Potential remote drug delivery failures due to temperature-dependent viscosity and drug-loss of aqueous and emulsion-based fluids

The ability to inject wild animals from a distance using remote drug delivery systems (RDDS) is one of the most effective and humane practices in wildlife management. Several factors affect the successful administration of drugs using RDDS. For example, temperature-dependent viscosity change in aqueous (Newtonian) or water-in-oil emulsion (non-Newtonian) fluids, commonly used in tranquilizer and adjuvant-based vaccines, respectively, can potentially result in drug delivery failure. To better understand impacts due to viscosity changes, we investigated the fluid dynamics and ballistics involved in remote drug delivery. Our research was divided into two phases: we investigated the viscosimetric physics in the first phase to determine the fluid behavior under different temperature settings, simulating recommended storage temperature (7ºC), plus an ambient temperature (20ºC). In the second phase of our study, we assessed the drug delivery efficiency by specialized darts, using a precision CO2 projector and a blowgun. Efficiency assessment was done by comparing the original drug volume with the actual volume injected after firing the dart into a fresh pork hide mounted on a ballistic gel. Before testing, we configured the required minimum impact velocity for our parameters and intramuscular injection (determined as ˃ 40 m/sec). All executed dart-deployments performed satisfactorily, despite initial concerns of potential incomplete drug delivery, however, noteworthy drug loss was observed (˃10%) associated with drug residues in syringe/dart dead space and within the transfer needle. This could potentially result in inaccurate dosing depending on the drug used. Furthermore, the use of a blowgun for remote drug delivery (>3m) is discouraged, especially when using specialized darts, as the required minimum dart velocity for adequate penetration is difficult to reach, in addition to a loss of precision during targeting.

Effect of Different Subculture Methods on Fruit-Body Yield of Cordyceps militaris

Different inoculation methods were employed in the process of the Cordyceps militaris subculture. The experimental results indicated that fruit-body yields of strains obtained by mycelium subculture using transfer needle were unstable, and the subcultures obtained by transferring mycelial cakes made by using a punching bear had the relatively high stability. Two kind of subcultures had a significant difference in fruit-body yield using one-way ANOVA analysis (P<0.05).

Time and Cost Savings with Bio-Set® Device in Reconstituting FVIII Concentrate.

Introduction: Bio-Set® (Biodome, Issoire France) is a new needleless device developed for the reconstitution of a factor VIII concentrate, Kogenate® FS (Bayer HealthCare, Elkhart IN). Objectives: Quantitate time required to prepare FVIII concentrate for infusion and estimate the cost of medical waste produced using 3 reconstitution methods. Methods: 161 subjects (35 patients; 67 caregivers; and 59 nurses) were recruited from the US and Canada following an IRB-approved protocol. Reconstitution methods were Bio-Set®, the conventional 2 vial transfer needle reconstitution method, and 2 vial Baxject method (Baxter Healthcare, Westlake Village CA). Video and interviewer demonstrations were conducted, then participants practiced each reconstitution method once before performing a timed round. Diluent volume for the conventional reconstitution method and Baxject were controlled at 5 mL. After each timed round, participants separated reconstitution refuse into either medical waste or regular trash. The weights of component pieces were added and a cost for disposal of the medical waste was determined. Results: Participants completed preparation of the infusion with Bio-Set® in the shortest amount of time compared to the conventional method and Baxject (both p<0.0001). Results were similar across the 3 participant groups. The average weight of medical waste was lowest for Bio-Set® and highest for Baxject. The resulting disposal cost was significantly lower for Bio-Set® (p<0.0001). Conclusions: The results of the time study showed a reduction of 33% in infusion preparation time with the Bio-Set® when compared to the conventional method and 29% when compared to the Baxject. The cost of disposal of medical waste should be reduced with the use of the Bio-Set®.

User Preference for 3 Hemophilia Factor Reconstitution Methods.

Introduction: Treatment of hemophilia includes the reconstitution of lyophilized FVIII concentrates with diluent followed by intravenous injection. Several reconstitution devices exist for infusion of concentrates. The Bio-Set® (Biodome, Issoire France) is a new needleless device for reconstituting a factor VIII concentrate, Kogenate® FS (Bayer Healthcare, Elkhart, IN). Objective: Comparison of preferences for reconstitution methods by hemophilia patients, caregivers to hemophilia patients, and care providers. Methods: A total of 35 hemophilia A patients who infuse themselves, 67 caregivers, and 59 infusion nurses were recruited following an IRB-approved protocol. Infusion method names were blinded to participants to prevent brand recognition. Reconstitution methods used in this study were Bio-Set®, a conventional 2 vial, transfer needle reconstitution method, and Baxject (Baxter Healthcare, Westlake Village CA). Participants viewed a video demonstrating the three methods, watched the interviewer demonstrate each method, and then practiced each method once. Each participant performed 1 timed round with each method and completed preference questionnaires about each method. The preference questionnaire was scored into domains for safety/worry and ease/confidence, in addition to a total preference score. Participants’ comments about the reconstitution methods were also recorded. Results: Participants preferred the Bio-Set® in terms of worry/safety, ease/confidence, and overall preference. These results were consistent across participant group. Participants agreed on their preferences for the Bio-Set® in terms of safety from needlesticks, amount of waste produced, and convenience for traveling (all p<0.0001). Analysis of the qualitative data indicated that exposure to needles and product contamination were issues commonly noted. Safety and complexity of instructions were also common issues for participants. Conclusions: Results of this study show that patients, caregivers, and nurse providers prefer the Bio-Set® reconstitution device over other methods for preparing factor concentrates for infusion.

Effect of Moisture and Incubation Time on Ochratoxin A Production by an Isolate of Aspergillus ochraceus

Experiments were conducted to determine the culture requirements that would insure a probability of high ochratoxin production with a given isolate. Experiments at ambient temperatures (72 ± 2°F) determined the levels of the two most readily controlled variables, time and moisture content, during the growth of a high toxin-producing isolate (M298) of Aspergillus ochraceus. Tests were conducted in 2.8 L - Fernbach flasks containing 100 g shredded wheat and inoculated with spores on a transfer needle. Amounts of ochratoxin A/flask were determined by comparison against standards on TLC after chloroform extraction. Statistical analysis showed a relation between ochratoxin yield, water levels, and incubation periods. A water level of 40–70 ml/flask with an incubation period of 19-21 days at ambient temperatures should give a near to maximum yield of ochratoxin A.