Topical bioequivalence of acyclovir creams using dermal microdialysis in pigs: a new model to evaluate bioequivalence for topical formulations

References

• Lippold BC, Schneemann H. (1991). The influence of vehicles on the local bioavailability of betamethasone-17-benzoate from solution- and suspension-type ointments. Int J Pharm, 1:31–43.
   Google Scholar
• Williams AC, Barry BW. (1991). Terpenes and the lipid-protein-partitioning theory of skin penetration enhancement. Pharm Res, 8:17–24.
   PubMed Web of Science ®Google Scholar
• Megrab NA, Williams AC, Barry BW. (1995). Oestradiol permeation through human skin and silastic membrane: Effects of propylene glycol and supersaturation. Journal of Controlled Release, 3:277–294.
   Google Scholar
• Kreilgaard M, Kemme MJ, Burggraaf J, Schoemaker RC, Cohen AF. (2001). Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics. Pharm Res, 18:593–599.
   PubMed Web of Science ®Google Scholar
• Benfeldt E, Hansen SH, Vølund A, Menné T, Shah VP. (2007). Bioequivalence of topical formulations in humans: Evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method. J Invest Dermatol, 127:170–178.
   PubMed Web of Science ®Google Scholar
• Bach M, Lippold BC. (1998). Influence of penetration enhancers on the blanching intensity of betamethasone 17-benzoate. Int J Pharm, 1:97–108.
   Google Scholar
• Herkenne C, Naik A, Kalia YN, Hadgraft J, Guy RH. (2007). Ibuprofen transport into and through skin from topical formulations: In vitro-in vivo comparison. J Invest Dermatol, 127:135–142.
   PubMed Web of Science ®Google Scholar
• Trottet L, Owen H, Holme P, Heylings J, Collin IP, Breen AP et al. (2005). Are all aciclovir cream formulations bioequivalent? Int J Pharm, 304:63–71.
   PubMed Web of Science ®Google Scholar
• García Ortiz P, Hansen SH, Shah VP, Sonne J, Benfeldt E. (2011). Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology. Skin Pharmacol Physiol, 24:44–53.
   PubMed Web of Science ®Google Scholar
• Lademann J, Jacobi U, Surber C, Weigmann HJ, Fluhr JW. (2009). The tape stripping procedure–evaluation of some critical parameters. Eur J Pharm Biopharm, 72:317–323.
   PubMed Web of Science ®Google Scholar
• Shah VP, Flynn GL, Yacobi A, Maibach HI, Bon C, Fleischer NM, Franz TJ, Kaplan SA, Kawamoto J, Lesko LJ, Marty JP, Pershing LK, Schaefer H, Sequeira JA, Shrivastava SP, Wilkin J, Williams RL. (1998). Bioequivalence of topical dermatological dosage forms—methods of evaluation of bioequivalence. AAPS/FDA Workshop on ‘Bioequivalence of Topical Dermatological Dosage Forms— Methods of Evaluating Bioequivalence’, September 4–6, 1996, Bethesda, Md. Skin Pharmacol Appl Skin Physiol, 2:117–124.
   Google Scholar
• Garcia Ortiz P, Hansen SH, Shah VP, Menné T, Benfeldt E. (2009). Impact of adult atopic dermatitis on topical drug penetration: Assessment by cutaneous microdialysis and tape stripping. Acta Derm Venereol, 89:33–38.
   PubMed Web of Science ®Google Scholar
• Wiedersberg S, Leopold CS, Guy RH. (2008). Bioavailability and bioequivalence of topical glucocorticoids. Eur J Pharm Biopharm, 68:453–466.
   PubMed Web of Science ®Google Scholar
• Narkar Y. (2010). Bioequivalence for topical products–an update. Pharm Res, 27:2590–2601.
   PubMed Web of Science ®Google Scholar
• Ault JM, Riley CM, Meltzer NM, Lunte CE. (1994). Dermal microdialysis sampling in vivo. Pharm Res, 11:1631–1639.
   PubMed Web of Science ®Google Scholar
• Benfeldt E, Serup J, Menné T. (1999). Effect of barrier perturbation on cutaneous salicylic acid penetration in human skin: In vivo pharmacokinetics using microdialysis and non-invasive quantification of barrier function. Br J Dermatol, 140:739–748.
   PubMed Web of Science ®Google Scholar
• Jou NT, Ma SX. (2009). Responses of nitric oxide-cGMP release in acupuncture point to electroacupuncture in human skin in vivo using dermal microdialysis. Microcirculation, 16:434–443.
   PubMed Web of Science ®Google Scholar
• Kreilgaard M. (2001). Dermal pharmacokinetics of microemulsion formulations determined by in vivo microdialysis. Pharm Res, 18:367–373.
   PubMed Web of Science ®Google Scholar
• Murakami T, Yoshioka M, Okamoto I, Yumoto R, Higashi Y, Okahara K et al. (1998). Effect of ointment bases on topical and transdermal delivery of salicylic acid in rats: Evaluation by skin microdialysis. J Pharm Pharmacol, 50:55–61.
   PubMed Web of Science ®Google Scholar
• Schlereth T, Schönefeld S, Birklein F, Kirkpatrick CJ, Wessler I. (2007). In vivo release of non-neuronal acetylcholine from human skin by dermal microdialysis: Effects of sunlight, UV-A and tactile stimulus. Life Sci, 80:2239–2242.
   PubMed Web of Science ®Google Scholar
• Simonsen L, Jørgensen A, Benfeldt E, Groth L. (2004). Differentiated in vivo skin penetration of salicylic compounds in hairless rats measured by cutaneous microdialysis. Eur J Pharm Sci, 21:379–388.
   PubMed Web of Science ®Google Scholar
• Stagni G, Ali ME, Weng D. (2004). Pharmacokinetics of acyclovir in rabbit skin after i.v.-bolus, ointment, and iontophoretic administrations. Int J Pharm, 274:201–211.
   PubMed Web of Science ®Google Scholar
• Stagni G, Shukla C. (2003). Pharmacokinetics of methotrexate in rabbit skin and plasma after iv-bolus and iontophoretic administrations. J Control Release, 93:283–292.
   PubMed Web of Science ®Google Scholar
• Patel S, Shukla C, Patel G, Stagni G. (2010). Pharmacokinetics of amitriptyline in rabbit skin and plasma following iontophoretic administrations. Drug Dev Ind Pharm, 36:379–384.
   PubMed Web of Science ®Google Scholar
• Patel M, Joshi A, Hassanzadeth H, Juluru R, Stagni G. (2011). Quantification of dermal and transdermal delivery of meloxicam gels in rabbits. Drug Dev Ind Pharm, 37:613–617.
   PubMed Web of Science ®Google Scholar
• Tettey-Amlalo RN, Kanfer I, Skinner MF, Benfeldt E, Verbeeck RK. (2009). Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel. Eur J Pharm Sci, 36:219–225.
   PubMed Web of Science ®Google Scholar
• Holmgaard R, Nielsen JB, Benfeldt E. (2010). Microdialysis sampling for investigations of bioavailability and bioequivalence of topically administered drugs: Current state and future perspectives. Skin Pharmacol Physiol, 23:225–243.
   PubMed Web of Science ®Google Scholar
• Wei H, Chen Y, Xu L, Zheng J. (2007). Percutaneous penetration kinetics of lidocaine and prilocaine in two local anesthetic formulations assessed by in vivo microdialysis in pigs. Biol Pharm Bull, 30:830–834.
   PubMed Web of Science ®Google Scholar
• Higuchi WI. (1962). Analysis of data on the medicament release from ointments. J Pharm Sci, 51:802–804.
   PubMed Web of Science ®Google Scholar
• FDA. Guidance for Industry: Topical Dermatological Drug Product NDAs and ANDAs—In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies. Food and Drug Administration 1998: WD, USA.
   Google Scholar
• Roush WB, Tozer PR. (2004). The power of tests for bioequivalence in feed experiments with poultry. J Anim Sci, 82 E-Suppl:E110–E118.
   PubMedGoogle Scholar
• Morgan CJ, Renwick AG, Friedmann PS. (2003). The role of stratum corneum and dermal microvascular perfusion in penetration and tissue levels of water-soluble drugs investigated by microdialysis. Br J Dermatol, 148:434–443.
   PubMed Web of Science ®Google Scholar
• Shukla C, Friden P, Juluru R, Stagni G. (2009). In vivo quantification of acyclovir exposure in the dermis following iontophoresis of semisolid formulations. J Pharm Sci, 98:917–925.
   PubMed Web of Science ®Google Scholar
• Klimowicz A, Farfal S, Bielecka-Grzela S. (2007). Evaluation of skin penetration of topically applied drugs in humans by cutaneous microdialysis: Acyclovir vs. salicylic acid. J Clin Pharm Ther, 32:143–148.
   PubMed Web of Science ®Google Scholar
• Bouclier M, Chatelus C, Hensby C. (1989). In vivo animal models for the evaluation of anti-inflammatory drug action in the skin. Nonsteroidal Anti-Inflammatory Drugs. Karger Basel, 2:118–135.
   Google Scholar
• Lin SY, Hou SJ, Hsu TH, Yeh FL. (1992). Comparisons of different animal skins with human skin in drug percutaneous penetration studies. Methods Find Exp Clin Pharmacol, 14:645–654.
   PubMed Web of Science ®Google Scholar