The effects of system parameters on in vivo injection performance of a needle-free injector in human volunteers

Pharmaceutical Research

Volumn 24, Issue 8, 2007, Pages 1501-1507

  Linn, Lawrence ^a   Boyd, Brooks ^a,b   Iontchev, Hristo ^a   King, Toby ^a,c   Farr, Stephen J ^a,b  

^a ARADIGM CORPORATION   (United States)

^b Zogenix Inc   (United States)

^c Insensys Ltd   (United Kingdom)

Author keywords

Device and subject variables; In vivo performance; Needle free injection systems; Safety and tolerability

Indexed keywords

ABDOMEN; ADULT; AGE; AGED; ARTICLE; BODY MASS; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; FEMALE; HUMAN; IN VIVO STUDY; INJECTION SITE; MALE; MEDICAL INSTRUMENTATION; NEEDLE FREE INJECTOR; NORMAL HUMAN; PRESSURE CHAMBER; PRIORITY JOURNAL; SEX DIFFERENCE; SKINFOLD THICKNESS; STATISTICAL SIGNIFICANCE; SUBCUTANEOUS DRUG ADMINISTRATION;

ABDOMEN; ADULT; ANALYSIS OF VARIANCE; BODY MASS INDEX; DOUBLE-BLIND METHOD; EPIDERMIS; FEMALE; HUMANS; INJECTIONS, JET; INJECTIONS, SUBCUTANEOUS; MALE; PHARMACEUTICAL PREPARATIONS; PRESSURE; REPRODUCIBILITY OF RESULTS; SKIN; TREATMENT OUTCOME;

EID: 34250847060     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9268-6     Document Type: Article

References (18)

1. R. A. Hingson, H. S. Davis, and M. Rosen. The historical development of jet injection and envisioned uses in mass immunization and mass therapy based upon two decades' experience. Mil. Med. 128:516-524 (1963).
2. R. A. Hingson, H. S. Davis, and M. Rosen. Clinical experience with one and a half million jet injections in parenteral therapy and in preventive medicine. Mil. Med. 128:525-528 (1963).
3. F. H. J. Figge and D. J. Barnett. Anatomic evaluation of a jet injection instrument designed to minimize pain and inconvenience of parenteral therapy. Am. Pract. 3:197-206 (1948).
4. E. K. Zsigmond. Jet anesthesia and jet local anesthesia for the 21st century. J. Natl. Med. Assoc. 94:1004-1006 (2002).
5. F. Béclard. Présentation de l'injecteur de Galante, Séance du 18 décembre 1866, Présidence de M. Bouchardat. Bulletin de l'Académie Impériale de Médecine 32:321-327 (1866).
6. M. Lockhart. US Patent No. 69,199 (1936).
7. T. King. Needle-free drug delivery. In J. Swarbrick and J. C. Boylan (eds.), Encyclopedia of Pharmaceutical Technology, 2nd Edition Taylor & Francis, New York, 2004, pp. 1-12.
8. J. Schramm and S. Mitragotri. Transdermal drug delivery by jet injectors: energetics of jet formation and penetration. Pharm. Res. 19:1673-1679 (2002).
9. J. M. Pereira, J. M. Mansour, and B. R. Davis. The effects of layer properties on shear disturbance propagation in skin. J. Biomech. Eng. 113:30-35 (1991).
10. J. M. Pereira, J. M. Mansour, and B. R. Davis. Analysis of shear wave propagation in skin; application to an experimental procedure. J. Biomech. 23:745-751 (1990).
11. M. Mridha, S. Ödman, and P. Ä. Öberg. Mechanical pulse wave propagation in gel, normal and oedematous tissues. J. Biomech. 25:1213-1218 (1992).
12. J. F. M. Manschot and A. J. M. Brakkee. The measurement and modelling of the mechanical properties of human skin in vivo-I. The measurement. J. Biomech. 19:511-515 (1986).
13. R. H. Wildnauer, J. W. Bothwell, and A. B. Douglass. Stratum corneum biomechanical properties. I. Influence of relative humidity on normal and extracted human strateum corneum. J. Invest. Derm. 56:72-78 (1971).
14. E. Berardesca and H. I. Maibach. Is skin color expression of racial differences in skin function? (http://www.ulb.ac.be/medecine/loce/espcr/b_iss/ Dis-9b.htm).
15. O. A. Shergold. The mechanics of needle-free injection. PhD thesis. Cambridge University (2004).
16. J. Schramm-Baxter and S. Mitragotri. Needle-free jet injections: dependence of jet penetration and dispersion in the skin on jet power. J. Contr. Rel. 97:527-535 (2004).
17. L. H. Jansen and P. B. Rottier. Comparison of the mechanical properties of strips of human abdominal skin excised from below and above the umbilicus. Dermatologica 117:252-258 (1958).
18. J. Baxter and S. Mitragotri. Jet-induced skin puncture and its impact on needle-free jet injections: experimental studies and a predictive model. J. Contr. Rel. 106:361-373 (2005).