Loratadine bioavailability via buccal transferosomal gel: formulation, statistical optimization, in vitro/in vivo characterization, and pharmacokinetics in human volunteers

References

• Abdel-Mottaleb MM, Lamprecht A. (2011). Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I. Drug Dev Ind Pharm 37:178–84
   PubMed Web of Science ®Google Scholar
• Abdellatif AA, Tawfeek HM. (2016). Transfersomal nanoparticles for enhanced transdermal delivery of clindamycin. AAPS PharmSciTech 17:1067–74
   PubMed Web of Science ®Google Scholar
• Aboud HM, El Komy MH, Ali AA, et al. (2016). Development, optimization, and evaluation of carvedilol-loaded solid lipid nanoparticles for intranasal drug delivery. AAPS PharmSciTech 17:1353–65
   PubMed Web of Science ®Google Scholar
• Ahad A, Aqil M, Kohli K, et al. (2016). The ameliorated longevity and pharmacokinetics of valsartan released from a gel system of ultradeformable vesicles. Artif Cells Nanomed Biotechnol 44:1457–63
   PubMed Web of Science ®Google Scholar
• Ahmed TA. (2015). Preparation of transfersomes encapsulating sildenafil aimed for transdermal drug delivery: Plackett–Burman design and characterization. J Liposome Res 25:1–10
   PubMed Web of Science ®Google Scholar
• Akaike H. (1974). A new look at the statistical model identification. IEEE Trans Autom Control 19:716–23
   Web of Science ®Google Scholar
• Arya A, Sharma V, Pathak K. (2013). Pharmaceutical evaluation and dynamic vapor sorption studies of fast dissolving intraoral films of loratadine. Pharm Dev Technol 18:1329–38
   PubMed Web of Science ®Google Scholar
• Ascenso A, Salgado A, Euleterio C, et al. (2014). In vitro and in vivo topical delivery studies of tretinoin-loaded ultradeformable vesicles. Eur J Pharm Biopharm 88:48–55
   PubMed Web of Science ®Google Scholar
• Cevc G. (1996). Transfersomes, liposomes and other lipid suspensions on the skin: permeation enhancement, vesicle penetration, and transdermal drug delivery. Crit Rev Ther Drug Carrier Syst 13:257–388
   PubMed Web of Science ®Google Scholar
• Chakraborty P, Parcha V, Chakraborty DD, et al. (2014). Comparative study on the predictability of statistical models (RSM and ANN) on the behavior of optimized buccoadhesive wafers containing loratadine and their in vivo assessment. Drug Deliv 23:1016–27
   Web of Science ®Google Scholar
• Cho C-W, Choi J-S, Kim SJ, et al. (2009). Enhanced transdermal delivery of loratadine from the EVA matrix. Drug Deliv 16:230–5
   PubMed Web of Science ®Google Scholar
• Cooper DL, Harirforoosh S. (2014). Effect of formulation variables on preparation of celecoxib loaded polylactide-co-glycolide nanoparticles. PloS One 9:e113558
   PubMed Web of Science ®Google Scholar
• De Gier J, Mandersloot J, van Deenen LL, et al. (1968). Lipid composition and permeability of liposomes. BBA Biomembranes 150:666–75
   PubMed Web of Science ®Google Scholar
• Derringer G, Suich R. (1980). Simultaneous optimization of several response variables. J Qual Technol 12:214–9
   Web of Science ®Google Scholar
• El Azim HA, Nafee N, Ramadan A, et al. (2015). Liposomal buccal mucoadhesive film for improved delivery and permeation of water-soluble vitamins. Int J Pharm 488:78–85
   PubMed Web of Science ®Google Scholar
• El-Hammadi M, Awad N. (2012). Investigating the use of liquisolid compacts technique to minimize the influence of pH variations on loratadine release. Aaps Pharmscitech 13:53–8
   PubMed Web of Science ®Google Scholar
• Elkomy MH, El Menshawe SF, Eid HM, Ali AMA. (2017). Development of a nanogel formulation for transdermal delivery of tenoxicam: a pharmacokinetic-pharmacodynamic modeling approach for quantitative prediction of skin absorption. Drug Dev Ind Pharm 43:531–44
   PubMed Web of Science ®Google Scholar
• Elnaggar YS, El-Massik MA, Abdallah OY. (2011). Fabrication, appraisal, and transdermal permeation of sildenafil citrate-loaded nanostructured lipid carriers versus solid lipid nanoparticles. Int J Nanomed 6:3195
   PubMed Web of Science ®Google Scholar
• Gulati M, Grover M, Singh S, et al. (1998). Lipophilic drug derivatives in liposomes. Int J Pharm 165:129–68
   Web of Science ®Google Scholar
• Gupta A, Aggarwal G, Singla S, et al. (2012). Transfersomes: a novel vesicular carrier for enhanced transdermal delivery of sertraline: development, characterization, and performance evaluation. Sci Pharm 80:1061
   PubMedGoogle Scholar
• Hao Y, Zhao F, Li N, et al. (2002). Studies on a high encapsulation of colchicine by a niosome system. Int J Pharm 244:73–80
   PubMed Web of Science ®Google Scholar
• Hazzah HA, Farid RM, Nasra MM, et al. (2016). A new approach for treatment of precancerous lesions with curcumin solid–lipid nanoparticle-loaded gels: in vitro and clinical evaluation. Drug Deliv 23:1409–19
   PubMed Web of Science ®Google Scholar
• Kulkarni VS. (2009). Handbook of non-invasive drug delivery systems: science and technology. Oxford, UK: Elsevier
   Google Scholar
• Kumria R, Nair AB, Al-Dhubiab BE. (2014). Loratidine buccal films for allergic rhinitis: development and evaluation. Drug Dev Ind Pharm 40:625–31
   PubMed Web of Science ®Google Scholar
• Kunicki PK. (2001). Determination of loratadine in human plasma by high-performance liquid chromatographic method with ultraviolet detection. J Chromatogr B Biomed Sci Appl 755:331–5
   PubMed Web of Science ®Google Scholar
• Li H, Tan Y, Yang L, et al. (2015). Dissolution evaluation in vitro and bioavailability in vivo of self-microemulsifying drug delivery systems for pH-sensitive drug loratadine. J Microencapsul 32:175–80
   PubMed Web of Science ®Google Scholar
• Manconi M, Valenti D, Sinico C, et al. (2003). Niosomes as carriers for tretinoin: II. Influence of vesicular incorporation on tretinoin photostability. Int J Pharm 260:261–72
   PubMed Web of Science ®Google Scholar
• McIntyre J, Robertson S, Norris E, et al. (2005). Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 366:205–10
   PubMed Web of Science ®Google Scholar
• Mokhtar M, Sammour OA, Hammad MA, et al. (2008). Effect of some formulation parameters on flurbiprofen encapsulation and release rates of niosomes prepared from proniosomes. Int J Pharm 361:104–11
   PubMed Web of Science ®Google Scholar
• Patil P, Paradkar A. (2006). Porous polystyrene beads as carriers for self-emulsifying system containing loratadine. AAPS PharmSciTech 7:E199–205
   PubMed Web of Science ®Google Scholar
• Scheffé H. (1958). Experiments with mixtures. J R Stat Soc Series B 20:344–60
   Google Scholar
• Shah B, Khunt D, Bhatt H, et al. (2015). Application of quality by design approach for intranasal delivery of rivastigmine loaded solid lipid nanoparticles: effect on formulation and characterization parameters. Eur J Pharm Sci 78:54–66
   PubMed Web of Science ®Google Scholar
• Singh RMP, Kumar A, Pathak K. (2013). Thermally triggered mucoadhesive in situ gel of loratadine: β-cyclodextrin complex for nasal delivery. AAPS PharmSciTech 14:412–24
   PubMed Web of Science ®Google Scholar
• Song J-H, Shin S-C. (2009). Development of the loratadine gel for enhanced transdermal delivery. Drug Dev Ind Pharm 35:897–903
   PubMed Web of Science ®Google Scholar
• Szabados-Nacsa Á, Sipos P, Martinek T, et al. (2011). Physico-chemical characterization and in vitro/in vivo evaluation of loratadine: dimethyl-β-cyclodextrin inclusion complexes. J Pharm Biomed Anal 55:294–300
   PubMed Web of Science ®Google Scholar
• Uppoor VRS. (2001). Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Release 72:127–32
   PubMed Web of Science ®Google Scholar
• US FDA. (2001). Guidance of industry-bioanalytical method validation. Rockville, MD: FDA
   Google Scholar
• Veng-Pedersen P. (1988). System approaches in pharmacokinetics: I. basic concepts. J Clin Pharm 28:1–5
   PubMed Web of Science ®Google Scholar
• Vondracek M, Xi Z, Larsson P, et al. (2001). Cytochrome P450 expression and related metabolism in human buccal mucosa. Carcinogenesis 22:481–8
   PubMed Web of Science ®Google Scholar
• Wagner JG, Nelson E. (1963). Per cent absorbed time plots derived from blood level and/or urinary excretion data. J Pharm Sci 52:610–11
   PubMed Web of Science ®Google Scholar
• Wan L, Lee P. (1974). Studies on surface films of sorbitan-esters at air/water interface. 1. effect of compression rate on surface pressure-area isotherms of sorbitan-esters. Can J Pharm Sci 9:82–5
   Web of Science ®Google Scholar
• Yoshioka T, Sternberg B, Florence AT. (1994). Preparation and properties of vesicles (niosomes) of sorbitan monoesters (Span 20, 40, 60 and 80) and a sorbitan triester (Span 85). Int J Pharm 105:1–6
   Web of Science ®Google Scholar
• Yumibe N, Huie K, Chen KJ, et al. (1996). Identification of human liver cytochrome P450 enzymes that metabolize the nonsedating antihistamine loratadine: formation of descarboethoxyloratadine by CYP3A4 and CYP2D6. Biochem Pharmacol 51:165–72
   PubMed Web of Science ®Google Scholar