Intranasal spray of cubosomal tizanidine hydrochloride for brain targeting: in vitro and in vivo characterisation

References

• Abdelrahman, F.E., et al., 2015. Investigating the cubosomal ability for transnasal brain targeting: in vitro optimization, ex vivo permeation and in vivo biodistribution. International journal of pharmaceutics, 490 (1–2), 281–291.
   PubMed Web of Science ®Google Scholar
• Agency, E.M., 2011. ICH guideline Q3C (R5) on impurities: guideline for residual solvents. International conference on harmonisation of technical requirements for registration pharmaceuticals human use.
   Google Scholar
• Ahirrao, M. and Shrotriya, S., 2017. In vitro and in vivo evaluation of cubosomal in situ nasal gel containing resveratrol for brain targeting. Drug development and industrial pharmacy, 43 (10), 1686–1693.
   PubMed Web of Science ®Google Scholar
• Amidi, M., et al., 2006. Preparation and characterization of protein-loaded N-trimethyl chitosan nanoparticles as nasal delivery system. Journal of controlled release, 111 (1–2), 107–116.
   PubMed Web of Science ®Google Scholar
• Anderson, M., et al., 2009. Stat-Ease handbook for experimenters. Minneapolis: Stat-Ease.
   Google Scholar
• Anklam, E., et al., 2002. Analytical methods for detection and determination of genetically modified organisms in agricultural crops and plant-derived food products. European food research and technology, 214 (1), 3–26.
   Web of Science ®Google Scholar
• Bancroft, J.D. and Gamble, M., 2008. Theory and practice of histological techniques. Churchill Livingstone, London: Elsevier Health Sciences.
   Google Scholar
• Deshpande, S., et al., 2014. Enhancing cubosome functionality by coating with a single layer of poly-ε-lysine. ACS applied materials & interfaces, 6 (19), 17126–17133.
   PubMed Web of Science ®Google Scholar
• Fudin, J. and Raouf, M., 2016. A review of skeletal muscle relaxants for pain management. Practical pain management, 16, 1–15.
   Google Scholar
• Gänger, S. and Schindowski, K., 2018. Tailoring formulations for intranasal nose-to-brain delivery: a review on architecture, physico-chemical characteristics and mucociliary clearance of the nasal olfactory mucosa. Pharmaceutics, 10 (3), 116.
   PubMed Web of Science ®Google Scholar
• Ghai, A., et al., 2013. Spasticity – pathogenesis, prevention and treatment strategies. Saudi journal of anaesthesia, 7 (4), 453–460.
   PubMedGoogle Scholar
• Guideline, I.H., 1996. Stability testing: requirements for new dosage forms Q1C. Amsterdam, The Netherlands: European medicine agency.
   Google Scholar
• Harikrishnan, V., Madhusudhan, S., and Santhiagu, A., 2015. Evaluation of a novel, natural badam gum as a sustained release and mucoadhesive component of tizanidine HCl buccal tablets. Asian journal of pharmacy and technology, 5 (2), 71–78.
   Google Scholar
• Hirai, M., 2000. Prevalence and characteristics of muscle cramps in patients with varicose veins. Vasa, 29 (4), 269–273.
   PubMed Web of Science ®Google Scholar
• Industry, G.F. 2002. Nasal spray and inhalation solution, suspension, and spray drug products—chemistry, manufacturing and controls documentation. Rockville, MD: Center for Drug Evaluation and Research Food and Drug Administration.
   Google Scholar
• Innes, A., et al., 1994. Complement activation by cellulosic dialysis membranes. Journal of clinical pathology, 47 (2), 155–158.
   PubMed Web of Science ®Google Scholar
• Jaiswal, N., Sharma, P.K., and Kumar, A., 2017. Scope of nasal drug delivery: current challenges. World journal of medical sciences, 14, 97–112.
   Google Scholar
• Japanese Pharmacopoeia, 2017. Tizanidine HCl 2207. Tokyo: Pharmaceuticals and Medical Devices Agency.
   Google Scholar
• Javia, A. and Thakkar, H., 2017. Intranasal delivery of tapentadol hydrochloride-loaded chitosan nanoparticles: formulation, characterisation and its in vivo evaluation. Journal of microencapsulation, 34 (7), 644–658.
   PubMed Web of Science ®Google Scholar
• Jones, T.M., 2018. Preformulation studies. Croydon: The Royal Society of Chemistry.
   Google Scholar
• Kala, S. and Juyal, D., 2016. Preformulation and characterization studies of aceclofenac active ingredient. Pharma innovation, 5, 110.
   Google Scholar
• Karami, Z. and Hamidi, M., 2016. Cubosomes: remarkable drug delivery potential. Drug discovery today, 21 (5), 789–801.
   PubMed Web of Science ®Google Scholar
• Mansouri, S., et al., 2006. Characterization of folate–chitosan–DNA nanoparticles for gene therapy. Biomaterials, 27 (9), 2060–2065.
   PubMed Web of Science ®Google Scholar
• Misra, A., et al., 2003. Drug delivery to the central nervous system: a review. Journal of pharmacy & pharmaceutical sciences, 6, 252–273.
   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
• Mukherjee, A. and Chakravarty, A., 2010. Spasticity mechanisms – for the clinician. Frontiers in neurology, 1, 149.
   PubMed Web of Science ®Google Scholar
• Pan, Y., et al., 2002. Bioadhesive polysaccharide in protein delivery system: chitosan nanoparticles improve the intestinal absorption of insulin in vivo. International journal of pharmaceutics, 249 (1–2), 139–147.
   PubMed Web of Science ®Google Scholar
• Patel, B. and Thakkar, H.J.P., 2023. Formulation development of fast dissolving microneedles loaded with cubosomes of febuxostat: in vitro and in vivo evaluation. Pharmaceutics, 15 (1), 224.
   PubMed Web of Science ®Google Scholar
• Patel, D., Naik, S., and Misra, A., 2012. Improved transnasal transport and brain uptake of tizanidine HCl-loaded thiolated chitosan nanoparticles for alleviation of pain. Journal of pharmaceutical sciences, 101 (2), 690–706.
   PubMed Web of Science ®Google Scholar
• Patil, R.P., et al., 2019. Nanostructured cubosomes in an in situ nasal gel system: an alternative approach for the controlled delivery of donepezil HCl to brain. Journal of liposome research, 29 (3), 264–273.
   PubMed Web of Science ®Google Scholar
• Pendekal, M.S. and Tegginamat, P.K., 2012. Formulation and evaluation of a bioadhesive patch for buccal delivery of tizanidine. Acta pharmaceutica sinica B, 2, 318–324.
   Google Scholar
• Prakash, V., 2023. Determination of log P and log s of CNS active drugs. Available from: https://www.academia.edu/3621739/log_P_and_log_s_of_CNS_active_drugs [Accessed 11 May 2023].
   Google Scholar
• Pramanik, S. and Thakkar, H., 2020. Development of solid self-microemulsifying system of tizanidine hydrochloride for oral bioavailability enhancement: in vitro and in vivo evaluation. AAPS PharmSciTech, 21 (5), 1–11.
   Web of Science ®Google Scholar
• Qi, L., et al., 2004. Preparation and antibacterial activity of chitosan nanoparticles. Carbohydrate research, 339 (16), 2693–2700.
   PubMed Web of Science ®Google Scholar
• Rizwan, S., et al., 2007. Characterisation of bicontinuous cubic liquid crystalline systems of phytantriol and water using cryo field emission scanning electron microscopy (cryo FESEM). Micron, 38 (5), 478–485.
   PubMed Web of Science ®Google Scholar
• Salah, S., Mahmoud, A.A., and Kamel, A.O., 2017. Etodolac transdermal cubosomes for the treatment of rheumatoid arthritis: ex vivo permeation and in vivo pharmacokinetic studies. Drug delivery, 24 (1), 846–856.
   PubMed Web of Science ®Google Scholar
• See, S. and Ginzburg, R., 2008. Skeletal muscle relaxants. Pharmacotherapy, 28 (2), 207–213.
   PubMed Web of Science ®Google Scholar
• Selvaraj, K., Gowthamarajan, K., and Karri, V.V.S.R., 2018. Nose to brain transport pathways an overview: potential of nanostructured lipid carriers in nose to brain targeting. Artificial cells, nanomedicine, and biotechnology, 46 (8), 2088–2095.
   PubMed Web of Science ®Google Scholar
• Shahid, N., et al., 2018. Fabrication and characterization of matrix type transdermal patches loaded with tizanidine hydrochloride: potential sustained release delivery system. Drug development and industrial pharmacy, 44 (12), 2061–2070.
   PubMed Web of Science ®Google Scholar
• Singh, K., Mishra, A., and Singh, A., 2018. Synthesis characterization and in vitro release study of ciprofloxacin-loaded chitosan nanoparticle. BioNanoScience, 8 (1), 229–236.
   Web of Science ®Google Scholar
• Sonawane, M., Gaikwad, S., and Derle, D., 2013. Formulation, optimization and evaluation of pH dependent colon targeted drug delivery system of tizanidine hydrochloride. Inventi rapid pharm tech, 1, 1–7.
   Google Scholar
• Suryawanshi, V.A., et al., 2015. Formulation and evaluation of tizanidine hydrochloride mouth dissolving film. Indo American journal of pharmaceutical research, 5, 3.
   Google Scholar
• Vitale, D.C., et al., 2013. Pharmacokinetic characterization of tizanidine nasal spray, a novel intranasal delivery method for the treatment of skeletal muscle spasm. Clinical drug investigation, 33 (12), 885–891.
   PubMed Web of Science ®Google Scholar
• Wagstaff, A.J. and Bryson, H.M., 1997. Tizanidine. Drugs, 53 (3), 435–452.
   PubMed Web of Science ®Google Scholar
• Witenko, C., et al., 2014. Considerations for the appropriate use of skeletal muscle relaxants for the management of acute low back pain. P T, 39, 427.
   PubMedGoogle Scholar
• Witschi, C. and Doelker, E., 1997. Residual solvents in pharmaceutical products: acceptable limits, influences on physicochemical properties, analytical methods and documented values. European journal of pharmaceutics and biopharmaceutics, 43 (3), 215–242.
   Web of Science ®Google Scholar
• Yin, Y., et al., 2006. Preparation and evaluation of lectin-conjugated PLGA nanoparticles for oral delivery of thymopentin. Journal of controlled release, 116 (3), 337–345.
   PubMed Web of Science ®Google Scholar