ORAL DELIVERY OF ZOLMITRIPTAN LOADED FAST DISINTEGRATING FILM: FORMULATION DEVELOPMENT, STATISTICAL OPTIMIZATION, IN-VITRO AND IN-VIVO EVALUATION
Abstract
Introduction: Fast dissolving film technology has been developed out as a alternative drug delivery system that gives an exception advantage for taking medications. Objective: The aim of this study was to formulate and evaluate the Zolmitriptan loaded fast disintegrating oral film by solvent casting method. Material and methods: A preliminary study was conducted to select a suitable film forming polymer and plasticiser concentration.The formulation was optimized with the help of 22 factorial designs in which polymer and plasticizer concentration at two levels was taken as independent factors and disintegration time, tensile strength and % elongation were taken as dependent factors. The optimized formulation OP1 was subjected to stability study as per the ICH guidelines at 40 ± 0.50C / 75 ± 5% RH for six months. In vivo studies were conducted on Wister albino rats and concentration of drug in blood was analysed by HPLC technique. Various pharmacokinetic parameters for OP1 were determined and compared with reference formulation (drug sol.). Result and Discussion: For optimized formulation various parameters were found to be in acceptable range and it was stable under specified conditions. The value of AUC0–t (ng h/ml), AUC0–∞ (ng h/ml) of the OP1 was found to be 723.91± 84.21, 770.90 ± 104.32, respectively, for the drug sol 468.56 ± 79.36, 500.37 ± 95.43 respectively. Relative bioavailability of OP1 was 1.55 time than that of drug sol. Conclusion: The formulation not only increases the bioavailability of drug but also produce the quick action for the migraine patients.
Downloads
References
2. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. International Journal of Pharmaceutical Investigation. 2013; 3(2): 67-76.
3. Panda BP, Dey NS, Rao MEB. Development of innovative orally fast disintegrating film dosage forms: A review. International Journal of Pharmaceutical Sciences and Nanotechnology. 2012; 5(2):1666-1674.
4. Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Orally disintegrating films: A modern expansion in drug delivery system. Saudi Pharmaceutical Journal 2016; 24:537-546.
5. Bird S, Derry S, Moore R. Zolmitriptan for acute migraine attacks in adults. [ONLINE]. Available at: https://www.cochrane.org/CD008616/SYMPT_Zolmitriptan-acute-migraine-attacks-adults. [Accessed 21 September 2018].
6. Spencer CM, Gunasekara NS, Hills C. Zolmitriptan: a review of its use in migraine. Drugs. 1999; 58(2):347-74.
7. Prajapati ST, Patel MV, Patel CN. Preparation and evaluation of sublingual tablets of Zolmitriptan. International Journal of Pharmaceutical Investigation. 2014; 4(1): 27-31.
8. Goadsby PJ, Yates R. Zolmitriptan intranasal: a review of the pharmacokinetics and clinical efficacy. Headache. 2006; 46 (1): 138-149.
9. Washington N, Washington C, Wilson C. Physiological Pharmaceutics: Barriers to Drug Absorption. New York, USA: Taylor & Francis 2000.
10. Rx List: 2016, The Internet drug index. [ONLINE]. Available at: https://www.rxlist.com/zomig-nasal-spray-side-effects-drug-center .htm .[Accessed on 21 Sep 2018]
11. Yasir M, Sara UVS. Solid lipid nanoparticles for nose to brain delivery of haloperidol: In vitro drug release and pharmacokinetics evaluation. Acta Pharmaceutica Sinica B. 2014; 4(6): 454-463.
12. Choudhary DR, Patel VA, Chhalotiya UK, Patel HV, Kundawala AJ. Development and characterization of pharmacokinetic parameters of fast-dissolving films containing levocetirizine. Scientia Pharmaceutica. 2012; 80 (3): 779-787.
13. Thakur RR, Rathore DS, Narwal S. Orally disintegrating preparations: recent advancement in formulation and technology. Journal of Drug Delivery and Therapeutics. 2012; 2 (3): 87-96.
14. Venkateshwari Y, Jayachandra RB, Sampath KD, Mittal N, Pandit JK. Development of low cost tetracycline strip for long term treatment of periodontal disease. Indian Drugs. 1995; 32: 205-9.
15. Purohit KK, Jangid MK, John AS, Shivanand K. Formulation and evaluation of Timolol maleate buccal mucoadhesive patches. J. of Pharm. Res. 2010; 32 (5): 2031-35.
16. Devi VK, Saisivam S, Maria GR, Deep PU. Design and evaluation of matrix diffusion controlled transdermal patches of verapamil hydrochloride. Drug Development and Industrial Pharmacy. 2003; 29 (5): 495–503.
17. Seth AK, Aggarwal GP, Saini TR. Evaluation of free films. Indian Drugs. 1985; 23(1): 45-47.
18. Chauhan I, Bajpai M. Formulation and evaluation of transdermal drug delivery of raloxifene hydrochloride. International Journal of Pharmaceutical Sciences and Research. 2010; 1(12):72-79.
19. Dhanikula AB, Panchagnula R. Development and characterization of biodegradable chitosan films for local delivery of Paclitaxel. AAPS Journal. 2004; 6 (3): 88-99.
20. Nair A, Kumria R, Harsha S, Attimarad M, Al-Dhubiab BA. In vitro techniques to evaluate buccal films. Journal of Controlled Release. 2013; 166 (1): 10–21.
21. Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. Journal of Controlled Release. 2009; 139 (2): 94-107.
22. Patel VM, Prajapati BG, Patel MM. Design and characterization of chitosan-containing mucoadhesive buccal patches of Propranolol hydrochloride. Acta Pharmaceutica. 2007; 57 (1): 61-72.
23. Ubaidulla, U, Reddy VS, Rickman S. Transdermal therapeutic system of carvedilol: effect of hydrophilic and hydrophobic hatrix on in vitro and in vivo characteristics. AAPS PharmSciTech. 2007; 8 (1), E1-E8.
24. Guidance for Industry: Orally Disintegrating Tablets, Center for Drug Evaluation and Research (Centre for Drug Evaluation and Research, CDER) US FDA, Dec 2008.[Available http://www.fda.gov/cder/Guidance/ 8528fnl.pdf ]. [Accessed 20 September 2018].
25. ElMeshad AN, El Hagrasy AS. Characterization and optimization of orodispersible Mosapride film formulations. AAPS Pharm-SciTech 2011; 12(4), 1384-1392.
26. Dalpiaz A, Marchetti N, Cavazzini A, Pastib L, Velaga S , Gavini E. Quantitative determination of Zolmitriptan in rat blood and cerebrospinal fluid by reversed phase HPLC–ESI-MS/MS analysis: Application to in-vivo preclinical pharmacokinetic study. Journal of Chromatography B. 2012; 901 (4):72– 78.
All the articles published in JAPSR are distributed under a creative commons license (CC BY-NC-SA 4.0)
Under this license, you are free to:
- Share- copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt- remix, transform, and build upon the material for any purpose, even commercially.
The licensor cannot revoke these freedoms as long as you follow the license terms.
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- NonCommercial — You may not use the material for commercial purposes .
- ShareAlike — If you remix, transform, or build upon the material, you must distribute your contributions under the same license as the original.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Copyright policy
The journal allows the author(s) to hold the copyright of their work. That means the authors do not need to transfer the copyright of their work to the journal. However, the authors grant JAPSR a license to publish the article and identify itself as the original publisher.
Licensing policy
The journal allows the author(s) to hold the copyright of their work. That means the authors do not need to transfer the copyright of their work to the journal. However, the authors grant JAPSR a license to publish the article and identify itself as the original publisher.