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Pharmacokinetics of Intranasal Scopolamine Gel Formulation (Inscop)Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during early flight days of space missions. Orally administered scopolamine is commonly used by astronauts to prevent SMS. Bioavailability of oral (PO) SMS medications is often low and highly variable. Intranasal (IN) administration of medications achieves higher and more reliable bioavailability than from an equivalent PO dose. Methods: To test the safety and reliability of INSCOP, two clinical studies were performed, a dose escalation study and a comparison study administering INSCOP during normal ambulation and head down tilt bedrest. Efficacy was evaluated by testing INSCOP with two, different motion sickness inducing paradigms. Results: Preliminary results indicate that INSCOP demonstrates linear pharmacokinetics and a low side effect profile. In head down tilt bedrest, relative bioavailability of INSCOP was increased for females at both doses (0.2 and 0.4 mg) and for males at the higher dose (0.4 mg) but is reduced at the lower dose (0.2 mg) compared to normal ambulation. INSCOP displays gender specific differences during ABR. One of the treatment efficacy trials conducted at Dartmouth Hitchcock Medical Center demonstrated that INSCOP is efficacious at both doses (0.2 and 0.4 mg) in suppressing motion sickness symptoms as indicated by longer chair ride times with INSCOP administration than with placebo, and efficacy increases with dose. Similar results were seen using another motion sickness simulator, the motion simulator dome, at the Naval Aerospace Medical Research Laboratory, with significantly increased time in the dome in motion-susceptible subjects when using INSCOP compared to untreated controls. Conclusion: Higher bioavailability, linear pharmacokinetics, a low incidence of side effects, and a favorable efficacy profile make INSCOP a desirable formulation for prophylactic and rescue treatment of astronauts in space and military personnel on duty.
Document ID
20090002615
Acquisition Source
Johnson Space Center
Document Type
Conference Paper
Authors
Boyd, Jason L.
(Universities Space Research Association Houston, TX, United States)
Du, Brian
(Wyle Labs., Inc. Houston, TX, United States)
Daniels, Vernie
(Wyle Labs., Inc. Houston, TX, United States)
Simmons, Rita
(Naval Aerospace Medical Inst. Pensacola, FL, United States)
Buckey, Jay
(Dartmouth-Hitchcock Medical Center Lebanon, NH, United States)
Putcha, Lakshmi
(NASA Johnson Space Center Houston, TX, United States)
Date Acquired
August 24, 2013
Publication Date
January 1, 2009
Subject Category
Aerospace Medicine
Meeting Information
Meeting: Human Research Program Investigators'' Workshop
Location: League City, TX
Country: United States
Start Date: February 2, 2009
End Date: February 4, 2009
Distribution Limits
Public
Copyright
Other

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