Progesterone-loaded nanosized transethosomes for vaginal permeation enhancement: formulation, statistical optimization, and clinical evaluation in anovulatory polycystic ovary syndrome

References

• Abdulbaqi, I.M., et al., 2016. Ethosomal nanocarriers: the impact of constituents and formulation techniques on ethosomal properties, in vivo studies, and clinical trials. International journal of nanomedicine, 11, 2279.
   PubMed Web of Science ®Google Scholar
• Aboud, H.M., et al., 2016. Development, optimization, and evaluation of carvedilol-loaded solid lipid nanoparticles for intranasal drug delivery. AAPS pharmscitech, 17 (6), 1353–1365.
   PubMed Web of Science ®Google Scholar
• Ahad, A., et al., 2012. Formulation and optimization of nanotransfersomes using experimental design technique for accentuated transdermal delivery of valsartan. Nanomedicine: nanotechnology, biology and medicine, 8 (2), 237–249.
   PubMed Web of Science ®Google Scholar
• Ahmed, S., et al., 2016. In vitro and preclinical assessment of factorial design based nanoethosomes transgel formulation of an opioid analgesic. Artificial cells, nanomedicine, and biotechnology, 44 (8), 1793–1802.
   PubMed Web of Science ®Google Scholar
• Ahmed, T.A., 2015. Preparation of transfersomes encapsulating sildenafil aimed for transdermal drug delivery: Plackett–Burman design and characterization. Journal of liposome research, 25 (1), 1–10.
   PubMed Web of Science ®Google Scholar
• Ascenso, A., et al., 2015. Development, characterization, and skin delivery studies of related ultradeformable vesicles: transfersomes, ethosomes, and transethosomes. International journal of nanomedicine, 10, 5837.
   PubMed Web of Science ®Google Scholar
• Balen, A.H., 2013. Ovulation induction in the management of anovulatory polycystic ovary syndrome. Molecular and cellular endocrinology, 373 (1–2), 77–82.
   PubMed Web of Science ®Google Scholar
• Berginc, K., et al., 2012. Development and evaluation of an in vitro vaginal model for assessment of drug’s biopharmaceutical properties: curcumin. AAPS pharmscitech, 13 (4), 1045–1053.
   PubMed Web of Science ®Google Scholar
• Bernkop-Schnürch, A. and Hornof, M., 2003. Intravaginal drug delivery systems. American journal of drug delivery, 1 (4), 241–254.
   Google Scholar
• Bragagni, M., et al., 2012. Comparative study of liposomes, transfersomes and ethosomes as carriers for improving topical delivery of celecoxib. Drug delivery, 19 (7), 354–361.
   PubMed Web of Science ®Google Scholar
• Campaña-Seoane, M., et al., 2014. Bioadhesive emulsions for control release of progesterone resistant to vaginal fluids clearance. International journal of pharmaceutics, 477 (1–2), 495–505.
   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. Critical reviews in therapeutic drug carrier system, 13 (3–4), 257–388.
   PubMed Web of Science ®Google Scholar
• Chen, Z., et al., 2017. Evaluation of paeonol-loaded transethosomes as transdermal delivery carriers. European journal of pharmaceutical sciences, 99, 240–245.
   PubMed Web of Science ®Google Scholar
• Choi, J.-H., et al., 2015. Ethosomes and transfersomes for topical delivery of ginsenoside Rh1 from red ginseng: characterization and in vitro evaluation. Journal of nanoscience and nanotechnology, 15 (8), 5660–5662.
   PubMed Web of Science ®Google Scholar
• Chourasia, M.K., Kang, L., and Chan, S.Y., 2011. Nanosized ethosomes bearing ketoprofen for improved transdermal delivery. Results in pharma sciences, 1, 60–67.
   PubMedGoogle Scholar
• Cicinelli, E., et al., 2000. Direct transport of progesterone from vagina to uterus. Obstetrics and gynecology, 95 (3), 403–406.
   PubMed Web of Science ®Google Scholar
• de Ziegler, D., 1995. Hormonal control of endometrial receptivity. Human reproduction, 10 (1), 4–7.
   PubMed Web of Science ®Google Scholar
• Dobaria, N., Mashru, R., and Vadia, N., 2007. Vaginal drug delivery systems: a review of current status. East and Central African journal of pharmaceutical sciences, 10, 3–13.
   Google Scholar
• Dora, C.P., et al., 2010. Development and characterization of nanoparticles of glibenclamide by solvent displacement method. Acta poloniae pharmaceutica, 67 (3), 283–290.
   PubMed Web of Science ®Google Scholar
• Dubey, V., et al., 2007. Vesicles as tools for the modulation of skin permeability. Expert opinion on drug delivery, 4 (6), 579–593.
   PubMed Web of Science ®Google Scholar
• Azim, E.L., et al., 2015. Liposomal buccal mucoadhesive film for improved delivery and permeation of water-soluble vitamins. International journal of pharmaceutics, 488 (1–2), 78–85.
   PubMed Web of Science ®Google Scholar
• Elgindy, N.A., Mehanna, M.M., and Mohyeldin, S.M., 2016. Self-assembled nano-architecture liquid crystalline particles as a promising carrier for progesterone transdermal delivery. International journal of pharmaceutics, 501 (1–2), 167–179.
   PubMed Web of Science ®Google Scholar
• Elnaggar, Y.S., El-Massik, M.A., and Abdallah, O.Y., 2011. Fabrication, appraisal, and transdermal permeation of sildenafil citrate-loaded nanostructured lipid carriers versus solid lipid nanoparticles. International journal of nanomedicine, 6, 3195.
   PubMed Web of Science ®Google Scholar
• Elsayed, M.M., et al., 2006. Deformable liposomes and ethosomes: mechanism of enhanced skin delivery. International journal of pharmaceutics, 322 (1–2), 60–66.
   PubMed Web of Science ®Google Scholar
• Goindi, S., Dhatt, B., and Kaur, A., 2014. Ethosomes-based topical delivery system of antihistaminic drug for treatment of skin allergies. Journal of microencapsulation, 31 (7), 716–724.
   PubMed Web of Science ®Google Scholar
• Gupta, P.N., et al., 2012. Development of liposome gel based formulations for intravaginal delivery of the recombinant HIV-1 envelope protein CN54gp140. European journal of pharmaceutical sciences, 46 (5), 315–322.
   PubMed Web of Science ®Google Scholar
• Hazzah, H.A., et al., 2015. A new approach for treatment of precancerous lesions with curcumin solid–lipid nanoparticle-loaded gels: in vitro and clinical evaluation. Drug delivery, 23, 1409–1419.
   PubMed Web of Science ®Google Scholar
• Jain, S., et al., 2004. Ethosomes: a novel vesicular carrier for enhanced transdermal delivery of an antiHIV agent. Indian journal of pharmaceutical sciences, 66, 72.
   Google Scholar
• Jain, S.K., Singh, R., and Sahu, B., 1997. Development of a liposome based contraceptive system for intravaginal administration of progesterone. Drug development and industrial pharmacy, 23 (8), 827–830.
   Web of Science ®Google Scholar
• Jiang, C., et al., 1992. Progesterone induces endothelium-independent relaxation of rabbit coronary artery in vitro. European journal of pharmacology, 211 (2), 163–167.
   PubMed Web of Science ®Google Scholar
• Li, G., et al., 2012. Tacrolimus-loaded ethosomes: physicochemical characterization and in vivo evaluation. European journal of pharmaceutics and biopharmaceutics, 82 (1), 49–57.
   PubMed Web of Science ®Google Scholar
• Mahmoud, M.O., et al., 2017. Transdermal delivery of atorvastatin calcium from novel nanovesicular systems using polyethylene glycol fatty acid esters: Ameliorated effect without liver toxicity in poloxamer 407-induced hyperlipidemic rats. Journal of controlled release, 254 10–22.
   PubMed Web of Science ®Google Scholar
• Malakar, J., et al., 2012. Formulation, optimization and evaluation of transferosomal gel for transdermal insulin delivery. Saudi pharmaceutical journal, 20 (4), 355–363.
   PubMed Web of Science ®Google Scholar
• Maliwal, D., et al., 2009. Determination of progesterone in capsules by high-performance liquid chromatography and UV-spectrophotometry. Journal of young pharmacists, 1 (4), 371.
   Google Scholar
• Meng, S., et al., 2013. Enhanced transdermal bioavailability of testosterone propionate via surfactant-modified ethosomes. International journal of nanomedicine, 8, 3051.
   PubMed Web of Science ®Google Scholar
• Moawad, F.A., Ali, A.A., and Salem, H.F., 2017. Nanotransfersomes-loaded thermosensitive in situ gel as a rectal delivery system of tizanidine HCl: preparation, in vitro and in vivo performance. Drug delivery, 24 (1), 252–260.
   PubMed Web of Science ®Google Scholar
• Montville, C.P., et al., 2010. Luteal support with intravaginal progesterone increases clinical pregnancy rates in women with polycystic ovary syndrome using letrozole for ovulation induction. Fertility and sterility, 94 (2), 678–683.
   PubMed Web of Science ®Google Scholar
• Nakamura, S., et al., 1996. Relationship between sonographic endometrial thickness and progestin-induced withdrawal bleeding. Obstetrics and gynecology, 87, 722–725.
   PubMed Web of Science ®Google Scholar
• Partridge, A., 2007. Letrozole reduces estrogen and gonadotropin exposure in women with breast cancer undergoing ovarian stimulation before chemotherapy. Breast diseases, 18 (2), 203.
   Google Scholar
• Pavelić, Z., Skalko-Basnet, N., and Schubert, R., 2001. Liposomal gels for vaginal drug delivery. International journal of pharmaceutics, 219 (1–2), 139–149.
   PubMed Web of Science ®Google Scholar
• Pereira, G., Marchetti, J., and Bentley, M., 2000. A rapid method for determination of progesterone by reversed-phase liquid chromatography from aqueous media. Analytical letters, 33 (5), 881–889.
   Web of Science ®Google Scholar
• Prasanthi, D., and Lakshmi, P., 2012. Development of ethosomes with taguchi robust design-based studies for transdermal delivery of alfuzosin hydrochloride. International current pharmaceutical journal, 1, 370–375.
   Google Scholar
• Refai, H., Hassan, D., and Abdelmonem, R., 2017. Development and characterization of polymer-coated liposomes for vaginal delivery of sildenafil citrate. Drug delivery, 24 (1), 278–288.
   PubMed Web of Science ®Google Scholar
• Robinson, J. R., and Bologna, W. J., 1994. Vaginal and reproductive system treatments using a bioadhesive polymer. Advances in drug delivery systems, 6. Elsevier.
   Google Scholar
• Sakamoto, C., et al., 1988. Sonographic study of the endometrial responses to ovarian hormones in patients receiving ovarian stimulation. International journal of gynecology and obstetrics, 27 (3), 407–414.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., 2010. Sustained-release progesterone nanosuspension following intramuscular injection in ovariectomized rats. International journal of nanomedicine, 5, 943.
   PubMed Web of Science ®Google Scholar
• Salih, O.S., Samein, L.H., and Ali, W.K., 2013. Formulation and in vitro evaluation of rosuvastatin calcium niosomes. International journal of pharmacy and pharmaceutical sciences, 5, 525–535.
   Google Scholar
• Sarwa, K.K., et al., 2015. Potential of capsaicin-loaded transfersomes in arthritic rats. Drug delivery, 22 (5), 638–646.
   PubMed Web of Science ®Google Scholar
• Schumacher, M., et al., 2004. Local synthesis and dual actions of progesterone in the nervous system: neuroprotection and myelination. Growth hormone and IGF research, 14, 18–33.
   PubMed Web of Science ®Google Scholar
• Shen, L.-N., et al., 2014. Enhanced in vitro and in vivo skin deposition of apigenin delivered using ethosomes. International journal of pharmaceutics, 460 (1–2), 280–288.
   PubMed Web of Science ®Google Scholar
• Song, C.K., et al., 2012. A novel vesicular carrier, transethosome, for enhanced skin delivery of voriconazole: characterization and in vitro/in vivo evaluation. Colloids and surfaces B: biointerfaces, 92, 299–304.
   PubMed Web of Science ®Google Scholar
• Takalkar, D., and Desai, N., 2018. Nanolipid gel of an antimycotic drug for treating vulvovaginal candidiasis—development and evaluation. AAPS pharmscitech, 1, 11.
   Google Scholar
• Tien, C.Y., et al., 2013. Preparation of liposomal progesterone and its application on the measurement of progesterone interpreted via electrochemical and colorimetric sensing platforms. Electroanalysis, 25 (4), 1017–1022.
   Web of Science ®Google Scholar
• Touitou, E., et al., 2000. Ethosomes—novel vesicular carriers for enhanced delivery: characterization and skin penetration properties. Journal of controlled release, 65 (3), 403–418.
   PubMed Web of Science ®Google Scholar
• Unfer, V., et al., 2005. Different routes of progesterone administration and polycystic ovary syndrome: A review of the literature. Gynecological endocrinology, 21 (2), 119–127.
   PubMed Web of Science ®Google Scholar
• Vermani, K., and Garg, S., 2000. The scope and potential of vaginal drug delivery. Pharmaceutical science and technology today, 3 (10), 359–364.
   PubMedGoogle Scholar