Test methods

Standard high-performance liquid chromatography testing for potency and content uniformity apply to thin-film oral dosage forms. Analytical methods for testing films are similar to other solid dosage forms, but the potential interference of the film-forming polymers during methods development must not be overlooked. Taste-masking analysis is conducted through qualified human panels and/or in vitro testing using electronic techniques (7).

Testing methods used to characterize dissolvable films include USP tests for disintegration and dissolution. Additional test methods may be developed to simulate environmental influences such as pH and temperature.

Finally, stability of OTFs has been demonstrated by the various commercial products claiming 2- to 3-year expiration date periods. Although these products tend to be sensitive to environmental moisture, the primary packaging is critical and sufficient for meeting the International Conference on Harmonization stability requirements for extended expiration dating (11).

Beyond immediate-release applications

Figure 3

Summary

The true potential for oral thin-film technology is only beginning to be recognized. Additional immediate release over-the-counter OTFs, and eventually prescription drug OTFs will be commercially launched. Future dissolvable films will likely evolve beyond immediate-release oral delivery of drug compounds; exploration into the use of film formats to deliver nano-scale to large molecules is already underway. In addition, the chemistry and processing of the dissolvable-film platform technology broadens the application potential into implantable, topical, sublingual, dermal and gastro-retentive applications. Ultimately, dissolvable-film technology is only limited by the imagination and capabilities of the formulator.

Beth Vondrak is vice-president and general manager at ARx, LLC, a wholly owned subsidiary of Adhesives Research, Inc., and Scott Barnhart is technical director at ARx, LLC, PO Box 100, 100 Seaks Run Road, Glen Rock, PA 17327, tel. 717.227.3260/3206, fax 717.235.0172, [email protected]
or [email protected]

References

1. S.B. Borsadia et al., "Quick-Dissolving Films—A Novel Approach to Drug Delivery," Drug Delivery Technol. 3 (3), 63–66 (2003).

2. P. Frey, "Film Strips and Pharmaceuticals," Pharma. Mfg. & Packag. Sourcer, Winter, 92–93 (2006).

3. "Oral Thin Films," in Orally Disintegrating Tablet and Film Technologies, 4th ed. (Technology Catalysts International, Falls Church, VA, 2006), 18–31.

4. S.D. Barnhart and M.S. Sloboda, "The Future of Dissolvable Films," Drug Delivery Technol. 7 (8), 34–37 (2007).

5. I. Muir, "Growing Sales and New Opportunities for Oral Fast Dissolve," ONDrugDelivery—Oral Drug Delivery: When You Find the Holy Grail (East Sussex, UK), http://www.ondrugdelivery.com/publications/Oral_Drug_Delivery_07.pdf, accessed Feb. 20, 2008.

6. P. Van Arnum, "Outsourcing Solid Dosage Manufacturing," Pharmaceutical Technol. 30 (6), 44–52 (2006).

7. S.D. Barnhart, "Thin Film Oral Dosage Forms," in Modified Release Drug Delivery Technology, 2nd ed., Vol. 1, in press (Informa Healthcare; New York, NY, 2008) 209-216.

8. Novartis Pharmaceuticals Annual Report (2005), p. 43.

9. C. Moritz, "Films that Dissolve Diagnostics Manufacturer's Needs," Med. Design Technol. 10 (10), 11–13 (2006).

10. B. Meathrel and C. Moritz, "Dissolvable Films and Their Potential in IVDs," IVD Technol. 13 (9), 53–58 (2007).

11. ICH, "ICH Q1C Stability Testing for New Dosage Forms," Federal Register 62 (90), 25634–25635 (1997).