| A Multi-chambered Single Autoinjector and KMARK-1 Containing Atropine and 2-PAM: Comparative Bioavailability Studies Using Single Intramuscular Injection with Beagle Dogs |
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Keunwoo Lee, Seoyeon An, Taekeun Kwon, Inhong Jung, Dongyeon Kim |
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Samyang Chemical Research Institute of Technology Development |
| 아트로핀 및 팜 함유 다중챔버 단일주사기 및 KMARK-1: 비글개를 이용한 단회 근육투여 비교 생체이용률 연구 |
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이근우, 안서연, 권태근, 정인홍, 김동연 |
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삼양화학공업(주) 기술연구소 |
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| Abstract |
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In this study, multi-chambered single autoinjector(2in1) and KMARK-1 containing atropine and 2-PAM(pyridine-2-aldoxime methylchloride) were administered to the beagle's muscle, and blood samples were taken for a certain period of time to compare and evaluate the pharmacokinetic profiles of the two drugs. Male beagles were used and classified into two test groups(G1, G2), and crossover pharmacokinetic studies were performed in two test groups. Blood samples were collected from the jugular vein for analysis after administration. The 90 % confidence interval(CI) for log transformed data indicated that the Cmax for both atropine(log 0.9683 ~ log 1.113) and 2-PAM(log 0.9453 ~ log 1.214) was within the limits of bioequivalence criteria, but the AUC for atropine(log 1.1786 ~ log 1.3238) failed to meet this criteria. This is expected as the amount of atropine dose is 25 % higher for the test as compared to the reference formulation. In summary, in view of the ATNAA(antidote for nerve agent of US) authorization, the Cmax equivalence was more important than AUC equivalence, so in this study, we also focused on verifying the equality of Cmax between the two autoinjectors. |
| Key Words:
Antidote, Autoinjector, Pharmacokinetics, Bioavailability |
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