Formulation and ex vivo skin permeation of lidocaine HCl topical gels using dillenia (Dillenia indica L.) fruit gum
Abstract
Current work was endeavoured to formulate the topical gels of 4 % lidocaine HCl by employing dillenia (Dillenia indica L.,) fruit gum (DG) extracted from ripen fruits (14.73% yield). Physicochemical properties such as colour, odour, taste, aqueous solubility, pH and viscosity of this extracted DG were evaluated. Occurrence of carbohydrates and mucilage was confirmed by phytochemical identification tests and was characterized by employing FTIR and 1H NMR spectroscopy. Employing extracted DG along with Carbopol 940 (as gel-forming materials), propylene glycol (as plasticizer), methyl paraben (as preservative) and menthol (as permeation enhancer), topical gels containing 4 % lidocaine HCl were formulated. The pH and viscosity of these gels were satisfactory. The ex vivo skin permeation of lidocaine HCl across excised porcine ear skin membrane from formulated and marketed topical gels containing 4 % lidocaine HCl exhibited sustained permeation over 7 h. Highest lidocaine HCl permeation flux (1589.66 ± 13.36 µg/cm2/h) was measured for the gel containing 0.1 % menthol. Korsmeyer-Peppas model was found as the best-fitting drug permeation model (R2 = 0.9944-0.9992) with super case-II transport mechanism (n = 0.97-1.07). These topical gels of lidocaine HCl (4 %) were found physically stable enough without syneresis in the freeze thaw cycling process.
References
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[26] A.K. Nayak, S.A. Ahmed, M. Tabish, M.S. Hasnain. Natural polysaccharides in tissue engineering applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 531-548.
[27] H. Bera, Y.F. Abbasi, M.S. Hasnain, A.K. Nayak. Sterculia gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 223-247.
[28] S. Dey, B.C. Nandy, J.N. De, M.S. Hasnain, A.K. Nayak. Tamarind gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 285-306.
[29] A. Samanta, A. De, M.S. Hasnain, H. Bera, A.K. Nayak. Gum odina as pharmaceutical excipient. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 327-337.
[30] A.K. Nayak, M.T. Ansari, F. Sami, H. Bera, M.S. Hasnain. Cashew gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 263-283.
[31] M.T. Ansari, F. Sami, S. Majeed, M.S. Hasnain, V.B. Badgujar. Design and evaluation of topical herbal antifungal stick containing extracts of Rhinacanthus nasutus. J Herb Med. (2019) 100290.
[32] P.R. Guru, H. Bera, M.P. Das, M.S. Hasnain, A.K. Nayak. Aceclofenac-loaded Plantago ovata F. husk mucilage-Zn+2-pectinate controlled-release matrices. Starch. 70(3-4) 1700136.
[33] B.P. Sahu, H.K. Sharma, M.K. Das. Development and evaluation of a mucoadhesive nasal gel of felodipine prepared with mucoadhesive substance of Dillenia indica L. Asian J Pharm Sci. 5(2011) 175-187.
[34] H.K. Sharma, S. Lahkar, L.K. Nath. Extraction, Characterisation and compatibility study of polysaccharides from Dillenia indica and Abelmoschus esculentus with metformin hydrochloride for development of drug delivery system. Int J PharmTech Res. 5(2013) 275-283.
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[36] H.K. Sharma, S.P. Pradhan, B. Sarangi. Preparation and in vitro evaluation of mucoadhesive microbeads containing timolol maleate using mucoadhesive substances of Dellinia india L. Arch Pharm Res. 1(2009) 181-188.
[37] H.K. Sharma, S.P. Pradhan, B. Sarangi. Enteric controlled release pantoprazole loaded microbeads using natural mucoadhesive substance from Dillenia indica L. Int J PharmTech Res. 2(2010) 542-551.
[38] A.K. Nayak, D. Pal, K. Santra. Screening of polysaccharides from tamarind, fenugreek and jackfruit seeds as pharmaceutical excipients. Int J Biol Macromol. 79(2015) 756-760.
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[40] A.K. Nayak, D. Pal, D.R. Pany, B. Mohanty. Evaluation of Spinacia oleracea L. leaves mucilage as innovative suspending agent. J Adv Pharm Technol Res. 1(2010) 338-341.
[41] A.K. Nayak, D. Pal, J. Pradhan, T. Ghorai. The potential of Trigonella foenum-graecum L. seed mucilage as suspending agent. Indian J Pharm Educ Res. 46(2012) 312-317.
[42] J. Malakar, S.O. Sen, A.K. Nayak, K.K. Sen. Development and evaluation of microemulsions for transdermal delivery of insulin, ISRN Pharm. 2011, Article ID 780150.
[43] J. Malakar, S.O. Sen, A.K. Nayak, K.K. Formulation, optimization and evaluation of transferosomal gel for transdermal insulin delivery, Saudi Pharm J. 20(2012) 355-363.
[44] S.W. Cui. Structural analysis of polysaccharides, In: Cui SW (ed) Food Carbohydrates: Chemistry, Physical Properties, and Applications. Taylor and Francis, Boca Raton, 2005 pp. 105-57.
[45] M.S Hasnain, P. Rishishwar, S. Rishishwar, S. Ali, A.K. Nayak. Isolation and characterization of Linum usitatisimum polysaccharide to prepare mucoadhesive beads of diclofenac sodium. Int J Biol Macromol. 116(2018) 162-172.
[46] M.S Hasnain, P. Rishishwar, S. Rishishwar, S. Ali, A.K. Nayak. Extraction and characterization of cashew tree (Anacardium occidentale) gum; use in aceclofenac dental pastes. Int J Biol Macromol. 116(2018) 1074-1081.
[47] I.B. Pathan, C.M. Setty. Chemical penetration enhancers for transdermal drug delivery systems. Trop J Pharm Res. 8(2009) 173-179.
[48] A.K. Jain, N.S. Thomas, R. Panchangnula. Transdermal drug delivery of imipramine hydrochloride.: I. Effect of terpenes. J Control Rel. 79(2002) 93-101.
[2] T. Waghule, V.K. Rapalli, G. Singhvi, P. Manchanda, N. Hans, S.K. Dubey, M.S. Hasnain, A.K. Nayak. Voriconazole loaded nanostructured lipid carriers based topical delivery system: QbD based designing, characterization, in-vitro and ex-vivo evaluation. J Drug Deliv Sci Technol. 52(2019) 303-315.
[3] B. Das, S.O. Sen, R. Maji, A.K. Nayak, K.K. Sen. Transferosomal gel for transdermal delivery of risperidone. J Drug Deliv Sci Technol. 38((2017) ) 59-71.
[4] S. Jana, S.A. Ali, A.K. Nayak, K.K. Sen, S.K. Basu. Development and optimization of topical gel containing aceclofenac-crospovidone solid dispersion by “Quality by Design” approach. Chem Eng Res Des. 92(2014) 2095-2105.
[5] S. Jana, S. Manna, A.K. Nayak, K.K. Sen, S.K. Basu. Carbopol gel containing chitosan-egg albumin nanoparticles for transdermal aceclofenac delivery. Colloids Surf. B: Biointerf. 114(2014) 36-44.
[6] J. Malakar, A. Basu, A.K. Nayak. Candesartan cilexetil microemulsions for transdermal delivery: Formulation, in-vitro skin permeation and stability assessment. Curr Drug Deliv. 11(2014) 313-321.
[7] M.S. Hasnain, M.N. Javed, M.S. Alam, P. Rishishwar, S. Rishishwar, S. Ali, A.K. Nayak, S. Beg. Anthocyanin mediated Green Synthesis of Optimized Silver Nanoparticles from Purple Heart Plant: Investigation of process-variables impact using Box-Behnken and Evaluation of Antimicrobial Activity. Materials Science & Engineering C. 99(2019) 1105-114.
[8] H.A.E. Benson. Skin structure, function, and permeation. In: Watkinson, AC & Benson HA (eds), Topical and Transdermal Drug Delivery and Development. John Wiley & Sons Inc., NJ, USA, (2012) pp. 3–22.
[9] K. Dua, K. Pabreja, M.V. Ramana. Aceclofenac topical dosage forms: In vitro and in vivo characterization. Acta Pharm. 60(2010) 467-478.
[10] Y.G. Bachhav, V.B. Patravale. Formulation and evaluation of meloxicam gels. Acta Pharm. 60(2010) 153–163.
[11] A.K. Nayak, B. Mohanty, K.K. Sen. Comparative evaluation of in vitro diclofenac sodium permeability across excised mouse skin from different common pharmaceutical vehicles. Int J PharmTech Res. 2(2010) 920-930.
[12] G.M.E. Reiz, S.L. Reiz. EMLA – a eutectic mixture of local anaesthetics for topical anaesthesia. Acta Anaesthesiol Scand. 26(1982) 596–598.
[13] B. Das, A.K. Nayak, U. Nanda. Topical gels of lidocaine HCl using cashew gum and Carbopol 940: Preparation and in vitro skin permeation. Int J Biol Macromol. 62(2013) 514-517.
[14] Y. Wang, W. Su, Q. Li, C. Li, H. Wang, Y. Li, Y. Cao, J. Chang, L. Zhang. Preparation and evaluation of lidocaine hydrochloride-loaded TAT-conjugated polymeric liposomes for transdermal delivery. Int J Pharm. 441(2013) 748-756.
[15] P.J. Lee, N. Ahamad, R. Langer, S. Mitragotri, V.P. Shastri. Evaluation of chemical enhancers in the transdermal delivery of lidocaine, Int J Pharm. 308(2006) 33-39.
[16] D.W. Smith, M.R. Peterson, S.C. DeBerard. Regional anesthesia; Nerve blocks of the extremities and face. Postgrad Med. 106(1999) 57–60.
[17] P.P. Sarpotdar, J.L. Zatz. Evaluation of penetration enhancement of lidocaine by nonionic surfactants through hairless mouse skin in vitro. J Pharm Sci. 75(1986) 176–181.
[18] M.S. Hasnain, P. Rishishwar, S. Ali. Use of cashew bark exudate gum in the preparation of 4 % lidocaine HCL topical gels. Int J Pharm Pharm Sci. 9(2017) 146-150.
[19] M.C. Rowbotham, P.S. Davies, H.L. Fields. Topical lidocaine gel reduces pain in post-herpetic neuralgia. Ann Neurol. 37(1995) 246-253.
[20] C.C. Mueller-Goymann, S.G. Frank. Interaction of lidocaine and lidocaine-HCl with liquid crystal structure of topical preparations. Int J Pharm. 29(1986) 147-159.
[21] S.C. Shin, C.W. Cho, K.H. Yang. Development of lidocaine gels for enhanced local anesthetic action. Int J Pharm. 287(2004) 73–78.
[22] A.K. Nayak, J. Malakar, D. Pal, M.S. Hasnain, S. Beg. Soluble starch-blended Ca2+-Zn2+-alginate composites-based microparticles of aceclofenac: Formulation development and in vitro characterization. Fut J Pharm Scien. 4(2017) 63-70. https://doi.org/10.1016/j.fjps.2017.10.001.
[23] A.K. Nayak, T.J. Ara, M.S. Hasnain, N. Hoda. Okra gum-alginate composites for controlled drug releasing delivery. Inamuddin (eds). In: Applications of Nanocomposite Materials in Drug Delivery. Elsevier, Cambridge: UK, 2018, pp 761-785.
[24] M. Milivojevic, I. Pajic-Lijakovic, B. Bugarski, A.K. Nayak, M.S. Hasnain. Gellan gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 145-186.
[25] S.M.M. Hasnain, M.S. Hasnain A.K. Nayak. Natural polysaccharides: sources and extraction methodologies. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 1-14.
[26] A.K. Nayak, S.A. Ahmed, M. Tabish, M.S. Hasnain. Natural polysaccharides in tissue engineering applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 531-548.
[27] H. Bera, Y.F. Abbasi, M.S. Hasnain, A.K. Nayak. Sterculia gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 223-247.
[28] S. Dey, B.C. Nandy, J.N. De, M.S. Hasnain, A.K. Nayak. Tamarind gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 285-306.
[29] A. Samanta, A. De, M.S. Hasnain, H. Bera, A.K. Nayak. Gum odina as pharmaceutical excipient. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 327-337.
[30] A.K. Nayak, M.T. Ansari, F. Sami, H. Bera, M.S. Hasnain. Cashew gum in drug delivery applications. M.S. Hasnain, A.K. Nayak (eds). In: Natural Polysaccharides in Drug Delivery and Biomedical Applications. Elsevier, Cambridge: UK, 2019, pp 263-283.
[31] M.T. Ansari, F. Sami, S. Majeed, M.S. Hasnain, V.B. Badgujar. Design and evaluation of topical herbal antifungal stick containing extracts of Rhinacanthus nasutus. J Herb Med. (2019) 100290.
[32] P.R. Guru, H. Bera, M.P. Das, M.S. Hasnain, A.K. Nayak. Aceclofenac-loaded Plantago ovata F. husk mucilage-Zn+2-pectinate controlled-release matrices. Starch. 70(3-4) 1700136.
[33] B.P. Sahu, H.K. Sharma, M.K. Das. Development and evaluation of a mucoadhesive nasal gel of felodipine prepared with mucoadhesive substance of Dillenia indica L. Asian J Pharm Sci. 5(2011) 175-187.
[34] H.K. Sharma, S. Lahkar, L.K. Nath. Extraction, Characterisation and compatibility study of polysaccharides from Dillenia indica and Abelmoschus esculentus with metformin hydrochloride for development of drug delivery system. Int J PharmTech Res. 5(2013) 275-283.
[35] K. Ketousetuo, A.K. Bandyopadhyay. Development of oxytocin nasal gel using natural mucoadhesive agent obtained from the fruits of Dellinia indica. L. Sci Asia. 33(2007) 57-60.
[36] H.K. Sharma, S.P. Pradhan, B. Sarangi. Preparation and in vitro evaluation of mucoadhesive microbeads containing timolol maleate using mucoadhesive substances of Dellinia india L. Arch Pharm Res. 1(2009) 181-188.
[37] H.K. Sharma, S.P. Pradhan, B. Sarangi. Enteric controlled release pantoprazole loaded microbeads using natural mucoadhesive substance from Dillenia indica L. Int J PharmTech Res. 2(2010) 542-551.
[38] A.K. Nayak, D. Pal, K. Santra. Screening of polysaccharides from tamarind, fenugreek and jackfruit seeds as pharmaceutical excipients. Int J Biol Macromol. 79(2015) 756-760.
[39] C.K. Kokate, A.P. Purohit, S.B. Gokhale. Text Book of Pharmacognosy, 38th edition, Nirali Prakashan, Pune, India, 2000, pp. 7135-445.
[40] A.K. Nayak, D. Pal, D.R. Pany, B. Mohanty. Evaluation of Spinacia oleracea L. leaves mucilage as innovative suspending agent. J Adv Pharm Technol Res. 1(2010) 338-341.
[41] A.K. Nayak, D. Pal, J. Pradhan, T. Ghorai. The potential of Trigonella foenum-graecum L. seed mucilage as suspending agent. Indian J Pharm Educ Res. 46(2012) 312-317.
[42] J. Malakar, S.O. Sen, A.K. Nayak, K.K. Sen. Development and evaluation of microemulsions for transdermal delivery of insulin, ISRN Pharm. 2011, Article ID 780150.
[43] J. Malakar, S.O. Sen, A.K. Nayak, K.K. Formulation, optimization and evaluation of transferosomal gel for transdermal insulin delivery, Saudi Pharm J. 20(2012) 355-363.
[44] S.W. Cui. Structural analysis of polysaccharides, In: Cui SW (ed) Food Carbohydrates: Chemistry, Physical Properties, and Applications. Taylor and Francis, Boca Raton, 2005 pp. 105-57.
[45] M.S Hasnain, P. Rishishwar, S. Rishishwar, S. Ali, A.K. Nayak. Isolation and characterization of Linum usitatisimum polysaccharide to prepare mucoadhesive beads of diclofenac sodium. Int J Biol Macromol. 116(2018) 162-172.
[46] M.S Hasnain, P. Rishishwar, S. Rishishwar, S. Ali, A.K. Nayak. Extraction and characterization of cashew tree (Anacardium occidentale) gum; use in aceclofenac dental pastes. Int J Biol Macromol. 116(2018) 1074-1081.
[47] I.B. Pathan, C.M. Setty. Chemical penetration enhancers for transdermal drug delivery systems. Trop J Pharm Res. 8(2009) 173-179.
[48] A.K. Jain, N.S. Thomas, R. Panchangnula. Transdermal drug delivery of imipramine hydrochloride.: I. Effect of terpenes. J Control Rel. 79(2002) 93-101.
Published
2020-03-20
How to Cite
Hasnain, M., Rishishwar, P., Ali, S., Alkahtani, S., Tabish, M., Milivojevic, M., Ansari, M., & Nayak, A. (2020). Formulation and ex vivo skin permeation of lidocaine HCl topical gels using dillenia (Dillenia indica L.) fruit gum. Revista Mexicana De Ingeniería Química, 19(3), 1465-1476. https://doi.org/10.24275/rmiq/Mat1185
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Materials
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