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Results of the present study indicated that diazepam can be safely and reliably administered IM using a diazepam autoinjector.

A diazepam 10-mg autoinjector was evaluated in bioequivalence and dose proportionality studies; both involved 24 young, healthy subjects and used randomized, open-label, 2-treatment, 2-period crossover designs with a 3-week washout period between treatments. The bioequivalence study compared a single diazepam 10-mg autoinjector with a conventional needle and syringe containing 10 mg of diazepam injectable. The dose proportionality study compared the pharmacokinetics of a single diazepam 10-mg autoinjector with that of 2 diazepam 10-mg autoinjectors given simultaneously (20 mg). Injections were intramuscular in the midanterolateral thigh in both studies. The studies showed that the diazepam autoinjector produced consistent plasma diazepam levels, with a rapid onset of absorption. The diazepam 10-mg autoinjector given intramuscularly was bioequivalent to a conventional syringe containing diazepam 10 mg. A single (10-mg) autoinjector and 2 (20-mg) diazepam autoinjectors administered simultaneously produced plasma diazepam concentrations that were essentially dose proportional.

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Commercially manufactured wet/dry autoinjectors containing atropine in solution and powdered HI-6 were evaluated using HPLC for consistency of drug delivery with various solvation times and stability of drugs postsolvation at a temperature of 40 degrees C. Three configurations of autoinjector were tested. System A (SYS A), with a specified mixing time of 5 sec, delivered a volume of 3.0 ml containing 1.86 mg of atropine sulfate and 443 mg of the bispyridinium oxime HI-6 dichloride. System B1 (SYS B1) and System B2 (SYS B2), with specified mixing times of 40 sec, delivered volumes of 2.3 ml containing 2.13 and 2.06 mg atropine citrate and 424 and 545 mg HI-6 dichloride, respectively. Average coefficients of variation for SYS A were 3.4% for atropine and 5.8% for HI-6 and for SYS B1 and B2 were 5.2% for atropine and 7.0% for HI-6 determinations. Stored from 3 to 14 days at 40 degrees C after the autoinjector contents were mixed, SYS A delivered 1.77 mg atropine sulfate and SYS B1 and B2 delivered 2.02 mg atropine citrate. The delivery of HI-6 dichloride decreased with a half-life of 34 days for SYS A, 39 days for SYS B1, and 32 days for SYS B2. This resulted in a decrease to 90% of the respective day 0 amount after 4 (SYS A) or 5 (SYS B1 or B2) days.