메뉴 건너뛰기




Volumn 88, Issue SUPPL., 2010, Pages

Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets

Author keywords

Acceptability; Controlled release; Films; Gels; HIV; Microbicides; Regulations; Scale up; Tablets; Vaginal formulations

Indexed keywords

ANTIRETROVIRUS AGENT; CANDID V6; CANDIZOLE; CELLULOSE ACETATE; CELLULOSE ACETATE 1,2 BENZENEDICARBOXYLATE; CELLULOSE SULFATE; CLINDAMYCIN PHOSPHATE; CLOMAX; CLOTRIMAZOLE; DAPIVIRINE; DODECYL SULFATE SODIUM; DS 003; ITRACONAZOLE; MICONAZOLE; MICROBICIDE; N [4 CHLORO 3 (3 METHYL 2 BUTENYLOXY)PHENYL] 2 METHYL 3 FURANCARBOTHIOAMIDE; NEOMYCIN; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; NONOXINOL 9; POLYSTYRENESULFONIC ACID; POVIDONE IODINE; PRANEEM POLYHERBAL; RNA DIRECTED DNA POLYMERASE INHIBITOR; TENOFOVIR; TINIDAZOLE; UNCLASSIFIED DRUG;

EID: 78649436881     PISSN: 01663542     EISSN: 18729096     Source Type: Journal    
DOI: 10.1016/j.antiviral.2010.09.010     Document Type: Review
Times cited : (101)

References (57)
  • 1
    • 78649439979 scopus 로고    scopus 로고
    • Anon., a. Guidance for Industry, Q8(R2) Pharmaceutical Development.
    • Anon., 2009a. Guidance for Industry, Q8(R2) Pharmaceutical Development. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf.
    • (2009)
  • 2
    • 78649438108 scopus 로고    scopus 로고
    • Anon., b. Pharmaceutical cGMPS for the 21st Century - A Risk-Based Approach: Second Progress Report and Implementation Plan.
    • Anon., 2009b. Pharmaceutical cGMPS for the 21st Century - A Risk-Based Approach: Second Progress Report and Implementation Plan. http://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm071836.
    • (2009)
  • 3
    • 58149154649 scopus 로고    scopus 로고
    • Development and in vitro evaluation of an acid buffering bioadhesive vaginal gel for mixed infections
    • Ahmad F.J., Alam M.A., Khan Z.I., Khar R.K., Ali M. Development and in vitro evaluation of an acid buffering bioadhesive vaginal gel for mixed infections. Acta Pharm. 2008, 58:407-419.
    • (2008) Acta Pharm. , vol.58 , pp. 407-419
    • Ahmad, F.J.1    Alam, M.A.2    Khan, Z.I.3    Khar, R.K.4    Ali, M.5
  • 5
    • 78649394664 scopus 로고    scopus 로고
    • British Pharmacopoeia, 2007.
    • British Pharmacopoeia, 2007.
  • 6
    • 60149089459 scopus 로고    scopus 로고
    • Barrier properties of mucus
    • Cone R.A. Barrier properties of mucus. Adv. Drug Deliv. Rev. 2009, 61:75-85.
    • (2009) Adv. Drug Deliv. Rev. , vol.61 , pp. 75-85
    • Cone, R.A.1
  • 7
    • 33745504777 scopus 로고    scopus 로고
    • Gels as vaginal delivery systems
    • Das Neves J., Bahia M.F. Gels as vaginal delivery systems. Int. J. Pharm. 2006, 318:1-14.
    • (2006) Int. J. Pharm. , vol.318 , pp. 1-14
    • Das Neves, J.1    Bahia, M.F.2
  • 8
    • 78649437612 scopus 로고    scopus 로고
    • Rectal Microbicides Update: Nonclinical Evaluation. Microbicides India.
    • Dezzutti, C.S., 2008. Rectal Microbicides Update: Nonclinical Evaluation. Microbicides India. http://www.rectalmicrobicides.org/docs/Charlene%2520S.%2520Dezzutti.pdf.
    • (2008)
    • Dezzutti, C.S.1
  • 9
    • 77953984131 scopus 로고    scopus 로고
    • Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for clindamycin phosphate
    • Dobaria N., Mashru R. Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for clindamycin phosphate. Pharm. Dev. Technol. 2010, 15:405-414.
    • (2010) Pharm. Dev. Technol. , vol.15 , pp. 405-414
    • Dobaria, N.1    Mashru, R.2
  • 10
    • 70449524333 scopus 로고    scopus 로고
    • A novel itraconazole bioadhesive film for vaginal delivery: design, optimization, and physicodynamic characterization
    • Dobaria N.B., Badhan A.C., Mashru R.C. A novel itraconazole bioadhesive film for vaginal delivery: design, optimization, and physicodynamic characterization. AAPS PharmSciTech 2009, 10:951-959.
    • (2009) AAPS PharmSciTech , vol.10 , pp. 951-959
    • Dobaria, N.B.1    Badhan, A.C.2    Mashru, R.C.3
  • 11
    • 78649435148 scopus 로고    scopus 로고
    • Preclinical evaluation of anti-HIV microbicide products: new models and biomarkers
    • Doncel G., Clark M. Preclinical evaluation of anti-HIV microbicide products: new models and biomarkers. Antiviral Res. 2010, 88:S10-S18.
    • (2010) Antiviral Res. , vol.88
    • Doncel, G.1    Clark, M.2
  • 13
    • 67649890169 scopus 로고    scopus 로고
    • Mucoadhesive vaginal tablets of natamycin for vaginal candidiasis
    • El-Gindy G., El-Sayed A.M., Mohamed A.A. Mucoadhesive vaginal tablets of natamycin for vaginal candidiasis. Bull. Pharm. Sci. 2003, 26:29-40.
    • (2003) Bull. Pharm. Sci. , vol.26 , pp. 29-40
    • El-Gindy, G.1    El-Sayed, A.M.2    Mohamed, A.A.3
  • 14
    • 0036754357 scopus 로고    scopus 로고
    • Bioadhesive controlled release metronidazole vaginal tablets
    • El-Kamel A., Sokar M., Naggar V., Gamal S. Bioadhesive controlled release metronidazole vaginal tablets. Acta Pharm. 2002, 52:171-179.
    • (2002) Acta Pharm. , vol.52 , pp. 171-179
    • El-Kamel, A.1    Sokar, M.2    Naggar, V.3    Gamal, S.4
  • 15
    • 0035081058 scopus 로고    scopus 로고
    • Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: where have we been? Where are we going?
    • Elias C., Coggins C. Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: where have we been? Where are we going?. J. Womens Health Gend. Based Med. 2001, 10:163-173.
    • (2001) J. Womens Health Gend. Based Med. , vol.10 , pp. 163-173
    • Elias, C.1    Coggins, C.2
  • 16
    • 78649393167 scopus 로고    scopus 로고
    • Combining prevention of HIV-1, other sexually transmitted infections and unintended pregnancies: development of dual-protection technologies
    • Friend D.R., Doncel G.F. Combining prevention of HIV-1, other sexually transmitted infections and unintended pregnancies: development of dual-protection technologies. Antiviral Res. 2010, 88:S47-S54.
    • (2010) Antiviral Res. , vol.88
    • Friend, D.R.1    Doncel, G.F.2
  • 17
    • 18744386141 scopus 로고    scopus 로고
    • Orally fast disintegrating tablets: developments, technologies taste-masking and clinical studies
    • Fu Y., Yang S., Seong S.H., Kimura S., Park K. Orally fast disintegrating tablets: developments, technologies taste-masking and clinical studies. Crit. Rev. Ther. Drug Carrier Syst. 2004, 21:433-475.
    • (2004) Crit. Rev. Ther. Drug Carrier Syst. , vol.21 , pp. 433-475
    • Fu, Y.1    Yang, S.2    Seong, S.H.3    Kimura, S.4    Park, K.5
  • 18
    • 18044393199 scopus 로고    scopus 로고
    • Development and characterization of bioadhesive vaginal films of sodium polystyrene sulfonate (PSS), a novel contraceptive antimicrobial agent
    • Garg S., Vermani K., Garg A., Anderson R.A., Rencher W.B., Zaneveld L.J. Development and characterization of bioadhesive vaginal films of sodium polystyrene sulfonate (PSS), a novel contraceptive antimicrobial agent. Pharm. Res. 2005, 22:584-595.
    • (2005) Pharm. Res. , vol.22 , pp. 584-595
    • Garg, S.1    Vermani, K.2    Garg, A.3    Anderson, R.A.4    Rencher, W.B.5    Zaneveld, L.J.6
  • 20
    • 0343674585 scopus 로고    scopus 로고
    • Studies on vaginal bioadhesive tablets of acyclovir
    • Genc L., Oguzlar C., Guler E. Studies on vaginal bioadhesive tablets of acyclovir. Pharmazie 2000, 55:297-299.
    • (2000) Pharmazie , vol.55 , pp. 297-299
    • Genc, L.1    Oguzlar, C.2    Guler, E.3
  • 21
    • 78649433269 scopus 로고    scopus 로고
    • US Patent Publication No.: US 2005/0181041 A1.
    • Goldman, D., 2005. US Patent Publication No.: US 2005/0181041 A1.
    • (2005)
    • Goldman, D.1
  • 22
    • 0026352483 scopus 로고
    • Testing of drug release from bioadhesive vaginal tablets
    • Gursoy A., Bayhan A. Testing of drug release from bioadhesive vaginal tablets. Drug Dev. Ind. Pharm. 1991, 17:2457-2475.
    • (1991) Drug Dev. Ind. Pharm. , vol.17 , pp. 2457-2475
    • Gursoy, A.1    Bayhan, A.2
  • 23
    • 60149105478 scopus 로고    scopus 로고
    • Targeted delivery of PSC-RANTES for HIV-1 prevention using biodegradable nanoparticles
    • Ham A.S., Cost M.R., Sassi A.B., Dezzutti C.S., Rohan L.C. Targeted delivery of PSC-RANTES for HIV-1 prevention using biodegradable nanoparticles. Pharm. Res. 2009, 26:502-511.
    • (2009) Pharm. Res. , vol.26 , pp. 502-511
    • Ham, A.S.1    Cost, M.R.2    Sassi, A.B.3    Dezzutti, C.S.4    Rohan, L.C.5
  • 24
    • 65349175947 scopus 로고    scopus 로고
    • Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms
    • Hariharan M., Bogue B.A. Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms. Drug Deliv. Technol. 2009, 9:24-29.
    • (2009) Drug Deliv. Technol. , vol.9 , pp. 24-29
    • Hariharan, M.1    Bogue, B.A.2
  • 25
    • 78649439228 scopus 로고    scopus 로고
    • Preventing mucosal HIV transmission with topical microbicides - challenges and opportunities
    • Hladik F., Doncel G.F. Preventing mucosal HIV transmission with topical microbicides - challenges and opportunities. Antiviral Res. 2010, 88:S3-S9.
    • (2010) Antiviral Res. , vol.88
    • Hladik, F.1    Doncel, G.F.2
  • 26
    • 0028915506 scopus 로고
    • Comparative bioavailability of metronidazole formulations (Vagimid) after oral and vaginal administration
    • Hoffman C. Comparative bioavailability of metronidazole formulations (Vagimid) after oral and vaginal administration. Int. J. Clin. Pharmacol. Ther. 1995, 33:232-239.
    • (1995) Int. J. Clin. Pharmacol. Ther. , vol.33 , pp. 232-239
    • Hoffman, C.1
  • 27
    • 33745477882 scopus 로고    scopus 로고
    • Acceptability of Praneem polyherbal vaginal tablet among HIV-unaffected women and their male partners in Pune India - phase I study
    • Joglekar N., Joshi S., Navlakha S., Katti U.R., Mehendale S.M. Acceptability of Praneem polyherbal vaginal tablet among HIV-unaffected women and their male partners in Pune India - phase I study. Indian J. Med. Res. 2006, 123:547-552.
    • (2006) Indian J. Med. Res. , vol.123 , pp. 547-552
    • Joglekar, N.1    Joshi, S.2    Navlakha, S.3    Katti, U.R.4    Mehendale, S.M.5
  • 28
    • 23844515523 scopus 로고    scopus 로고
    • Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-unaffected women and their male partners in Pune India
    • Joshi S., Kati U., Godebole S. Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-unaffected women and their male partners in Pune India. Trans. R. Soc. Trop. Med. Hyg. 2005, 99:769-774.
    • (2005) Trans. R. Soc. Trop. Med. Hyg. , vol.99 , pp. 769-774
    • Joshi, S.1    Kati, U.2    Godebole, S.3
  • 29
    • 58849144982 scopus 로고    scopus 로고
    • Proposed design of a dissolution apparatus for vaginal formulations containing probiotics
    • Kale V., Trivedi R., Muley P. Proposed design of a dissolution apparatus for vaginal formulations containing probiotics. Dissol. Technol. 2008, 15:27-29.
    • (2008) Dissol. Technol. , vol.15 , pp. 27-29
    • Kale, V.1    Trivedi, R.2    Muley, P.3
  • 30
    • 39649091895 scopus 로고    scopus 로고
    • Antiretroviral drug-based microbicides to prevent HIV-1 sexual transmission
    • Klasse P., Shattock R., Moore J.P. Antiretroviral drug-based microbicides to prevent HIV-1 sexual transmission. Annu. Rev. Med. 2008, 59:455-471.
    • (2008) Annu. Rev. Med. , vol.59 , pp. 455-471
    • Klasse, P.1    Shattock, R.2    Moore, J.P.3
  • 31
    • 78649400063 scopus 로고
    • Comments on the Ph. Eur. and the B. P. 80 disintegration test for suppositories and pessaries
    • Kryger S., Moller N., Rassing M. Comments on the Ph. Eur. and the B. P. 80 disintegration test for suppositories and pessaries. Arch. Pharm. Chem. Sci. Ed. 1983, 11:79-84.
    • (1983) Arch. Pharm. Chem. Sci. Ed. , vol.11 , pp. 79-84
    • Kryger, S.1    Moller, N.2    Rassing, M.3
  • 32
    • 39749099504 scopus 로고    scopus 로고
    • Dilution of microbicide gels with vaginal fluid and semen stimulants effect the rheological properties and coating properties
    • Lai B.E., Xie Q.Y., Lavine M.J., Szeri A.J., Owen D.H., Katz D.F. Dilution of microbicide gels with vaginal fluid and semen stimulants effect the rheological properties and coating properties. J. Pharm. Sci. 2008, 97:1030-1038.
    • (2008) J. Pharm. Sci. , vol.97 , pp. 1030-1038
    • Lai, B.E.1    Xie, Q.Y.2    Lavine, M.J.3    Szeri, A.J.4    Owen, D.H.5    Katz, D.F.6
  • 33
    • 0018885655 scopus 로고
    • Combined vaginal and vulval treatment of vaginal candidiasis with econazole
    • Larsson B., Kjaeldgaard A. Combined vaginal and vulval treatment of vaginal candidiasis with econazole. Curr. Ther. Res. Clin. Exp. 1980, 27:664-669.
    • (1980) Curr. Ther. Res. Clin. Exp. , vol.27 , pp. 664-669
    • Larsson, B.1    Kjaeldgaard, A.2
  • 34
    • 0029965810 scopus 로고    scopus 로고
    • Development and evaluation of mucoadhesive drug delivery system for dual controlled delivery of nonoxynol-9
    • Lee C., Chien Y. Development and evaluation of mucoadhesive drug delivery system for dual controlled delivery of nonoxynol-9. J. Control. Release 1996, 39:93-103.
    • (1996) J. Control. Release , vol.39 , pp. 93-103
    • Lee, C.1    Chien, Y.2
  • 36
    • 0030768422 scopus 로고    scopus 로고
    • A phase I comparative study of three contraceptive vaginal films containing nonoxynol-9. Postcoital testing and colposcopy
    • Mauck C.K., Baker J.M., Barr S.P., Johanson W.M., Archer D.F. A phase I comparative study of three contraceptive vaginal films containing nonoxynol-9. Postcoital testing and colposcopy. Contraception 1997, 56:97-102.
    • (1997) Contraception , vol.56 , pp. 97-102
    • Mauck, C.K.1    Baker, J.M.2    Barr, S.P.3    Johanson, W.M.4    Archer, D.F.5
  • 38
    • 78649407259 scopus 로고    scopus 로고
    • Clinical evaluation of microbicide formulations
    • Morrow K., Hendrix C. Clinical evaluation of microbicide formulations. Antiviral Res. 2010, 88:S40-S46.
    • (2010) Antiviral Res. , vol.88
    • Morrow, K.1    Hendrix, C.2
  • 39
    • 51449112802 scopus 로고    scopus 로고
    • A review of current intravaginal drug delivery approaches employed for the prophylaxis of HIV/AIDS and prevention of sexually transmitted infections
    • Ndesendo V.M., Pillay V., Choonara Y.E., Buchmann E., Bayever D.N., Meyer L.C. A review of current intravaginal drug delivery approaches employed for the prophylaxis of HIV/AIDS and prevention of sexually transmitted infections. AAPS PharmSciTech 2008, 9:505-520.
    • (2008) AAPS PharmSciTech , vol.9 , pp. 505-520
    • Ndesendo, V.M.1    Pillay, V.2    Choonara, Y.E.3    Buchmann, E.4    Bayever, D.N.5    Meyer, L.C.6
  • 40
    • 2442642818 scopus 로고    scopus 로고
    • Water dispersible microbicidal cellulose acetate phthalate film
    • Neurath A.R., Strick N., Li Y.Y. Water dispersible microbicidal cellulose acetate phthalate film. BMC Infect. Dis. 2003, 3:27.
    • (2003) BMC Infect. Dis. , vol.3 , pp. 27
    • Neurath, A.R.1    Strick, N.2    Li, Y.Y.3
  • 44
    • 0032552228 scopus 로고    scopus 로고
    • A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases
    • Roddy R.E., Zekeng L., Ryan K.A., Tamoufe U., Weir S.S., Wong E.L. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N. Engl. J. Med. 1998, 339:504-510.
    • (1998) N. Engl. J. Med. , vol.339 , pp. 504-510
    • Roddy, R.E.1    Zekeng, L.2    Ryan, K.A.3    Tamoufe, U.4    Weir, S.S.5    Wong, E.L.6
  • 45
    • 52449109917 scopus 로고    scopus 로고
    • Effects of physiological fluids on physical-chemical characteristics and activity of topical vaginal microbicide products
    • Sassi A.B., Isaacs C.E., Moncla B.J., Gupta P., Hillier S.L., Rohan L.C. Effects of physiological fluids on physical-chemical characteristics and activity of topical vaginal microbicide products. J. Pharm. Sci. 2008, 97:3123-3139.
    • (2008) J. Pharm. Sci. , vol.97 , pp. 3123-3139
    • Sassi, A.B.1    Isaacs, C.E.2    Moncla, B.J.3    Gupta, P.4    Hillier, S.L.5    Rohan, L.C.6
  • 48
    • 51249094482 scopus 로고    scopus 로고
    • A model of transluminal flow of an anti-HIV microbicide vehicle: combined elastic squeezing and gravitational sliding
    • Szeri A.J., Park S.C., Verguet A., Weiss A., Katz D.F. A model of transluminal flow of an anti-HIV microbicide vehicle: combined elastic squeezing and gravitational sliding. Phys. Fluids 2008, 20:83-101.
    • (2008) Phys. Fluids , vol.20 , pp. 83-101
    • Szeri, A.J.1    Park, S.C.2    Verguet, A.3    Weiss, A.4    Katz, D.F.5
  • 49
    • 0035856812 scopus 로고    scopus 로고
    • Development and in vitro evaluation of a mucoadhesive vaginal delivery system for progesterone
    • Valenta C., Kast C., Harich I., Schnurch A.B. Development and in vitro evaluation of a mucoadhesive vaginal delivery system for progesterone. J. Control. Release 2001, 77:323-332.
    • (2001) J. Control. Release , vol.77 , pp. 323-332
    • Valenta, C.1    Kast, C.2    Harich, I.3    Schnurch, A.B.4
  • 51
    • 38349169237 scopus 로고    scopus 로고
    • A novel ketoconazole bioadhesive tablet for vaginal delivery: design, in vitro and in vivo evaluation
    • Wang L., Tang X. A novel ketoconazole bioadhesive tablet for vaginal delivery: design, in vitro and in vivo evaluation. Int. J. Pharm. 2008, 350:181-187.
    • (2008) Int. J. Pharm. , vol.350 , pp. 181-187
    • Wang, L.1    Tang, X.2
  • 52
    • 78649419410 scopus 로고    scopus 로고
    • Novel approaches to vaginal delivery and safety of microbicides: biopharmaceuticals, nanoparticles and vaccines
    • Whaley K.J., Hanes J., Shattock R., Cone R.A., Friend D.R. Novel approaches to vaginal delivery and safety of microbicides: biopharmaceuticals, nanoparticles and vaccines. Antiviral Res. 2010, 88:S55-S66.
    • (2010) Antiviral Res. , vol.88
    • Whaley, K.J.1    Hanes, J.2    Shattock, R.3    Cone, R.A.4    Friend, D.R.5
  • 53
  • 54
    • 33750012577 scopus 로고    scopus 로고
    • Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide
    • Woolfson A., Malcom R., Morrow R., Toner C., McCullagh S. Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide. Int. J. Pharm. 2006, 325:82-89.
    • (2006) Int. J. Pharm. , vol.325 , pp. 82-89
    • Woolfson, A.1    Malcom, R.2    Morrow, R.3    Toner, C.4    McCullagh, S.5
  • 55
    • 0022680209 scopus 로고
    • Design and evaluation of a new disintegration test apparatus for vaginal tablets
    • Yamaguchi M., Tanno K. Design and evaluation of a new disintegration test apparatus for vaginal tablets. J. Pharm. Soc. Jpn. 1986, 106:228-232.
    • (1986) J. Pharm. Soc. Jpn. , vol.106 , pp. 228-232
    • Yamaguchi, M.1    Tanno, K.2
  • 57
    • 31144448147 scopus 로고    scopus 로고
    • The physicodynamic properties of mucoadhesive polymeric films developed as female controlled drug delivery system
    • Yoo J.W., Dharmala K., Lee C.H. The physicodynamic properties of mucoadhesive polymeric films developed as female controlled drug delivery system. Int. J. Pharm. 2006, 309:139-145.
    • (2006) Int. J. Pharm. , vol.309 , pp. 139-145
    • Yoo, J.W.1    Dharmala, K.2    Lee, C.H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.