Development and in vitro-in vivo evaluation of fenretinide-loaded oral mucoadhesive patches for site-specific chemoprevention of oral cancer

Pharmaceutical Research

Volumn 28, Issue 10, 2011, Pages 2599-2609

  Desai, Kashappa Goud H ^a   Mallery, Susan R ^b   Holpuch, Andrew S ^b   Schwendeman, Steven P ^a  

^a UNIVERSITY OF MICHIGAN   (United States)

^b OHIO STATE UNIVERSITY   (United States)

Author keywords

cancer chemoprevention; controlled release; Eudragit ; fenretinide; intraoral drug delivery; mucoadhesive patch; solubilization

Indexed keywords

CHOLIC ACID; DEOXYCHOLATE SODIUM; EUDRAGIT; FENRETINIDE; GLYCOCHOLATE SODIUM; PHOSPHATIDYLCHOLINE; POLIDOCANOL; POLYOXYETHYLENE OLEYL ETHER; POLYSORBATE 80; POLYURETHAN; SOLUBILIZER; SOUPLUS; SURFACTANT; TAUROCHOLIC ACID; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CANCER PREVENTION; CHEEK MUCOSA; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG DEGRADATION; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; DRUG STABILITY; FEMALE; FILM; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; IN VIVO STUDY; LIGHT EXPOSURE; MICROENCAPSULATION; MISCIBILITY; MOUTH CANCER; MOUTH CAVITY; MUCOADHESION; NONHUMAN; ORAL MUCOADHESIVE PATCH; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SALIVA; SIMULATION; SOLUBILIZATION; X RAY DIFFRACTION;

ADHESIVES; ADMINISTRATION, BUCCAL; ANIMALS; BILE ACIDS AND SALTS; CHEMOPREVENTION; DOSAGE FORMS; DRUG DESIGN; FEMALE; FENRETINIDE; MOUTH MUCOSA; MOUTH NEOPLASMS; PHOSPHOLIPIDS; POLYMERS; RABBITS; SALIVA; SOLUBILITY; SURFACE-ACTIVE AGENTS;

EID: 80054752013     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0489-3     Document Type: Article

References (52)

1. http://seer.cancer.gov/statfacts/html/oralcav.html.
2. JL Lefebvre 2005 Current clinical outcomes demand new treatment options for SCCHN Ann Oncol 16 VI7 VI12 15987995 10.1093/annonc/mdi452 (Pubitemid 41487945)
3. S Choi JN Myers 2008 Molecular pathogenesis of oral squamous cell carcinoma: implications for therapy J Dent Res 87 14 32 18096889 10.1177/154405910808700104 1:CAS:528:DC%2BD1cXhtFKmtLs%3D
4. SY Chen W Samuel RN Fariss T Duncan RK Kutty B Wiggert 2003 Differentiation of human retinal pigment epithelial cells into neuronal phenotype by N-(4-hydroxyphenyl)retinamide J Neurochem 84 972 981 12603822 10.1046/j.1471-4159.2003.01608.x 1:CAS:528:DC%2BD3sXit1ejt7o%3D (Pubitemid 36330651)
5. N Hail HJ Kim R Lotan 2006 Mechanisms of fenretinide-induced apoptosis Apoptosis 11 1677 1694 16850162 10.1007/s10495-006-9289-3 1:CAS:528: DC%2BD28XptF2rurg%3D (Pubitemid 44376243)
6. SM Lippman JJ Lee JW Martin AK El-Naggar XC Xu DM Shin M Thomas L Mao HA Fritsche X Zhou V Papadimitrakopoulou FR Khuri H Tran GL Clayman WN Hittelman WK Hong R Lotan 2006 Fenretinide activity in retinoid-resistant oral leukoplakia Clin Cancer Res 12 3109 3114 16707609 10.1158/1078-0432.CCR-05-2636 1:CAS:528:DC%2BD28Xks1Citbk%3D (Pubitemid 43837358)
7. F Chiesa N Tradati R Grigolato P Boracchi E Biganzoli N Crose E Cavadini F Formelli L Costa R Giardini S Zurrida A Costa G De Palo U Veronesi 2005 Randomized trial of fenretinide (4-HPR) to prevent recurrences, new localizations and carcinomas in patients operated on for oral leukoplakia: long-term results Int J Cancer 115 625 629 15700313 10.1002/ijc.20923 1:CAS:528:DC%2BD2MXksFKit7o%3D (Pubitemid 40656722)
8. T Okuda S Kawakami Y Higuchi T Satoh Y Oka M Yokoyama F Yamashita M Hashida 2009 Enhanced in vivo antitumor efficacy of fenretinide encapsulated in polymeric micelles Int J Pharm 373 100 106 19429294 10.1016/j.ijpharm.2009.01. 019 1:CAS:528:DC%2BD1MXltlSjsLo%3D
9. A Kokate XL Li B Jasti 2007 Transport of a novel anti-cancer agent, fenretinide across Caco-2 monolayers Invest New Drug 25 197 203 10.1007/s10637-006-9026-3 1:CAS:528:DC%2BD2sXltlartrg%3D (Pubitemid 46774700)
10. WN William JJ Lee SM Lippman JW Martin N Chakravarti HT Tran AL Sabichi ES Kim L Feng R Lotan VA Papadimitrakopoulou 2009 High-dose fenretinide in oral leukoplakia Cancer Prev Res 2 22 26 10.1158/1940-6207.CAPR-08-0100 1:CAS:528:DC%2BC3cXptFOju7s%3D
11. B Conley J O'Shaughnessy S Prindiville J Lawrence C Chow E Jones MJ Merino MI Kaiser-Kupfer RC Caruso M Podger B Goldspiel D Venzon D Danforth SL Wu M Noone J Goldstein KH Cowan J Zujewski 2000 Pilot trial of the safety, tolerability, and retinoid levels of N-(4-hydroxyphenyl) retinamide in combination with tamoxifen in patients at high risk for developing invasive breast cancer J Clin Oncol 18 275 283 10637240 1:CAS:528:DC%2BD3cXps1Oruw%3D%3D (Pubitemid 30056415)
12. LH Reddy 2005 Drug delivery to tumours: recent strategies J Pharm Pharmacol 57 1231 1242 16259751 10.1211/jpp.57.10.0001 1:CAS:528: DC%2BD2MXhtFCgsLvE (Pubitemid 41545888)
13. S GuhaSarkar R Banerjee 2010 Intravesical drug delivery: challenges, current status, opportunities and novel strategies J Control Release 148 147 159 20831887 10.1016/j.jconrel.2010.08.031 1:CAS:528:DC%2BC3cXhsVCmsr3M
14. BD Weinberg H Ai E Blanco JM Anderson JM Gao 2007 Antitumor efficacy and local distribution of doxorubicin via intratumoral delivery from polymer millirods J Biomed Mater Res A 81A 161 170 10.1002/jbm.a.30914 1:CAS:528:DC%2BD2sXjsVSltrc%3D (Pubitemid 46435463)
15. L Zhang D Russell BR Conway H Batchelor 2008 Strategies and therapeutic opportunities for the delivery of drugs to the esophagus Crit Rev Ther Drug 25 259 304 (Pubitemid 351655042)
16. SR Mallery JC Zwick P Pei M Tong PE Larsen BS Shumway B Lu HW Fields RJ Mumper GD Stoner 2008 Topical application of a bioadhesive black raspberry gel modulates gene expression and reduces cyclooxygenase 2 protein in human premalignant oral lesions Cancer Res 68 4945 4957 18559542 10.1158/0008-5472. CAN-08-0568 1:CAS:528:DC%2BD1cXnt1ejt7Y%3D
17. CM Ugalde ZF Liu C Ren KK Chan KA Rodrigo Y Ling PE Larsen GE Chacon GD Stoner RJ Mumper HW Fields SR Mallery 2009 Distribution of anthocyanins delivered from a bioadhesive black raspberry gel following topical intraoral application in normal healthy volunteers Pharm Res 26 977 986 19137418 10.1007/s11095-008-9806-x 1:CAS:528:DC%2BD1MXktVaguw%3D%3D
18. BS Shumway LA Kresty PE Larsen JC Zwick B Lu HW Field RJ Mumper GD Stoner SR Mallery 2008 Effects of a topically applied bioadhesive berry gel on loss of heterozygosity indices in premalignant oral lesions Clin Cancer Res 14 2421 2430 18413833 10.1158/1078-0432.CCR-07-4096 (Pubitemid 351551076)
19. AS Holpuch GJ Hummel M Tong GA Seghi P Pei P Ma RJ Mumper SR Mallery 2010 Nanoparticles for local drug delivery to the oral mucosa: proof of principle studies Pharm Res 27 1224 1236 20354767 10.1007/s11095-010-0121-y 1:CAS:528:DC%2BC3cXktVahs78%3D
20. C Wischke Y Zhang S Mittal SP Schwendeman 2010 Development of PLGA-based injectable delivery systems for hydrophobic fenretinide Pharm Res 27 2063 2074 20668921 10.1007/s11095-010-0202-y 1:CAS:528:DC%2BC3cXpsVKjtbk%3D
21. M Dittgen M Durrani K Lehmann 1997 Acrylic polymers-a review of pharmaceutical applications STP Pharm Sci 7 403 437 1:CAS:528:DyaK1cXhsFWqtLs%3D
22. M Hombreiro-Perez J Siepmann C Zinutti A Lamprecht N Ubrich M Hoffman R Bodmeier P Maincent 2003 Non-degradable microparticles containing a hydrophilic and/or a lipophilic drug: preparation, characterization and drug release modeling J Control Release 88 413 428 12644367 10.1016/S0168-3659(03)00030-0 1:CAS:528:DC%2BD3sXitVGhsLY%3D (Pubitemid 36331883)
23. L Perioli A Ambrogi F Angelici M Ricci S Giovagnoli M Capuccella C Rossi 2004 Development of mucoadhesive patches for buccal administration of ibuprofen J Control Release 99 73 82 15342182 10.1016/j.jconrel.2004.06.005 1:CAS:528:DC%2BD2cXnt1Kjt78%3D (Pubitemid 39165735)
24. CF Wong KH Yuen KK Peh 1999 An in-vitro method for buccal adhesion studies: importance of instrument variables Int J Pharm 180 47 57 10089291 10.1016/S0378-5173(98)00402-5 1:CAS:528:DyaK1MXhvFCru7c%3D (Pubitemid 29131442)
25. F Formelli E Cavadini R Luksch A Garaventa MG Villani V Appierto S Persiani 2008 Pharmacokinetics of oral fenretinide in neuroblastoma patients: indications for optimal dose and dosing schedule also with respect to the active metabolite 4-oxo-fenretinide Cancer Chemother Pharmacol 62 655 665 18066548 10.1007/s00280-007-0649-7 1:CAS:528:DC%2BD1cXos1Wqu70%3D
26. F Formelli R Luksch E Cavadini M Ponzoni PG Montaldo F Fossati Bellani A Garaventa 1998 Phase I and pharmacokinetic evaluation of fenretinide in children with advanced neuroblastoma Proc Am Assoc Cancer Res 39 322
27. A Garaventa R Luksch MS Lo Piccolo E Cavadini PG Montaldo MR Pizzitola L Boni M Ponzoni A Decensi B De Bernardi FF Bellani F Formelli 2003 Phase I trial and pharmacokinetics of fenretinide in children with neuroblastoma Clin Cancer Res 9 2032 2039 12796365 1:CAS:528:DC%2BD3sXksVWqtbk%3D (Pubitemid 36687622)
28. T Arai O Benny T Joki LG Menon M Machluf T Abe RS Carroll PM Black 2010 Novel local drug delivery system using thermoreversible gel in combination with polymeric microspheres or liposomes Anticancer Res 30 1057 1064 20530409 1:CAS:528:DC%2BC3cXovV2htbc%3D
29. M Petelin M Sentjurc Z Stolic U Skaleric 1998 EPR study of mucoadhesive ointments for delivery of liposomes into the oral mucosa Int J Pharm 173 193 202 10.1016/S0378-5173(98)00232-4 1:CAS:528:DyaK1cXmt1elsbs%3D (Pubitemid 29027773)
30. A Shemer B Amichai H Trau N Nathansohn B Mizrahi AJ Domb 2008 Efficacy of a mucoadhesive patch compared with an oral solution for treatment of aphthous stomatitis Drugs R&D 9 29 35 10.2165/00126839-200809010-00003 1:CAS:528:DC%2BD1cXivFKitb0%3D
31. AL Thakkar 1970 Solubilization of some steroid hormones in aqueous solutions of bile salts J Pharm Sci 59 1499 1501 5471963 10.1002/jps.2600591030 1:CAS:528:DyaE3cXlt1enurw%3D
32. SD Mithani V Bakatselou CN TenHoor JB Dressman 1996 Estimation of the increase in solubility of drugs as a function of bile salt concentration Pharm Res 13 163 167 8668668 10.1023/A:1016062224568 1:CAS:528:DyaK28XhtFajs7k%3D (Pubitemid 26076314)
33. TS Wiedmann L Kamel 2002 Examination of the solubilization of drugs by bile salt micelles J Pharm Sci 91 1743 1764 12115803 10.1002/jps.10158 1:CAS:528:DC%2BD38XlvV2ks74%3D (Pubitemid 34810521)
34. MW Samaha VF Naggar 1988 Micellar properties of non-ionic surfactants in relation to their solubility parameters Int J Pharm 42 1 9 10.1016/0378-5173(88) 90152-4 1:CAS:528:DyaL1cXhvFaltLs%3D (Pubitemid 18092085)
35. GB Dutt 2003 Rotational diffusion of hydrophobic probes in Brij-35 micelles: effect of temperature on micellar internal environment J Phys Chem B 107 10546 10551 10.1021/jp034708m 1:CAS:528:DC%2BD3sXms12rs78%3D
36. GA Magee J French B Gibbon C Luscombe 2003 Bile salt/lecithin mixed micelles optimized for the solubilization of a poorly soluble steroid molecule using statistical experimental design Drug Dev Ind Pharm 29 441 450 12737537 10.1081/DDC-120018379 1:CAS:528:DC%2BD3sXjsFCrtb4%3D (Pubitemid 36528611)
37. VP Torchilin 2001 Structure and design of polymeric surfactant-based drug delivery systems J Control Release 73 137 172 11516494 10.1016/S0168-3659(01) 00299-1 1:CAS:528:DC%2BD3MXksVSqtbo%3D (Pubitemid 32544594)
38. Y Sudhakar K Kuotsu AK Bandyopadhyay 2006 Buccal bioadhesive drug delivery-a promising option for orally less efficient drugs J Control Release 114 15 40 16828915 10.1016/j.jconrel.2006.04.012 1:CAS:528:DC%2BD28XnsFCrtrw%3D (Pubitemid 44128620)
39. JD Smart 1993 Drug delivery using buccal-adhesive systems Adv Drug Deliv Rev 11 253 270 10.1016/0169-409X(93)90012-S 1:CAS:528:DyaK2cXhsVKqug%3D%3D (Pubitemid 23302848)
40. DR De Araujo C Padula CMS Cereda GR Tofoli RB Brito E De Paula S Nicoli P Santi 2010 Bioadhesive films containing benzocaine: correlation between in vitro permeation and in vivo local anesthetic effect Pharm Res 27 1677 1686 20422264 10.1007/s11095-010-0151-5
41. KGH Desai TMP Kumar 2004 Preparation and evaluation of a novel buccal adhesive system AAPS PharmSciTech 5 9 10.1208/pt050335
42. J Siepmann NA Peppas 2001 Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC) Adv Drug Deliv Rev 48 139 157 11369079 10.1016/S0169-409X(01)00112-0 1:CAS:528:DC%2BD3MXjtlaqsrk%3D (Pubitemid 32434400)
43. V Jain D Jain R Singh 2011 Factors effecting the morphology of eudragit S-100 based microsponges bearing dicyclomine for colonic delivery J Pharm Sci 100 1545 1552 10.1002/jps.22360 1:CAS:528:DC%2BC3MXisVenu7s%3D
44. Y Zhu KA Mehta JW McGinity 2006 Influence of plasticizer level on the drug release from sustained release film coated and hot-melt extruded dosage forms Pharm Dev Technol 11 285 294 16895839 10.1080/10409230600767551 1:CAS:528:DC%2BD28XoslaitbY%3D (Pubitemid 44221682)
45. PD Sawant D Luu R Ye R Buchta 2010 Drug release from hydroethanolic gels. Effect of drug's lipophilicity (log P), polymer-drug interactions and solvent lipophilicity Int J Pharm 396 45 52 20540996 10.1016/j.ijpharm.2010.06.008 1:CAS:528:DC%2BC3cXpt1Sqtbk%3D
46. F Acartürk A Encan 1996 Investigation of the effect of different adjuvants on felodipine release kinetics from sustained release monolithic films Int J Pharm 131 183 189 10.1016/0378-5173(95)04321-7 (Pubitemid 26144953)
47. CY Li CL Zimmerman TS Wiedmann 1996 Solubilization of retinoids by bile salt/phospholipid aggregates Pharm Res 13 907 913 8792431 10.1023/A: 1016013414457 1:CAS:528:DyaK28Xjs1yrt7k%3D (Pubitemid 26227749)
48. Cussler EL. Diffusion: mass transfer in fluid systems. Cambridge: Cambridge University Press; 2009.
49. SC Shin JY Kim 2000 Enhanced permeation of triamcinolone acetonide through the buccal mucosa Eur J Pharm Biopharm 50 217 220 10962230 10.1016/S0939-6411(00)00101-6 1:CAS:528:DC%2BD3cXlvFWhsbs%3D
50. JA Nicolazzo BL Reed BC Finnin 2005 Buccal penetration enhancers-how do they really work? J Control Release 105 1 15 15894393 10.1016/j.jconrel.2005.01. 024 1:CAS:528:DC%2BD2MXlt1Smtb4%3D (Pubitemid 40805471)
51. JA Nicolazzo BL Reed BC Finnin 2005 Enhanced buccal mucosal retention and reduced buccal permeability of estradiol in the presence of padimate O and Azone®: a mechanistic study J Pharm Sci 94 873 882 15736191 10.1002/jps.20240 1:CAS:528:DC%2BD2MXjtFCju7w%3D (Pubitemid 40577319)
52. HE Junginger JA Hoogstraate JC Verhoef 1999 Recent advances in buccal drug delivery and absorption-in vitro and in vivo studies J Control Release 62 149 159 10518646 10.1016/S0168-3659(99)00032-2 1:CAS:528:DyaK1MXmsV2qsro%3D (Pubitemid 29486493)