A Review on Fast Dissolving Oral Films for Pediatric Patients

Author

Baliram Kumar, Dr. Revathi A. Gupta, Mrs. Azra Shaikh, Mrs. Nutan Mimrot


Abstract

 Paediatric patients often experience difficulties swallowing traditional solid dosage forms such as tablets and capsules, which can result in poor medication adherence and reduced therapeutic efficacy. Fast dissolving oral films (FDOFs) are a novel oral drug delivery system designed to overcome these limitations. These thin, flexible films disintegrate or dissolve quickly in the oral cavity without the need for water, making them particularly suitable for pediatric patients. FDOFs can provide accurate drug dosing, rapid drug release, improved patient compliance, and ease of administration. They are usually formulated using hydrophilic film forming polymers with suitable plasticizers, sweeteners, flavoring agents and other pharmaceutical excipients. Various manufacturing techniques including solvent casting, hot-melt extrusion, and semi-solid casting have been investigated for the preparation of oral films. Important evaluation parameters include appearance, thickness, weight variation, folding endurance, surface pH, tensile strength, disintegration time, drug content uniformity, dissolution behavior and stability. This review discusses formulation approaches, polymers and excipients, manufacturing methods, evaluation parameters, advantages, limitations and recent advances in fast-dissolving oral films, with special emphasis on their application in pediatric drug delivery. FDOFs represent a promising and patient-friendly dosage form that can improve drug acceptability and compliance in children.



Keywords

rapid dissolving oral films, pediatric drug delivery, oral thin films, patient compliance, rapid disintegration, drug delivery system, children.



Full Text:

Download Paper PDF


References


  1. Ishikawa T, Koizumi N, Mukai B. Pharmacokinetics of acetaminophen from rapidly disintegrating compressed tablet prepared using microcrystalline cellulose (PHM06) and spherical sugar granules. Chem Pharm Bull (Tokyo) 2001; 49: 230-32.  
  2. Price TM, Blauer KL, Hansen M, Stanczyk F, Lobo R, Bates GW. Singledose pharmacokinetics of sublingual versus oral administration of micronized 17 beta estradiol. Obstet Gynecol 1997; 89: 34045.  
  3. R.P Walton Absorption of drugs through the oral mucosa. III Fat water solubility coefficient of alkaloids. Proc Soc Exp Bio Med 1935; 32: 1488.  
  4. Kurosaki Y, Takatori T, Nishimura H, Nakayama T, Kimura T . Regional variation in oral mucosal drug absorption permeability and degree of keratinization in hamster oral cavity. Pharm Res 1991; 8: 1297-1301.  
  5. Ghosh TK, Chatterjee DJ, Pfister WR. Quick dissolving oral dosage forms: Scientific and regulatory considerations from a clinical pharmacology and biopharmaceutical perspective. In: Ghosh TK and Pfister WR (Eds). Drug Delivery to the Oral Cavity Molecules to Market. NY, USA: CRC Press, 2005: 337-356.  
  6. Boer D et al. Drug absorption by sublingual and rectal routes. British J Anaesthesia 1984; 56: 69-82.
  7. Mary Elizabeth RN, Martelli BS. Sublingual and buccal medication administration. Encyclopedia of Nursing and Allied Health, 20050229
  8. Lea L. Sublingual Administration. Colon Health 1996; 13.
  9. Galey, W.R., H.K. Lonsdale and S. Nacht, 1976. The in vitro permeability of skin and buccal mucosa to selected drugs and tritiated water. J. Investigative Dermatol., 67(6): 713-717.  
  10. Malke, M., S. Shidhaye and V.J. Kadam, 2007. Formulation and evaluation of Oxacarbazine fast dissolve tablets. Indian J. Pharmaceutical Sci., 69(2): 211-214.  
  11. Technology catalysts International Corporation, accessed on Jun. 15th 2011 Available from http://www. technologycatalysts.com.  
  12. Frey P.Films strips and pharmaceuticals, pharm mf. & package. Sourcer, winter; 2006. P. 92-93.
  13. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery; clinical pharmaco-kinetics and therapeutic applications, Clin pharmacokinet 2002, 41(9): 661-680.
  14. http://www.gas-x.com.
  15. Vondrak B, Barnhart, Scott. Dissolvable films: Dissolvable films for flex product format in drug delivery. Pharm rechnol 2008. P. 1-5.
  16. Bhupinder Bhyan, Sarita Jangra, Mandeep Kaur, Harmanpreet Singh; Orally Fast Dissolving films: Innovation in formulation and technology. International journal of pharmaceutical science review and research ISSN 0976-044X, Vol. 9, Issue 2, Aug 2010. Article-009.
  17. Shojaei, A.H., 1998. Buccal Mucosa as A Route for Systemic Drug Delivery: A Review. J. Pharmacy and Pharmaceutical Sci., 1(1): 15-30.  
  18. Harris, D. and J.R. Robinson, 1992. Drug delivery via the mucous membranes of the oral cavity. J. Pharmaceutical Sci., 81: 1-10.  
  19. Siegel, I.A. and H.P. Gordon, 1985. Effects of surfactants on the permeability of canine oral mucosa in vitro. Toxicology Letters, 26(2-3): 153-157.  
  20. Siegel, I.A. and H.P. Gordon, 1985. Surfactant- induced increase of permeability of rat oral mucosa to non-electolytes in vivo. Archives of Oral Biol., 30: 43-47.
  21. Siegel, I.A. and H.P. Gordon, 1985. Effects of surfactants on the permeability of canine oral mucosa in vitro. Toxicology Letters, 26(2-3): 153-157.
  22. R Dixit; S Puthli. J of Controlled Release: (Mumbai, India) Official J of Controlled Release Society, 139(2), 94-107.
  23. C. Corniello, Quick dissolving strips: from concept to commercialization, DrugDel. Technol. 6 (2) (2006) 68–71.
  24. C. Frankhauser, G. Slominski, S. Meyer, Disintegrable oral films, U.S. Patent 2007/0202057, Aug. 30, 2007.
  25. R. Scott, D. Cade, X. He, Pullulan film compositions, U.S. Patent 7,267,718, Sept. 11,2007.
  26. S. Lydzinski, T. Manegold, D. Solarek, J. Tsai, C. Puglisi, Film containing starch, U.S.Patent 2003/0099692, May 29, 2003.
  27. N. Kulkarni, L.D. Kumar, A. Sorg, Fast dissolving orally consumable films containing an antitussive and a mucosa coating agent, U.S. Patent 2003/206942, Nov 6, 2003.  
  28. S. Ali, A. Quadir, High molecular weight povidone polymer-based films for fast dissolving drug delivery applications, Drug Del. Technol. 7 (6) (2007) 36–43.  
  29. M. Nishimura, K. Matsuura, T. Tsukioka, H. Yamashita, N. Inagaki, T. Sugiyama, Y. Itoh, In vitro and in vivo characteristics of prochlorperazine oral disintegrating film, Int J Pharm. 368 (1–2) (2009) 98–102.
  30. I.D. Consuelo, F. Falson, R.H. Guy, Y. Jacques, Ex vivo evaluation of bioadhesive films for buccal delivery of fentanyl, J. Control. Release 122 (2007) 135–140.  

 

 

Share your valuable work from Social Media Buttons