10.1007/s40204-021-00164-5

Evaluation of sonication on stability-indicating properties of optimized pilocarpine hydrochloride-loaded niosomes in ocular drug delivery

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  • Kruga Owodeha-Ashaka*1,
  • Margaret O. Ilomuanya2,
  • Affiong Iyire1,
  1. Aston Pharmacy School, College of Life and Health Sciences, Aston University, Birmingham, B4 7ET, GB
  2. Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Lagos, Yaba, Lagos State, NG
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Published in Issue 2021-09-22

How to Cite

Owodeha-Ashaka, K., Ilomuanya, M. O., & Iyire, A. (2021). Evaluation of sonication on stability-indicating properties of optimized pilocarpine hydrochloride-loaded niosomes in ocular drug delivery. Progress in Biomaterials, 10(3 (September 2021). https://doi.org/10.1007/s40204-021-00164-5
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Abstract

Abstract Niosomes are increasingly explored for enhancing drug penetration and retention in ocular tissues for both posterior and anterior eye delivery. They have been employed in encapsulating both hydrophilic and hydrophobic drugs, but their use is still plagued with challenges of stability and poor entrapment efficiency particularly with hydrophilic drugs. As a result, focus is on understanding the parameters that affect their stability and their optimization for improved results. Pilocarpine hydrochloride (HCl), a hydrophilic drug is used in the management of intraocular pressure in glaucoma. We aimed at optimizing pilocarpine HCl niosomes and evaluating the effect of sonication on its stability-indicating properties such as particle size, polydispersity index (PDI), zeta potential and entrapment efficiency. Pilocarpine niosomes were prepared by ether injection method. Composition concentrations were varied and the effects of these variations on niosomal properties were evaluated. The effects of sonication on niosomes were determined by sonicating optimized drug-loaded formulations for 30 min and 60 min. Tween 60 was confirmed to be more suitable over Span 60 for encapsulating hydrophilic drugs, resulting in the highest entrapment efficiency (EE) and better polydispersity and particle size indices. Optimum sonication duration as a process variable was determined to be 30 min which increased EE from 24.5% to 42% and zeta potential from (−)14.39 ± 8.55 mV to (−)18.92 ± 7.53 mV. In addition to selecting the appropriate surfactants and varying product composition concentrations, optimizing sonication parameters can be used to fine-tune niosomal properties to those most desirable for extended eye retainment and maintenance of long term stability.

Keywords

  • Niosomes,
  • Sonication,
  • Stability,
  • Non-ionic surfactants
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References

  1. Akbari et al. (2013) Ciprofloxacin nano-niosomes for targeting intracellular infections: an in vitro evaluation https://doi.org/10.1007/s11051-013-1556-y
  2. Akbari et al. (2015) Release studies on ciprofloxacin loaded non-ionic surfactant vesicles (pp. 69-75)
  3. Alyami et al. (2020) Nonionic surfactant vesicles (niosomes) for ocular drug delivery: development, evaluation, and toxicological profiling https://doi.org/10.1016/j.jddst.2020.102069
  4. Anbarasan et al. (2013) Optimization of the formulation and in-vitro evaluation of capecitabine niosomes for the treatment of colon cancer 4(4) (pp. 1504-1513) https://doi.org/10.13040/IJPSR.0975-8232.4(4).1504-13
  5. Anumolu et al. (2009) Design and evaluation of novel fast forming pilocarpine-loaded ocular hydrogels for sustained pharmacological response (pp. 152-159) https://doi.org/10.1016/j.jconrel.2009.03.01
  6. Bagheri et al. (2014) Niosomal drug delivery systems: formulation, preparation and applications (pp. 1671-1685) https://doi.org/10.5829/idosi.wasj.2014.32.08.848
  7. Balakrishnan et al. (2009) Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery (pp. 1-8) https://doi.org/10.1016/j.ijpharm.2009.04.020
  8. Barakat et al. (2014) Vancomycin-eluting niosomes: a new approach to the inhibition of staphylococcal biofilm on abiotic surfaces https://doi.org/10.1208/s12249-014-0141-8
  9. Basiri et al. (2017) α-Tocopherol-loaded niosome prepared by heating method and its release behavior (pp. 620-628) https://doi.org/10.1016/j.foodchem.2016.11.129
  10. Bayindir and Yuksel (2010) Characterization of niosomes prepared with various nonionic surfactants for paclitaxel oral delivery (pp. 2049-2060) https://doi.org/10.1002/jps.2194
  11. Bhardwaj et al. (2020) Niosomes: a review on niosomal research in the last decade https://doi.org/10.1016/j.jddst.2020.101581
  12. Bnyan et al. (2018) Surfactant effects on lipid-based vesicles properties (pp. 1237-1246) https://doi.org/10.1016/j.xphs.2018.01.005
  13. Chen et al. (2019) Recent advances in non-ionic surfactant vesicles (niosomes): fabrication, characterization, pharmaceutical and cosmetic applications (pp. 18-39) https://doi.org/10.1016/j.ejpb.2019.08.015
  14. Cho et al. (2013) Nanoparticle characterization: state of the art, challenges, and emerging technologies (pp. 2093-2110) https://doi.org/10.1021/mp300697h
  15. Cholkar et al. (2013) Novel strategies for anterior segment ocular drug delivery (pp. 106-123) https://doi.org/10.1089/jop.2012.0200
  16. De et al. (2018) Smart niosomes of temozolomide for enhancement of brain targeting (pp. 1-11) https://doi.org/10.1177/1849543518805355
  17. Di Marzio et al. (2011) Novel pH-sensitive non-ionic surfactant vesicles: comparison between Tween 21 and Tween 20 (pp. 18-24) https://doi.org/10.1016/j.colsurfb.2010.08.004
  18. Diskaeva (2018) Investigation ultrasound influence on the size of niosomes vesicles on the based of P EG - 12 dimethicone 9(6)
  19. Dukhin and Goetz (2006) How non-ionic “electrically neutral” surfactants enhance electrical conductivity and ion stability in non-polar liquids (pp. 44-50) https://doi.org/10.1016/j.jelechem.2005.12.001
  20. El Deeb et al. (2006) Evaluation of monolithic C18 HPLC columns for the fast analysis ofpilocarpine hydrochloride in the presence of its degradation products (pp. 751-756) https://doi.org/10.1080/10717544.2019.1609622
  21. Essa (2010) Effect of formulation and processing variables on the particle size of sorbitan monopalmitate niosome https://doi.org/10.4103/0973-8398.76752
  22. Fan et al. (1996) Improved high-performance liquid chromatographic determination of pilocarpine and its degradation products in ophthalmic solutions importance of octadecylsilane column choice (pp. 289-295) https://doi.org/10.1016/0021-9673(96)00120-3
  23. Farmoudeh et al. (2020) Methylene blue-loaded niosome: preparation, physicochemical characterization, and in vivo wound healing assessment (pp. 1428-1441) https://doi.org/10.1007/s13346-020-00715-6
  24. García-Manrique et al. (2020) Effect of drug molecular weight on niosomes size and encapsulation efficiency https://doi.org/10.1016/j.colsurfb.2019.110711
  25. Gaudana et al. (2009) Recent perspectives in ocular drug delivery (pp. 1197-1216) https://doi.org/10.1007/s11095-008-9694-0
  26. Ghafelehbashi et al. (2019) Preparation, physicochemical properties, in vitro evaluation and release behavior of cephalexin-loaded niosomes https://doi.org/10.1016/j.ijpharm.2019.118580
  27. Gugleva et al. (2019) Design and in vitro evaluation of doxycycline hyclate niosomes as a potential ocular delivery system https://doi.org/10.1016/j.ijpharm.2019.06.022
  28. Guinedi et al. (2005) Preparation and evaluation of reverse-phase evaporation and multilamellar niosomes as ophthalmic carriers of acetazolamide (pp. 71-82) https://doi.org/10.1016/j.ijpharm.2005.09.023
  29. Guo et al. (2010) Electric charging in nonpolar liquids because of nonionizable surfactants (pp. 3203-3207) https://doi.org/10.1021/la903182e
  30. Hashemi Dehaghi et al. (2017) Dorzolamide loaded niosomal vesicles: comparison of passive and remote loading methods (pp. 413-422)
  31. Unknown (2005) International Conference on Harmonisation
  32. Iyire et al. (2018) Development, optimisation, validation and inter-laboratory verification of a reversed phase HPLC method for quantification of human recombinant insulin (pp. 984-998) https://doi.org/10.1016/j.jddst.2020.102069
  33. Jain and Verma (2020) Formulation and investigation of pilocarpine hydrochloride niosomal gels for the treatment of glaucoma: intraocular pressure measurement in white albino rabbits https://doi.org/10.1080/10717544.2020.1775726
  34. Joshi et al. (2020) Comprehensive screening of drug encapsulation and co-encapsulation into niosomes produced using a microfluidic device 8(5) https://doi.org/10.3390/pr8050535
  35. Junyaprasert et al. (2012) Physicochemical properties and skin permeation of Span 60/Tween 60 niosomes of ellagic acid (pp. 303-311) https://doi.org/10.1016/j.ijpharm.2011.11.032
  36. Kaur et al. (2016) Development, optimization and evaluation of surfactant-based pulmonary nanolipid carrier system of paclitaxel for the management of drug resistance lung cancer using Box-Behnken design (pp. 1912-1925) https://doi.org/10.3109/10717544.2014.993486
  37. Keipert et al. (1996) Interactions between cyclodextrins and pilocarpine: as an example of a hydrophilic drug (pp. 153-162) https://doi.org/10.1016/0378-5173(96)04660-1
  38. Khan et al. (2017) Ultrasonic processing technique as a green preparation approach for diacerein-loaded niosomes (pp. 1554-1563) https://doi.org/10.1208/s12249-016-0622-z
  39. Kumar and Rajeshwarrao (2011) Nonionic surfactant vesicular systems for effective drug delivery—an overview (pp. 208-219) https://doi.org/10.1016/j.apsb.2011.09.002
  40. Loftsson et al. (2008) Topical drug delivery to the posterior segment of the eye: anatomical and physiological considerations (pp. 171-179) https://doi.org/10.1691/ph.2008.7322
  41. Lu et al. (2019) Niosomal nanocarriers for enhanced skin delivery of quercetin with functions of anti-tyrosinase and antioxidant https://doi.org/10.3390/molecules24122322
  42. Manosroi et al. (2003) Characterization of vesicles prepared with various non-ionic surfactants mixed with cholesterol (pp. 129-138) https://doi.org/10.1016/S0927-7765(03)00080-8
  43. Manosroi et al. (2010) Transdermal absorption enhancement through rat skin of gallidermin loaded in niosomes (pp. 304-310) https://doi.org/10.1016/j.ijpharm.2010.03.064
  44. Marwa et al. (2013) Preparation and in-vitro evaluation of diclofenac sodium niosomal formulations 4(5) (pp. 1757-1765) https://doi.org/10.13040/IJPSR.0975-8232.4(5).1757-65
  45. Mavaddati et al. (2015) Effect of formulation and processing variables on dexamethasone entrapment and release of niosomes (pp. 2065-2078) https://doi.org/10.1007/s10876-015-0908-4
  46. Naderinezhad et al. (2017) Co-delivery of hydrophilic and hydrophobic anticancer drugs using biocompatible pH-sensitive lipid-based nano-carriers for multidrug-resistant cancers (pp. 30008-30019) https://doi.org/10.1039/C7RA01736G
  47. Nadzir MM, Fen TW, Mohamed AR, Hisham SF (2017) Size and Stability of Curcumin Niosomes from Combinations of Tween 80 and Span 80. Sains Malaysiana 46(12):2455–2460.
  48. https://doi.org/10.17576/jsm-2017-4612-22
  49. Nakatuka et al. (2015) The effect of particle size distribution on effective zeta-potential by use of the sedimentation method (pp. 650-656) https://doi.org/10.1016/j.apt.2015.01.017
  50. Naveh et al. (1994) Pilocarpine incorporated into a submicron emulsion vehicle causes an unexpectedly prolonged ocular hypotensive effect in rabbits (pp. 509-520) https://doi.org/10.1089/jop.1994.10.509
  51. Nayak et al. (2020) Tailoring solulan C24 based niosomes for transdermal delivery of donepezil: In vitro characterization, evaluation of pH sensitivity, and microneedle-assisted Ex vivo permeation studies https://doi.org/10.1016/j.jddst.2020.101945
  52. Nowroozi et al. (2018) Effect of surfactant type, cholesterol content and various downsizing methods on the particle size of niosomes (pp. 1-11)
  53. Okore et al. (2011) Formulation and evaluation of niosomes (pp. 323-328) https://doi.org/10.4103/0250-474X.93515
  54. Palozza et al. (2006) Solubilization and stabilization of β-carotene in niosomes: delivery to cultured cells (pp. 32-42) https://doi.org/10.1016/j.chemphyslip.2005.09.004
  55. Pereira-Lachataignerais et al. (2006) Study and formation of vesicle systems with low polydispersity index by ultrasound method (pp. 88-97) https://doi.org/10.1016/j.chemphyslip.2006.01.008
  56. Prabhu et al. (2010) Preparation and evaluation of nano-vesicles of brimonidine tartrate as an ocular drug delivery system (pp. 356-361) https://doi.org/10.4103/0975-1483.71623
  57. Rangasamy et al. (2008) Formulation and in vitro evaluation of niosome encapsulated acyclovir (pp. 163-166)
  58. Ravalika and Krishna (2017) Formulation and evaluation of etoricoxib niosomes by thin film hydration technique and ether injection method 9(3) (pp. 242-248) https://doi.org/10.5101/nbe.v9i3.p242-248
  59. Rehman et al. (2018) Development and in vitro characterization of niosomal formulations of immunosuppressant model drug 31(6) (pp. 2623-2628)
  60. Ruckmani and Sankar (2010) Formulation and optimization of Zidovudine niosomes (pp. 1119-1127) https://doi.org/10.1208/s12249-010-9480-2
  61. Sadeghi et al. (2020) Design and physicochemical characterization of lysozyme loaded niosomal formulations as a new controlled delivery system (pp. 921-930) https://doi.org/10.1007/s11094-020-02100-6
  62. Sahoo et al. (2014) Nonionic surfactant vesicles in ocular delivery: innovative approaches and perspectives https://doi.org/10.1155/2014/263604
  63. Sankhyan and Pawar (2013) Metformin loaded non-ionic surfactant vesicles: optimization of formulation, effect of process variables and characterization (pp. 7-7) https://doi.org/10.7324/JAPS.2012.2625
  64. Seleci et al. (2016) Niosomes as nanoparticular drug carriers https://doi.org/10.1155/2016/7372306
  65. Sezgin-Bayindir and Yuksel (2012) Investigation of formulation variables and excipient interaction on the production of niosomes (pp. 826-835) https://doi.org/10.1208/s12249-012-9805-4
  66. Shah et al. (2020) Evaluations of Quality by Design (QbD) elements impact for developing niosomes as a promising topical drug delivery platform https://doi.org/10.3390/pharmaceutics12030246
  67. Sharma et al. (2016) Effect of process and formulation variables on the preparation of parenteral paclitaxel-loaded biodegradable polymeric nanoparticles: a co-surfactant study (pp. 404-416) https://doi.org/10.1016/j.ajps.2015.09.004
  68. Shete et al. (2012) Formulation and evaluation of PEGylated lipid coated niosomes of 5-flourouracil for parenteral drug delivery 4(1) (pp. 71-77)
  69. Shi et al. (2018) Experimental determination of particle size-dependent surface charge density for silica nanospheres (pp. 23764-23771) https://doi.org/10.1021/acs.jpcc.8b07566
  70. Smith and Eastoe (2013) Controlling colloid charge in nonpolar liquids with surfactants (pp. 424-439) https://doi.org/10.1039/C2CP42625K
  71. Tavano et al. (2013) Doxorubicin loaded magneto-niosomes for targeted drug delivery (pp. 803-807) https://doi.org/10.1016/j.colsurfb.2012.09.019
  72. Taymouri and Varshosaz (2016) Effect of different types of surfactants on the physical properties and stability of carvedilol nano-niosomes https://doi.org/10.4103/2277-9175.178781
  73. Uchegbu and Vyas (1998) Non-ionic surfactant based vesicles (niosomes) in drug delivery (pp. 33-70) https://doi.org/10.1016/S0378-5173(98)00169-0
  74. Vankayala et al. (2018) Surfactants and fatty alcohol based novel nanovesicles for resveratrol: process optimization, characterization and evaluation of functional properties in RAW 264.7 macrophage cells (pp. 387-396) https://doi.org/10.1016/j.molliq.2018.04.058
  75. Verma et al. (2019) Systematic optimization of cationic surface engineered mucoadhesive vesicles employing Design of Experiment (DoE): a preclinical investigation (pp. 1142-1155) https://doi.org/10.1016/j.ijbiomac.2019.04.118
  76. Wang and Gao (2018) Effects of length and unsaturation of the alkyl chain on the hydrophobic binding of curcumin with Tween micelles (pp. 242-248) https://doi.org/10.1016/j.foodchem.2017.11.024
  77. Widayanti et al. (2017) Effects of sonicator usage time on entrapment efficiency of liposome magnesium ascorbyl phosphate made by thin layer hydration method 8(1S)
  78. Wilson et al. (2001) Status of methods for assessing bacterial cell surface charge properties based on zeta potential measurements (pp. 153-164) https://doi.org/10.1016/S0167-7012(00)00224-4
  79. Yeo et al. (2019) The effects of hydration parameters and co-surfactants on methylene blue-loaded niosomes prepared by the thin film hydration method https://doi.org/10.3390/ph12020046
  80. Yoshioka et al. (1994) Preparation and properties of vesicles (niosomes) of sorbitan monoesters (Span 20, 40, 60 and 80) and a sorbitan triester (Span 85) (pp. 1-6) https://doi.org/10.1016/0378-5173(94)90228-3
  81. Zasadzinski JA, Wong B, Forbes N, Braun G, Wu G (2011) Novel Methods of Enhanced Retention in and Rapid, Targeted Release from Liposomes. Curr Opin in Colloid & Interface Sci 16:203–214.
  82. https://doi.org/10.1016/j.cocis.2010.12.004
  83. Zhang et al. (2020) Sodium dodecyl sulfate improved stability and transdermal delivery of salidroside-encapsulated niosomes via effects on zeta potential https://doi.org/10.1016/j.ijpharm.2020.119183