Abstract
In recent days, the prerequisite for effective and innovative drug delivery has increased and so the oral film technology (OFT) arena is being explored extensively. Oral films rapidly dissolve and are adsorbed in the buccal cavity; thereby, the incorporated therapeutic agent(s) in them are delivered into the systemic circulation and overcome the first-pass effect. It also uplifts the efficacy and bioavailability of therapeutics with minimal or no toxicity. Owing to its simpler mode of administration, patient compliance is increased even in non-cooperative and bedridden patients in comparison to conventional solid and liquid dosage forms. The present review provides an overview of the benefits and shortcomings of oral film technologies, anatomy, physiology of the oral cavity, and the transport and mucoadhesion mechanisms of the drug through the oral mucosa. This review also highlights the different components supporting drug delivery by oral films, the various production methods of oral films, and clinical trials along with commercial films available in the market.
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M. Irfan, S. Rabel, Q. Bukhtar et al., Orally disintegrating films: a modern expansion in drug delivery system. Saudi Pharm J. 24(5), 537–546 (2016)
A. Arya, A. Chandra, V. Sharma et al., Fast dissolving oral films: an innovative drug delivery system and dosage form. Int. J. Chem. Tech. Res. 2(1), 576–583 (2010)
R.G. Annigeri, M. Jadhav, Mucoadhesive patch: a novel drug delivery. Res. Rev. J. Pharm. Pharm. Sci. 3(2), 56–62 (2014)
M. Mahboob, T. Riaz, M. Jamshaid et al., Oral films: a comprehensive review. Int. Curr. Pharm. J. 5(12), 111–117 (2016)
R.P. Dixit, S.P. Puthli, Oral strip technology: overview and future potential. J. Control Release. 139(2), 94–107 (2009)
A.H. Shojaei, Buccal mucosa as a route for systemic drug delivery: a review. J. Pharm. Pharmaceut. Sci. 1(1), 15–30 (1998)
S. Maher, D.J. Brayden, L. Casettari et al., Application of penetration enhancers in oral delivery of macromolecules: an update. Pharmaceutics. 11(1), 1–23 (2019)
H. Kathpalia, A. Gupte, An introduction to fast dissolving oral thin film drug delivery systems: a review. Curr Drug Deliv. 10(6), 667–684 (2013)
B.M. Silva, A.F. Borges, C. Silva et al., Mucoadhesive oral films: the potential for unmet needs. Int J Pharm. 494(1), 537–551 (2015)
V.F. Patel, F. Liu, M.B. Brown, Advances in oral transmucosal drug delivery. J Control Release. 153(2), 106–116 (2011)
A. Jithan, Oral drug delivery technology, 2nd edn. (Pharma Med Press, Hyderabad, 2014)
C. Belk, V.B. Maier, Biology science for life with physiology, 3rd edn. (Pearson Benjamin Cummings, New York, 2010)
C.A. Squier, The permeability of oral mucosa. Crit. Rev. Oral. Bio Med. 2(1), 13–32 (1991)
J.G. Meher, N.P. Yadav, K.S. Yadav et al., Buccal drug delivery system and penetration enhancer: a review. Pharma Rev. 10, 113–117 (2012)
F. Veuillez, Y.N. Kalia, Y. Jacques et al., Factors and strategies for improving buccal absorption of peptides. Eur. J. Pharm Biopharm. 51(2), 93–109 (2001)
A. Ganem-Quintanar, Y.N. Kalia, F. Falson-Rieg et al., Mechanisms of oral penetration enhancement. Int. J. Pharm. 156(2), 127–142 (1997)
N. Hassan, A. Ahad, M. Ali et al., Chemical penetration enhancers for transbuccal drug delivery. Expert Opin. Drug Deliv. 7(1), 97–112 (2010)
A. Pathan, M.K. Gupta, N.K. Jain et al., Formulation and evaluation of fast dissolving oral film of promethazine hydrochloride using different surfactant. J. Innov. Pharm. Biol. Sci. 3(1), 74–84 (2016)
H. Sohi, A. Ahuja, F.J. Ahmad et al., Critical evaluation of penetration enhancers for oral mucosal drug delivery. Drug Dev. Ind. Pharm. 36(3), 254–282 (2010)
Y. Chen, Y. Lu, J. Chen et al., Enhanced bioavailability of the poorly water-soluble drug fenofibrate by using liposomes containing a bile salt. Int. J. Pharm. 376(1–2), 153–160 (2009)
M. Thanou, J.C. Verhoef, H.E. Junginger, Oral drug absorption enhancement by chitosan and its derivatives. Adv. Drug Deliv. Rev. 52(2), 117–126 (2001)
Y.P. Cid, V. Pedrazzi, V.P. De Sousa et al., In vitro characterization of chitosan gels for buccal delivery of celecoxib: influence of a penetration enhancer. AAPS Pharm. Sci. Tech. 13(1), 101–111 (2012)
J.D. Smart, The basics and underlying mechanisms of mucoadhesion. Adv. Drug Deliv. Rev. 57(11), 1556–1568 (2005)
Gibson M, Pharmaceutical preformulation and formulation—a practical guide from candidate drug selection to commercial dosage form, Vol. 199. 1st edn. New York (NY): CRC Press (2001)
G. Mythri, K. Kavitha, M.R. Kumar et al., Novel mucoadhesive polymers—a review. J. App. Pharm. Sci. 1(8), 37–42 (2011)
Y.W. Chien, Novel drug delivery systems, 2nd edn. (Marcel Dekker, New York, 1992). (Revised and expanded)
B.M. Boddupalli, Z.N. Mohammed, R.A. Nath et al., Mucoadhesive drug delivery system: an overview. J. Adv. Pharm. Technol. Res. 1(4), 381–387 (2010)
R. Singh, D. Sharma, R. Garg, Review on mucoadhesive drug delivery system with special emphasis on buccal route: an important tool in designing of novel controlled drug delivery system for the effective delivery of pharmaceuticals. J. Dev. Drugs. 6(1), 1–12 (2017)
V.V. Khutoryanskiy, Mucoadhesive materials and drug delivery systems, 1st edn. (John Wiley & Sons, Chichester, 2014)
A. Amit, S. Sharad, Ajazuddin, et al., Theories and factors affecting mucoadhesive drug delivery systems: a review. Int. J. Res. Ayurveda Pharm. 2(4), 1155–1161 (2011)
H. Zhang, J. Zhang, J.B. Streisand, Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin. Pharmacokinet. 41(9), 661–680 (2002)
C. Paderni, D. Compilato, L.I. Giannola et al., Oral local drug delivery and new perspectives in oral drug formulation. Oral. Surg. Oral. Med. Oral. Pathol. Oral. Radiol. 114, e25–e34 (2012)
N. Narang, J. Sharma, Sublingual mucosa as a route for systemic drug delivery. Int. J. Pharm. Sci. 3(2), 18–22 (2011)
Punj A, Secretions of human salivary gland”; Salivary glands—new approaches in diagnostics and treatment. IşılAdadanGüvenç, IntechOpen; (2018)
D.M. Shinkar, A.S. Dhake, C.M. Setty, Drug delivery from the oral cavity: a focus on mucoadhesive buccal drug delivery systems. PDA J. Pharm. Sci. Technol. 66, 466–500 (2012)
R. Hooda, M. Tripathi, K. Kapoor, A review on oral mucosal drug delivery system. Pharma Innov. 1, 14–21 (2012)
R. Bhati, R.K. Nagrajan, A detailed review on oral mucosal drug delivery system. Int. J. Pharm. Sci. Res. 4, 659–681 (2012)
P.C. Reddy, K.S.C. Chaitanya, Y.M. Rao, A review on bioadhesive buccal drug delivery systems: current status of formulation and evaluation methods. Daru 19(6), 385–403 (2011)
Y.S. Pathare, V.S. Hastak, A.N. Bajaj, Polymers used for fast disintegrating oral films: a review. Int. J. Pharm. Sci. Rev. Res. 21(1), 169–178 (2013)
F.P. Fernandes, A.C. Fortes, S.G. da Cruz Fonseca et al., Manufacture and characterization of mucoadhesive buccal films based on pectin and gellan gum containing triamcinolone acetonide. Int. J. Polym. Sci. 2018(2), 1–10 (2018)
R.R. Tiwari, M.S. Umashankar, N. Damodharan, Recent update on oral films: a bench to market potential. Int. J. App. Pharm. 10(6), 27–33 (2018)
A. Mishra, A.K. Pathak, Plasticizers: a vital excipient in novel pharmaceutical formulations. Curr. Res. Pharm. Sci. 7(1), 1–10 (2017)
K.S. Remya, P. Beena, P.V. Bijesh et al., Formulation development, evaluation and comparative study of effects of super disintegrants in cefixime oral disintegrating tablets. J. Young Pharm. 2(3), 234–239 (2010)
H. Jaiswal, Oral strip technology: a review. Indian J. Pharm. Biol. Res. 2(2), 130–143 (2014)
P.M. Amin, A.B. Gangurde, P.V. Alai, Oral film technology: challenges and future scope for pharmaceutical industry. Int. J. Pharm. Pharm. Res. Human. 3(3), 183–203 (2015)
L. Milind, S.A. Payghan, T. Zaki et al., Polymer based wafer technology: a review. Int. J. Pharm. Biol. Sci. Arch. 4(6), 1060–1074 (2013)
P. Saini, A. Kumar, P. Sharma et al., Fast disintegrating oral Films: a recent trend of drug delivery. Int. J. Drug Dev. Res. 4(4), 80–94 (2012)
R. Bala, P. Pawar, S. Khanna et al., Orally dissolving strips: a new approach to oral drug delivery system. Int. J. Pharm Investig. 3(2), 67–76 (2013)
P. Kaur, R. Garg, Oral dissolving film: present and future aspects. J. Drug Del. Ther. 8(6), 373–377 (2018)
P.P. Ghodake, K.M. Karande, R.A. Osmani et al., Mouth dissolving films: innovative vehicle for oral drug delivery. IJPRR. 2(10), 41–47 (2013)
B.P. Panda, N.S. Dey, M.E.B. Rao, Development of innovative orally fast disintegrating film dosage forms: a review. Int. J. Pharm. Sci. Nanotech. 5(2), 1666–1674 (2012)
S. Karki, H. Kim, S. Na et al., Thin films as an emerging platform for drug delivery. Asian J. Pharm. Sci. 11(5), 559–574 (2016)
P.M. Castro, P. Fonte, F. Sousa et al., Oral films as breakthrough tools for oral delivery of proteins/peptides. J. Control Release. 211, 63–73 (2015)
R. Kolakovic, T. Viitala, P. Ihalainen et al., Printing technologies in fabrication of drug delivery systems. Expert Opin. Drug Deliv. 10(12), 1711–1723 (2013)
A. Shafiee, A. Atala, Printing technologies for medical applications. Trends Mol. Med. 22(3), 254–265 (2016)
M. Preis, J. Breitkreutz, N. Sandler, Perspective: concepts of printing technologies for oral film formulations. Int. J. Pharmaceut. 494(2), 578–584 (2015)
M.M. Nair, A. Shajan, L. Jacob, Formulation and evaluation of mouth dissolving film of a poorly soluble antihypertensive drug. Int. J. Pharm. Technol. 8, 21635–21661 (2016)
P.A. Padamwar, P.P. Phasate, Formulation and evaluation of fast dissolving oral film of bisoprolol fumarate. Int. J. Pharm. Sci. Res. 1(6), 135–142 (2015)
K.M. Maheswari, P.K. Devineni, S. Deekonda et al., Development and evaluation of mouth dissolving films of amlodipine besylate for enhanced therapeutic efficacy. J. Pharm. (Cairo). 2014, 520949 (2014)
P.V. Shelke, A.S. Dumbare, M.V. Gadhave et al., Formulation and evaluation of rapidly disintegrating film of amlodipine besylate. J. Drug Deliv. Ther. 2(2), 72–75 (2012)
B.V. Bhagat, S.A. Hapse, S.L. Darkunde et al., Formulation, development and evaluation of fast dissolving film of an antihypertensive drug. Asian J. Pharm. Technol. Innov. 4(16), 23–30 (2016)
P. Prabhu, A. Dubey, K. Kamath, Formulation and evaluation of fast-dissolving films of lisinopril. Egypt Pharm. J. 14, 56–64 (2015)
S. Bansal, M. Bansal, G. Garg, Formulation and evaluation of fast dissolving film of an antihypertensive drug. Int. J. Pharm. Chem. Biol. Sci. 3(4), 1097–1108 (2013)
J.S. Patil, A.B. Deokar, K.V. Vilegave et al., Design, evaluation and characterization of rapidly dissolving oral strips of metoprolol succinate. J. Pharm. Anal. Insights. 1(2), 1–6 (2016)
E. Jasvanth, D. Teja, B. Mounika et al., Formulation and evaluation of ramipril mouth dissolving films. Int. J. App. Pharm. 11(3), 124–129 (2019)
V.Y. Londhe, K.B. Umalkar, Formulation development and evaluation of fast dissolving film of telmisartan. Indian J. Pharm. Sci. 74(2), 122–126 (2012)
D. Patil, A.H. Ahmed, M. Awais et al., Design and development of fast dissolving film of telmisartan. Pharm. Sci. Monit. 9(1), 171–187 (2018)
M.I. Mohamed, M. Haider, M.A.M. Ali, Buccal mucoadhesive films containing antihypertensive drug: in vitro/in vivo evaluation. J. Chem. Pharm. Res. 3(6), 665–686 (2011)
C. Kaur, N. Chauhan, N. Mehta et al., Release kinetics pattern and formulation development of fast dissolving film of an antihypertensive agent. Adv. Sci. Focus. 1, 124–128 (2013)
S. Kunte, P. Tandale, Fast dissolving strips: a novel approach for the delivery of verapamil. J. Pharm. Bioallied Sci. 2(4), 325–328 (2010)
R. Kaza, P.R. Yalavarthi, N. Ravouru, Design and characterization of fast dissolving films of valsartan. Turk. J. Pharm. Sci. 11(2), 175–184 (2014)
A.M.J. Newton, S.M. Rani, K. Sukhjinder, Fabrication and evaluation of fast disintegrating oral hybrid films of propranolol hydrochloride by using pectin and synthetic polymers. J. Dev. Drugs. 5(2), 157 (2016)
J. Induru, A. Firdous, Preliminary screening and development of formulation design space for buccal thin films of isradipine. Int. J. Pharm. Pharm. Sci. 4(2), 179–184 (2012)
V.S. Kadam, V.B. Bharkad, G.A. Shete et al., Formulation and evaluation of fast dissolving oral film of metoclopramide HCl. World J. Pharm. Pharm. Sci. 6(8), 2052–2066 (2017)
S.K. Bajpai, F.F. Shah, M. Bajpai et al., Dynamic release of amoxicillin from orally dissolving film (ODF) composed of casein and sodium alginate. J. Drug Res. Dev. 3(2), 1–7 (2017)
H. Kathpalia, A. Patil, Formulation and evaluation of orally disintegrating films of levocetirizine dihydrochloride. Indian J. Pharm. Sci. 79(2), 204–211 (2017)
P. Prabhu, R. Malli, M. Koland et al., Formulation and evaluation of fast dissolving films of levocitirizine dihydrochloride. Int. J. Pharm. Investig. 1(2), 99–104 (2011)
M.A. Bonsu, K. Ofori-Kwakye, S.L. Kipo et al., Development of oral dissolvable films of diclofenac sodium for osteoarthritis using Albizia and Khaya gums as hydrophilic film formers. J. Drug Deliv. 2016, 1–11 (2016)
P.K. Singh, D. Singh, R.K. Bijauliya, Formulation and characterization of mouth dissolving mucoadhesive buccal film of zolmitriptan. Int. J. Res. Dev. Pharm. L Sci. 6(3), 2625–2630 (2017)
S.E. Haque, A. Sheela, Development of polymer bound fast dissolving metformin buccal film with disintegrants. Int. J. Nanomed. 10(1), 199–205 (2015)
S.V. Pawar, M.S. Junagade, Formulation and evaluation of mouth dissolving film of risperidone. Int. J. Pharm. Tech. Res. 8(6), 218–230 (2015)
B.R. Yasmeen, S. Firoz, Y.C. Mouli et al., Preparation and evaluation of oral fast dissolving films of citalopram hydrobromide. Int. J. Biopharm. 3(2), 103–106 (2012)
R. Nagaraju, B. Sujatha, S. Vidyadhara et al., Design and evaluation of fast dissolving films containing nizatidine. Ind. J. Pharm. Edu. Res. 46(4), 318–322 (2012)
R.D. Pooja, F.J. Sayyad, Design, development and evaluation of oxcarbazepine loaded fast dissolving oral film. Int. J. Drug Dev. Res. 10, 12–24 (2018)
D. Sharma, D. Kaur, S. Verma et al., Fast dissolving oral films technology: a recent trend for an innovative oral drug delivery system. Int. J. Drug Deliv. 7(2), 60–75 (2015)
A.F. Borges, C. Silva, J.F. Coelho et al., Oral films: current status and future perspectives II Intellectual property, technologies and market needs. J. Control Release. 206, 108–121 (2015)
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); [cited 18 Apr 2020]. Available from: https://clinicaltrials.gov/
curepharmaceutical.com. [Internet]. Oxnard (CA): CURE Pharmaceutical Holding Corp; [cited 23 Apr 2020]. Available from: https://curepharmaceutical.com/products/product-pipeline/
aavishkar.com [Internet].Hyderabad (India): Aavishkar Oral Strips Pvt Ltd; [cited 23 Apr 2020]. Available from: http://www.aavishkar.com/products/
aquestive.com [Internet]. Warren (NJ): Aquestive Therapeutics, Inc; [cited 23 Apr 2020]. Available from: https://aquestive.com/innovative-drug-delivery-pharmfilm/
umangpharmaceuticals.com [Internet]. Vasai (India): Umang Pharmatech Pvt Ltd; [cited 23 Apr 2020]. Available from: http://umangpharmaceuticals.com/oral-films-pellets.html
livkonpharma.com [Internet]. Mumbai (India): Livkon Pharmaceutical Pvt Ltd; [cited 2020 Apr 23]. Available from: http://www.livkonpharma.com/productlist.html.
zimlab.in [Internet]. Nagpur (India): Zim Laboratories Limited; [cited 23 Apr 2020]. Available from: https://www.zimlab.in/product/
Y.G. Jadhav, U.C. Galgatte, P.D. Chaudhari, Challenges in formulation development of fast dissolving oral films. Indo Am. J. Pharm. Res. 3(8), 6391–6407 (2013)
F.L. Lopez, T.B. Ernest, C. Tuleu et al., Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert Opin. Drug Deliv. 12(11), 1–14 (2015)
M. Dahiya, S. Saha, A.F. Shahiwala, A review on mouth dissolving films. Curr. Drug Deliv. 6(5), 469–476 (2009)
R. Sheoran, Fast dissolving oral films: a review with future prospects. Int. J. Pharm. Pharm. Res. Human. 12(2), 15–32 (2018)
C. Saraiva, C. Praca, R. Ferreira et al., Nanoparticle-mediated brain drug delivery: overcoming blood-brain barrier to treat neurodegenerative diseases. J. Control Release. 235, 34–47 (2016)
A.F. Borges, C. Silva, J.F. Coelho et al., Oral films: current status and future perspectives: I—galenical development and quality attributes. J. Control Release. 206, 1–19 (2015)
Acknowledgements
The authors gratefully acknowledge the Department of Science and Technology (GoI), New Delhi and the support from National Facility for Drug Development for Academia, Pharmaceutical and Allied Industries (NFDD) (Ref No. VI- D&P/349/10-11/TDT/1 Dt: 21.10.2010) and National Facility for Bioactive Peptides from Milk (NFBP) Project (Ref No. VI- D&P/545/2016-17/TDT; Dt: 28.02.2017).
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Suresh, J., Aravindaraj, N., Krishnaswami, V. et al. Oral film technology: a perspective on translational research and clinical studies. Macromol. Res. 31, 917–932 (2023). https://doi.org/10.1007/s13233-023-00185-y
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DOI: https://doi.org/10.1007/s13233-023-00185-y