BENAZEPRIL HYDROCHLORIDE LOADED NIOSOMAL FORMULATION FOR ORAL DELIVERY: FORMULATION AND CHARACTERIZATION
Keywords:Benazepril hydrochloride, Niosomes, Oral delivery, Thin film hydration
Objective: The objective of the present study was to formulate niosomal formulations of benazepril hydrochloride in an attempt to overcome the hurdles associated with itÊ¼s poor oral absorption.
Methods: Nine formulations were prepared with various ratios of sorbitan monostearate (span 60), sorbitan monopalmitate (span 40) and polyoxyethylene 2 stearyl ether (brij 72) as non-ionic surfactants, cholesterol as a stabilizing agent and soya lecithin as a charge imparting agent. Then, they were characterized for vesicle size, polydispersity (PDI), entrapment efficiency (EE %), release profile, zeta (Î¶) potential and transmission electron microscopy (TEM).
Results: Niosomal formulations exhibited an efficient entrapment range between (80.4-97.8) percent, vesicles size analyses revealed the formation of homogenously dispersed vesicles having a size range of (3.9Â±1.7-8.72Â±4.4) micrometers. The in vitro release studies revealed that all formulations displayed sustained release in comparison with the pure drug. Formulations prepared with span 60 and span 40 possessed adequate stability according to zeta potential analysis, whereas brij 72 failed the test and possessed inadequate zeta potential range. TEM images of the optimized formulations (F7 and F8) have confirmed the formation of vesicles with spherical shapes.
Conclusion: Based on the study results, niosomal formulations seem to be attractive alternatives to conventional delivery for benazepril hydrochloride.
Mahale NB, Thakkar PD, Mali RG, Walunj DR, Chaudhari SR. Niosomes: novel sustained release nonionic stable vesicular systems-an overview. Adv Colloid Interface Sci 2012;183â€“184:46â€“54.
Rai AK, Alam G, Singh AP, Verma NK. Niosomes: an approach to current drug delivery-a review. Int J Adv Pharm 2017;6:41-8.
Bayindir ZS, Yuksel N. Characterization of niosomes prepared with various nonionic surfactants for paclitaxel oral delivery. J Pharm Sci 2010;99:2049â€“60.
Sweetman SS. Martindale: the complete drug reference. 36th ed. London: Pharmaceutical Press; 2009. p. 582.
Sharma Y, Kumar K, Padhy SK. Formulation and evaluation of atorvastatin calcium niosomes. Int J Life Sci Sci Res 2016;2:462-5.
Nadzir MM, Fen TW, Mohamed A, Hisham SF. Size and stability of curcumin niosomes from combinations of tween 80 and span 80. Sains Malays 2017;46:2455â€“60.
Vyshnavi V, Indira S, Srinivas P. Formulation and evaluation of nasal niosomal in situ gels of loratadine. Int J Pharm Sci Drug Res 2015;7:13-21.
Awad RS, Abdelwahed W, Bitar Y. Evaluating the impact of preparation conditions and formulation on the accelerated stability of tretinoin loaded liposomes prepared by the heating method. Int J Pharm Pharm Sci 2015;7:171-8.
Imran M, Shah MR, Ullah F, Ullah S, Elhissi AM, Nawaz W, et al. Sugar-based novel niosomal nanocarrier system for enhanced oral bioavailability of levofloxacin. Drug Delivery 2016;23: 3653-64.
The United States Pharmacopoeia (USP) 30, NF 25. USA: The United States Pharmacopeial Convention Inc; 2006.
Isnan AP, Jufri M. Formulation of niosomal gel containing green tea extract (Camellia Sinensis L. Kuntze) using thin-layer hydration. Int J Appl Pharm 2017;9 Suppl 1:38-43.
Alemi A, Reza JZ, Haghiralsadat F, Jaliani HZ, Karamallah MH, Hosseini SA, et al. Paclitaxel and curcumin coadministration in novel cationic pegylated niosomal formulations exhibit enhanced synergistic antitumor efficacy. J Nanobiotechnol 2018;16:28.
Mohsen AM, AbouSamra MM, ElShebiney SA. Enhanced oral bioavailability and sustained delivery of glimepiride via niosomal encapsulation: in vitro characterization and in vivo evaluation. Drug Dev Ind Pharm 2017;43:1254-64.
El-Laithy HM, Shoukry O, Mahran LG. Novel sugar esters proniosomes for transdermal delivery of vinpocetine: preclinical and clinical studies. Eur J Pharm Biopharm 2011;77:43-55.
Sezgin Bayindir Z, Antep MN, Yuksel N. Development and characterization of mixed niosomes for oral delivery using candesartan cilexetil as a model poorly water-soluble drug. AAPS PharmSciTech 2015;16:108â€“17.
Obeid MA, Gebril AM, Tate RJ, Mullen AB, Ferro VA. Comparison of the physical characteristics of monodisperse non-ionic surfactant vesicles (NISV) prepared using different manufacturing methods. Int J Pharm 2017;521:54-60.
Haoa YM, Li K. Entrapment and release difference resulting from hydrogen bonding interactions in niosome. Int J Pharm 2011;403:245â€“53.
Salih OS, Samein LH, Ali WK. Formulation and in vitro evaluation of rosuvastatin calcium niosomes. Int J Pharm Pharm Sci 2013;5 Suppl 4:525-35.
Alsarra IA, Bosela AA, Ahmed SM, Mahrous GM. Proniosomes as drug carrier for transdermal delivery of ketorolac. Eur J Pharm Biopharm 2005;59:485-90.
Kassem MA, Megahed MA, Abu Elyazid SK, Abd-Allah FI, Abdelghany TM, Al-Abd AM, et al. Enhancing the therapeutic efficacy of tamoxifen citrate loaded span-based nano-vesicles on human breast adenocarcinoma cells. AAPS PharmSciTech 2018;19:1529â€“43.
Girigoswami A, Das S, De S. Fluorescence and dynamic light scattering studies of niosomes membrane mimetic systems. Spectrochim Acta Part A 2006;64:859â€“66.
Ruckmani K, Sankar V. Formulation and optimization of zidovudine niosomes. AAPS PharmSciTech 2010;11:1119â€“27.
Yang DB, Zhu JB, Huang ZJ, Ren HX, Zheng ZJ. Synthesis and application of poly (ethylene glycol)-cholesterol (Chol-PEGm) conjugates in the physicochemical characterization of nonionic surfactant vesicles. Colloids Surf B 2008;63:192â€“9.
Madni A, Rahim MA, Mahmood MA, Jabar A, Rehman M, Shah H, et al. Enhancement of dissolution and skin permeability of pentazocine by proniosomes and niosomal gel. AAPS PharmSciTech 2018;19:1544-53.
El-ridy MS, Badawi AA, Safar MM, Mohsen AM. Niosomes as a novel pharmaceutical formulation encapsulating the hepatoprotective drug silymarin. Int J Pharm Pharm Sci 2012;4:549-59.
Sinko PJ, Colloidal dispersions. In: Martinâ€™s physical pharmacy and pharmaceutical sciences.6th ed. Philadelphia: Lippincott Williams and Wilkins; 2011. p. 732.
Shiny A, Toomu MC, Dhurke RK. Enhanced dermal delivery of nadifloxacin using liposomes. Int J Appl Pharm 2016;8:53-9.
Mohawed OAM, El-ashmoony MM, Elgazayerly ON. Niosome-encapsulated clomipramine for transdermal controlled delivery. Int J Pharm Pharm Sci 2014;6:567-75.