THE DEVELOPMENT AND CHARACTERISATION OF FAST DISSOLVING FILM OF POORLY WATER SOLUBLE DRUG LURASIDONE HYDROCHLORIDE

  • Mrs. Asmita Arondekar Goa University
  • Dr. Prashant Bhide
  • Anagh Prabhu
  • Mrs. Shweta Borkar

Abstract

Objective: The objective of the present work is to formulate and evaluate a fast dissolving oral film of lurasidone hydrochloride used as an atypical antipsychotic for the treatment of schizophrenia capable of providing faster onset of action.


Methods: Fast dissolving films of lurasidone hydrochloride were prepared by 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 was prepared and evaluated for specific parameters.


Results: The prepared films exhibited uniform and a smooth surface with uniform weight and thickness, with a neutral surface, 88-90% mg drug content. Lurasidone hydrochloride was rapidly released in vitro from all formulations and release was found to be rapid and maximum 41.5% in Phosphate buffer pH 6.8 and 58.6% in 0.1 N hydrochloric acid over a period of 30 m. Optimized formulation showed a faster and maximum release 78% as compared to the marketed tablet 74%.


Conclusion: The developed formulation is a better alternative to tablets by virtue of its ability to produce good drug release

Keywords: Lurasidone hydrochloride, Hydroxyl propyl methyl cellulose, Fast dissolving films, Solvent casting, in vitro drug release

Author Biographies

Mrs. Asmita Arondekar, Goa University

Mrs Asmita Arondekar

Assistant Professor,

Department of Pharmacology

Goa College of Pharmacy

Panaji-Goa

Dr. Prashant Bhide

Dr . Prashant Bhide 

Professor, HOD

Department of Pharmaceutics

Goa College of Pharmacy

Panaji-Goa

Anagh Prabhu

M-Pharm Research Scholar

Goa College of Pharmacy

Panaji-Goa

Mrs. Shweta Borkar

Mrs. Shweta Borkar

Assistant Professor

Department of Pharmaceutical Analysis

Goa College of Pharmacy

Panaji-Goa

References

1. Kinon, Bruce & Hill, Angela & Liu-Seifert, Hong & Kollack-Walker, Sara. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia. Int. J. Neuropsychopharmacol. 2003; 6: 97-102.
2. A. Arya, A. Chandra, V. Sharma, K. Pathak. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int. J. Chem. Tech. Res. 2010; 2:576-583.
3. San L, Casillas M, Ciudad A, Gilaberte I. Olanzapine orally disintegrating tablet: a review of efficacy and compliance. CNS Neurosci Ther. 2008; 14(3):203-214.
4. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. Int. J. Pharm. Invest. 2013; 3(2):67-76
5. Lee, Y., Kim, K., Kim, M. et al. Orally disintegrating films focusing on formulation, manufacturing process, and characterization. J. Pharm. Invest. 2017; 47:183–201).
6. Jonathan M Meyer, Antony D Loebel & Edward Schweizer Lurasidone: a new drug in development for schizophrenia, Exprt. Opin. Invest. Drugs 2009; 18:11, 1715-1726
7. Franklin R, Zorowitz S, Corse AK, Widge AS, Deckersbach T. Lurasidone for the treatment of bipolar depression: an evidence-based review. Neuropsychiatr. Dis. Treat. 2015; 11:2143-52.
8. Cruz MP. Lurasidone HCl (Latuda), an oral, once-daily atypical antipsychotic agent for the treatment of patients with schizophrenia. Pharmacy and Therapeutics. 2011; 36(8):489-92.
9. Bawa R, Scarff JR. Lurasidone: a new treatment option for bipolar depression—a review. Innov Clin Neurosci. 2015; 12(1-2):21-23.
10. Franklin R, Zorowitz S, Corse AK, Widge AS, Deckersbach T. Lurasidone for the treatment of bipolar depression: an evidence-based review. Neuropsychiatr. Dis. Treat. 2015; 11:2143-52.
11. Silva BM, Borges AF, Silva C, Coelho JF, Simoes S. Mucoadhesive oral films: the potential for unmet needs. Int J Pharm. 2015; 494(1):537-51.
12. Shah S, Parmar B, Soniwala M, Chavda J. Design, optimization, and evaluation of lurasidone hydrochloride nanocrystals. AAPS PharmSciTech. 2016; 17(5):1150-8.
13. Soni MM, Patel KR. Formulation and evaluation of fast dissolving films of lurasidone hydrochloride. Int. J. Pharm. Res. Bio-Sci. 2016; 5(2):101-23.
14. Clinical pharmacology and biopharmaceutics review(s) [cited on 2018 August]. Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200603Orig1s000ClinPharmR.pdf
15. Latuda prescribing information sheet. [Cited on 2018 July]. Available at http://www.latuda.com/LatudaPrescribingInformation.pdf
16. Product monograph PrLATUDA®, [cited on 2018 July]. Available at http://www.sunovion.ca/monographs/latuda.pdf
17. Mor J, Dubey V, Jalwal P. Formulation and evaluation of oral dissolving films of lisinopril. Int. J. Res. Pharm. Sci. 2016; 1(2): 34-8.
18. Hussain MW, Kushwaha P, Rahman MA, Akhtar J. Development and Evaluation of Fast Dissolving Film for Oro-Buccal Drug Delivery of Chlorpromazine. Int. J. Pharm Edu. Res. 2017; 51(4S):S539-47.
19. 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.
20. 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. Int. J. Drug Dev. & Res. 2012; 4(2): 408-17.
21. Indian Pharmacopoeia. 7th ed. Ghaziabad: The Indian Pharmacopoeial Commission; 2014.
22. Mali KK, J Dias RJ, Ghorpade VS, Havaldar VD. Taste masked oral fast dissolving sublingual strips of rizatriptan benzoate for migraine therapy. Marmara Pharm. J. 2017; 21(2): 235-42.
23. Daud AS, Sapkal NP, Bonde MN. Development of Zingiber officinale in oral dissolving films: Effect of polymers on in vitro, in vivo parameters and clinical efficacy. Asian J.Pharm. 2011; 5:183-9.
24. 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. Pharm. 2017; 11(04):S846-53.
25. Desai P, Basu B. Design and evaluation of fast dissolving film of domperidone. Int Res J Pharm. 2012; 3(9):134-45.
26. Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm. J. 2016; 24(5):537-46.
27. Lakshmi PK, Sreekanth J, Sridharan A. Formulation development of fast releasing oral thin films of levocetirizine dihydrochloride with Eudragit® EPO and optimization through Taguchi orthogonal experimental design. Asian J. Pharm. 2011; 5(2):84-92.
28. Maddela S. et al. Formulation and characterization of fast dissolving films containing paracetamol. Indo Am. J. Pharm. Res., 2016; 6(11):7:98-110.
29. Prabhu P, Dubey A, Kamath K. Formulation and evaluation of fast dissolving films of lisinopril. Egyptian Pharm. J. 2015; 14(1):56-64.
30. Bonsu MA, Ofori-Kwakye K, Kipo SL, Boakye-Gyasi ME, Fosu MA. Development of oral dissolvable films of diclofenac sodium for osteoarthritis using Albizia and Khaya gums as hydrophilic film formers. J. drug delivery. 2016; 2016:6459280.
31. Senthilkumar K, Vijaya C. Formulation Development of Mouth Dissolving Film of Etoricoxib for Pain Management. Advances in P’ceutics. 2015; 2015:702963.
32. Prabhudessai SM, Dandagi PM, Lakshman Y, Gadad AP. Development and characterization of fast dissolving oral films of orciprenaline sulphate. Ind J. Pharm. Edu. Res. 2017; 51(4):536-42.
33. Reddy KA, Rao YS. Evaluation of palonosetron HCl mouth dissolving films in the management of chemotherapy-induced vomiting. Int. J. Pharm. Sci. Nanotech 2017; 10(6): 3930-36.
34. Dinge A, Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech. 2008; 9(2):349-56.
35. Gurdale MS, Lade MS, Payghan SA, D’souza JI. Fast dissolving HPMC E5 based oral film for rapid absorption of Metoprolol Tartrate. Eur. J. Pharm. Med. Res. 2014; 1(1):75-91.
Statistics
1 Views | Downloads
How to Cite
Arondekar, A., Bhide, P., Prabhu, A., & Borkar, S. (2020). THE DEVELOPMENT AND CHARACTERISATION OF FAST DISSOLVING FILM OF POORLY WATER SOLUBLE DRUG LURASIDONE HYDROCHLORIDE. International Journal of Applied Pharmaceutics, 13(1). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39492
Section
Original Article(s)