Stability of Vancomycin 25 mg/mL in Ora-Sweet

3 Jan


Orally administered vancomycin is indicated for the treat­ment of Clostridium difficile infections and is often used as the first-line agent in severe cases. With the rising incidence of C. difficile infection in the health care setting, usage of oral vancomycin has also increased. Typically, oral vancomycin is administered in capsule form. However, vancomycin in a liquid form is required for patients who have nasogastric and other feeding tubes and also for many patients in the elderly and pediatric populations.

Vancomycin as an oral solution is not available commer­cially in Canada or the United States. Currently, pharmacists must prepare the oral liquid extemporaneously from the injectable or oral capsule form. An unpublished survey conducted within the Fraser Health region revealed that pharmacy staff members were preparing oral vancomycin liquid from the injectable form (i.e., powder requiring recon- stitution in vials) and supplying it as patient-specific prescrip­tions in small volumes with short expiry dates. Without published stability information, pharmacists were recommending storage in the refrigerator anywhere from 4 days to 14 days. This represented significant workload and logistic challenges in both the pharmacy and the patient care areas. From the patients’ perspective, the oral solution was very unpalatable. Although it is possible to improve palatability by mixing a dose of the drug with flavouring (syrups) or acidic juices, these would have to be added immediately before administration, which would contribute to inconvenience on the part of the patient or caregiver. Pharmacy staff were unable to find stability information for any palatable oral liquid formulation that would allow it to be prepared in advance and stored before administration; all existing information indicated that the sweetener had to be added immediately before administration.
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This study examined the physical characteristics and chemical stability (defined as maintenance of more than 90% of initial concentration) of extemporaneously prepared vancomycin oral solution 25 mg/mL in a mixture of equal volumes of Ora-Sweet vehicle and water, stored in 2 types of containers (unit-dose polyethylene cups and plastic bottles) at 4°C and 25°C throughout a 75-day study period.