FORMULATION AND EVALUATION OF MOUTH-DISSOLVING FILM OF AN H1 ANTIHISTAMINE DRUG
DOI:
https://doi.org/10.22159/ijcpr.2022v14i6.2062Keywords:
Mouth dissolving films, Sodium alginate, Guar-gum, Disintegration, Drug content, Dissolution and solvent casting methodAbstract
Objective: The objective of present work was to develop a Mouth dissolving film of Levocetirizine dihydrochloride drug by Solvent casting method using different natural polymers. The best polymer was selected on the basis of the release of the drug and disintegration time.
Methods: Sodium alginate and Guar gum are used as a natural polymers. Starch is used as a disintegrant. Glycerol is used as a plasticizer. Citric acid is usedas a saliva-stimulating agent. Mannitol is used as a sweetener. Peppermint oil as a flavoring agent. Mouth-dissolving films were prepared by using the solvent casting method.
Results: The compatibility study of the drug with different natural polymers was carried out. The IR spectral studies showed no interaction between drug and polymers. Obtained satisfactory results for Preformulation and post-formulation tests. Formulation F6 containing sodium alginate, F9 containing guar gum and F14 containing a combination ratio of (Sodium alginate: guar gum) showed good results throughout the study. The stability studies on the formulations F6, F9 and F14 indicates that there is no significant change in physical appearance, disintegration time and drug content release study.
Conclusion: From the results, it was concluded that the Mouth dissolving films of Levocetirizine dihydrochloride containing natural polymer sodium alginate (F6) showed the least disintegration time (14.28 sec), highest dissolution rate (98.24%) than the formulation containing natural polymer guar gum and combination ratio of (Sodium alginate: guar gum).
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Yadav VK, Patel AK, Mishra MK. Formulation and evaluation of mouth dissolving tablet of Levocetrizine dihydrochloride. Int J Sci Eng Res (IJSR). 2018;7(6):549-58. doi: 10.21275/ART20183181.
Saini S, Nanda A, Dhari J. Formulation development and evaluation of oral fast dissolving anti-allergic film of Levocetrizine dihydrochloride. J Pharm Sci Res. 2011;3(7):1322-5.
Jahangir MA, Saleem MA, Patel HR, Kazmi I, Muheem A, Ahmad K. Formulation and evaluation of oral fast dissolving films of levocetirizine. World J Pharm Pharm Sci. 2014;3(9):1310-23.
Yadav A, Sharma V, Tripathi S, Soni SL. Oral fast dissolving film: a novel formulation, Asian. J Pharm Res Dev. 2020;8(4):77-82.
Aggarwal J, Jindal K, Singh G. Formulation and evaluation of oral fast dissolving films of granisetron hydrochloride using different polymers. Int Res J Pharm. 2015;6(10):724-8. doi: 10.7897/2230-8407.0610141.
Parthasarathi K Keshavarao, Dixit Mudit, Gunashekara K, Shahnawazanis, Singhmangla N, Kulkarni Ajay. Formulation and evaluation of Mouth dissolving film containing Rofecoxib. International Research Journal of Pharmacy 2011;2(3):273-8.
Patil P, Shrivastava SK. Fast dissolving oral films: an innovative drug delivery system. Int J Sci Eng Res. 2014;3:2088-93.
Radhakisan UR, Chavan V, Tribhuvan N. Mouth dissolving film and their [patent]. An overview. International Research Journal of Pharmacy. 2012;3(9):39-42.
Shelar AC, Patil PS, Rane RA, Gurchal AB, Nair SM, Kanitkar SV. A comprehensive review on fast mouth dissolving film as novel drug delivery system. Int J Pharm Life Sci. 2020;11(7):6797-811.
Panchal MS, Patel Hiren, Aarti Bagada, Vadalia KR. Formulation and evaluation of mouth-dissolving film of ropinirole hydrochloride by using pullulan polymers. Int J Pharm Res Allied Sci. 2012;1(3):60-72.
Sevinc Ozakar R, Ozakar E. Current overview of oral thin films. Turk J Pharm Sci. 2021;18(1):111-21. doi: 10.4274/tjps.galenos.2020.76390. PMID 33634686.
Meghana R. An overview on mouth dissolving film. Asian J Pharm Clin Res 2018;11(4). doi: 10.22159/ajpcr.2018.v11s4.31712.
Bilal Quazi, Unhale S, Shelke S, Kale P, Prof Sarode R, Biyani KR. A review on mouth dissolving films, European. J Pharm Med Res. 2020;7(3):232-8. doi: https://www.researchgate.net/publication/339599756.
Bhattarai M, Gupta AK. Fast dissolving oral films: a novel trend to oral drug delivery system. Sunsari Tech Coll J. 2015;2(1):58-68. doi: 10.3126/stcj.v2i1.14802.
Kiran Reddy TU, Kumar Reddy KS, Katta, Manogna Prof K, Thyagaraju A. Detailed review on fast dissolving oral films. Indo Am J Pharm Res. 2018;8(6):1315-26.
Pandit Shubham R, Shendge Raosaheb S, Pulate Aniket J, Patil Suresh D, Pathare Vaishnavi B, Punekar AS. A review on: mouth dissolving film. Int J Pharm Res Appl. 2021:370-8.
Harshal Ashokpawar, Swati Ramesh Kamat. Development and evaluation of mouth-dissolving film of ondansetron hydrochloride using HPMC E5 in combination with taro gum and other commercially available gums. J Mol Pharm Org Process Res. 2017;5(1):138.
Shinde M, Choure V, Rathod S, Birajdar A, Amithjadhav. Formulation and evaluation of oral fast dissolving film of Cinnerizine. Indo Am J Pharm Sci. 2018;5(4):2316-25.
Rana S, Raju L, Dhatwalia V, Yadav V. Formulation and evaluation of domperidone fast dissolving film by using different polymers. Int J Pharm Res Health Sci. 2014;2(5):374-8.
irfan M, Rabel S. Quratuain Bukhtar, Muhammad Imran Qadir, Farhat Jabeen and Ahmed Khan. Orally disintegrating films: A modern expansion in drug delivery System. Saudi Pharma J 2016;24(5):537-46.
koland M, Sandeep VP, Charyulu NR. Fast dissolving sublingual Films of ondansetron hydrochloride: effect of additives on in vitro drug release and mucosal permeation. J Young Pharm. 2010;2(3):216-22. doi: 10.4103/0975-1483.66790, PMID 21042474.
Anjumpathan M Kumargupta, Neetesh Kumarjain, Ankitadubey, Ankit Agrawal. Formulation and evaluation of fast-dissolving oral film of promethazine hydrochloride using different surfactant. J Innov Pharm Biol Sci. 2016;3(1):74-84.
Trivedi J, Jankipatel U. Formulation development and evaluation of fast dissolving film of Cinnerizine. Int J Pharm Res Biosci. 2014;3(2):639-52.
Maheshwari KM, Devineni P, Deekonda S, Shaik S Nagapravallikauppala, Buchi N Nalluri. Development and evaluation of mouth-dissolving films of amlodipine besylate for enhanced therapeutic efficacy. J Pharm. 2014;10:1-10.
B Sontakke Patil S, Daswadkar DS. A comprehensive review: natural polymers used for fast dissolving mouth film. IJPSRR 2020;65(2):14-21. doi: 10.47583/ijpsrr.2020.v65i02.003.
Ravi SK, Chandrakala V. Mouth dissolving films: an innovative drug delivery system, international. Mod Pharm Res. 2021;5(4):47-53.
Yadav A, Sharma V, Tripathi S, Soni SL. Oral fast dissolving film: A novel formulation, Asian. J Pharm Res Dev. 2020;8(4):77-82. doi: 10.22270/ajprd.v8i4.769.
Anjuman Pathan M Kumargupta, Neetesh Kumarjain, Ankita Dubey, Ankit Agarwal. Formulation and evaluation of fast dissolving oral film of Promethazine HCL using different super Surfactant. Journal of Innovations in Pharmaceuticals and Biological Sciences 2016;3(1):78-84.
Akhtar S, Hussain S, Mandal SK. Formulation development and characterization of effervescent tablets along with levocetirizine dihydrochloride. Asian J Pharm Clin Res. 2020;13(8):124-30. doi: 10.22159/ajpcr.2020.v13i8.38058.
Pagilla P, Vishnu P, Konde A. Formulation and evaluation of lovastatin oral disintegration thin films. GSC Biol Pharm Sci; 2018;3(2):35-42. doi: 10.30574/gscbps.2018.3.2.0061.
Ravi SK, V Chandrakala. Mouth dissolving films: an innovative drug delivery system. International Journal of Modern Pharmaceutical Research. 2021;5(4):47-53.
Baviskar Ad. Bari MM, Barhatesd. Formulation optimization and evaluation of mouth dissolving film of aprepitant. Asian J Pharm Clin Res. 2019;12(9):154-63. doi: 10.22159/ajpcr.2019.v12i9.34553.
Nair SS. Roopitha Padmanabhanandsreena K. Development and evaluation of fast dissolving oral thin film Containing prochlorperazine maleate. Eur J Pharm Med Res. 2016;3(1):379-84.
Neelima Rani T. Mallareddy pharmacy college, dhulapally, secunderabad, formulation development and optimization of oral thin films of Zolpidem Tartarate. Medical Science and Healthcare Practice. 2017;1(1):26-41. doi: 10.22158/mshp.v1n1p26.
Kathpalia H, Patil A. Formulation and evaluation of orally disintegrating films of levocetirizine dihydrochloride. Indian J Pharm Sci. 2017;79(2):204-11. doi: 10.4172/Pharmaceutical-Sciences.1000218.
Jadhav SD, Kalambe RN, Jadhav CM, Tekade BW, Patil VR. Formulation and evaluation of fast-dissolving oral film of levocetirizine dihydrochlorid. Int J Pharm Pharm Sci. 2012;4(1):337-41.
Nirmala P. Formulation and evaluation of fast dissolving oral films incorporated with ramipril and Β-cyclodextrin complex. Int J Pharm Sci Drug Res. 2020;12(4):390-5. doi: 10.25004/IJPSDR.2020.120412.
Shruthi BK, Chandrakala V, Srinivasan S. Role of superdisintegrants in rapid dissolving oral film. Int J Pharm Sci Rev Res. 2022;75(2):110-6. doi: 10.47583/ijpsrr.2022.v75i02.018.
Bhageerathy A, Sandhya Murali TST, Sigi Vasanthkumar PV. Formulation and evaluation of fast-dissolving film of losartan potassium. Int J Pharm Sci Rev Res. 2021;68(1):237-41. doi: 10.47583/Ijpsrr.2021.V68i01.036.
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