Quantitative evaluation of a hydrophilic matrix intravaginal ring for the sustained delivery of tenofovir

Journal of Controlled Release

Volumn 163, Issue 2, 2012, Pages 240-248

  Clark, Justin T ^a   Johnson, Todd J ^a   Clark, Meredith R ^b   Nebeker, Joel S ^a   Fabian, Judit ^a   Tuitupou, Anthony L ^a   Ponnapalli, Satya ^a   Smith, Eric M ^a   Friend, David R ^b   Kiser, Patrick F ^a,c  

^a Department of Electrical and Computer Engineering   (United States)

^b EASTERN VIRGINIA MEDICAL SCHOOL   (United States)

^c UNIVERSITY OF UTAH   (United States)

Author keywords

Drug release modeling; Hydrophilic polyether urethane; Intravaginal ring; Microbicides for HIV prevention; Tenofovir

Indexed keywords

ANTI-HIV AGENTS; DEVICE DESIGN; DIFFUSION MODEL; DOSAGE FORMS; DRUG LOADING; DRUG RELEASE; HOT MELT; HYDROPHILIC MATRIX; HYDROPHILIC POLYETHERS; IN-VITRO; MECHANICAL MODEL; MICROBICIDES; MODEL PREDICTION; PSEUDO STEADY STATE; QUANTITATIVE EVALUATION; RING COMPRESSION; SWELLING KINETICS; TENOFOVIR; WOMEN'S HEALTH;

DRUG PRODUCTS; ESTERS; ETHERS; HYDROPHILICITY; MECHANICAL PROPERTIES; MELT SPINNING;

MATRIX ALGEBRA;

POLYETHERURETHAN; TENOFOVIR;

ARTICLE; COMPRESSION; DIFFUSION; DRUG FORMULATION; DRUG SOLUBILITY; ELASTICITY; EQUIPMENT DESIGN; HYDROPHILICITY; MECHANICS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SUSTAINED DRUG RELEASE; VAGINA RING; VISCOELASTICITY; YOUNG MODULUS;

ADENINE; ADMINISTRATION, INTRAVAGINAL; ANTI-HIV AGENTS; DRUG DELIVERY SYSTEMS; HYDROPHOBIC AND HYDROPHILIC INTERACTIONS; MODELS, THEORETICAL; ORGANOPHOSPHONATES; POLYURETHANES; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 84867647527     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2012.08.033     Document Type: Article

References (42)

1. C. Celum, and J.M. Baeten Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence Curr. Opin. Infect. Dis. 25 1 2012 51 57
2. J. Cohen FDA panel recommends anti-HIV drug for prevention Science 336 6083 2012 792
3. Q. Abdool Karim, S.S. Abdool Karim, J.A. Frohlich, A.C. Grobler, C. Baxter, L.E. Mansoor, A.B. Kharsany, S. Sibeko, K.P. Mlisana, Z. Omar, T.N. Gengiah, S. Maarschalk, N. Arulappan, M. Mlotshwa, L. Morris, and D. Taylor Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 5996 2010 1168 1174
4. R.M. Grant, D. Hamer, T. Hope, R. Johnston, J. Lange, M.M. Lederman, J. Lieberman, C.J. Miller, J.P. Moore, D.E. Mosier, D.D. Richman, R.T. Schooley, M.S. Springer, R.S. Veazey, and M.A. Wainberg Whither or wither microbicides? Science 321 5888 2008 532 534
5. L. Rossi Microbicide trials network statement on decision to discontinue use of tenofovir gel in VOICE, a major HIV prevention study in women 2011 Microbicide Trials Network
6. Y.W. Chien, H.J. Lambert, and D.E. Grant Controlled drug release from polymeric devices. I. Technique for rapid in vitro release studies J. Pharm. Sci. 63 3 1974 365 369
7. D.R. Mishell, M. Talas, A.F. Parlow, and D.L. Moyer Contraception by means of a silastic vaginal ring impregnated with medroxyprogesterone acetate Am. J. Obstet. Gynecol. 107 1 1970 100 107
8. J.A. van Laarhoven, M.A. Kruft, and H. Vromans In vitro release properties of etonogestrel and ethinyl estradiol from a contraceptive vaginal ring Int. J. Pharm. 232 1-2 2002 163 173 (Pubitemid 34076762)
9. R.K. Malcolm, A.D. Woolfson, C.F. Toner, R.J. Morrow, 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 (Pubitemid 41631926)
10. R.K. Malcolm, K.-L. Edwards, P. Kiser, J. Romano, and T.J. Smith Advances in microbicide vaginal rings Antivir. Res. 88 Supplement 1 2010 S30 S39
11. K.M. Gupta, S.M. Pearce, A.E. Poursaid, H.A. Aliyar, P.A. Tresco, M.A. Mitchnik, and P.F. 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
12. P.F. Kiser, T.J. Johnson, and J.T. Clark State of the art in intravaginal ring technology for topical prophylaxis of HIV infection AIDS Rev. 14 1 2012 62 77
13. A. Novak, C. de la Loge, L. Abetz, and E.A. van der Meulen The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability Contraception 67 3 2003 187 194 (Pubitemid 36255655)
14. R.K. Malcolm Modified-Release Drug Delivery Technology M.J. Rathbone, 2008 Informa Healthcare New York 499 510
15. M. Arimilli Synthesis, in vitro biological evaluation and oral bioavailability of 9-[2-(phosphonomethoxy)propyl]adenine (PMPA) prodrugs Antivir. Chem. Chemother. 8 6 1997 557 564 (Pubitemid 27504721)
16. 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 4 2010 203 212
17. R.W. Korsmeyer, S.R. Lustig, and N.A. Peppas Solute and penetrant diffusion in swellable polymers. I. Mathematical modeling J. Polym. Sci. Part B: Polym. Phys. 24 2 1986 395 408
18. R.W. Korsmeyer, E. Von Meerwall, and N.A. Peppas Solute and penetrant diffusion in swellable polymers. II. Verification of theoretical models J. Polym. Sci. Part B: Polym. Phys. 24 2 1986 409 434 (Pubitemid 16477349)
19. J. Siepmann, and F. Siepmann Mathematical modeling of drug delivery Int. J. Pharm. 364 2 2008 328 343
20. W. Bounds, A. Szarewski, D. Lowe, and J. Guillebaud Preliminary report of unexpected local reactions to a progestogen-releasing contraceptive vaginal ring Eur. J. Obstet. Gynecol. Reprod. Biol. 48 2 1993 123 125 (Pubitemid 23108943)
21. S. Koetsawang, G. Ji, U. Krishna, A. Cuadros, G.I. Dhall, R. Wyss, J. Rodriquez la Puenta, A.T. Andrade, T. Khan, E.S. Kononova, J.P. Lawson, U. Parekh, M. Elstein, V. Hingorani, Wang Na-ning, Yao Zhong-beng, B.M. Landgren, R. Boukhris, Lo Li-lan, S. Boccard, D. Machin, A. Pinol, and P.J. Rowe Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. II. Expulsions and removals. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation Contraception 41 2 1990 125 141 (Pubitemid 20060854)
22. E. Weisberg, I.S. Fraser, J. Baker, D. Archer, B.M. Landgren, S. Killick, P. Soutter, T. Krause, and C. d'Arcangues A randomized comparison of the effects on vaginal and cervical epithelium of a placebo vaginal ring with non-use of a ring Contraception 62 2 2000 83 89
23. T. Higuchi Mechanism of Sustained-Action Medication. Theoretical Analysis of Rate of Release of Solid Drugs Dispersed in Solid Matrices J. Pharm. Sci. 52 1963 1145 1149
24. T.J. Roseman, and W.I. Higuchi Release of medroxyprogesterone acetate from a silicone polymer J. Pharm. Sci. 59 3 1970 353 357
25. T.J. Roseman Release of steroids from a silicone polymer J. Pharm. Sci. 61 1 1972 46 50
26. J. Siepmann, and F. Siepmann Modeling of diffusion controlled drug delivery J. Control. Release 161 2 2012 351 362
27. R.M. Corless, G.H. Gonnet, D.E.G. Hare, D.J. Jeffrey, and D.E. Knuth On the Lambert W function Adv. Comput. Math. 5 1 1996 329 359 (Pubitemid 126729167)
28. I.M. Helbling, J.A. Luna, and M.I. Cabrera Mathematical modeling of drug delivery from torus-shaped single-layer devices J. Control. Release 149 3 2011 258 263
29. R. Huston Practical Stress Analysis in Engineering Design 2009 CRC Press Boca Raton
30. M.R. Clark, T.J. Johnson, R.T. McCabe, J.T. Clark, A. Tuitupou, H. Elgendy, D.R. Friend, and P.F. Kiser A hot-melt extruded intravaginal ring for the sustained delivery of the antiretroviral microbicide UC781 J. Pharm. Sci. 101 2 2012 576 587
31. K.T. Barnhart, K. Timbers, E.S. Pretorius, K. Lin, and A. Shaunik In vivo assessment of NuvaRing placement Contraception 72 3 2005 196 199
32. L. Zema, G. Loreti, A. Melocchi, A. Maroni, and A. Gazzaniga Injection Molding and its application to drug delivery J. Control. Release 159 3 2012 324 331
33. V. Brache, and A. Faundes Contraceptive vaginal rings: a review Contraception 82 5 2010 418 427
34. A. Martinelli, L. D'Ilario, I. Francolini, and A. Piozzi Water state effect on drug release from an antibiotic loaded polyurethane matrix containing albumin nanoparticles Int. J. Pharm. 407 1-2 2011 197 206
35. J. Berriot, F. Lequeux, H. Montes, and H. Pernot Reinforcement of model filled elastomers: experimental and theoretical approach of swelling properties Polymer 43 23 2002 6131 6138
36. R.W. Seymour, and S.L. Cooper Viscoelastic properties of polyurethane block polymers J. Polym. Sci. Polym. Symp. 46 1 1974 69 81
37. D.R. Paul Elaborations on the Higuchi model for drug delivery Int. J. Pharm. 418 1 2011 13 17
38. G. Truskey Transport Phenomena in Biological Systems 2004 Pearson Prentice Hall Upper Saddle River, New Jersey
39. S.S. Abdool Karim, A.D. Kashuba, L. Werner, and Q. Abdool Karim Drug concentrations after topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women Lancet 378 9787 2011 279 281
40. T.J. Johnson, P. Srinivasan, T.H. Albright, K. Watson-Buckheit, L. Rabe, A. Martin, C.P. Pau, R.M. Hendry, R. Otten, J. McNicholl, R. Buckheit Jr., J. Smith, and P.F. Kiser Safe and sustained vaginal delivery of pyrimidinedione HIV-1 inhibitors from polyurethane intravaginal rings Antimicrob. Agents Chemother. 56 3 2012 1291 1299
41. C. Dobard, S. Sharma, A. Martin, C.P. Pau, A. Holder, Z. Kuklenyik, J. Lipscomb, D.L. Hanson, J. Smith, F.J. Novembre, J.G. Garcia-Lerma, and W. Heneine Durable protection from vaginal simian-human immunodeficiency virus infection in macaques by tenofovir gel and its relationship to drug levels in tissue J. Virol. 86 2 2012 718 725
42. T.J. Johnson, M.R. Clark, T.H. Albright, J.S. Nebeker, A.L. Tuitupou, J.T. Clark, Judit Fabian, R.T. McCabe, N. Chandra, G.F. Doncel, D.R. Friend, P.F. Kiser, A ninety day tenofovir reservoir intravaginal ring for mucosal HIV prophylaxis, Antimicrob. Agents Chemother. (2012, accepted manuscript).