Improved skin-permeated diclofenac-loaded lyotropic liquid crystal nanoparticles: QbD-driven industrial feasible process and assessment of skin deposition

References

• Rannou F, Pelletier JP, Martel-Pelletier J. Efficacy and safety of topical NSAIDs in the management of osteoarthritis: evidence from real-life setting trials and surveys. Semin Arthritis Rheum. 2016;45:S18–S21.
   PubMed Web of Science ®Google Scholar
• Khanolkar A, Thorat V, Raut P, et al. Application of quality by design: development to manufacturing of diclofenac sodium topical gel. AAPS PharmSciTech. 2017;18:2754–2763.
   PubMed Web of Science ®Google Scholar
• Hagen M, Baker M. Skin penetration and tissue permeation after topical administration of diclofenac. Curr Med Res Opin. 2017;33:1623–1634.
   PubMed Web of Science ®Google Scholar
• Soeters PB, Wolfe RR, Hypoalbuminemia: SA. Pathogenesis and Clinical Significance. J Parenter Enter Nutr. 2019;43:181–193.
   PubMed Web of Science ®Google Scholar
• Kendroud SAH. Physiology, nociceptive pathways. InStatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019.
   Google Scholar
• Zacher J, Altman R, Bellamy N, et al. Topical diclofenac and its role in pain and inflammation: an evidence-based review. Curr Med Res Opin. 2008;24:925–950.
   PubMed Web of Science ®Google Scholar
• Singhvi G, Hejmady S, Rapalli VK, et al. Nanocarriers for topical delivery in psoriasis. In: Shegokar R editor. Deliv. Drugs. Germany: Elsevier Inc.; 2020. p. 75–96.
   Google Scholar
• Girdhar V, Patil S, Banerjee S, et al. Nanocarriers for drug delivery: mini review. Curr Nanomed. 2018;8:88–99.
   Google Scholar
• Waghule T, Sankar S, Rapalli VK, et al. Emerging role of nanocarriers based topical delivery of anti‐fungal agents in combating growing fungal infections. Dermatol Ther. 2020. DOI:10.1111/dth.13905.
   Web of Science ®Google Scholar
• Dey S, Datta S, Dasgupta S, et al. Chapter 13. Lipid nanoparticles for topical application of drugs for skin diseases. In: Grumezescu AM editor. Nanobiomaterials Galen. Formul. Cosmet. UK: Elsevier Inc.; 2016. p. 327–362.
   Google Scholar
• Patel DK, Kesharwani R, Kumar V. Lipid nanoparticle topical and transdermal delivery: a review on production, penetration mechanism to skin. Int J Pharm Investig. 2019;9:148–153.
   Web of Science ®Google Scholar
• Singhvi G, Dubey SK, Patil S, et al. Nanocarriers for Topical Drug Delivery: approaches and Advancements. Nanosci Nanotechnol Asia. 2019;08:329–336.
   Google Scholar
• Waghule T, Rapalli VK, Gorantla S, et al. Nanostructured Lipid Carriers as Potential Drug Delivery Systems for Skin disorders. Curr Pharm Des. 2020. DOI:10.2174/1381612826666200614175236.
   PubMed Web of Science ®Google Scholar
• Rajak P, Nath LK, Bhuyan B. Liquid crystals: an approach in drug delivery. Indian J Pharm Sci. 2019;81:11–23.
   Web of Science ®Google Scholar
• Tamamushi B, Kodaira Y, Matsumura M. A comparative study of thermotropic and lyotropic mesophases formed by ammonium dodecanoate. Colloid Polym Sci. 1976;576:571–576.
   Web of Science ®Google Scholar
• Singhvi G, Banerjee S, Khosa A. Lyotropic liquid crystal nanoparticles: A novel improved lipidic drug delivery system. In: Grumezescu AM, editor. Org. Mater. as Smart Nanocarriers Drug Deliv. UK: William Andrew Publishing; 2018. p. 471–517.
   Google Scholar
• Waghule T, Rapalli VK, Singhvi G, et al. Design of temozolomide-loaded proliposomes and lipid crystal nanoparticles with industrial feasible approaches: comparative assessment of drug loading, entrapment efficiency, and stability at plasma pH. J Liposome Res. 2020;1–11. DOI:10.1080/08982104.2020.1748648
   PubMed Web of Science ®Google Scholar
• Lim DG, Jeong WW, Kim NA, et al. Effect of the glyceryl monooleate-based lyotropic phases on skin permeation using invitro diffusion and skin imaging. Asian J Pharm Sci. 2014;9:324–329.
   Google Scholar
• Yariv D, Efrat R, Libster D, et al. In vitro permeation of diclofenac salts from lyotropic liquid crystalline systems. Colloids Surf B Biointerfaces. 2010;78:185–192.
   PubMed Web of Science ®Google Scholar
• Hundekar YR, Saboji DJK, Patil SM, et al. Preparation and evaluation of diclofenac sodium cubosomes for percutaneous administration. J Pharm Pharm Sci. 2014;3:523–539.
   Google Scholar
• Cohen-Avrahami M, Aserin A, Garti N. HII mesophase and peptide cell-penetrating enhancers for improved transdermal delivery of sodium diclofenac. Colloids Surf B Biointerfaces. 2010;77:131–138.
   PubMed Web of Science ®Google Scholar
• Rapalli VK, Khosa A, Singhvi G, et al. Application of QbD principles in nanocarrier-based drug delivery systems. In: Sarwar Beg MSH, editor. Pharm. Qual. by Des. Academic Press; 2019. p. 255–296.
   Google Scholar
• Soans D, Chandramouli R, Kavitha AN. Roopesh S K SS. Application of design of experiments for optimizing critical quality attributes (CQA) in routine. J Pharm Res. 2016;15:96–100.
   Google Scholar
• Javed MN, Alam MS, Waziri A, et al. QbD applications for the development of nanopharmaceutical products. In: Sarwar Beg MSH, editor, Pharm Qual Des. Academic Press, Cambridge. 2019;229–253.
   Google Scholar
• Srinivas NSK, Verma R, Kulyadi GP, et al. A quality by design approach on polymeric nanocarrier delivery of gefitinib: formulation, in vitro, and in vivo characterization. Int J Nanomedicine. 2017;12:15–28.
   PubMed Web of Science ®Google Scholar
• Garg NK, Sharma G, Singh B, et al. Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): an improved dermatokinetic profile for inflammatory disorder(s). Int J Pharm. 2017;517:413–431.
   PubMed Web of Science ®Google Scholar
• Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2017;12:1–8.
   PubMed Web of Science ®Google Scholar
• Ranga S, Jaimini M, Sharma SK, et al. A review on design of experiments (DOE). Int J Pharm Chem Sci. 2014;3:216–224.
   Google Scholar
• Waghule T, Rapalli VK, Singhvi G, et al. Voriconazole loaded nanostructured lipid carriers based topical delivery system: qbD based designing, characterization, in-vitro and ex-vivo evaluation. J Drug Deliv Sci Technol. 2019;52:303–315.
   Web of Science ®Google Scholar
• Rapalli VK, Banerjee S, Khan S, Jha PN, Gupta G, Dua K, Hasnain MS, Nayak AK, Dubey SK, Singhvi G. QbD-driven formulation development and evaluation of topical hydrogel containing ketoconazole loaded cubosomes. Materials Science and Engineering: C. 2020; 119:111548. .
   Google Scholar
• Anbarasan B, FG X, Shanmuganathan S. An overview of cubosomes - smart drug delivery system. 2015;8:1–4.
   Google Scholar
• Jain S, Yadav P, Swami R, et al. Lyotropic liquid crystalline nanoparticles of amphotericin B: implication of phytantriol and glyceryl monooleate on bioavailability enhancement. AAPS PharmSciTech. 2018;19:1699–1711.
   PubMed Web of Science ®Google Scholar
• Bhattacharjee S. DLS and zeta potential - What they are and what they are not? J Control Release. 2016;235:337–351.
   PubMed Web of Science ®Google Scholar
• Zhang P, Jing T, Zhang J. Preparation, characterization, and evaluation of amphotericin B-loaded MPEG-PCL-g-PEI micelles for local treatment of oral Candida albicans. Int J Nanomedicine. 2017;12:4269–4283.
   PubMed Web of Science ®Google Scholar
• Pradhan M, Singh D, Murthy SN, et al. Design, characterization and skin permeating potential of fluocinolone acetonide loaded nanostructured lipid carriers for topical treatment of psoriasis. Steroids. 2015;101:56–63.
   PubMed Web of Science ®Google Scholar
• Omar S, Ismail A, Hassanin K, et al. Formulation and evaluation of cubosomes as skin retentive system for topical delivery of clotrimazole. J Adv Pharm Res. 2019;3:68–82.
   Google Scholar
• Kosela M. Microscopic methods in analysis of submicron phospholipid dispersions. Acta Pharm. 2016;66:1–22.
   PubMed Web of Science ®Google Scholar
• Sharma A, Sood A, Mehta V, et al. Formulation and physicochemical evaluation of nanostructured lipid carrier for codelivery of clotrimazole and ciprofloxacin. Asian J Pharm Clin Res. 2016;9:356–360.
   Google Scholar
• Agrawal Y, Petkar KC, Sawant KK. Development, evaluation and clinical studies of Acitretin loaded nanostructured lipid carriers for topical treatment of psoriasis. Int J Pharm. 2010;401:93–102.
   PubMed Web of Science ®Google Scholar
• Esposito E, Mariani P, Markus Drechsler RC. Structural studies of lipid-based nanosystems for drug delivery: X-ray Diffraction (XRD) and Cryogenic Transmission Electron Microscopy (Cryo-TEM). In: Aliofkhazraei M, editor. Handb. Nanoparticles. Switzerland: Springer International Publishing; 2015. p. 1–1426.
   Google Scholar
• Zhao L, Xiong H, Peng H. PEG-coated lyophilized proliposomes: preparation, characterizations and in vitro release evaluation of vitamin E. Eur Food Res Technol. 2011;232:647–654.
   Web of Science ®Google Scholar
• Mahmood A, Krishna V, Waghule T, et al. UV spectrophotometric method for simultaneous estimation of betamethasone valerate and tazarotene with absorption factor method: application for in-vitro and ex-vivo characterization of lipidic nanocarriers for topical delivery. Spectrochim Acta Part A Mol Biomol Spectrosc. 2020;235:118310.
   Web of Science ®Google Scholar
• Nogueira AL, Machado RAF, de Souza AZ, et al. Influence of process parameters and scalability of the semi-batch production of functionalized silver nanoparticles. Can J Chem Eng. 2016;94:1472–1485.
   Web of Science ®Google Scholar
• Ramasamy T, Khandasami US, Ruttala H, et al. Development of solid lipid nanoparticles enriched hydrogels for topical delivery of anti-fungal agent. Macromol Res. 2012;20:682–692.
   Web of Science ®Google Scholar
• Abdul Rahman MN, Qader OAJA, Sukmasari S, et al. Rheological characterization of different gelling polymers for dental gel formulation. J Pharm Sci Res. 2017;9:2633–2640.
   Google Scholar
• Jyoti BVS, Baek SW. Rheological Characterization of Ethanolamine Gel Propellants. J Energ Mater. 2016;34:260–278.
   Web of Science ®Google Scholar
• Deuschle VCKN, Norbert Deuschle RA, Bortoluzzi MR, et al. Physical chemistry evaluation of stability, spreadability, in vitro antioxidant, and photo-protective capacities of topical formulations containing calendula officinalis L. Leaf extract. Brazilian J Pharm Sci. 2015;51:63–75.
   Web of Science ®Google Scholar
• Bhabani Shankar N, Prasant Kumar R, Udaya Kumar N, et al. Development and characterization of bioadhesive gel of microencapsulated metronidazole for vaginal use. Iran J Pharm Res IJPR. 2010;9:209–219.
   PubMed Web of Science ®Google Scholar
• Rapalli VK, Kaul V, Gorantla S, et al. UV Spectrophotometric method for characterization of curcumin loaded nanostructured lipid nanocarriers in simulated conditions: method development, in-vitro and ex-vivo applications in topical delivery. Spectrochim Acta Part A Mol Biomol Spectrosc. 2020;224:117392.
   PubMed Web of Science ®Google Scholar
• Luís A, Ruela M, Perissinato AG, et al. Evaluation of skin absorption of drugs from topical and transdermal formulations. Brazilian J Pharm Sci. 2016;52:527–544.
   Web of Science ®Google Scholar
• Rapalli VK, Kaul V, Waghule T, et al. Curcumin loaded nanostructured lipid carriers for enhanced skin retained topical delivery: optimization, scale-up, in-vitro characterization and assessment of ex-vivo skin deposition. Eur J Pharm Sci. 2020;152:105438.
   PubMed Web of Science ®Google Scholar
• Kumar P, Singh S, Mishra D, et al. Enhancement of ketorolac tromethamine permeability through rat skin using penetration enhancers: an ex-vivo study. Int J Pharm Investig. 2015;5:142.
   PubMed Web of Science ®Google Scholar
• Opatrilova R, Cernikova A, Coufalova L, et al. In vitro permeation of micronized and nanonized alaptide from semisolid formulations. Sci World J. 2013;2013. DOI:10.1155/2013/787283
   Web of Science ®Google Scholar
• Padula C, Nicoli S, Pescina S, et al. The influence of formulation and excipients on propranolol skin permeation and retention. BioMed Res Int. 2018;2018. DOI:10.1155/2018/1281673
   Web of Science ®Google Scholar
• Abioye AO, Issah S, Kola-Mustapha AT. Ex vivo skin permeation and retention studies on chitosan-ibuprofen-gellan ternary nanogel prepared by in situ ionic gelation technique - A tool for controlled transdermal delivery of ibuprofen. Int J Pharm. 2015;490:112–130.
   PubMed Web of Science ®Google Scholar
• Dantas MGB, Reis SAGB, Damasceno CMD, et al. Development and evaluation of stability of a gel formulation containing the monoterpene borneol. Sci World J. 2016;2016. DOI:10.1155/2016/7394685
   Google Scholar
• Almousallam M, Moia C, Zhu H. Development of nanostructured lipid carrier for dacarbazine delivery. Int Nano Lett. 2015;5:241–248.
   Web of Science ®Google Scholar
• Wang X, Zhang Y, Gui S, et al. Characterization of lipid-based lyotropic liquid crystal and effects of guest molecules on its microstructure: a systematic review. AAPS PharmSciTech. 2018;19:2023–2040.
   PubMed Web of Science ®Google Scholar
• Nair HA. Optimization of formulation parameters for preparation of docetaxel loaded nanostructured lipid carriers. Int J Pharm Sci Res. 2015;6:2846–2857.
   Web of Science ®Google Scholar
• Madhav S. A review on microemulsion based system. Int J Pharm Sci Res. 2011;2:1888–1899.
   Google Scholar
• Kazemi M, Jaleh Varshosaz MT. Preparation and Evaluation of Lipid-Based Liquid Crystalline Formulation of Fenofibrate. Adv Biomed Res. 2019;6:1–13.
   Google Scholar
• Fini A, Fazio G, Benetti L, et al. Thermal analysis of some diclofenac salts with alkyl and alkylhydroxy amines. Thermochim Acta. 2007;464:65–74.
   Web of Science ®Google Scholar
• Nasr M, Ghorab MK, Abdelazem A. In vitro and in vivo evaluation of cubosomes containing 5-fluorouracil for liver targeting. Acta Pharm Sin B. 2015;5:79–88.
   PubMed Web of Science ®Google Scholar
• El-Enin HA, AL-Shanbari AH. Nanostructured liquid crystalline formulation as a remarkable new drug delivery system of anti-epileptic drugs for treating children patients. Saudi Pharm J. 2018;26:790–800.
   PubMed Web of Science ®Google Scholar
• Zuo J, Gao Y, Bou-Chacra N, et al. Evaluation of the DDSolver software applications. BioMed Res Int. 2014;2014.
   Web of Science ®Google Scholar
• Zhang Y, Huo M, Zhou J, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J. 2010;12:263–271.
   PubMed Web of Science ®Google Scholar
• Effect of compositions in nanostructured lipid carriers (NLC) on skin hydration and occlusion. Int J Nanomedicine. 2013;8:13–22.
   PubMed Web of Science ®Google Scholar
• Peng X, Zhou Y, Han K, et al. Characterization of cubosomes as a targeted and sustained transdermal delivery system for capsaicin. Drug Des Devel Ther. 2015;9:4209–4218.
   PubMed Web of Science ®Google Scholar