PROPRANOLOL HYDROCHLORIDE TOPICAL GEL FOR THE TREATMENT OF INFANTILE HEMANGIOMA
DOI:
https://doi.org/10.22159/ijap.2020v12i6.34373Keywords:
Infantile Hemangioma, Propranolol hydrochloride, Topical gelAbstract
Objective: To formulate and evaluate propranolol hydrochloride topical gel for overcoming the limitations and low oral bioavailability associated with conventional therapy.
Methods: The propranolol hydrochloride topical gels were prepared by the cold mechanical method. The preliminary evaluation and further characterisation studies was conducted to find the optimised formulation. The in vitro release and ex vivo permeation studies were investigated. The histopathological studies and stability studies was also assessed.
Results: The propranolol hydrochloride topical gel was successfully prepared. The in vitro release of optimized topical propranolol hydrochloride gel formulation (G2) showed the highest cumulative percentage drug release that is, 95.55%±0.15 after 7.5 h. (G2) the formulation showed a higher flux value of 4.61μg/cm2/h. The histopathological study using pig skin revealed that the optimized formulation was found to be safe for topical application.
Conclusion: The formulated topical gel containing propranolol Hydrochloride seems to be a promising dosage form for enhanced skin delivery of propranolol hydrochloride in treating Infantile Hemangioma.
Downloads
References
Anil A, Anupa MJ, Gillian R. Approach to infantile hemangiomas. Indian J Dermatol 2016;61:181-6.
Anna LB, Ilona JF. Infantile hemangioma. J Am Acad Dermatol 2006;55:671-82.
Baer AH, Parmar HA. Hemangioma and vascular malformations of the head and neck: a simplified approach. Neuroimaging Clin N Am 2011;21:641-58.
Gresham TR, Adra BF. Hemangioma and vascular malformations: current theory and management. Int J Pediatr 2012:1-10. DOI:10.1155/2012/645678.
Tina SC, Lawrence FE, Sherla F. Infantile hemangiomas: an update on pathogenesis and therapy. J Peditar 2013;131:99-108.
Anita R, Zilda N, Prado D. Infantile hemangioma: pathogenesis and mechanism of action of propranolol. J Dtsch Dermatol Ges 2017;15:1185-90.
Manesh KS, Resham J. Use of propranolol in infantile hemangioma. Indian J Drugs Dermatol 2007;3:40-52.
Price A, Rai S, Mcleod RWJ, Brichall JC. Topical propranolol for infantile haemangiomas: a systemic review. J Eur Acad Dermatol Venereol 2018;32:2083-9.
Deepinder SM, Neeraj M, Gurpreet K. Topical drug delivery systems: a patent review. J Exp Opi Ther Patents 2016;26:213-28.
Debjit B, Harish G, Pragati K. Recent advances in novel topical drug delivery system. T Pharm Inno J 2012;1:12-30.
Hong E, Fischer G. Propranolol for recalcitrant ulcerated hemangioma of infancy. Pediatr Dermatol 2012;29:64-7.
Ashni VE, Sukhdev SI, Rupinder KA, Upendra KJ. A review: topical gels as drug delivery systems. Int J Pharm Sci Rev Res 2013;23:374-82.
Loveleen PR, Tarun KG. Topical gel: a recent approach for novel drug delivery. Asian J Biomed Pharm Sci 2013;3:1-5.
Debjit B, Hareesh G, Pragati B, Duraivel S, Sampath KP. Recent advances in novel drug delivery system. Pharma Innovation 2012;1:12-31.
Karina L, Anthony J. Infantile hemangiomas: an update on pathogenesis, associations and management. Indian J Pae Dermatol 2018;19:293-303.
Poonam M, Kalyanisundarrao K, Dipti G. Formulation and evaluation of topical antifungal gel containing itraconazole. Int J Curr Pharm Res 2018;10:71-4.
Malumani M, Jianbo WU, Song JI. Efficacy of topical propranolol gel in infantile hemangioma. Acad J Ped Neonatol 2018;7:1-3.
Yuanyuan W, Xingeun Z, Yadong X, Junbozhang, Yunchuan Y, Yuangang L. Efficacy and safety of 2% propranolol hydrochloride cream for the treatment of proliferating infantile strawberry hemangioma. Indian J Pediatr 2017;84:425-9.
Arucha T, Suthida C, Nattakarn W, Pattara W. The efficacy of 0.1 % adapalene gel for use in the treatment of childhood acanthosisnigrican: a pilot study. Indian J Dermatol 2015;60:103.
Wenhu Z, Shiyinghe, Yijun Y, Dan J, Xiang C, Jinsong D. Formulation, characterization and clinical evaluation of propranolol hydrochloride gel for transdermal treatment of superficial infantile hemangioma. Drug Dev Ind Pharm J 2014;7:1109-19.
Angush G, Simusingh, Niranj G, Thomas J. Formulation and evaluation of topical niosomal gel containing a combination of benzoyl peroxide and tretinoin for anti-acne activity. Int J Nanomed 2014;10:171-82.
Karin K. Topical propranolol therapy for infantile hemangioma. Pediatr Dermatol 2012;29:154-9.
Veronique S. Propranolol for severe infantile hemangioma: follow up report. Pediatr Dermatol 2009;3:423-8.
Lakshmi PK, Devi G, Bhaskaran S, Sachidanand S. Neosomal methotrexate gel in the treatment of localised psoriasis: phase 1 and phase 11 study. Indian J Dermatol 2007;3:157-67.
Ali I, Arash I, Jonathan K. Propranolol versus corticosteroids in the treatment of infantile hemangioma: a systemic review and meta-analysis. Plast Reconstr Surg 2013;131:601-13.
Li J, Chen X, Zaho S. Demographic and clinical characteristics and risk factors for infantile hemangioma: achinese case-control study. Arch Dermatol 2011;147:1049-56.
Leaute C, Roque ED, Hubiche T, Boralevi F. Propranolol for severe hemangiomas of infancy. N Engl J Med 2008;358:2649-51.
Lou Y, Peng W, Cao Y, Xie J. The effectiveness of propranolol in treating infantile hemangiomas: a meta-analysis including 35 studies. Br J Clin Pharmacol 2013;78:44-57.
Stefan P, James B. Anhydrous carbapol polymer gels for the topical delivery of oxygen/water-sensitive compounds. Int J Pharm Dev Tech 2000;2:249-55.
Yin Z, Wu Qing, Yan Hong S. Effects of carbapol 934 proportion on nanoemulsion gel for topical and transdermal drug delivery: a skin permeation study. Int J Nanomed 2016;11:5971-87.
Tamasree M, Gopa R, Sutapa B. Hydroxypropyl methyl cellulose: different aspects in drug delivery. J Pharm Pharmacol 2016;4:381-5.
Huichao W, Shouying D, Yang L. The application of biomedical polymer material hydroxyl propyl methyl cellulose in pharmaceutical preparations. J Chem Pharm Res 2014;6:155-60.
Libei S. The estrogenicity of methylparaben and ethylparaben at doses close to the acceptable daily intake in premature sprague-dawley rats. Sci Rep 2016;6:251-73.
Markus S, Andreas R, Hansjoer, Peter R. Topical treatment with propranolol gel as a supplement to the existing treatment of hemangiomas. World J Pediatr 2014;10:313-7.
Lopalco A, Ali H, Denora N, Rytting E. Oxcarbamazepine loaded polymeric nanoparticles: development and permeability studies across in vitro models of the blood-brain barrier and human placental trophoblast. Int J Nanomed 2015;10:1895-996.
Pardakhty A, Varshosaz J, Rouholamini A. In vitro study of polyoxyethylene alkyl ether niosomes for delivery of insulin. Int J Pharm 2007;328:130-41.
Stan CD, Tataringa G, Gafitanu C, Dragan M, Braha S, Popescu MC, et al. Preparation and characterization of niosomes containing metronidazole. Res J Pharm Biol Chem Sci 2013;61:1178-85.
Japan P, Brijesh P, Hardeeosingh B, Kaushal P. Formulation and evaluation of topical aceclofenac gel using the different gelling agent. Int J Drug Dev Res 2011;3:156-64.
Harish NM, Prabhu P, Charyulu RN, Gulzar MA, Subrahmanyam EVS. Formulation and evaluation of insitu gels containing clotrimazole for oral candidiasis. Indian J Pharm Sci 2009;71:421-7.
Sreeja CN, Mable SJ, Anoop KR. In situ gel: an innovative approach for safe and sustained nasal drug delivery. Int J Pharm Sci Rev 2014;24:1-7.
Roychowdhury S, Singh DH, Gupta R, Masih D. A review on the pharmaceutical gel. Int J Pharm Res Bio Sci 2012;1:21-36.
Swetha CH, Sellappan VP, Narayana RG, Nagarjuna R. Formulation and evaluation of clarithromycin topical gel. Int J Drug Dev Res 2013;5:194-202.
Jain S, Padsalg BD, Patel AK, Mokale V. Formulation, development and evaluation of fluconazole gel in various polymer bases. Asian J Pharm 2017;1:3-8.
Cristina P, Sara N, Silvia P, Patrizia S. The influence of formulation and excipients on propranolol skin permeation and retention. Biomed Res Int 2018;8:1-7.
Markus S, Andreas R, Hansjoer, Peter R. Topical treatment with propranolol gel as a supplement to the existing treatment of hemangiomas. World J Pediatr 2014;10:313-7.
Prateek CH, Rajesh ST, Umesh RA. A review on the topical gel. Int J Pharm Bio Agric 2013;4:606-13.
Sudipta DA, Arnab SA, Ananya BO. Design, development and evaluation of fluconazole topical gel. Asian J Pharm Clin Res 2015;8:132-5.
Gupta A, Mishra AK, Singh AK, Gupta V, Bansal P. Formulation and evaluation of topical gel of diclofenac sodium using different polymers. Drug Invent Today 2010;2:250-3.
Modamio CF, Lastra, Marino EL. A comparative in vitro study percutaneous penetration of β-blockers in human skin. Int J Pharm 2000;194:249-59.
Suneetha C, Uma R, Kiranmai M, Vidhyallatha C. Formulation and evaluation of transdermal drug delivery of topiramate. Int J Pharma Investig 2017;1:10-7.
Sherafudheen SP, Vasantha PV. Development and evaluation of in situ nasal gel formulations of loratadine. Res Pharm Sci 2015;10:466-76.
Andre L, Aline G, Monica E. Evaluation of skin absorption of drugs from topical and transdermal formulations. Braz J Pharm Sci 2016;3:528-44.
Chantasart D, Hao J, Li S. Evaluation of skin permeation of β-blockers for topical drug delivery. Pharm Res 2013;30:866-77.
Kumar MV, Aravindram AS, Rohitash K, Gowda DV, Parjanya K. Formulation and evaluation of in-situ gel of bromhexine hydrochloride for nasal delivery. Der Pharma Sin 2012;3:699-707.
Kute JU, Darekar AB, Saudagar RB. In situ gel-novel approach for nasal delivery. World J Pharm Pharm Sci 2013;3:187-203.
Mandal S, Thimmasetty MK, Prabhushankar GL, Geetha MS. Formulation and evaluation of an insitu gel-forming ophthalmic formulation of moxifloxacin hydrochloride. Int J Pharma Investig 2012;2:78-82.
Ahamed U, Gihan F, Tahani EF. Performance of meloxicam niosomal gel formulations for transdermal drug delivery. Br J Pharm Res 2016;12:1-14.
Kumar PA, Singh P, Karthick K, Arulkumaran KS. Formulation and evaluation of sustained released niosomes containing pregabalin. Int J Pharm Life Sci 2013;4:2770-4.
Guadalupe N, Elizabeth P, Luis M, David Q, Adriana G. Formulation and in vitro, ex vivo and in vivo evaluation of elastic liposomes for transdermal delivery of ketorolac tromethamine. Int J Pharm 2011;3:954-70.
Aswathy SN, Vidhya KM, Saranya TR, Sreelakshmy KR, Sreeja CN. Mucoadhesive buccal patch of cefixime trihydrate using biodegradable natural polymer. Int J Pharm Pharm Sci 2014;6:366-71.
Soumya S, Doney AB, Sabitha M. Current trends in lipid-based delivery systems and its applications in drug delivery. Asian J Pharm Clin Res 2012;4:4-9.
Published
How to Cite
Issue
Section
