A Modern Approach on Mouth Dissolving Drug Technology: Film-Based Oral Delivery

Authors

  • Ram Babu Sharma Professor & Principal, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh
  • Ankit Kumar M. Pharm Scholar, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh
  • Anjali Dixit Associate Professor, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

Abstract

Since oral drug delivery is convenient, affordable, and patient-compliant, it continues to be the most used method. However, taking medications can be difficult for both young and old, increasing the danger of choking. Since its introduction in the 1970s, buccal mucosal dosage forms and fast-dissolving drug delivery systems (FDDS) have improved in terms of usability and safety. Fast-dissolving oral films (OFDFs) are one of them that have become more well-liked due to their capacity to dissolve on the tongue rapidly without the need for water or chewing, enhancing self-administration. Improved bioavailability, decreased first-pass metabolism, quick onset of action, and compatibility with water-insoluble medications are just a few of the many benefits that OFDFs provide. They can be made using solvent casting, hot-melt extrusion, rolling, or solid dispersion extrusion procedures, and they can be prepared with polymers, plasticisers, surfactants, sweeteners, and flavor/color agents. Controlled or targeted release is provided by innovations such multilayered, mucoadhesive, and nanotechnological films (e.g., containing nanoparticles or cyclodextrin complexes). OFDFs appeal to a wide range of patients, including youngsters, migraineurs, and those with Parkinson's and Alzheimer's diseases. Strict quality, packaging, and labelling standards are guaranteed by regulatory guidelines issued by organisations like the FDA, CDSCO, and EMA. Film performance is assessed using characterisation techniques such as morphology, thickness, tensile strength, disintegration, moisture uptake, in vitro dissolution, and palatability. New technologies like as WafertabTM, SoluleavesTM, and FoamburstTM, customised and stimulus-responsive films, and environmentally friendly production techniques show great promise as the area develops. This review highlights OFDFs' expanding importance in patient-centric treatments by synthesising recent advancements and potential future approaches.

Keywords: Fast dissolving, Oral film, Drug delivery, regulatory agencies.

Keywords:

Fast dissolving, Oral film, Drug delivery, regulatory agencies

DOI

https://doi.org/10.22270/jddt.v15i8.7346

Author Biographies

Ram Babu Sharma , Professor & Principal, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

Professor & Principal, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

Ankit Kumar , M. Pharm Scholar, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

M. Pharm Scholar, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

Anjali Dixit , Associate Professor, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

Associate Professor, Himalayan Institute of Pharmacy, Kala-Amb, Sirmour, Himachal Pradesh

References

1. Gangurde VS, Kapse PH, Jadhav K, Bachhav R. Mouth dissolving films: a novel approach in oral drug delivery. Int J Pharm Sci. 2024;2(4):1223-1236. doi:10.5281/zenodo.11080675

2. Reddy TUK, Reddy KSK, Manogna K, Thyagaraju K. A detailed review on fast dissolving oral films. J Pharm Res. 2018;8(6)

3. Prajapati VD, Chaudhari AM, Gandhi AK, Maheriya P. Pullulan based oral thin film formulation of zolmitriptan: development and optimization using factorial design. Int J BiolMacromol. 2018;107:2075-2085. https://doi.org/10.1016/j.ijbiomac.2017.10.082 PMid:29074082

4. Karaman DŞ, Patrignani G, Rosqvist E, Smått J H, Orłowska A, Mustafa R, et al. Mesoporous silica nanoparticles facilitating the dissolution of poorly soluble drugs in orodispersible films. Eur J Pharm Sci. 2018;122:152-159. https://doi.org/10.1016/j.ejps.2018.06.027 PMid:29966736

5. Speer I, Lenhart V, Preis M, Breitkreutz J. Prolonged release from orodispersible films by incorporation of diclofenac loaded micropellets. Int J Pharm. 2019;554:149-160. https://doi.org/10.1016/j.ijpharm.2018.11.013 PMid:30414477

6. Visser JC, Woerdenbag HJ, Hanff LM, Frijlink HW. Personalized medicine in pediatrics: the clinical potential of orodispersible films. AAPS PharmsciTech. 2017;18(2):267-272. https://doi.org/10.1208/s12249-016-0515-1 PMid:27044380

7. Jacob S, Boddu SH, Bhandare R, Ahmad SS, Nair AB. Orodispersible films: current innovations and emerging trends. Pharmaceutics. 2023;15(12):2753. https://doi.org/10.3390/pharmaceutics15122753 PMid:38140094 PMCid:PMC10747242

8. Suripeddi M, Ramya K, Narayana TV, Sumaltha G, Rani N, Jayasree Prasanna R, et al. Oral dissolving films: a review. Int J Res Rev. 2023;10(9):450-468. https://doi.org/10.52403/ijrr.20230946

9. Saxena A, Singh T. Oral dissolving films: a comprehensive review on recent perspectives and current approach to effective drug delivery. J Drug Deliv Ther. 2022;12(2):139-147. https://doi.org/10.22270/jddt.v12i2.5244

10. Singh S, Pawar R, Patidar S. A review on mouth dissolving film - a novel approach. Int J Pharm Sci Med. 2024;9(2):36-51. https://doi.org/10.47760/ijpsm.2024.v09i02.006

11. Senthilkumar K, Vijaya C. Formulation development of mouth dissolving film of etoricoxib for pain management. Adv Pharmaceutics. 2015;2015:1-11. https://doi.org/10.1155/2015/702963

12. Jelvehgari M, Montazam SH, Soltani S, Mohammadi R, Azar K, Montazam SA. Fast dissolving oral thin film drug delivery systems consist of ergotamine tartrate and caffeine anhydrous. Pharmaceut Sci. 2015;21:102-110. https://doi.org/10.15171/PS.2015.24

13. Kunte S, Tandale P. Fast dissolving strips: a novel approach for the delivery of verapamil. J Pharm Bio Sci. 2010;2(4):325-328. https://doi.org/10.4103/0975-7406.72133 PMid:21180465 PMCid:PMC2996061

14. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Control Release. 2009; (3):94-97. https://doi.org/10.1016/j.jconrel.2009.06.014 PMid:19559740

15. Sharma R, Joshi D, Singh B, Semwal N. A review on orodispersible film: a novel approach of drug delivery system. World J Biol Pharm Health Sci. 2022;12(1):001-011. https://doi.org/10.30574/wjbphs.2022.12.1.0130

16. Chinnala KM, Vodithala S. Formulation and evaluation of fast disintegrating oral thin films of cinitapride hydrogen tartarate. Int J Curr Adv Res. 2017;6:4737-4740.

17. Murthy AV, Ayalasomayajula LU, Earle RR, Jyotsna P. Formulation and evaluation of tramadol hydrochloride oral thin films. Int J Pharm Sci. 2018;9:1692-1698. doi:10.13040/IJPSR.0975-8232.9(4).1692-98 https://doi.org/10.13040/IJPSR.0975-8232.9(4).1692-98

18. Musazzi UM, Khalid GM, Selmin F, Minghetti P, Cilurzo F. Trends in the production methods of orodispersible films. Int J Pharm. 2019;-. https://doi.org/10.1016/j.ijpharm.2019.118963 PMid:31857185

19. Sjöholm E, Sandler N. Additive manufacturing of personalized orodispersible warfarin films. Int J Pharm. 2019;564:117-123. https://doi.org/10.1016/j.ijpharm.2019.04.018 PMid:30974195

20. Sharma R, Kamboj S, Singh G, Rana V. Development of aprepitant loaded orally disintegrating films for enhanced pharmacokinetic performance. Eur J Pharm Sci. 2016;84:55-69. https://doi.org/10.1016/j.ejps.2016.01.006 PMid:26780381

21. Sen Karaman DŞ, Patrignani G, Rosqvist E, Smått J H, Orłowska A, Mustafa R, Preis M, Rosenholm JM. Mesoporous silica nanoparticles facilitating the dissolution of poorly soluble drugs in orodispersible films. Eur J Pharm Sci. 2018;122:152-159. https://doi.org/10.1016/j.ejps.2018.06.027 PMid:29966736

22. Karavasili C, Eleftheriadis GK, Gioumouxouzis C, Andriotis EG, Fatouros DG. Mucosal drug delivery and 3D printing technologies: a focus on special patient populations. Adv Drug Deliv Rev. 2021 Sep;176:113857. https://doi.org/10.1016/j.addr.2021.113857 PMid:34389172

23. Karavas E, Koutris E, Samara V, Koutri I, Kalaskani A, Kalantzi L, Kakouris A, Diakidou A, Gotzamanis G, Georgousis Z, Konstanti L, et al. Orodispersible film composition comprising enalapril for the treatment of hypertension in a pediatric population. US Patent 11,154,585. 2021 Oct 26.

24. Reddy UKT, Reddy SK, Manogna K, Thyagaraju P. A detailed review on fast dissolving oral films. Indo Am J Pharm Res. 2018;8(6):1315-1326.

25. Kumar RS, Yagnesh Satya NT. Oral dissolving films: an effective tool for fast therapeutic action. J Drug Deliv Ther. 2019;9(1 s):490-492. https://doi.org/10.22270/jddt.v9i1-s.2395

26. Cilurzo F, Musazzi UM, Franzé S, Selmin F, Minghetti P. Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements. Drug Discov Today. 2018;23(2):251-259. https://doi.org/10.1016/j.drudis.2017.10.003 PMid:29030242

27. Balusamy B, Celebioglu A, Senthamizhan A, Uyar T. Progress in the design and development of "fast dissolving" electrospunnanofibers based drug delivery systems - a systematic review. J Control Release. 2020;326:482-509. https://doi.org/10.1016/j.jconrel.2020.07.038 PMid:32721525

Published

2025-08-15
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How to Cite

1.
Sharma RB, Kumar A, Dixit A. A Modern Approach on Mouth Dissolving Drug Technology: Film-Based Oral Delivery. J. Drug Delivery Ther. [Internet]. 2025 Aug. 15 [cited 2026 Jan. 22];15(8):307-14. Available from: https://jddtonline.info/index.php/jddt/article/view/7346

How to Cite

1.
Sharma RB, Kumar A, Dixit A. A Modern Approach on Mouth Dissolving Drug Technology: Film-Based Oral Delivery. J. Drug Delivery Ther. [Internet]. 2025 Aug. 15 [cited 2026 Jan. 22];15(8):307-14. Available from: https://jddtonline.info/index.php/jddt/article/view/7346

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