Oct 26, 2015; 117333; P43 Disclosure(s): Physicians Services Incorporated of Ontario
Nicole Zytaruk
Nicole Zytaruk
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Abstract
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P43


Topic: Clinical Trial


Colour Stability Testing in Pantoprazole Formulations



Nicole Zytaruk, L. Saunders, W. Alhazzani, C. Wallace, S. Kanji, S. English, T. Karachi, B. Rochwerg, J. Muscedere, R. Hall, J. Marshall, M. Alshahrani, A. Deane, S. Finfer, J. Barletta, G. Guyatt, D. Cook

Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada | Critical Care Research, St. Joseph's Healthcare Hamilton, Hamilton, Canada | Medicine, McMaster University, Hamilton, Canada | Research Pharmacy, St. Joseph's Healthcare Hamilton, Hamilton, Canada | Clincal Pharmacy, The Ottawa Research Institute, Ottawa, Canada | Critical Care, The Ottawa Research Institute, Ottawa, Canada | Medicine, McMaster University, Hamilton, Canada | Medicine, McMaster University, Hamilton, Canada | Critical Care, Queens University, Kingston, Canada | Critical Care, Dalhousie University, Halifax, Canada | Critical Care, St. Michael's Hospital, Toronto, Canada | Critical Care, Dammam University, Dammam, Saudi Arabia | Critical Care, Royal North Shore, Sydney, Australia | Critical Care Research, The George Institute, Sydney, Australia | Critical Care, Midwestern University, Glendale, United States of America | Departments of Medicine and Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Canada | Departments of Medicine and Clinical Epidemiology & Biostatistics, McMas

Introduction: 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. The REVISE Pilot Trial is evaluating the feasibility of a larger trial, based on 3 feasibility outcomes: the informed consent rate; recruitment rate; and protocol adherence. Pantoprazole has been shown to be chemically stable by retaining its potency at 0.8mg/ml when mixed in NS for up to 28 days in the fridge (2-8°C)1,2,3. However, some studies evaluating the stability of pantoprazole in solution have observed a change in color over time. Color change in study drug over time may represent a degradation of product, or affect the integrity of blinding in a clinical trial.

Objectives:

The objective of this study was to test the colour stability (change in colour) in refrigerated conditions (2-8°C) for 5 different pantoprazole parenteral formulations (40mg of lyophilized powder / vial) are available in Canada or Saudi Arabia (Table).



Methods:

With the assistance of Pharmacy Research personnel, 5 samples of each of the identified parenteral pantoprazole product were prepared. Each pantoprazole vial of 40mg was reconstituted with 10 ml of 0.9% NaCl (NS). From this vial of reconstituted pantoprazole, the pharmacy technician withdrew 10mL (40mg) and injected the dose into a 50mL NS mini-bag from which 10mL had been removed. The final concentration of pantoprazole was 40mg/50mL (0.8mg/mL). Each mini-bag was labeled and stored protected from light and refrigerated ( 2-8°Celcius). A continuous temperature measurement device was in the refrigerator throughout the testing period, recording the minimum and maximum temperature daily for 5 days. Using a transparent 10 ml syringe, 10 ml from each sample mini-bag was withdrawn, one at a time, and compared with 10 ml of 0.9%NaCl (NS) in an identical syringe (placebo). Both syringes were placed on bright white paper for 20 minutes (the duration of study drug administration) under room light and at room temperature. This was completed for 5 samples of each product daily for 5 days. Two research coordinators inspected and took daily photos of each syringe of study product to compare with placebo, seeking any colour change as judged by duplicate independent observation.

Product Name

Manufacturer

Pantoprazole for Injection

PPC Inc

Panto IV

Takeda

Pantoprazole for Injection

Teva Canada Ltd

Pantoprazole Sodium for Injection

Sandoz Canada Inc

PMS-Pantoprazole

Pharmascience Inc.



Results:

Duplicate independent observation by visual inspection and using daily photographs of syringes of each reconstituted pantoprazole solution as compared to syringes of placebo revealed no colour change over 5 days in any of the products at any time (100% crude agreement). Within the limitations of visual inspection, this suggests that the REVISE study drug can be prepared in the pharmacy and stored in the pharmacy or ICU up to 5 days under refrigerated conditions (2-8°) without jeopardizing its identity.



Conclusion:

This colour stability study confirms that pantoprazole can be stored for 5 days without risking unblinding on the grounds of colour change, facilitating weekend study drug batching in the REVISE Pilot Trial.



References:

1. Walker S, Iazzetta J, Law S. Extended stability of pantoprazole for injection in 0.9% sodium chloride or 5% dextrose at 4°C and 23°C. CJHP 2009; 62(2):135-141

2. Donnelly RF. Stability of pantoprazole sodium in glass vials, polyvinyl chloride minibags and polypropylene syringes. CJHP 2011; 6(3):192-8

3. USP (United States Pharmacopeia) Chapter <797> recommends that low-risk sterile preparations not be stored longer than 14d under refrigeration.

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