The Effects of System Parameters on In Vivo Injection Performance of a Needle-Free Injector in Human Volunteers
العنوان: | The Effects of System Parameters on In Vivo Injection Performance of a Needle-Free Injector in Human Volunteers |
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المؤلفون: | Hristo Iontchev, Stephen J. Farr, Toby King, Lawrence S. Linn, Brooks M. Boyd |
المصدر: | Pharmaceutical Research. 24:1501-1507 |
بيانات النشر: | Springer Science and Business Media LLC, 2007. |
سنة النشر: | 2007 |
مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Injections, Subcutaneous, Pharmacology toxicology, Pharmaceutical Science, Pharmacy, Body Mass Index, law.invention, Double-Blind Method, Pharmaceutical technology, law, In vivo, Abdomen, Pressure, medicine, Humans, Pharmacology (medical), Skin, Pharmacology, Needle free, Analysis of Variance, business.industry, Organic Chemistry, Reproducibility of Results, Injector, Surgery, Treatment Outcome, Pharmaceutical Preparations, System parameters, Injections, Jet, Molecular Medicine, Female, Epidermis, business, Biotechnology, Biomedical engineering |
الوصف: | For a novel needle-free injection (NFI) system, the relationship between frequency of wet or incomplete injections and device-related factors and subject physiological variables was examined.A total of 26 device configurations of a single-use pre-filled NFI system (Intraject) were used to deliver a total of 3,211 subcutaneous injections into the abdomen of 302 healthy volunteers. Two validated methods were used to determine completeness of each injection (defined asor=90% dose delivery). Skin-fold thickness, body mass index (BMI), Fitzpatrick skin type, sex, age, and injection site were noted for each volunteer.The proportion of complete injections ranged from 59-98% among the various combinations of device configurations. Two device parameters and two subject-related variables showed strong association with injection performance; Device gas mass (chamber pressure) and orifice size demonstrated statistically significant, independent effects, with increasing gas mass and larger orifice size associated with improved injection performance. BMI and site of injection on the abdomen also demonstrated statistically significant effects with increasing BMI and lateral rather than medial injection sites associated with better injections.Both device-related factors and subject variables interact to mediate in vivo performance of a needle-free injector. |
تدمد: | 1573-904X 0724-8741 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a22df7a01c802916f22d6241b4f9ad6 https://doi.org/10.1007/s11095-007-9268-6 |
حقوق: | CLOSED |
رقم الأكسشن: | edsair.doi.dedup.....7a22df7a01c802916f22d6241b4f9ad6 |
قاعدة البيانات: | OpenAIRE |
تدمد: | 1573904X 07248741 |
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