Novel Drug Delivery Systems for Herbal Antidepressants
- 1.3k Downloads
Depression, a potentially life-threatening mood disorder, affects one in six persons in the United States, or approximately 17.6 million Americans each year. It is one of the top ten causes of morbidity and mortality worldwide as reported by the World Health Organization. Depressed patients are more likely to develop secondary diseases like type 2 diabetes and cardiovascular disease. Furthermore, depression is the third leading cause of global disease burden, accounting for 4.3 % of the total disability-adjusted life years. Predictions based on current exponential rise may assign it to be the leading cause of disease burden by the year 2030.
Despite advances in the treatment of depression with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), there continue to be several unmet clinical needs with respect to both the efficacy and the persisting side effects. Herbal drugs with evident antidepressant activity are purported to possess lower risk of precipitating side effects and can be explored as novel drug candidates. Though they find ample space to broaden their therapeutic segment at lab scale, their translation to clinics often has resulted in a failure. The latter is assigned to their compromised bioavailability across the blood–brain barrier (BBB) and attributed to their poor solubility and permeability, photodegradation and lower available systemic concentrations. All these concerns call for the development of novel drug delivery systems (NDDS), which include oral gastro-resistant formulations; transdermal delivery; nasal therapies; nanotechnology-based products, i.e. polymeric and lipidic nanoparticles; self-emulsifying novel drug delivery systems; liposomes; nanostructured lipid carriers; to nanodevices. The commercialisation of the herbal NDDS products especially the nanotech-based delivery system, is governed by stringent regulations, though a few products which fall into the category of modified conventional therapies may get approvals from FDA.
This chapter elaborates the need for developing the NDDS for herbal antidepressants (AD). Furthermore, an extensive review of the work done by the researchers around the globe and the constraints are also presented herewith. The regulations governing the approval of product for commercialisation and the future direction for these herbal antidepressants are also discussed.
KeywordsAntidepressants Bioavailability Herbals FDA Novel delivery system
The author reports no conflict of interest in this work.
- Abdelrahman FE et al. Investigating the cubosomal ability for transnasal brain targeting: In vitro optimization, ex vivo permeation and in vivo biodistribution. Int J Pharm. 2015;490(1–2):281–91. Available at: http://www.sciencedirect.com/science/article/pii/S0378517315004937.Google Scholar
- Anton N, Jakhmola A, Vandamme TF. Trojan microparticles for drug delivery. Pharmaceutics. 2012;4(1):1–25. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3834908/.Google Scholar
- Appleton J. Lavender oil for anxiety and depression. Nat Med J. 2012;4(2).Google Scholar
- Dhiman A, Nanda A, Ahmad S. Novel herbal drug delivery system ( NHDDS ): the need of hour. IPCBEE. 2012;49:171–5.Google Scholar
- EMEA. Note for guidance specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. Reproduction, 2(November 1999); 2006. p. 1–15. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22167572.
- FDA. Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics., (February), 2014; p. 18. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf [Accessed 25 Aug 2015].
- Guest JA, Grant RS. Effects of dietary derived antioxidants on the central nervous system. Int J Nutr Pharmacol Neurol Dis. 2012;2(3):195–7.Google Scholar
- Jessen L, Kovalick LJ, Azzaro AJ. The selegiline transdermal system (Emsam): a therapeutic option for the treatment of major depressive disorder. Pharm Therapeut. 2008;33(4):212–46. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730099/.
- De Jong WH, Borm PJA. Drug delivery and nanoparticles: applications and hazards. Int J Nanomedicine. 2008;3(2):133–49. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2527668/.
- Kakkar V, Kaur IP. Antidepressant activity of curcumin loaded solid lipid nanoparticles (C-SLNs) in mice. Am J Pharm Res. 2012;2(3).Google Scholar
- Kateb B et al. Nanoplatforms for constructing new approaches to cancer treatment, imaging, and drug delivery: what should be the policy? NeuroImage. 2011;54 Suppl 1:S106–24. Available at: http://www.sciencedirect.com/science/article/pii/S1053811910001448 [Accessed 4 May 2015].
- Lee B-H, Kim Y-K. The roles of BDNF in the pathophysiology of major depression and in antidepressant treatment. Psychiatry Investig. 2010;7(4):231–5. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3022308/.Google Scholar
- Litt B. Nanodevices to Treat Neurological Diseases. Brain Research Foundation; 2013. Available at: http://www.thebrf.org/Pages/Topic?id=1426 [Accessed 25 Aug 2015].
- Ma P, Mumper RJ. Paclitaxel nano-delivery systems: a comprehensive review. Journal of nanomedicine nanotechnology. 2013;4(2):1000164. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3806207/.
- Marcus M et al. DEPRESSION: A Global Public Health Concern. WHO Department of Mental Health and Substance Abuse; 2012. p. 6–8. Available at: http://www.who.int/mental_health/management/depression/who_paper_depression_wfmh_2012.pdf [Accessed 28 Aug 2015].
- Mathers C, Boerma T and Fat DM. The global burden of disease; 2004. p. 1–160. Available at: http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/ [Accessed 28 Aug 2015].
- Mattson MP. Glutamate and neurotrophic factors in neuronal plasticity and disease. Ann N Y Acad Sci. 2008;1144:97–112. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2614307/.Google Scholar
- Mercola J. 10 Antidepressant Alternatives Proven to Work; 2009. Available at: Mercola.com [Accessed 10 Aug 2015].Google Scholar
- MHDaily. Nanotechnology for depression: the futuristic potential of nanopsychiatry. Mental Health Blog; 2015. Available at: http://mentalhealthdaily.com/2015/08/31/nanotechnology-for-depression-the-futuristic-potential-of-nanopsychiatry/ [Accessed 25 Sept 2015].
- Pandey KB, Rizvi SI. Plant polyphenols as dietary antioxidants in human health and disease. Oxidative Med Cell Longev. 2009;2(5):270–8. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835915/.Google Scholar
- Pick M. Antidepressants and natural alternatives. Emotions, anxiety and mood. 2015. Available at: https://www.womentowomen.com/emotions-anxiety-mood/antidepressants-alternatives/.
- Rabanel J-M et al. Effect of polymer architecture on curcumin encapsulation and release from PEGylated polymer nanoparticles: Toward a drug delivery nano-platform to the CNS. European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V; 2015.Google Scholar
- Roy-Byrne P. Herbal Psychotropic Medications: Promises and Pitfalls. Psychiatry; 1998. Available at: http://www.jwatch.org/jp199811010000019/1998/11/01/herbal-psychotropic-medications-promises-and [Accessed 20 Aug 2015].
- Sayyah M, Sayyah M, Kamalinejad M. A preliminary randomized double blind clinical trial on the efficacy of aqueous extract of Echium amoenum in the treatment of mild to moderate major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2006;30(1):166–9.Google Scholar
- Spinella M. The Psychopharmacology of Herbal Medicine Plant Drugs That Alter Mind Brain and Behavior by Marcello Spinella Information 6586th ed., London, England: Mit Press; 2001. Available at: https://books.google.co.in/books?id=jZeaRiIFbhsC&dq=The+Psychopharmacology+of+Herbal+Medicine+Plant+Drugs+That+Alter+Mind+Brain+and+Behavior+by+Marcello+Spinella+Information&source=gbs_navlinks_s.
- Stevens JR et al. The use of transdermal therapeutic systems in psychiatric care: a primer on patches. Psychosomatics. 2015;56(5):423–44. Available at: http://www.sciencedirect.com/science/article/pii/S0033318215000602.Google Scholar
- Tiwari G et al. Drug delivery systems: an updated review. Int J Pharmaceut Investig. 2012;2(1):2–11. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3465154/.Google Scholar
- Upadhyay RK. Drug delivery systems, CNS protection, and the blood brain barrier. BioMed Res Int. 2014;2014:869269. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4127280/.Google Scholar
- Uttara B et al. Oxidative stress and neurodegenerative diseases: a review of upstream and downstream antioxidant therapeutic options. Curr Neuropharmacol. 2009;7(1):65–74. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2724665/.Google Scholar
- Vauzour D. Dietary polyphenols as modulators of brain functions: biological actions and molecular mechanisms underpinning their beneficial effects. Oxidative Medicine and Cellular Longevity; 2012. p. 1–16.Google Scholar
- Vijaya R, Ruckmani K. In vitro and In vivo characterization of the transdermal delivery of sertraline hydrochloride Films. DARU. 2011;19(6):424–32. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3436079/.
- Welch H and Hasbun R. Chapter 3 - Lumbar puncture and cerebrospinal fluid analysis. In Vinken PJ and Bruyn GW, Editors. Handbook of Clinical Neurology. Department of Medicine, Section of Infectious Diseases, University of Texas Medical School, Houston, TX, USA: North-Holland Publishing Company; 2010. p. 31–49. Available at: http://www.sciencedirect.com/science/article/pii/S0072975209960031.Google Scholar
- WFMH. Depression: A Global Crisis. World Fedaration of Mental Health; 2012. p. 1–32. Available at: http://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 12 Sept 2015].
- WHO. Annex 2: The International Pharmacopoeia: revised concepts and future perspectives; 2003. 1(908): 22–25. Available at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/PhIntRevisedConceptsFuturePerspectivesTRS908Annex2.pdf?ua=1 [Accessed 10 Oct 2015].
- WHO. Good practices for pharmaceutical quality control laboratories; 2010. (957): 81–129. Available at: http://apps.who.int/prequal/info_general/documents/trs957/gpcl_trs957_annex1.pdf [Accessed 10 Oct 2015].
- WHO. Suicide Prevention Across the Globe: Strengthening Protective Factors and Instilling Hope. International Association for Suicide Prevention; 2012. p. 1–3. Available at: www.iasp.info/wspd [Accessed 18 Oct 2015].
- WHO. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems; 2004. p. 1–82. Available at: http://apps.who.int/medicinedocs/documents/s7148e/s7148e.pdf [Accessed 10 Oct 2015].
- Wu L et al. Research article a self-microemulsifying drug delivery system ( SMEDDS ) for a Novel Medicative Compound Against Depression: a Preparation and Bioavailability Study in Rats. American Association of Pharmaceutical Scientists PharmSciTech; 2015. (13).Google Scholar