Sustained release of proteins from a modified vaginal ring device

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 77, Issue 1, 2011, Pages 3-10

  Morrow, Ryan J ^a   Woolfson, A David ^a   Donnelly, Louise ^a   Curran, Rhonda ^a   Andrews, Gavin ^a   Katinger, Dietmar ^b   Malcolm, R Karl ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^b POLYMUN SCIENTIFIC IMMUNBIOLOGISCHE FORSCHUNG GMBH   (Austria)

Author keywords

2F5; Lyophilisation; Microbicide; Protein drug delivery; Vaccine; Vaginal ring

Indexed keywords

ELASTOMER; MONOCLONAL ANTIBODY 2F5; SILICONE;

ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG RELEASE; ENZYME LINKED IMMUNOSORBENT ASSAY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INSERT VAGINAL RING; NANOFABRICATION; VAGINA RING; VIRUS TRANSMISSION;

ANTIBODIES, MONOCLONAL; CONTRACEPTIVE DEVICES, FEMALE; DELAYED-ACTION PREPARATIONS; EXCIPIENTS; PROTEINS; SILANES; SILICONE ELASTOMERS; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; TIME FACTORS; WATER;

EID: 78650698258     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.10.010     Document Type: Article

References (40)

1. C.A. Varga Sexual decision-making and negotiation in the midst of AIDS: Youth in KwaZulu/Natal, South Africa Health Trans. Rev. 7 3 1997 45 67
2. T.T. Langen Gender power imbalance on women's capacity to negotiate self-protection against HIV/AIDS in Botswana and South Africa Afr. Health Sci. 5 September 2005 188 197
3. R.A. Ayton, G.M. Darling, A.L. Murkies, E.A. Farell, E. Weisberg, I. Selinus, and I.S. Fraser A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy Br. J. Obstet. Gynecol. 103 1996 351 358
4. R. Barentsen, P. van de Weijer, and J. Schram Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy Eur. J. Obstet. Gynecol. Reprod. Biol. 71 1997 73 80
5. R.M. Curran, L. Donnelly, R.J. Morrow, C. Fraser, G. Andrews, M. Cranage, R.K. Malcolm, R.J. Shattock, and A.D. Woolfson Vaginal delivery of the recombinant HIV-1 clade-C trimeric gp140 envelope protein CN54gp140 within novel rheologically structured vehicles elicits specific immune responses Vaccine 27 2009 6791 6798
6. K. Gupta, S. Pearce, A. Poursaid, H. Aliyar, P. Tresco, M. Mitchnick, and P. Kiser Polyurethane intravaginal ring for controlled delivery of dapivirine, a nonnucleoside reverse transcriptase inhibitor of HIV-1 J. Pharm. Sci. 97 10 2008 4228 4239
7. R.K. Malcolm, A.D. Woolfson, R.J. Morrow, C.F. Toner, and S.D. McCullagh Long-term, controlled release of the HIV microbicide TMC120 from silicone elastomer vaginal rings J. Antimicrob. Chemother. 56 5 2005 954 956
8. A.D. Woolfson, R.K. Malcolm, R.J. Morrow, C.F. Toner, and S.D. McCullagh Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide Int. J. Pharm. 325 1-2 2006 82 89
9. H. Shen, E. Goldberg, and W. M Saltzman Gene expression and mucosal immune responses after vagina l DNA immunization in mice using a controlled delivery matrix J. Control. Release 86 2003 339 348
10. P.F. Zhang, F. Cham, M. Dong, A. Choudhary, P. Bouma, Z. Zhang, Y. Shao, Y. Feng, L. Wang, N. Mathy, G. Voss, C. C Broder, and G. V Quinnan Extensively cross-reactive anti-HIV-1 neutralizing antibodies induced by gp140 immunization PNAS 104 24 2007 10193 10198
11. R.K. Malcolm, S. D McCullagh, R.J. Morrow, and D. Woolfson Vagina and uterus as drug-absorbing organs E. Touitou, B. Barry, Enhancement in Drug Delivery 2007 CRC Press Boca Raton, FL 395 440
12. G. Dezarnaulds, and I.S. Fraser Vaginal ring delivery of hormone replacement therapy - a review Expert. Opin. Pharmacol. 4 2 2003 201 212
13. A.D. Woolfson, G.R.E. Elliott, C.A. Gilligan, and C.M. Passmore Design of an intravaginal ring for the controlled delivery of 17β-estradiol as its 3-acetate ester J. Control. Release 61 3 1999 319 328
14. R.K. Malcolm The intravaginal ring M.J. Rathbone, J. Hadgraft, M.S. Roberts, Modified-release Drug Delivery Technology 2003 Marcel Dekker Inc. New York 775 790
15. D.R. Mishell Vaginal contraceptive rings Ann. Med. 25 1993 191 197
16. Y.W. Chien, Novel Drug Delivery Systems, Drugs and the Pharmaceutical Sciences, second ed., vol. 50, Marcel Dekker Inc., New York, 1992, pp. 565-576.
17. A.D. Woolfson, R.K. Malcolm, and R. Gallagher Drug delivery by the intravaginal route Crit. Rev. Ther. Drug Carr. Syst. 17 2000 509 555
18. G. Di Colo, V. Careli, E. Nannipieri, M.F. Serafini, D. Vitale, and F. Bottari Effect of different water-soluble additives on the sustained release of sulphanilamide from silicone rubber matrices II Farmaco 37 1982 377 389
19. G. Di Colo, V. Campigli, V. Careli, E. Nannipieri, M.F. Serafini, and D. Vitale Release of osmotically active drugs from silicone rubbers II Farmaco 37 1984 310 319
20. D.S.T. Hsieh, and Y.W. Chien Enhanced release of drugs from silicone elastomers (II): induction of swelling and changes in microstructure Drug Dev. Ind. Pharm. 11 1982 1411 1432
21. J.R. Mascola, M.G. Lewis, G. Stiegler, H. Katinger, D. Harris, D. Hayes, M. Louder, T. Vancott, S. Frankel, C. Brown, C. Sapan, M. Robb, and D. Birx Protection of macaques against pathogenic simian/human immunodeficiency virus 89.6PD by passive transfer of neutralizing antibodies J. Virol. 73 1999 4009 4018
22. J.R. Mascola, G. Stiegler, T.C. VanCott, H. Katinger, C. B Carpenter, C.E. Hanson, H. Beary, D. Hayes, S.S. Frankel, D. L Birx, and M.G. Lewis Protection of macaques against vaginal transmission of a pathogenic HIV-1/SIV chimeric virus by passive infusion of neutralizing antibodies Nature Med. 6 2000 207 210
23. T.W. Baba, V. Liska, R. Hofmann-Lehmann, J. Vlasak, W. Xu, S. Ayehunie, L.A. Cavacini, M.R. Posner, H. Katinger, G. Stiegler, B.J. Bernacky, T.A. Rizvi, R. Schmidt, L.R. Hill, M.E. Keeling, Y. Lu, J.E. Wright, T.C. Chou, and R.M. Ruprecht Human neutralizing monoclonal antibodies of the IgG1 subtype protect against mucosal simian-human immunodeficiency virus infection Nature Med. 6 2000 200 206
24. C. Armbruster, G.M. Stiegler, B.A. Vcelarb, W.J. gerc, N.L. Michaeld, N. Vetter, and H.W.D. Katinger A phase I trial with two human monoclonal antibodies (hMAb 2F5, 2G12) against HIV-1 AIDS 16 2002 227 233
25. J.M. Binley, T. Wrin, B. Korber, M.B. Zwick, M. Wang, C. Chappey, G. Stiegler, R. Kunert, S. Zolla-Pazner, H. Katinger, C.J. Petropoulos, and D.R. Burton Comprehensive cross-clade neutralization analysis of a panel of anti-human immunodeficiency virus type 1 monoclonal antibodies J. Virol. 2004 13232 13252 (Pubitemid 39507829)
26. S. Mehandru, T. Wrin, J. Galovich, G. Stiegler, B. Vcelar, A. Hurley, C. Hogan, S. Vasan, H. Katinger, C. Petropoulos, and M. Markowitz Neutralization profiles of newly transmitted human immunodeficiency virus type 1 by monoclonal antibodies 2G12, 2F5, and 4E10 J. Virol. 2004 14039 14042
27. V. Tozzi, M. Zarccarelli, S. Bonfigli, P. Lorenzini, G. Liuzzi, M.P. Trotta, F. Forbici, C. Gori, A. Bertoli, R. Bellagamba, P. Narciso, C.F. Perno, and A. Antinorini Drug-class-wide resistance to antiretrovirals in HIV-infected patients failing therapy: prevalence, risk factors and virological outcome Antivir. Ther. 11 2006 553 560
28. P.J. Weidle, Kityo, C.M. Cissy, P. Mugyenyi, R. Downing, A. Kebba, D. Pieniazek, R. Respess, K. Hertogs, V. De Vroey, P. Dehertogh, S. Bloor, B. Larder, and E. Lackritz Resistance to antiretroviral therapy among patients in Uganda Jaids J. Acq. Immun. Def. Synd. 26 5 2001 495 500
29. S. Jacob, A.A. Shirwaikar, K.K. Srinivasan, J. Alex, S.L. Prabu, R. Mahalaxmi, and R. Kumar Stability of proteins in aqueous solution and solid state Indian J. Pharm. Sci. 68 2 2006 154 163
30. J. Jaspe, and S.J. Hagen Do protein molecules unfold in a simple shear flow? Biophys. J. 91 2006 3415 3424
31. S.T. Tzannis, W.J.M. Hrushesky, P.A. Wood, and T.M. Przybycien Adsorption of a formulated protein on a drug delivery device surface J. Colloid Interface Sci. 189 1997 216 228
32. P.M. Bummer, and S. Koppenol Chemical and physical considerations in protein and peptide stability Eugene McNally, Protein Formulation and Delivery 2000 Marcel Dekker New York
33. R. Siegel, and R. Langer Controlled release of polypeptides and other macromolecules Pharm. Res. 1 1984 2 10 (Pubitemid 14123791)
34. T.J. Johnson, K.M. Gupta, J. Fabian, T.H. Albright, and P.F. Kiser Segmented polyurethane intravaginal rings for the sustained combined delivery of antiretroviral agents dapivirine and tenofovir Eur. J. Pharm. Sci. 39 2010 203 212
35. M. Kajihara, T. Sugie, M. Mizuno, N. Tamura, A. Sano, K. Fujioka, Y. Kashiwazaki, T. Yamaoka, S. Sugawara, Y.E. Otto, Z. Long, Y. Chiang, G.J. McGarrity, and L.M. Muul Development of new drug delivery system for protein drugs using silicone (I) J. Control. Release 66 2000 49 61
36. M. Kajihara, T. Sugie, T. Hojo, H. Maeda, A. Sano, K. Fujioka, Y.S. Sugawara, and Y. Urabe Development of a new drug delivery system for protein drugs using silicone (II) J. Control. Release 73 2001 279 291
37. H. Maeda, E. Ohashic, A. Sanoa, H. Kawasakib, and Y. Kurosaki Investigation of the release behaviour of a covered-rod-type formulation using silicone J. Control. Release 90 2003 59 70
38. H. Maeda, M. Brandon, and A. Sano Design of controlled-release formulation for ivermectin using silicone Int. J. Pharm. 261 2003 9 19 (Pubitemid 36962741)
39. A.D. Woolfson, M.L. Umrethia, V.L. Kett, and R.K. Malcolm Freeze-dried, mucoadhesive system for vaginal delivery of the HIV microbicide, dapivirine: optimisation by an artificial neural network Int. J. Pharm. 30 388:1-2 2010 136 143
40. R.S. Veazey, R.J. Shattock, M. Pope, J.C. Kirijan, J. Jones, Q.X. Hu, T. Ketas, P.A. Marx, P.J. Klasse, D.R. Burton, and J.P. Moore Prevention of virus transmission to macaque monkeys by a vaginally applied monoclonal antibody to HIV-1 gp120 Nat. Med. 9 3 2003 343 346