Manufacturing Techniques of Orally Dissolving Films - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Manufacturing Techniques of Orally Dissolving Films
The manufacture of orally dissolving films is done by various methods such as solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling. The authors discuss these methods and the various parameters in which dissolving films are evaluated.

Pharmaceutical Technology
Volume 35, Issue 1, pp. 70-73

Clinical and regulatory requirement

To indicate bioequivalency of a product to that of existing oral drug, an abbreviated new drug application is required. In-vitro dissolution studies and therapeutic equivalence are considered. Comparative bioequivalence between an orally disintegrating tablet and an ODF can be evaluated. If the ODF exhibits a different target pharmacokinetic profile compared with the existing marketed product, the ODF is considered a new dosage form. For a new dosage form, a new clinical study is required. A new clinical study offers the advantage of three years of marketing exclusivity to the product. Preclinical toxicity studies are not required if the molecule is the same as that of the approved product. Safety, tolerability, and efficacy features are to be demonstrated in such trials. Oral mucosa-irritation testing is carried out in both animal models and humans. The hamster-cheek pouch is the most appropriate model for predicting irritation criteria before testing in humans (12).


ODFs are a possible alternative dosage form to orally disintegrating tablets. These films offer the benefits of pleasant mouthfeel and rapid disintegration in the mouth. Solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling are important manufacturing methods to produce these films.

Renuka Mishra* is an assistant professor, and Avani Amin is a professor in the Department of Pharmaceutics and Pharmaceutical Technology, the Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, India,

*To whom all correspondence should be addressed.


1. S. Borsadia, D. O'Halloran, and J.L. Osborne, Drug Del. Tech. 3 (3), 63–66 (2003).

2. T. Ghosh and W.Pfister, "Intraoral Delivery Systems: An Overview, Current Status and Future Trends," in Drug Delivery to the Oral Cavity: Molecules to Market, T. Ghosh and W. Pfister, Eds. (Taylor & Francis, Florida, CRC Press, 2005), pp. 1–34.

3. P. V. Arnum, "Outsourcing Solid Dosage Manufacturing," Pharm. Technol. 30 (6), 44–52 (2006).

4. R. Mishra and A. Amin, Pharm. Technol. Eur. 19 (10), 35–39 (2007).

5. M. Repka et al., "Hot Melt Extrusion," in Encyclopedia of Pharmaceutical Technology, J. Swarbrick and J. Boylan, Eds. (Marcel Dekker Inc., New York, Vol. 2, 2nd Edition, 2002), pp. 1488–1504.

6. M.A. Repka and J.W. McGinity, Pharm. Dev. Technol. 6 (3), 297–304 (2001).

7. M. Repka and J.W. McGinity, J. Controlled Release 76 (3), 341–351 (2001).

8. J. Breitenbach, Eur. J. Pharm. Biopharm. 54 (2), 107–117 (2002).

9. A. Arya et al., Int. J. Chem. Tech. Research 2 (1), 578–583 (2010).

10. Gole et al., "Pharmaceutical and Other Dosage Forms," US Patent 5648093, Jul. 1997.

11. R.K. Yang et al., "Thin Film with Non-Self Aggregating Uniform Heterogeneity and Drug Delivery Systems Made Therefrom," US Patent Application 20080226695.

12. R. Mishra and A. Amin, Pharm. Technol. 33 (2), 48–56 (2009).

13. R.P. Dixit, S.P. Puthli, J. Controlled Release 139 (2), 94–107 (2009).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here