THE DEVELOPMENT AND CHARACTERISATION OF FAST DISSOLVING FILM OF POORLY WATERSOLUBLE DRUG LURASIDONE HYDROCHLORIDE
DOI:
https://doi.org/10.22159/ijap.2021v13i1.39492Keywords:
Lurasidonehydrochloride, Hydroxyl propyl methylcellulose, Fastdissolving films, Solvent casting, In vitro drug releaseAbstract
Objective: The objective of the present work was to formulate and evaluate a fast-dissolving oral film of lurasidone hydrochlorideused as an atypical antipsychotic for the treatment of schizophrenia capable of providing faster onset of action.
Methods: The fastdissolving films of lurasidone hydrochloride were prepared by the solvent casting technique using different compositions and combinations of hydroxypropyl methylcellulose E-3, E-5, E-15, and K4M as fast-dissolving polymer bases. A set of seven formulations were prepared and evaluated for parameters like physical characterization, thickness, weight uniformity, mechanical characteristics (folding endurance,tensile strength), surface pH, in vitro disintegration time, drug content, and an in vitro drug release.
Results: The prepared films exhibited uniform and a smooth surface with uniform weight, thicknessand 89-90% mg drug content. The formulation F7 Showed excellent elasticity and disintegration within seconds. Lurasidone hydrochloride was rapidly released in vitro from all formulations. The release was found to be rapid and maximum of 41.5% in Phosphate buffer pH 6.8 and 58.6% in 0.1 N hydrochloric acid over a period of 30 min. The further optimized formulation F7Adepicted a faster and maximum release of 78% as compared to the marketed tablet 74%.
Conclusion: The developed formulation is a better alternative to tablets by its ability to produce good drug release.
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KinonBJ, Hill AL, Hong LS, KollackS. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia. Int J Neuropsychopharmacol2003;6:97-102.
Arya A, Chandra A, Sharma V,Pathak K. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J Chem Tech Res 2010;2:576-83.
San L, Casillas M, Ciudad A, Gilaberte I. Olanzapine orally disintegrating tablet: a review of efficacy and compliance. CNS NeurosciTher2008;14:203-14.
Tamer MA, Hammid SN, Ahmed B. Formulation and in vitro evaluation ofbromocriptinemesylate as fast dissolving oral film. Int J Appl Pharm 2018;10:7-20.
Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: a new approach to oral drug delivery system. IntJPharmInvest2013;3:67-76.
LeeY, KimK, Kim M, Choi DH, Jeong SH. Orally disintegrating films focusing on the formulation, manufacturing process, and characterization. J Pharm Invest2017;47:183–201.
Meyer J, Loebel AD,Schweizer E. Lurasidone: a new drug in development for schizophrenia. ExprtOpin Invest Drugs 2009;18:1715-26.
Franklin R, Zorowitz S, Corse AK, Widge AS, Deckersbach T. Lurasidone for the treatment of bipolar depression: an evidence-based review. NeuropsychiatrDisTreat2015;11:2143-52.
Cruz MP. LurasidoneHCl (Latuda), an oralonce-daily atypical antipsychotic agent for the treatment of patients with schizophrenia. Pharm Ther2011;36:489-92.
Bawa R, Scarff JR. Lurasidone: a new treatment option for bipolar depressiona review. InnovClinNeurosci2015;12:21-3.
Silva BM, Borges AF, Silva C, Coelho JF, Simoes S. Mucoadhesive oral films: the potential for unmet needs. Int J Pharm2015;494:537-51.
Shah S, Parmar B, Soniwala M, Chavda J. Design, optimization, and evaluation of lurasidone hydrochloride nanocrystals. AAPS PharmSciTech2016;17:1150-8.
Soni MM, Patel KR. Formulation and evaluation of fast dissolving films of lurasidone hydrochloride. IntJPharm ResBioSci2016;5:101-23.
Clinical pharmacology and biopharmaceutics review(s). Available from:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000ClinPharmR.pdf [Last accessed on 10 Aug 2018].
Latudaprescribing information sheet. Available from:http://www.latuda.com/latudaPrescribingInformation.pdf [Last accessed on 10 Jul 2018]
Product monograph PrLATUDA®. Available from:http://www.sunovion.ca/monographs/latuda.pdf [Last accessed on 05 Jul 2018]
Mor J, Dubey V, Jalwal P. Formulation and evaluation of oral dissolving films of lisinopril. IntJResPharmSci2016;1:34-8.
Hussain MW, Kushwaha P, Rahman MA, Akhtar J. Development and evaluation of fast dissolving film for oro-buccaldrug delivery of chlorpromazine. IntJPharm EduRes2017;51:539-47.
Bala R, Sharma S. Formulation optimization, and evaluation of fast dissolving film of aprepitant by using design of experiment. Bulletin of Faculty of Pharmacy, Cairo University; 2018.
Tomar A, Sharma K, Chauhan NS, Mittal A, Bajaj U. Formulation and evaluation of fast dissolving oral film of dicyclomine as potential route of buccal delivery. IntJ Drug Dev Res 2012;4:408-17.
Indian Pharmacopoeia. 7th ed. Ghaziabad: The Indian Pharmacopoeial Commission; 2014.
Mali KK, J Dias RJ, Ghorpade VS, Havaldar VD. Taste masked oral fast-dissolving sublingual strips of rizatriptan benzoate for migraine therapy. Marmara PharmJ2017;21:235-42.
Daud AS, Sapkal NP, Bonde MN. Development of zingiberofficinale in oral dissolving films: effect of polymers on in vitro, in vivo parameters and clinical efficacy. Asian JPharm 2011;5:183-9.
Chougule PC, Bhat MR, Chimkode RM. Design and evaluation of formulated mouth dissolving film of domperidone and study the effect of concentration of polymers on drug release. Asian J Pharm2017;11:846-53.
Desai P,Basu B. Design and evaluation of fast dissolving film of domperidone. IntRes J Pharm 2012;3:134-45.
Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm J2016;24:537-46.
Lakshmi PK, Sreekanth J, Sridharan A. Formulation development of fast releasing oral thin films of levocetirizinedihydrochloride with Eudragit EPO and optimization through Taguchi orthogonal experimental design. Asian JPharm2011;5:84-92.
Maddela S. Formulation and characterization of fast dissolving films containing paracetamol. Indo AmJ Pharm Res 2016;6:98-110.
Prabhu P, Dubey A, Kamath K. Formulation and evaluation of fast dissolving films of lisinopril. Egyptian PharmJ2015;14:56-64.
Bonsu MA, Ofori K, Kipo SL, Boakye ME, Fosu MA. Development of oral dissolvable films of diclofenac sodium for osteoarthritis using albiziaand khaya gums as hydrophilic film formers. JDrug Delivery 2016;1:1-11.
Senthilkumar K, Vijaya C. Formulation development of mouth dissolving film of etoricoxib for pain management. Advances inP’ceutics; 2015. https://doi.org/10.1155/2015/702963.
Prabhudessai SM, Dandagi PM, Lakshman Y, Gadad AP. Development and characterization of fast dissolving oral films of orciprenalinesulphate. Ind JPharmEdu Res 2017;51:536-42.
Reddy KA, Rao YS. Evaluation of palonosetronHCl mouth dissolving films in the management of chemotherapy-induced vomiting. IntJPharmSciNanotech2017;10:3930-6.
Dinge A, Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech2008;9:349-56.
Gurdale MS, Lade MS, Payghan SA, D’souza JI. Fast dissolving HPMC E5 based oral film for rapid absorption of Metoprolol Tartrate. EurJPharmMedRes 2014;1:75-91.
Soni MM, Patel KR. Formulation and evaluation of fast dissolving film of lurasidone hydrochloride. Int J Pharm Res Bio-Sci 2016;5:101-23.
Thayyilakandy S, Gayathri PS, Arjun KK, Krishnakumar G, NAIR SC. FastDissolvingsublingual patch of phenobarbital: formulation and in vitro evaluation. Int J Appl Pharm 2020;12:158-65.
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