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Population Pharmacokinetics of Intranasal Scopolamine
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Author and Affiliation:
Wu, L.(Houston Univ., Coll. of Pharmacy, Houston, TX, United States);
Chow, D. S. L.(Houston Univ., Coll. of Pharmacy, Houston, TX, United States);
Putcha, L.(NASA Johnson Space Center, Houston, TX, United States)
Abstract: Introduction: An intranasal gel dosage formulation of scopolamine (INSCOP) was developed for the treatment of Space Motion Sickness (SMS).The bioavailability and pharmacokinetics (PK) was evaluated using data collected in Phase II IND protocols. We reported earlier statistically significant gender differences in PK parameters of INSCOP at a dose level of 0.4 mg. To identify covariates that influence PK parameters of INSCOP, we examined population covariates of INSCOP PK model for 0.4 mg dose. Methods: Plasma scopolamine concentrations versus time data were collected from 20 normal healthy human subjects (11 male/9 female) after a 0.4 mg dose. Phoenix NLME was employed for PK analysis of these data using gender, body weight and age as covariates for model selection. Model selection was based on a likelihood ratio test on the difference of criteria (-2LL). Statistical significance for base model building and individual covariate analysis was set at P less than 0.05{delta(-2LL)=3.84}. Results: A one-compartment pharmacokinetic model with first-order elimination best described INSCOP concentration ]time profiles. Inclusion of gender, body weight and age as covariates individually significantly reduced -2LL by the cut-off value of 3.84(P less than 0.05) when tested against the base model. After the forward stepwise selection and backward elimination steps, gender was selected to add to the final model which had significant influence on absorption rate constant (ka) and the volume of distribution (V) of INSCOP. Conclusion: A population pharmacokinetic model for INSCOP has been identified and gender was a significant contributing covariate for the final model. The volume of distribution and Ka were significantly higher in males than in females which confirm gender-dependent pharmacokinetics of scopolamine after administration of a 0.4 mg dose.
Publication Date: Jan 01, 2013
Document ID:
20130013380
(Acquired May 09, 2013)
Subject Category: AEROSPACE MEDICINE
Report/Patent Number: JSC-CN-28713
Document Type: Conference Paper
Meeting Information: American Association of Pharmaceutical Scientists (AAPS)Annual Meeting; 10-14 Nov. 2013; San Antonio, TX; United States
Meeting Sponsor: American Association of Pharmaceutical Scientists; Arlington, VA, United States
Financial Sponsor: NASA Johnson Space Center; Houston, TX, United States
Organization Source: NASA Johnson Space Center; Houston, TX, United States
Description: 2p; In English
Distribution Limits: Unclassified; Publicly available; Unlimited
Rights: Copyright; Distribution as joint owner in the copyright
NASA Terms: HYOSCINE; PHARMACOLOGY; FEMALES; MALES; DOSAGE; MOTION SICKNESS; MOTION SICKNESS DRUGS; ANTIEMETICS AND ANTINAUSEANTS; STATISTICAL ANALYSIS; NOSE (ANATOMY); AEROSPACE MEDICINE
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