Authors : T. D. Farande; A. Purohit

Volume/Issue : Volume 11 - 2026, Issue 2 - February

Google Scholar : https://tinyurl.com/4a5sn392

Scribd : https://tinyurl.com/mr4863ta

DOI : https://doi.org/10.38124/ijisrt/26feb537

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : Fever is a prevalent clinical sign of infection and inflammation, driven by endogenous pyrogens and the synthesis of prostaglandin E2 (PGE2) in the hypothalamus. While conventional antipyretics, such as paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), are commonly utilized, their extended use can result in adverse effects including hepatotoxicity, nephrotoxicity, and gastrointestinal irritation. In contrast, herbal medicines are gaining popularity due to their multi-target pharmacological properties and enhanced safety profiles. Notably, Tulsi (Ocimum sanctum Linn.) and Guduchi (Tinospora cordifolia (Willd.) Miers) are well-known Ayurvedic herbs traditionally recognized as “Jwarahara” agents for managing fever. The antipyretic effects of these herbs are mainly linked to their bioactive components, which include eugenol, ursolic acid, rosmarinic acid, diterpenoid lactones, alkaloids, and immunomodulatory polysaccharides. These constituents demonstrate anti-inflammatory, antioxidant, antimicrobial, and immune-regulatory activities. However, traditional herbal dosage forms such as syrups, tablets, and decoctions often face challenges, including delayed onset of action, taste preferences, and poor compliance, particularly among pediatric and geriatric patients. Orodispersible films (ODFs) represent an innovative drug delivery system that rapidly disintegrates in the oral cavity without water, providing benefits such as swift onset, enhanced patient compliance, precise dosing, and convenience. This review explores the pharmacological foundations of Tulsi and Guduchi as herbal antipyretic agents, formulation strategies for integrating these extracts into ODFs, evaluation parameters to ensure quality and efficacy, and future possibilities including nano-enabled films, advanced manufacturing techniques, standardization methods, and clinical validation. Herbal antipyretic ODFs present a promising avenue for merging traditional herbal treatments with modern pharmaceutical advancements for effective and patient-friendly fever management.

Keywords : Orodispersible Films; Oral Thin Films; Herbal Antipyretic; Fever; Tulsi; Ocimum Sanctum; Guduchi; Tinospora Cordifolia; Fast Dissolving Films; Phytoconstituents; Solvent Casting; Patient Compliance.

References :

1. Dinarello CA. Infection, fever, and exogenous and endogenous pyrogens: some concepts have changed. J Endotoxin Res. 2004;10(4):201–222.
2. Walter EJ, Hanna-Jumma S, Carraretto M, Forni L. The pathophysiological basis and consequences of fever. Crit Care. 2016;20:200.
3. Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005;12(1):46–55.
4. Warden SJ. Prophylactic use of NSAIDs by athletes: a risk/benefit assessment. Phys Sportsmed. 2010;38(1):132–138.
5. Lesko SM, Mitchell AA. An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial. JAMA. 1995;273(12):929–933.
6. Lee WM. Acetaminophen toxicity: changing perceptions on a social/medical issue. Hepatology. 2007;46(4):966–970.
7. Ekor M. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol. 2014;4:177.
8. World Health Organization (WHO). WHO Traditional Medicine Strategy 2014–2023. Geneva: World Health Organization; 2013.
9. Fabricant DS, Farnsworth NR. The value of plants used in traditional medicine for drug discovery. Environ Health Perspect. 2001;109(Suppl 1):69–75.
10. Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. Fast dissolving films made of maltodextrins. Eur J Pharm Biopharm. 2008;70(3):895–900.
11. Fuisz RC, Myers GL. Oral film delivery systems. US Patent US20040219146A1; 2004.
12. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Control Release. 2009;139(2):94–107.
13. Preis M, Pein M, Breitkreutz J. Development of a taste-masked orodispersible film containing dimenhydrinate. Pharmaceutics. 2012;4(4):551–562.
14. Karki S, Kim H, Na SJ, Shin D, Jo K, Lee J. Thin films as an emerging platform for drug delivery. Asian J Pharm Sci. 2016;11(5):559–574.
15. Hoffmann EM, Breitenbach A, Breitkreutz J. Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv. 2011;8(3):299–316.
16. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: a new approach to oral drug delivery system. Int J Pharm Investig. 2013;3(2):67–76.
17. Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J ChemTech Res. 2010;2(1):576–583.
18. Borges AF, Silva C, Coelho JFJ, Simões S. Oral films: current status and future perspectives. J Control Release. 2015;206:1–19.
19. Senta-Loys Z, Bourgeois S, Pailler-Mattei C, Agusti G, Briançon S, Fessi H. Orodispersible films: a systematic review of characteristics and evaluation. Drug Dev Ind Pharm. 2017;43(9):1417–1429.
20. Liew KB, Tan YTF, Peh KK. Characterization of oral disintegrating film containing donepezil for Alzheimer disease. AAPS PharmSciTech. 2012;13(1):134–142.
21. Morales JO, McConville JT. Manufacture and characterization of mucoadhesive buccal films. Eur J Pharm Biopharm. 2011;77(2):187–199.
22. Patel VF, Liu F, Brown MB. Advances in oral transmucosal drug delivery. J Control Release. 2011;153(2):106–116.
23. Siepmann J, Siepmann F. Mathematical modeling of drug delivery. Int J Pharm. 2008;364(2):328–343.
24. Kathpalia H, Gupte A. An introduction to fast dissolving oral thin film drug delivery system: a review. Curr Drug Deliv. 2013;10(6):667–684.
25. Morales JO, Brayden DJ. Buccal delivery of small molecules and biologics: of mucoadhesive polymers, films and nanoparticles. Eur J Pharm Biopharm. 2017;113:130–143.
26. Preis M. Orally disintegrating films and mini-tablets—innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16(2):234–241.
27. Alhayali A, Uddin MN, Gill H. Oral thin films: dosage form, formulation factors and manufacturing methods. Pharmaceutics. 2020;12(10):1009.
28. Pattanayak P, Behera P, Das D, Panda SK. Ocimum sanctum Linn. A reservoir plant for therapeutic applications: an overview. Pharmacogn Rev. 2010;4(7):95–105.
29. Jamshidi N, Cohen MM. The clinical efficacy and safety of Tulsi in humans: a systematic review of the literature. Evid Based Complement Alternat Med. 2017;2017:9217567.
30. Prakash P, Gupta N. Therapeutic uses of Ocimum sanctum Linn (Tulsi) with a note on eugenol and its pharmacological actions: a short review. Indian J Physiol Pharmacol. 2005;49(2):125–131.
31. Singh S, Taneja M, Majumdar DK. Biological activities of Ocimum sanctum L. fixed oil—an overview. Indian J Exp Biol. 2007;45(5):403–412.
32. Cohen MM. Tulsi—Ocimum sanctum: a herb for all reasons. J Ayurveda Integr Med. 2014;5(4):251–259.
33. Mondal S, Mirdha BR, Mahapatra SC. The science behind sacredness of Tulsi (Ocimum sanctum Linn.). Indian J Physiol Pharmacol. 2009;53(4):291–306.
34. Kaur G, Kaur M, Kaur R. Formulation and evaluation of herbal fast dissolving oral films: an updated review. J Drug Deliv Ther. 2019;9(2):678–686.
35. Sinha K, Mishra NP, Singh J, Khanuja SPS. Tinospora cordifolia (Guduchi), a reservoir plant for therapeutic applications: a review. Indian J Tradit Knowl. 2004;3(3):257–270.
36. Sharma U, Bala M, Kumar N, Singh B, Munshi RK, Bhalerao S. Immunomodulatory active compounds from Tinospora cordifolia. J Ethnopharmacol. 2012;141(3):918–926.
37. Upadhyay AK, Kumar K, Kumar A, Mishra HS. Tinospora cordifolia (Willd.) Hook. f. and Thoms. (Guduchi)–validation of the Ayurvedic pharmacology through experimental and clinical studies. Int J Ayurveda Res. 2010;1(2):112–121.
38. Singh SS, Pandey SC, Srivastava S, Gupta VS, Patro B, Ghosh AC. Chemistry and medicinal properties of Tinospora cordifolia (Guduchi). Indian J Pharmacol. 2003;35(2):83–91.
39. Kapil A, Sharma S. Immunopotentiating compounds from Tinospora cordifolia. J Ethnopharmacol. 1997;58(2):89–95.
40. Sharma P, Dwivedee BP, Bisht D, Dash AK, Kumar D. The chemical constituents and diverse pharmacological importance of Tinospora cordifolia. Heliyon. 2019;5(9):e02437.
41. Sarmad A, Khan M, Hussain A. Taste masking strategies for bitter herbal extracts in oral thin films. Drug Dev Ind Pharm. 2021;47(2):179–194.
42. Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: innovations in formulation and technology. Int J Pharm Sci Rev Res. 2011;9(2):50–57.
43. 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):537–546.
44. Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of fast dissolving oral films: a review. Der Pharm Lett. 2011;3(1):152–165.
45. Vuddanda PR, Montenegro-Nicolini M, Morales JO, Velaga S. Effect of plasticizers on the physico-mechanical properties of pullulan based oral films. Drug Dev Ind Pharm. 2017;43(5):773–782.
46. Boateng JS, Ayensu I. Preparation and characterization of laminated herbal oral films for drug delivery. J Pharm Sci. 2014;103(8):2460–2469.
47. Bala R, Khanna S, Pawar P. Design optimization and evaluation of orally dissolving films: a review. Pharm Dev Technol. 2013;18(4):851–865.
48. Liew KB, Tan YTF, Peh KK. Effect of polymer, plasticizer and drug loading on disintegration and dissolution of oral films. Drug Dev Ind Pharm. 2014;40(1):110–120.
49. Garsuch V, Breitkreutz J. Comparative investigations on different polymers for the formulation of fast dissolving oral films. J Pharm Pharmacol. 2010;62(4):539–545.
50. Nair AB, Kumar A, Vyas H, et al. Development and evaluation of oral thin films: a review. Drug Deliv Transl Res. 2020;10:1–17.
51. Peh KK, Wong CF. Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties. J Pharm Pharm Sci. 1999;2(2):53–61.
52. Cilurzo F, Minghetti P, Selmin F, Montanari L. Fast dissolving films: from formulation to industrial production. AAPS PharmSciTech. 2011;12(4):1141–1147.
53. Preis M, Knop K, Breitkreutz J. Mechanical strength test for orodispersible films. Int J Pharm. 2014;461(1-2):22–29.
54. Indian Pharmacopoeia Commission. Indian Pharmacopoeia 2018. Ghaziabad: IPC; 2018.
55. International Council for Harmonisation (ICH). ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. Geneva: ICH; 2005.
56. International Council for Harmonisation (ICH). ICH Q1A(R2): Stability Testing of New Drug Substances and Products. Geneva: ICH; 2003.
57. Malekshahi MR, Majid M, Ghasemian E. SEM analysis of oral thin films: importance in surface morphology and uniformity. Microsc Res Tech. 2018;81(12):1452–1460.
58. Pawar HA, Lalitha KG, Ramesh G. FTIR and DSC studies for compatibility assessment in oral thin film formulations. J Appl Pharm Sci. 2016;6(4):180–185.
59. Patel RP, Patel DJ. Orodispersible films: emerging trends in nanotechnology-based delivery. J Drug Deliv Sci Technol. 2020;55:101451.
60. Tiwari G, Tiwari R, Rai AK. Cyclodextrins in delivery systems: applications in improving solubility and bioavailability. J Pharm Bioallied Sci. 2010;2(2):72–79.
61. Arafat B, Lam M, Sallam E, et al. 3D printing of oral films: innovative approaches for personalized drug delivery. Int J Pharm. 2018;544(2):383–392.
62. Repka MA, Bandari S, Kallakunta VR, et al. Melt extrusion for pharmaceutical applications: oral thin films and solid dispersions. Drug Dev Ind Pharm. 2018;44(12):1935–1952.
63. Mukherjee PK. Quality control of herbal drugs: an approach to evaluation of botanicals. Business Horizons. 2002;45(2):39–46.
64. Ghosh AK, Banerjee S, Acharya S. Clinical evaluation of Tinospora cordifolia in immunomodulation and fever management: review of evidence. J Ayurveda Integr Med. 2021;12(3):550–560.
65. Boulos MNK, Brewer AC, Karimkhani C, Buller DB, Dellavalle RP. Mobile medical and health apps: state of the art, concerns, regulatory control and certification. Online J Public Health Inform. 2014;5(3):229.
66. Parasuraman S, Thing GS, Dhanaraj SA. Polyherbal formulation: concept of Ayurveda. Pharmacogn Rev. 2014;8(16):73–80.
67. World Health Organization (WHO). WHO Guidelines on Good Manufacturing Practices (GMP) for Herbal Medicines. Geneva: WHO; 2007.
68. Prakash J, Gupta SK. Antioxidant and immunomodulatory activities of Ocimum sanctum. Indian J Exp Biol. 2005;43(9):833–837.
69. Thatte UM, Dahanukar SA. Immunotherapeutic modification by Tinospora cordifolia: a review. Indian J Pharmacol. 1989;21(1):21–26.
70. Boateng JS, Popescu C, Alqahtani S. Challenges in formulation of herbal oral thin films: stability and taste masking. Pharmaceutics. 2020;12(11):1022.
71. Senta-Loys Z, Bourgeois S, Pailler-Mattei C, Briançon S, Fessi H. Moisture uptake and stability issues in oral films: formulation challenges. Drug Dev Ind Pharm. 2018;44(6):911–921.
72. Rai VK, Mishra N, Yadav KS. Nanotechnology-based herbal drug delivery: current status and future prospects. J Drug Deliv Sci Technol. 2019;52:927–941.
73. Janga KY, Jukanti R, Velpula A, et al. Buccal films for systemic drug delivery: evaluation and future scope. Int J Pharm. 2017;525(2):1–13.