A novel itraconazole bioadhesive film for vaginal delivery: Design, optimization, and physicodynamic characterization

AAPS PharmSciTech

Volumn 10, Issue 3, 2009, Pages 951-959

  Dobaria, Nitin B ^a   Badhan, A C ^a   Mashru, R C ^a  

^a M S UNIVERSITY OF BARODA   (India)

Author keywords

Bioadhesive films; Factorial design; Physicochemical properties; Vaginal drug delivery

Indexed keywords

HYDROXYPROPYLCELLULOSE; ITRACONAZOLE; MACROGOL 400;

ARTICLE; CELL VIABILITY; CONTROLLED STUDY; DISPERSION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; HUMAN; HUMAN CELL; LACTOBACILLUS ACIDOPHILUS; MOISTURE; NONHUMAN; PHYSICAL CHEMISTRY; PROCESS OPTIMIZATION; TENSILE STRENGTH; VAGINA CANDIDIASIS; VAGINA FLORA; VAGINA MUCOSA;

ADHESIVES; ADMINISTRATION, INTRAVAGINAL; ALGORITHMS; ANTIFUNGAL AGENTS; CALORIMETRY, DIFFERENTIAL SCANNING; CELL SURVIVAL; CHEMISTRY, PHARMACEUTICAL; DRUG DESIGN; EXCIPIENTS; HELA CELLS; HUMANS; HUMIDITY; ITRACONAZOLE; LACTOBACILLUS; PARTICLE SIZE; TENSILE STRENGTH;

EID: 70449524333     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-009-9288-0     Document Type: Article

References (34)

1. P Nyririesy MV Weitz MH Grody B Lorber 2001 Chronic vulvovaginal candidiasis Am Fam Physician 63 697 702
2. JD Sobel 1988 Pathogenesis and epidemiology of vulvovaginal candidiasis Ann NY Acad Sci 544 547 557 3063184 10.1111/j.1749-6632.1988.tb40450.x 1:STN:280:DyaL1M7gsVaitQ%3D%3D
3. E Ghelardi A Tavati A Lupetti F Celandroni E Boldrini M Campa 1998 Control of Candida albicans murine vaginitis by topical administration of polycarbophil econazole complex Antimicrob Agents Chemother 42 2434 2436 9736578 1:CAS:528:DyaK1cXmtVWqt70%3D
4. Van Cutsem 1991 The in vitro activity of terconazole against yeasts: its topical long-acting therapeutic efficacy in experimental vaginal candidiasis in rats Am J Obstet Gynecol 165 1200 1206 1951575
5. NN Hire VR Gudsoorkar KS Bhise CD Upasani TD Nandgude H Dalvi 2007 Microparticulate drug delivery system for topical administration of ITR Asian J Pharmaceu 1 83 88
6. HY Karasulu S Hilmioglu DY Metin T Güneri 2004 Efficacy of a new ketoconazole bioadhesive vaginal tablet on Candida albicans IL FARMACO 59 163 167 14871509 10.1016/j.farmac.2003.11.018 1:CAS:528:DC%2BD2cXhtFWlsbw%3D (Pubitemid 38198274)
7. JD Sobel G Muller 1984 Ketoconazole in the prevention of experimental candidal vaginitis Antimicrob Agents Chemother. 25 281 282 6324671 1:CAS:528:DyaL2cXhtlaitL8%3D
8. S Jain V Sehgal 2001 ITR: an effective oral antifungal for onchyomychosis Int J Dermatol 40 1 5 11277944 10.1046/j.1365-4362.2001.01039.x 1:CAS:528:DC%2BD3MXns1Kiu7w%3D (Pubitemid 32201221)
9. S Grant S Clissold 1989 ITR: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in superficial and systemic mycoses Drugs 37 310 314 2540949 10.2165/00003495-198937030-00003 1:STN:280:DyaL1M3jtFGisQ%3D%3D
10. GE Stein N Mummaw 1993 Placebo-controlled trial of ITR for treatment of acute vaginal candidiasis Antimicrob Agents Chemother 37 89 92 8381643 1:STN:280:DyaK3s7lvFWmsA%3D%3D
11. G Bloch PG Barnard GD Burger JS Meyer JR Parkes E Smythe 1988 ITR in the treatment of acute vaginal candidiasis S Afr Med J 73 172 173 2829371 1:STN:280:DyaL1c7islCjsQ%3D%3D
12. F Sanz A Del Palacio Hermanz 1987 Randomized comparative trial of three regimens of ITR for treatment of vaginal mycoses Rev Infect Dis 9 S139 S142
13. K Vermani S Garg LJD Zaneveld KR Tambwekar 2002 Survey of vaginal formulations available in Indian market; physico-chemical characterization of selected products Int J Pharm Med 16 141 152
14. N Dobaria R Mashru NH Vadia 2007 Vaginal drug delivery systems: a review of current status East Cent Afr J Pharm Sci 10 3 13
15. GC Ceschel P Maffei SL Borgia C Ronchi S Rossi 2001 Development of a mucoadhesive dosage form for vaginal administration Drug Dev Ind Pharm 27 541 547 11548861 10.1081/DDC-100105179 1:CAS:528:DC%2BD3MXmslSrsL0%3D (Pubitemid 32803573)
16. CE Kast C Valenta M Leopold A Bernkop-Schnürch 2002 Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for CLT J Control Rel 81 347 354 10.1016/S0168-3659(02)00077-9 1:CAS:528: DC%2BD38XjvFCku78%3D (Pubitemid 34607154)
17. J Woodley 2001 Bioadhesion: new possibilities for drug administration Clin Pharmacokinet 40 77 84 11286325 10.2165/00003088-200140020-00001 1:CAS:528:DC%2BD3MXislansro%3D
18. G Sharma S Jain AK Tiwary G Kaur 2006 Once daily bioadhesive vaginal clotrimazole tablets: design and evaluation Acta Pharm 56 337 345 1:CAS:528:DC%2BD28XpvFahu70%3D
19. M Francois E Snoeckx P Putteman F Wouters ME Brewster 2003 A mucoadhesive, cyclodextrin-based vaginal cream formulation of ITR AAPS PharmSci 5 1 5 10.1208/ps050105 (Pubitemid 38097468)
20. C Coggins CJ Elias R Atisook MT Bassett V Ettiegnene traore PD Ghys 1998 Women's preferences regarding the formulation of over the counter vaginal spermicides AIDS 12 1389 1391 9708420 10.1097/00002030-199811000-00022 1:STN:280:DyaK1cznt1Whtw%3D%3D
21. S Garg R Kandarapu K Vermani KR Tambwekar A Garg DP Waller 2003 Development pharmaceutics of microbicide formulations part I: preformulation considerations and challenges AIDS Patient Care and STDS 17 17 32 12614517 10.1089/108729103321042881 (Pubitemid 36083819)
22. J Peeters P Neeskens JP Tollenaere PV Remoortere ME Brewster 2002 Characterization of the interaction of 2-hydroxypropyl-â-cyclodextrin with ITR at pH 2, 4 and 7 J Pharm Sci 91 1414 1422 12115841 10.1002/jps.10126 1:CAS:528:DC%2BD38XktlWrsrc%3D (Pubitemid 34633957)
23. G Verreck S Karel M Guy Van den L Baert J Peeters ME Brewster 2003 Characterization of solid dispersions of ITR and hydroxypropylmethyl cellulose prepared by melt extrusion-part I Int J Pharm 251 165 174 12527186 10.1016/S0378-5173(02)00591-4 1:CAS:528:DC%2BD3sXis1WgtA%3D%3D (Pubitemid 36071471)
24. S Garg K Vermani A Garg RA Anderson BW Rencher LJD Zaneveld 2005 Development and characterization of bioadhesive vaginal films of sodium polystyrene sufonate (PSS), a novel contraceptive antimicrobial agent Pharma Research 22 584 595 10.1007/s11095-005-2490-1 1:CAS:528:DC%2BD2MXjsFags78%3D (Pubitemid 40603256)
25. RC Mashru VB Sutariya MG Sankalia PP Parikh 2005 Development and evaluation of fast-dissolving film of salbutamol sulphate Drug Dev Ind Pharm 1 25 34
26. G Derringer R Suich 1980 Simultaneous optimization of several responses variables Journal Quality Technology 12 214 219
27. AM Repka JW McGinity 2000 Physical-mechanical, moisture absorption and bioadhesive properties of hydroxypropylcellulose hot-melt extruded films Biomaterials 21 509 517 10.1016/S0142-9612(00)00046-6 (Pubitemid 30259295)
28. J-W Yoo K Dharmala CH Lee 2006 The physicodynamic properties of bioadhesive polymeric films developed as female controlled drug delivery system Int J pharm 309 139 145 16376036 10.1016/j.ijpharm.2005.11.020 1:CAS:528:DC%2BD28XnvVWhuw%3D%3D (Pubitemid 43129476)
29. R Gannu YV Vishnu V Kishan YM Rao 2007 Development of nitrendipine transdermal patches: in vitro and ex vivo Characterization Current Drug Delivery 4 69 76 17269919 10.2174/156720107779314767 1:CAS:528:DC%2BD2sXitlamtbg%3D (Pubitemid 46066416)
30. KK Peh CF Wong 1999 Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties Journal of Pharmacy and Pharmaceutical Sciences 2 53 61 10952770 1:CAS:528:DyaK1MXmt12jsLg%3D
31. MA Alam FJ Ahmad ZI Khan RK Khar M Ali 2007 Development and evaluation of acid-buffering bioadhesive vaginal tablet for mixed vaginal infections AAPS PharmSciTech 8 109 10.1208/pt0804109
32. W Lei T Xing 2008 A novel ketoconazole bioadhesive effervescent tablet for vaginal delivery: design, in vitro and 'in vivo' evaluation International Journal of Pharmaceutics 350 181 187 10.1016/j.ijpharm.2007.08.042
33. HM E-aithy KBF E-Shaboury 2002 The development of cutina lipogels and gel microemulsion for topical administration of fluconazole AAPSPharm Sci Tech 3 35
34. Huang L, Shu-Ping Y. Method for preventing and/or treating vaginal and vulval infections. US Patent, US2006/0217443 A1, Sep 2006.