DESIGN, OPTIMIZATION AND EVALUATION OF CETRIZINE DIHYDROCHLORIDE FAST DISSOLVING FILMS EMPLOYING STARCH TARTRATE–A NOVEL SUPERDISINTEGRANT
Keywords:Fast dissolving Films, Superdisintegrant, Starch tartrate, Cetrizine dihydrochloride, Dissolution efficiency, Disintegration time
Objective: The aim of the current research is optimization, preparation and evaluation of starch tartrate (novel super disintegrant) and preparation of fast dissolving oral films of cetirizine dihydrochloride by employing starch tartrate.
Methods: To check the drug excipient compatibility studies of the selected drug (Cetrizine dihydrochloride) and the prepared excipient i. e starch tartrate, different studies like FTIR (Fourier-transform infrared spectroscopy), DSC (Differential scanning calorimetry) and thin-layer chromatography (TLC) were carried out to find out whether there is any interaction between cetirizine dihydrochloride and starch tartrate. The solvent casting method was used for the preparation of fast dissolving films. The prepared films were then evaluated for thickness, folding endurance, content uniformity, tensile strength, percent elongation, in vitro disintegration time and in-vitro dissolution studies. Response surface plots and contour plots were also plotted to know the individual and combined effect of starch tartrate (A), croscarmellose sodium (B) and crospovidone (C) on disintegration time and drug dissolution efficiency in 10 min (dependent variables).
Results: Films of all the formulations are of good quality, smooth and elegant by appearance. Drug content (100±5%), thickness (0.059 mm to 0.061 mm), the weight of films varies from 51.33 to 58.06 mg, folding endurance (52 to 67 times), tensile strength (10.25 to 12.08 N/mm2). Fast dissolving films were found to disintegrate between 34 to 69 sec. Percent dissolved in 5 min were found to be more in F1 formulation which confirms that starch tartrate was effective at 1%.
Conclusion: From the research conducted, it was proved that starch tartrate can be used in the formulation of fast dissolving films of cetirizine dihydrochloride. The disintegration time of the films was increased with increase in concentration of super disintegrant.
2. Aher Smita S, Saudagar RB, Shinde Mayuri S. Review: fast dissolving tablet. Int J Curr Pharm Res 2018;10:5-12.
3. Arun Arya, Amrish Chandra, Vijay Sharma, Kamla Pathak. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J Chem Tech Res 2010;2:576-83.
4. Swapnil S Bornare, Smita S Aher, Ravindranath B Saudagar. A review: film-forming gel novel drug delivery system. Int J Curr Pharm Res 2018;10:25-8.
5. K Pallavi, T Pallavi. Formulation and evaluation of fast dissolving films of eletriptan hydrobromide. Int J Curr Pharm Res 2017;9:59-63.
6. Sandeep Karki, Hyeongmin Kim, Seon Jeong Na, Dohyun Shin, Kanghee Jo, Jaehwi Lee. Thin films as an emerging platform for drug delivery. Asian J Pharm Sci 2016;11:559–74.
7. Raykar Meghana, Malarkodi Velraj. An overview on mouth dissolving film. Asian J Pharm Clin Res 2018;11:44-7.
8. Sanjay P, Vishal Gupta N, Gowda DV, Praveen Sivadasu. Formulation and development of in situ forming gel for the treatment of oral thrush. Asian J Pharm Clin Res 2018;11:312-5.
9. R Santosh Kumar, Kumari Annu, B Kusuma Latha, T Mallika. Design, optimization and evaluation of ibuprofen fast dissolving tablets employing starch phthalate-a novel super disintegrant. Int J Curr Pharm Res 2019;11:47-53.
10. Santosh Kumar, T Naga Satya Yagnesh, V Goutham Kumar. Optimisation of ibuprofen fast dissolving tablets employing starch xanthate using 23 factorial designs. Int J Appl Pharm 2017;9:51-9.
11. R Santosh Kumar, Ankita Ghosh. Design, optimization and evaluation of piroxicam fast dissolving tablets employing starch tartrate-a new super disintegrant. Int J Appl Pharm 2019;11:89-97.
12. Manar Adnan Tamer, Shaimaa Nazar ABD-Al Hammid, Balqis Ahmed. Formulation and in vitro evaluation of bromocriptine mesylate as fast dissolving oral film. Int J Appl Pharm 2018;10:7-20.
13. Ghada Ehab Yassin, Haidy Atef Abass. Design and evaluation of fast dissolving orodispersible films of metoclopramide hydrochloride using 32 multifactorial designs. Int J Pharm Pharm Sci 2016;8:218-22.
14. Balakrishna T, Vidyadhara S, Murthy Tegk, Ramu A, Sasidhar RLC. Formulation and evaluation of esomeprazole fast dissolving buccal films. Asian J Pharm Clin Res 2018;11:193-9.
15. Bobde Suwarna Suresh, Tank Hemraj M. Design and statistical optimization of mouth dissolving sublingual film of a fixed-dose combination of doxylamine succinate and pyridoxine hydrochloride using the design of experiment in the treatment of nausea and vomiting in pregnancy. Asian J Pharm Clin Res 2018;11:202-8.
16. Saba Abdulhadi Jabir, Halah Talal Sulaiman. Preparation and characterization of lafutidine as immediate-release oral strip using different types of the water-soluble polymer. Int J Appl Pharm 2018;10:249-60.
17. Aishali Kilor, Nidhi Sapkal, Anwar Daud, Shruti Humne, Tushar Gupta. Development of stable nanosuspension loaded oral films of glimepiride with improved bioavailability. Int J Appl Pharm 2017;9:28-33.