Formulation and Evaluation of Montelukast Sodium Oral Dissolving Film
The preliminary batches were planned for the formulation and development of placebos of fast dissolving film by using solvent casting method. Total 10 formulations were prepared by using concentration of polymer i.e pullulan in different proportion. In formulations F5 to F6 various concentration of pullulan were incorporated as well as in other formulation trails taken with different concentration of different natural i.e Sodium alginate, SSG and synthetic i.e HPMC, eudragit to find out best suitable polymer for the film formation. Among all formulations, formulation F5 was found to be satisfactory. The placebos were evaluated for various parameters such as physical appearance, weight variation, thickness, surface pH and disintegration time. F5 formulation came out with best result after various evaluations and so it was further prepared by incorporating Montelukast Sodium API. This formulation was then evaluated for various parameters along with assay, content uniformity and dissolution. The results obtained from the F5 formulation complied with the specifications given for ODF. A batch to batch was also observed after obtaining the results. Further, various batches were prepared with various concentration of PEG-400 and evaluated. It was observed that the batch with the higher concentrations of PEG-400 retarded release of drug from formulation. In vitro release studies showed that the formulation F5 match with the required dissolution profile, the drug release retarded in F1, F2 and F3 formulations due to different concentration of polymer and plasticizer, which did not match with the required dissolution profile. The in vitro release of formulation F5 was found to be most promising as it was in accordance required dissolution profile.
2. Nafee Na, Ismail Fa, Boraie Na, Mortada Lm. Mucoadhesive Buccal Patches of Miconazole Nitrate: In Vitro/In Vivo Performance and Effect of Ageing. Int J Pharm 2003; 264:1-14.
3. Singh S, Jain S, Muthu Ms, Tiwari S, Tilak R. Preparation and Evaluation of Buccal Bioadhesive Films Containing Clotrimazole. Aaps Pharmscitech2008; 9:660-667.
4. El-Samaligy Ms, Yahia Sa, Basalious Eb. Formulation and Evaluation of Diclofenac Sodium Buccoadhesive Discs. Int J Pharm 2004; 286:27-39
5. Chayed S, Winnik Fm. In Vitro Evaluation of the Mucoadhesive Properties of Polysaccharide-Based Nanoparticulate Oral Drug Delivery Systems. Eur J Pharm Biopharm 2007; 65:363-370.
6. Perioli L, Pagano C, Mazzitelli S, Rossi C, Nastruzzi C. Rheological and Functional Characterization of New Antiinflammatory Delivery Systems Designed For Buccal Administration. Int J Pharm2008; 356:19-28.
7. Narayana Pr, Kumar Ms, Reddy M, Ravishankar K. Formulation and Evaluation of Fast Dissolving Films of Loratidine by Solvent Casting Method. Pharm Innova J. 2013; 2(2): 31-35.
8. Siddeshwar Ss, Dattaprasad Nv, Waghmare Ga, Wadghule Pb, Varpe Ps. Fast Dissolving Oral Films: Easy Way Of Oral Delivery. Int J Curr Trends Pharmaceut. Res. 2014; 2(3):483-490.
9. Satam Mn, Bhuruk Md, Pawar Yd. Fast Dissolving Oral Thin Films. Int J Uni Pharm Bio-Sci. 2013; 2(4):27-39.
10. Bhyan B, Jangra S, Kaur M, Singh H. Orally Fast Dissolving Films: Innovations In Formulation And Technology. Int J Pharmaceut Sci. 2011; 9(2):50-57.
11. Aggarwal J, Singh G, Saini S, Rana Ac. Fast Dissolving Films: A Novel Approach to Oral Drug Delivery. Int Res J Pharm.2011; 2(12): 69-74.
12. Jaiswal, H. Oral Strip Technology. Ind J Pharmaceut Bio Res. 2014; 2(2):130- 114.
13. Kathpalia H, Sule B, Gupte A. Development and Evaluation of Orally Disintegrating Film of Tramadol Hydrochliride. Asian J Biomed Pharmaceut Sci. 2013; 3(24):27-32.
14. Dixit Rp, Puthli Sp. Oral Strip Technology: Overview and Future Potential. J Controlled Release. 2009; (3): 94-97.
15. Anand V, Kataria M, Kukkar V, Saharan V, Choudhury Pk. The Latest Trends in the Taste Assessment of Pharmaceuticals. Drug Discov Today 12 2007; 257-265.
16. Chen Q, Martin R, Hoag Sw, Wood Ra, Mao Hq, Keet C. Formulation And Characterization Of Orally Dissolving Thin Films Containing The German Cockroach Blatella Germanica (Bla G2) Allergen. Int J Pharmacuet Sci. 2014; 4(5):730-735.
17. Desu Pk, Bonthagarala B, Nama S, Nagalakshmi A. Formulation and Evaluation of Fast Dissolving Films of Rizatriptan. Int J Pharmaceut Res Bio-Sci. 2013; 2(3): 298-305.
18. 'T Jong Gw, Van Der Linden Pd, Bakker Em, Van Der Ln, Eland Ia, Stricker Bh, Van Den Anker Jn. Unlicensed And Off-Label Drug Use In A Paediatric Ward Of A General Hospital In The Netherlands. Eur J Clin Pharmacol, 2002; 58:293 297.
19. Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier J, Piccerelle P. Determination Of The In Vitro Disintegration Profile Of Rapidly Disintegrating Tablets And Correlation With Oral Disintegration. Int J Pharm 2005; 292:29-41.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).