Ethosomal gel for rectal transmucosal delivery of domperidone: design of experiment, in vitro, and in vivo evaluation

References

• Abdellatif AAH, Tawfeek HM. (2016). Transfersomal nanoparticles for enhanced transdermal delivery of clindamycin. AAPS PharmSciTech 17:1477–74.
   PubMed Web of Science ®Google Scholar
• Abdellatif MM, Khalil IA, Khalil MAF. (2017). Sertaconazole nitrate loaded nanovesicular systems for targeting skin fungal infection: in-vitro, ex-vivo and in-vivo evaluation. Int J Pharm 527:1–11.
   PubMed Web of Science ®Google Scholar
• Abdulbaqi IM, Darwis Y, Abdul Karim Khan N, et al. (2016). Ethosomal nanocarriers: the impact of constituents and formulation techniques on ethosomal properties, in vivo studies, and clinical trials. Int J Nanomed 25:2279–304.
   Web of Science ®Google Scholar
• Aboud HM, Ali AA, El-Menshawe SF, Elbary AA. (2016). Nanotransfersomes of carvedilol for intranasal delivery: formulation, characterization and in vivo evaluation. Drug Deliv 23:2471–81.
   PubMed Web of Science ®Google Scholar
• Afzal S, Zahid M, Rehan ZA, et al. (2022). Preparation and evaluation of polymer-based ultrasound gel and its application in ultrasonography. Gels 8:42.
   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
• Albash R, Abdelbary AA, Refai H, El-Nabarawi MA. (2019). Use of transethosomes for enhancing the transdermal delivery of olmesartan medoxomil: in vitro, ex vivo, and in vivo evaluation. Int J Nanomedicine 14:1953–68.
   PubMed Web of Science ®Google Scholar
• Al-Joufi F, Elmowafy M, Alruwaili NK, et al. (2021). Mucoadhesive in situ rectal gel loaded with rifampicin: strategy to improve bioavailability and alleviate liver toxicity. Pharmaceutics 13:336.
   PubMed Web of Science ®Google Scholar
• Al-Mahallawi AM, Abdelbary AA, Aburahma MH. (2015). Investigating the potential of employing bilosomes as a novel vesicular carrier for transdermal delivery of tenoxicam. Int J Pharm 485:329–40.
   PubMed Web of Science ®Google Scholar
• Ansari SA, Qadir A, Warsi MH, et al. (2021). Ethosomes-based gel formulation of karanjin for treatment of acne vulgaris: in vitro investigations and preclinical assessment. 3 Biotech 11:456.
   PubMedGoogle Scholar
• Asad MI, Khan D, Ur Rehman A, et al. (2021). Development and in vitro/in vivo evaluation of pH-sensitive polymeric nanoparticles loaded hydrogel for the management of psoriasis. Nanomaterials 11:3433–3.
   Web of Science ®Google Scholar
• Athukuri BL, Neerati P. (2017). Enhanced oral bioavailability of domperidone with piperine in male Wistar rats: involvement of CYP3A1 and P-gp inhibition. J Pharm Pharm Sci 20:28–37.
   PubMed Web of Science ®Google Scholar
• Balakrishnan P, Park E, Song C, et al. (2015). Carbopol-incorporated thermoreversible gel for intranasal drug delivery. Molecules 20:4124–35.
   PubMed Web of Science ®Google Scholar
• Begum MY, Alqahtani A, Ghazwani M, et al. (2021). Preparation of Carbopol 934 based ketorolac tromethamine buccal mucoadhesive film: in vitro, ex vivo, and in vivo assessments. Int J Polym Sci 2021:1–11.
   Web of Science ®Google Scholar
• Bendas ER, Tadros MI. (2007). Enhanced transdermal delivery of salbutamol sulfate via ethosomes. AAPS PharmSciTech 8:213–20.
   PubMed Web of Science ®Google Scholar
• Cevc G, Blume G. (1992). Lipid vesicles penetrate into intact skin owing to the transdermal osmotic gradients and hydration force. Biochim Biophys Acta 1104:226–32.
   PubMed Web of Science ®Google Scholar
• Dantas MGB, Reis SAGB, Damasceno CMD, et al. (2016). Development and evaluation of stability of a gel formulation containing the monoterpene borneol. ScientificWorldJournal 2016:7394685.
   PubMedGoogle Scholar
• David SR, Hui MS, Pin CF. (2013). Formulation and in vitro evaluation of ethosomes as vesicular carrier for enhanced topical delivery of isotretinoin. Int J Drug Deliv 5:28–34.
   Google Scholar
• Dawood NM, Jassim Z, Mowafaq G, Zaki H. (2019). Studying the effect of different gelling agent on the preparation and characterization of metronidazole as topical emulgel. Asian J Pharm Clin Res.
   Google Scholar
• El-Menshawe SFE, Kharshoum RM, El Sisi AM. (2017). Preparation and optimization of buccal propranolol hydrochloride nanoethosomal gel: a novel approach for enhancement of bioavailability. J Nanomed Nanotechnol 8:435.
   Google Scholar
• El Sayed MMA, Abdallah OY, Naggar VF, Khalafallah NM. (2006). Deformable liposomes and ethosomes: mechanism of enhanced skin delivery. Int J Pharm 322:60–6.
   PubMed Web of Science ®Google Scholar
• El-Leithy ES, Shaker DS, Ghorab MK, Abdel-Rashid RS. (2010). Evaluation of mucoadhesive hydrogels loaded with diclofenac sodium-chitosan microspheres for rectal administration. AAPS PharmSciTech 11:1695–702.
   PubMed Web of Science ®Google Scholar
• El-Leithy ES, Abdel-Rashid RS. (2017). Lipid nanocarriers for tamoxifen citrate/coenzyme Q10 dual delivery. J Drug Deliv Sci Technol 41:235–50.
   Web of Science ®Google Scholar
• El-Shenawy AA, Abdelhafez WA, Ismail A. (2019). Formulation and characterization of nanosized ethosomal formulations of antigout model drug (febuxostat) prepared by cold method: in vitro/ex vivo and in vivo assessment. AAPS PharmSciTech 21:1–31.
   PubMed Web of Science ®Google Scholar
• Enteshari S, Varshosaz J. (2018). Solubility enhancement of domperidone by solvent change in situ micronization technique. Adv Biomed Res 7:109.
   PubMedGoogle Scholar
• Ferrier J. (2014). Domperidone as an unintended antipsychotic. Can Pharm J 147:76–83.
   Google Scholar
• Hesketh PJ, Kris MG, Basch E, et al. (2017). Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 35:3240–61.
   PubMed Web of Science ®Google Scholar
• Honeywell-Nguyen PL, Frederik PM, Bomans PHH, et al. (2002). Transdermal delivery of pergolide from surfactant-based elastic and rigid vesicles: characterization and in vitro transport studies. Pharm Res 19:991–7.
   PubMed Web of Science ®Google Scholar
• Ismail TA, Shehata TM, Mohamed DI, et al. (2021). Quality by design for development, optimization and characterization of brucine ethosomal gel for skin cancer delivery. Molecules 26:3454.
   PubMed Web of Science ®Google Scholar
• Jain S, Jain P, Umamaheshwari RB, Jain NK. (2003). Transfersomes—a novel vesicular carrier for enhanced transdermal delivery: development, characterization, and performance evaluation. Drug Dev Ind Pharm 29:1013–26.
   PubMed Web of Science ®Google Scholar
• Jaswanth Gowda BH, Adinaryan S, Ahmed MG. (2021). Preparation and evaluation of in-situ gels containing hydrocortisone for the treatment of aphthous ulcer. J Oral Biol Craniofac Res 11:269–76.
   PubMedGoogle Scholar
• Kadam VS, Bharkad VB, Shete GA. (2017). Formulation and evaluation of fast dissolving oral film of metoclopramide HCl. World J Pharm Pharm Sci 6:2052–66.
   Google Scholar
• Kuligowski J, Quintás G, Garrigues S, de la Guardia M. (2008). Determination of lecithin and soybean oil in dietary supplements using partial least squares-Fourier transform infrared spectroscopy. Talanta 77:229–34.
   PubMed Web of Science ®Google Scholar
• Li X, Ye Z, Wang J, et al. (2017). Mucoadhesive buccal films of tramadol for effective pain management. Rev Bras Anestesiol 67:231–7.
   PubMed Web of Science ®Google Scholar
• Ma M, Wang J, Guo F. (2015). Development of nanovesicular systems for dermal imiquimod delivery: physicochemical characterization and in vitro/in vivo evaluation. J Mater Sci Mater Med 26:6–191.
   Web of Science ®Google Scholar
• Madishetti SK, Palem CR, Gannu R, et al. (2010). Development of domperidone bilayered matrix type transdermal patches: physicochemical, in vitro and ex vivo characterization. Daru 18:221–9.
   PubMed Web of Science ®Google Scholar
• Matthews M, Glackin M, Hughes C, Rogers KMA. (2015). Who accesses complementary therapies and why? An evaluation of a cancer care service. Complement Ther Clin Pract 21:19–25.
   PubMed Web of Science ®Google Scholar
• Morsi NM, Aboelwafa AA, Dawoud MHS. (2018). Enhancement of the bioavailability of an antihypertensive drug by transdermal protransfersomal system: formulation and in vivo study. J Liposome Res 28:137–48.
   PubMed Web of Science ®Google Scholar
• Mukherjee S, Ray S, Thakur RS. (2009). Design and evaluation of itraconazole loaded solid lipid nanoparticulate system for improving the antifungal therapy. Pak J Pharm Sci 22:131–8.
   PubMed Web of Science ®Google Scholar
• Paliwal S, Tilak A, Sharma J, et al. (2019). Flurbiprofen loaded ethosomes – transdermal delivery of anti-inflammatory effect in rat model. Lipids Health Dis 18:133.
   PubMed Web of Science ®Google Scholar
• Panwar P, Michael P, Devlin M, Martini M. (2020). Critical shear rate of polymer-enhanced hydraulic fluids. Lubricants 8:102.
   Web of Science ®Google Scholar
• Patel AP, Patel JK. (2020). Mucoadhesive in-situ gel formulation for vaginal delivery of tenofovir disoproxil fumarate. Indian J Pharm Educ Res 54:963–70.
   Web of Science ®Google Scholar
• Patil HG, Tiwari RV, Repka MA, Singh KK. (2016). Formulation and development of orodispersible sustained release tablet of domperidone. Drug Dev Ind Pharm 42:906–15.
   PubMed Web of Science ®Google Scholar
• Phillips RS, Friend AJ, Gibson F. (2016). Antiemetic medication for prevention and treatment of chemotherapy-induced nausea and vomiting in childhood. Cochrane Database Syst Rev 2:CD007786.
   PubMed Web of Science ®Google Scholar
• Pilch E, Musiał W. (2018). Liposomes with an ethanol fraction as an application for drug delivery. Int J Mol Sci 19:3806.
   PubMed Web of Science ®Google Scholar
• Prasanthi D, Lakshmi PK. (2012). Development of ethosomes with Taguchi robust design based studies for transdermal delivery of alfuzosin hydrochloride. Int Curr Pharm J 1:370–5.
   Google Scholar
• Putri DCA, Dwiastuti R, Marchaban M, Nugroho AK. (2017). Optimization of mixing temperature and sonication duration in liposome preparation. J Pharm Sci Community 14:79–85.
   Google Scholar
• Radtke M, Souto EB, Muller RH. (2005). Nanostructured lipid carriers: a novel generation of solid lipid drug carrier. Pharm Technol Eur 17:45–50.
   Google Scholar
• Ramadon D, Anwar E, Harahap Y. (2017). In vitro penetration and bioavailability of novel transdermal quercetin-loaded ethosomal gel. Indian J Pharm Sci 79:948–56.
   Web of Science ®Google Scholar
• Rao Amarachinta P, Sharma G, Samed N, et al. (2021). Central composite design for the development of carvedilol-loaded transdermal ethosomal hydrogel for extended and enhanced anti-hypertensive effect. J Nanobiotechnol 19:100.
   PubMed Web of Science ®Google Scholar
• Rathod H, Mehta D. (2015). A review on pharmaceutical gel. Int J Pharm Sci 1:33–47.
   Google Scholar
• Reagan-Shaw S, Nihal M, Ahmad N. (2008). Dose translation from animal to human studies revisited. FASEB J 22:659–61.
   PubMed Web of Science ®Google Scholar
• Safwat S, Ishak RAH, Hathout RM, Mortada ND. (2017). Nanostructured lipid carriers loaded with simvastatin: effect of PEG/glycerides on characterization, stability, cellular uptake efficiency and in vitro cytotoxicity. Drug Dev Ind Pharm 43:1112–25.
   PubMed Web of Science ®Google Scholar
• Salama AH, Aburahma MH. (2016). Ufasomes nano-vesicles-based lyophilized platforms for intranasal delivery of cinnarizine: preparation, optimization, ex-vivo histopathological safety assessment and mucosal confocal imaging. Pharm Dev Technol 21:706–15.
   PubMed Web of Science ®Google Scholar
• Satija A, Ahmed SM, Gupta R, et al. (2014). Breast cancer pain management—a review of current & novel therapies. Indian J Med Res 139:216–25.
   PubMed Web of Science ®Google Scholar
• Sayed SI, Mohammed A, Mohammed A, et al. (2015). Formulation by design-based proniosome for accentuated transdermal delivery of risperidone: in vitro characterization and in vivo pharmacokinetic study. Drug Deliv 22:1059–70.
   PubMed Web of Science ®Google Scholar
• Sguizzato M, Mariani P, Spinozzi F, et al. (2020). Ethosomes for coenzyme q10 cutaneous administration: from design to 3D skin tissue evaluation. Antioxidants 9:485.
   Web of Science ®Google Scholar
• Shah RA, Mehta MR, Patel DM, Patel CN. (2011). Design and optimization of mucoadhesive nasal in situ gel containing sodium cromoglycate using factorial design. Asian J Pharm 5:65–74.
   Google Scholar
• Shelke O, Kulkarni A. (2018). Formulation, development and evaluation of nano ethosomal gel of tramadol hydrochloride. J Nanomed Nanotechnol 9:514.
   Google Scholar
• Shen L-N, Zhang Y-T, Wang Q, et al. (2014). Enhanced in vitro and in vivo skin deposition of apigenin delivered using ethosomes. Int J Pharm 460:280–8.
   PubMed Web of Science ®Google Scholar
• Song CK, Balakrishnan P, Shim C-K, et al. (2012). A novel vesicular carrier, transethosome, for enhanced skin delivery of voriconazole: characterization and in vitro/in vivo evaluation. Colloids Surf B Biointerfaces 92:299–304.
   PubMed Web of Science ®Google Scholar
• Sugioka Y, Nakamura J, Ohtsuki C, Sugawara-Narutaki A. (2021). Thixotropic hydrogels composed of self-assembled nanofibers of double-hydrophobic elastin-like block polypeptides. Int J Mol Sci 22:4104.
   PubMed Web of Science ®Google Scholar
• Syed SI, Abdul A, Mohamed A, et al. (2017). Formulation by design based risperidone nano soft lipid vesicle as a new strategy for enhanced transdermal drug delivery: in-vitro characterization, and in-vivo appraisal. Mater Sci Eng C Mater Biol Appl 75:1198–205.
   PubMed Web of Science ®Google Scholar
• Thatipamula RP, Palem CR, Gannu R. (2011). Formulation and in vitro characterization of domperidone loaded solid lipid nanoparticles and nanostructured lipid carriers. Daru 19:23–32.
   PubMed Web of Science ®Google Scholar
• Tiwari A, Bag P, Sarkar M, et al. (2021). Formulation, validation and evaluation studies on metaxalone and diclofenac potassium topical gel. Environ Anal Health Toxicol 36:e2021001.
   PubMedGoogle Scholar
• Touitou E, Godin B, Dayan N, et al. (2001). Intracellular delivery mediated by an ethosomal carrier. Biomaterials 22:3053–9.
   PubMed Web of Science ®Google Scholar
• Verma P, Pathak K. (2012). Nanosized ethanolic vesicles loaded with econazole nitrate for the treatment of deep fungal infections through topical gel formulation. Nanomedicine 8:489–96.
   PubMed Web of Science ®Google Scholar
• Vijayanand P, Patil J, Reddy MV. (2016). Formulation, characterization and in vivo evaluation of novel edible dosage form containing nebivolol HCl. Braz J Pharm Sci 52:179–90.
   Web of Science ®Google Scholar
• Yeo L, Olusanya T, Chaw C, Elkordy A. (2018). Brief effect of a small hydrophobic drug (cinnarizine) on the physicochemical characterisation of niosomes produced by thin-film hydration and microfluidic methods. Pharmaceutics 10:185.
   PubMed Web of Science ®Google Scholar
• Zakaria AS, Afifi SA, Elkhodairy KA. (2016). Newly developed topical cefotaxime sodium hydrogels: antibacterial activity and in vivo evaluation. Biomed Res Int 2016:6525163.
   PubMed Web of Science ®Google Scholar
• Zeb A, Qureshi OS, Kim H-S, et al. (2016). Improved skin permeation of methotrexate via nanosized ultradeformable liposomes. Int J Nanomedicine 11:3813–24.
   PubMed Web of Science ®Google Scholar
• Zhou Y, Wei Y, Liu H, et al. (2010). Preparation and in vitro evaluation of ethosomal total alkaloids of Sophora alopecuroides loaded by a transmembrane pH-gradient method. AAPS PharmSciTech 11:1350–8.
   PubMed Web of Science ®Google Scholar