ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE
Abstract
This review represents importance of mouth dissolving films as compared to other oral dosage forms. Fast dissolving oral drug delivery system are solid dosage form which disintegrate or dissolve within seconds when placed in the mouth without need of water or chewing. First developed fast dissolving dosage form in formulation and the rapid disintegrating properties were obtained through a special procedure or formulation modification, hence mouth dissolving film is proved to be better alternative in such cases. This fast dissolving drug delivery system is suited for the drugs which undergo high first pass metabolism and is used for improving bioavailability. Mouth dissolving film consists of thin oral strip; which release active ingredients immediately after uptake into oral cavity. In present investigation, an attempt has been made to develop oral fast dissolving film. Availability of larger surface area that leads to rapid disintegrating and dissolution in the oral cavity.
Keywords:
Fast Dissolving Oral Films; Oral Strip; Film Forming Polymer; Solvent Casting Method.
Downloads
Download data is not yet available.
References
1. Satoskar R., Bhandarkar S., Rege N. Pharmacology and Pharmacotherapeutics. Revised 20th ed. Mumbai: Popular Prakashan. 2008 .p.330-32.
2. Sumitha C., Karuna S., Divya B., Madhavi K., Varma M., Charbe N. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating films. Int .J. of Chem. Res. 2009;1 (2): 24-7
3. Arya A., Chandra A., Sharma V., Pathak K., Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form. Int. J. of Chem Tech Research. 2010; 2(1): 576-83.
4. Dixit R.P., Puthli S.P. Oral strip technology: Overview and future potential. J. of Cont Release. 2009;139: 94–107.
5. Rathbone M., Drummond B and Tucker I. Oral cavity as a site for systemic drug delivery. Adv. Drug Del. Rev. 1994. 2009;13:1-22.
6. Zhang H, Zhang J, Streisand JB, Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic application .clin. pharmacokinetic . 2002; 41: 661-80.
7. Patel R. Design of a Novel Rapidly Dissolving Wafer System for Oromucosal Drug Delivery. September 2003; 21-5.
8. Ghosh TK, Pfister WR. Drugs and Pharmaceutical sciences. Drug delivery to oral cavity- Molecules to market. vol. 145 p. 2-40.
9. Gupta A, Mishra AK, Gupta V, Bansal P, Singh R, Singh AK. Recent Trends of Fast Dissolving Tablet-An Overview of Formulation Technology. Int J Pharm Biol Archives. 2010; 1(1): 1 – 10.
10. Ciper M, Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. Int J Pharm October. 2005; 303(1-2): 62-71.
11. Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for pediatric use. Eur J Pharm Biopharm. 2011; 78: 462–69.
12. Rowe, R., Sheskey, P., Owen, S. Handbook of Pharmaceutical Excipients. 5th ed. Pharmaceutical Press Grayslake, American Pharmacists Association, Washington: 2006.
13. Kulkarni A., Deokule H., Mane M. Exploration of different polymers for use in the formulation of oral fast dissolving strips. Journal of Current Pharmaceutical Research. 2010; 2(1): 33-5.
14. Angela A., Federica B., Teresa C., chitosan /gelatin films for buccal delivery of propranolol Hydrochloride Carbohydrate Polymers. 2012; 87: p.581– 5881.
15. Mahajan A, Chhabra N, Aggarwal G. Formulation and Characterization of Fast Dissolving Buccal Films: A Review. Scholars Research Library, Der Pharmacia Lettre. 2011; 3(1):152-65.
16. Sharma K, Ghosh TK, Pfister WR. Quick-Dispersing Oral Drug Delivery Systems. Drugs and Pharmaceutical sciences. Drug delivery to oral cavity- Molecules to market, vol. 145, p. 261-87.
17. Patel R. Design of a Novel Rapidly Dissolving Wafer System for Oromucosal Drug Delivery. September 2003; 21-5.
18. Ghosh TK, Pfister WR. Drugs and Pharmaceutical sciences Drug delivery to oral cavity- Molecules to market. vol. 145: p. 2-40
19. Aggarwal J., Singh G., Saini S., Fast dissolving films: A novel approach to oral drug delivery. Int .Res. J.of Pharm. 2011:2(12): 69-74.
20. 20. Jadhav S. D., Kalambe R., Jadhav M.. Formulation and evaluation of fast dissolving oral film of levocetirizine dihydrochlorid. Int J of Pharm and Pharma Sci. 2011; 4(1): 337-42
21. Shukla D., Chakraborty S., Singh S., Mouth dissolving tablets An overview of formulation technology. Scientia Pharmaceutica. 2009; 77: 309-26.
22. Mashru R. C., Sutariya V. B., Sankalia M. G., Parikh P. P. Development and evaluation of fast dissolving film of salbutamol sulphate. Drug Dev. Ind. Pharm. 2005; 31 (1) : 25–34.
23. Bandari S., Mittapalli R, Gannu R., Rao Y.M.. Orodispersible tablets: Overview. Asian J Pharma; Jan 2008; 2-10
24. Patel A., Prajapati D., Raval J., Fast dissolving films as a new venture in fast dissolving dosage forms, Int J of Drug Dev and Res. 2010; 2(2): 232-46.
25. Kulkarni A., Deokule H., Mane M., Exploration of different polymers for use in the formulation of oral fast dissolving strips. Journal of Current Pharmaceutical Research. 2010; 2(1): 33-35.
26. Kumari S, Visht S, Sharma PK, Yadav RK. Fast dissolving Drug delivery system. Review Article. J Pharm Res. 2010; 3: 1444-49.
27. Ciper M, Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. Int J Pharm. October 2005; 303(1-2), 13: 62-71.
28. Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for pediatric use. Eur J Pharm Biopharm. 2011; 78: 462–69.
29. Fu Y, Jeong SH, Callihan J, Kim J, Park K. Preparation of Fast-Dissolving Tablets Based on Mannose. ACS symposium series 924, Polymeric Drug Delivery II, Polymeric Matrices and Drug Particle Engineering, p. 340-51.
30. Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. J Control Release. 2009; 139 : 94–107.
31. Patel AR, Prajapati DS, Raval JA. Fast Dissolving Films (FDFs) As A Newer Venture in Fast Dissolving Dosage Forms. Int J Drug Develop Res. April-June 2010; 2(2): 232-46.
32. Kashyap S, Sharma V, Singh L. Fast Disintegrating Tablet: A Boon To Pediatric and Geriatric. Int J Pharm Professional. April 2011; 2(2): 318-26.
33. Saini S, Samt A, and Gupt S. Optimization of Formulation of fast dissolving Films made of Pullulan Polymer. Inte. J. Pharm. Sci. Rev & Res. 2011; 9: 1-24.
34. S. Raju, P. Sandeep Reddy V. Anirudh Kumar A., Deepthi K. Sreeramulu R., Madhava Reddy P.V. Flash release oral films of metoclopramide hydrochloride for pediatric use: Formulation and in-vitro evaluation. J. Chem. Pharm. Res. 2011; 3(4):636-46.
35. Vollmer U, Galfetti P: Rapid Film: Oral Thin Films as an Innovative Drug Delivery System and Dosage Form. Drug Development Report.2006; 2(1):1-5.
36. Rathi V, Kammili L, Hans R: A Brief Review on Oral film Technology. IJRAP. 2011; 2(4): 1138-47.
37. Kulkarni K, Dixit M, Shahnawaz A, Singh M and Kulkarni A. formulation and evaluation of mouth dissolving film containing Rofecoxib. IRJP. 2011; 2(3):273-78.
38. Ulrich Siemann: Solvent cast technology – a versatile tool for thin film production Progr Colloid. Polym. Sci. 2005; 1(14):130.
39. Singhal S, Lohar V.K., Arora V: Hot Melt Extrusion Technique. Web med Central Pharm.Sci. 2011; 2(1):001459.
40. Suneela P, Kevin L, Urman J U., Otaigbe, Michael A. Repka: Stabilization of Hot-Melt Extrusion Formulations Containing Solid Solutions Using Polymer Blends. AAPS PharmSciTech. 2007; 8(2):50.
41. Sandeep S., Arun N., Monika H., Komal. Fast Dissolving Films (FDF): Innovative Drug Delivery System. Pharmacologyonline. 2011; 2: 919-28.
42. Alpesh R. Patel, Dharmendra S. Prajapati, Jignyasha A. Raval. Fast Dissolving Films (FDFS) as a Newer Venture in Fast. Int. J. Drug Dev. & Res. 2010; 2(2): 0975-9344.
43. Mishra R, Amin A. Formulation development of taste-masked rapidly dissolving films of Cetirizine hydrochloride. Pharm Tech. 2010; 33(2): p.48-56.
44. Koland M, Sandeep V P, Charyulu N R. Fast dissolving Sublingual films of Ondansetron hydrochloride. Effect of Additives on in-vitro drug release and Mucosal permeation. J Young Pharm. 2010 Jul-Sep; 2(3): 216–22.
45. Squier C.A., Hall B.K. The permeability of mammalian non-keratinized oral epithelia to horse raddish peroxidase applied in vivo and in vitro, Arch. Oral Biol. 1984; 29:45-50.
46. Hill M.W., Squier C.A. The permeability of oral palatal mucosa maintained in organ culture, J. Anat. 1979;128:169-78.
47. Wertz P, Squier C. Cellular and molecular basis of barrier function in oral epithelium. Crit. Rev. Ther. Drug Carr. Sys. 1991; 8:237-69.
48. Tabak L, Levine J, Mandel I., Ellison A. Role of salivary mucins in the protection of the oral cavity. J. Oral Pathol. 1982;11:1-17.
49. Patil S, Mahaparale P, Shivnikar M. Fast dissolving oral films: an innovative drug delivery system. International Journal of Research and Reviews in Pharmacy and Applied science. 2(3): 482-96.
2. Sumitha C., Karuna S., Divya B., Madhavi K., Varma M., Charbe N. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating films. Int .J. of Chem. Res. 2009;1 (2): 24-7
3. Arya A., Chandra A., Sharma V., Pathak K., Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form. Int. J. of Chem Tech Research. 2010; 2(1): 576-83.
4. Dixit R.P., Puthli S.P. Oral strip technology: Overview and future potential. J. of Cont Release. 2009;139: 94–107.
5. Rathbone M., Drummond B and Tucker I. Oral cavity as a site for systemic drug delivery. Adv. Drug Del. Rev. 1994. 2009;13:1-22.
6. Zhang H, Zhang J, Streisand JB, Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic application .clin. pharmacokinetic . 2002; 41: 661-80.
7. Patel R. Design of a Novel Rapidly Dissolving Wafer System for Oromucosal Drug Delivery. September 2003; 21-5.
8. Ghosh TK, Pfister WR. Drugs and Pharmaceutical sciences. Drug delivery to oral cavity- Molecules to market. vol. 145 p. 2-40.
9. Gupta A, Mishra AK, Gupta V, Bansal P, Singh R, Singh AK. Recent Trends of Fast Dissolving Tablet-An Overview of Formulation Technology. Int J Pharm Biol Archives. 2010; 1(1): 1 – 10.
10. Ciper M, Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. Int J Pharm October. 2005; 303(1-2): 62-71.
11. Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for pediatric use. Eur J Pharm Biopharm. 2011; 78: 462–69.
12. Rowe, R., Sheskey, P., Owen, S. Handbook of Pharmaceutical Excipients. 5th ed. Pharmaceutical Press Grayslake, American Pharmacists Association, Washington: 2006.
13. Kulkarni A., Deokule H., Mane M. Exploration of different polymers for use in the formulation of oral fast dissolving strips. Journal of Current Pharmaceutical Research. 2010; 2(1): 33-5.
14. Angela A., Federica B., Teresa C., chitosan /gelatin films for buccal delivery of propranolol Hydrochloride Carbohydrate Polymers. 2012; 87: p.581– 5881.
15. Mahajan A, Chhabra N, Aggarwal G. Formulation and Characterization of Fast Dissolving Buccal Films: A Review. Scholars Research Library, Der Pharmacia Lettre. 2011; 3(1):152-65.
16. Sharma K, Ghosh TK, Pfister WR. Quick-Dispersing Oral Drug Delivery Systems. Drugs and Pharmaceutical sciences. Drug delivery to oral cavity- Molecules to market, vol. 145, p. 261-87.
17. Patel R. Design of a Novel Rapidly Dissolving Wafer System for Oromucosal Drug Delivery. September 2003; 21-5.
18. Ghosh TK, Pfister WR. Drugs and Pharmaceutical sciences Drug delivery to oral cavity- Molecules to market. vol. 145: p. 2-40
19. Aggarwal J., Singh G., Saini S., Fast dissolving films: A novel approach to oral drug delivery. Int .Res. J.of Pharm. 2011:2(12): 69-74.
20. 20. Jadhav S. D., Kalambe R., Jadhav M.. Formulation and evaluation of fast dissolving oral film of levocetirizine dihydrochlorid. Int J of Pharm and Pharma Sci. 2011; 4(1): 337-42
21. Shukla D., Chakraborty S., Singh S., Mouth dissolving tablets An overview of formulation technology. Scientia Pharmaceutica. 2009; 77: 309-26.
22. Mashru R. C., Sutariya V. B., Sankalia M. G., Parikh P. P. Development and evaluation of fast dissolving film of salbutamol sulphate. Drug Dev. Ind. Pharm. 2005; 31 (1) : 25–34.
23. Bandari S., Mittapalli R, Gannu R., Rao Y.M.. Orodispersible tablets: Overview. Asian J Pharma; Jan 2008; 2-10
24. Patel A., Prajapati D., Raval J., Fast dissolving films as a new venture in fast dissolving dosage forms, Int J of Drug Dev and Res. 2010; 2(2): 232-46.
25. Kulkarni A., Deokule H., Mane M., Exploration of different polymers for use in the formulation of oral fast dissolving strips. Journal of Current Pharmaceutical Research. 2010; 2(1): 33-35.
26. Kumari S, Visht S, Sharma PK, Yadav RK. Fast dissolving Drug delivery system. Review Article. J Pharm Res. 2010; 3: 1444-49.
27. Ciper M, Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. Int J Pharm. October 2005; 303(1-2), 13: 62-71.
28. Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for pediatric use. Eur J Pharm Biopharm. 2011; 78: 462–69.
29. Fu Y, Jeong SH, Callihan J, Kim J, Park K. Preparation of Fast-Dissolving Tablets Based on Mannose. ACS symposium series 924, Polymeric Drug Delivery II, Polymeric Matrices and Drug Particle Engineering, p. 340-51.
30. Dixit RP, Puthli SP. Oral strip technology: Overview and future potential. J Control Release. 2009; 139 : 94–107.
31. Patel AR, Prajapati DS, Raval JA. Fast Dissolving Films (FDFs) As A Newer Venture in Fast Dissolving Dosage Forms. Int J Drug Develop Res. April-June 2010; 2(2): 232-46.
32. Kashyap S, Sharma V, Singh L. Fast Disintegrating Tablet: A Boon To Pediatric and Geriatric. Int J Pharm Professional. April 2011; 2(2): 318-26.
33. Saini S, Samt A, and Gupt S. Optimization of Formulation of fast dissolving Films made of Pullulan Polymer. Inte. J. Pharm. Sci. Rev & Res. 2011; 9: 1-24.
34. S. Raju, P. Sandeep Reddy V. Anirudh Kumar A., Deepthi K. Sreeramulu R., Madhava Reddy P.V. Flash release oral films of metoclopramide hydrochloride for pediatric use: Formulation and in-vitro evaluation. J. Chem. Pharm. Res. 2011; 3(4):636-46.
35. Vollmer U, Galfetti P: Rapid Film: Oral Thin Films as an Innovative Drug Delivery System and Dosage Form. Drug Development Report.2006; 2(1):1-5.
36. Rathi V, Kammili L, Hans R: A Brief Review on Oral film Technology. IJRAP. 2011; 2(4): 1138-47.
37. Kulkarni K, Dixit M, Shahnawaz A, Singh M and Kulkarni A. formulation and evaluation of mouth dissolving film containing Rofecoxib. IRJP. 2011; 2(3):273-78.
38. Ulrich Siemann: Solvent cast technology – a versatile tool for thin film production Progr Colloid. Polym. Sci. 2005; 1(14):130.
39. Singhal S, Lohar V.K., Arora V: Hot Melt Extrusion Technique. Web med Central Pharm.Sci. 2011; 2(1):001459.
40. Suneela P, Kevin L, Urman J U., Otaigbe, Michael A. Repka: Stabilization of Hot-Melt Extrusion Formulations Containing Solid Solutions Using Polymer Blends. AAPS PharmSciTech. 2007; 8(2):50.
41. Sandeep S., Arun N., Monika H., Komal. Fast Dissolving Films (FDF): Innovative Drug Delivery System. Pharmacologyonline. 2011; 2: 919-28.
42. Alpesh R. Patel, Dharmendra S. Prajapati, Jignyasha A. Raval. Fast Dissolving Films (FDFS) as a Newer Venture in Fast. Int. J. Drug Dev. & Res. 2010; 2(2): 0975-9344.
43. Mishra R, Amin A. Formulation development of taste-masked rapidly dissolving films of Cetirizine hydrochloride. Pharm Tech. 2010; 33(2): p.48-56.
44. Koland M, Sandeep V P, Charyulu N R. Fast dissolving Sublingual films of Ondansetron hydrochloride. Effect of Additives on in-vitro drug release and Mucosal permeation. J Young Pharm. 2010 Jul-Sep; 2(3): 216–22.
45. Squier C.A., Hall B.K. The permeability of mammalian non-keratinized oral epithelia to horse raddish peroxidase applied in vivo and in vitro, Arch. Oral Biol. 1984; 29:45-50.
46. Hill M.W., Squier C.A. The permeability of oral palatal mucosa maintained in organ culture, J. Anat. 1979;128:169-78.
47. Wertz P, Squier C. Cellular and molecular basis of barrier function in oral epithelium. Crit. Rev. Ther. Drug Carr. Sys. 1991; 8:237-69.
48. Tabak L, Levine J, Mandel I., Ellison A. Role of salivary mucins in the protection of the oral cavity. J. Oral Pathol. 1982;11:1-17.
49. Patil S, Mahaparale P, Shivnikar M. Fast dissolving oral films: an innovative drug delivery system. International Journal of Research and Reviews in Pharmacy and Applied science. 2(3): 482-96.
Statistics
1689 Views | 924 Downloads
How to Cite
1.
Patil PC, Shrivastava SK, S. V, P. A. ORAL FAST DISSOLVING DRUG DELIVERY SYSTEM: A MODERN APPROACH FOR PATIENT COMPLIANCE. Int J Drug Reg Affairs [Internet]. 2018Feb.12 [cited 2025Apr.23];2(2):49-0. Available from: https://www.ijdra.com/index.php/journal/article/view/131
Section
Review
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
