Advancing ODT Technology - Pharmaceutical Technology

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Advancing ODT Technology
Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.


Pharmaceutical Technology



Table II. Select examples of oral thin-film pharmaceuticals and nutraceuticals.
Thin-film technology has primarily been used in over-the-counter (OTC) products (see Table II). The 2004 global market (based on ex-factory sales to wholesalers) for oral-thin film technology in pharmaceutical (OTC) and nutraceutical products was $25 million, says Technology Catalysts. The market is projected to increase to $500 million in the 2007 timeframe, conditioned on the entry of higher revenue-generating OTC products and possibly prescription drug products entering the market (3).

Companies with oral thin-film technologies and products include LTS Lohmann Therapy Systems (West Caldwell, NJ), Adhesives Research (GlenRock, PA), Applied Pharma Research (Balerna, Switzerland), and Meldex International (Cambridge, UK).

Adhesives Research provides active dissolvable films for Novartis's "Triaminic Thin Strips" pediatric cough and cold products and "Theraflu Thin Strips" cold and flu products. Its technology and product platform is "ARcare" dissolvable films.

Last month, Applied Pharma Research opened its US affiliate, Applied Pharma Research USA, in Charlotte, North Carolina. The company is in the final stages of developing ondansetron and donepezil formulations using its proprietary "RapidFilm" oral thin-film technology. The "Ondansetron RapidFilm" is a generic version of GlaxoSmithKline's "Zofran."

Meldex is developing DBP117, an oral film strip of a antimigraine drug. The company is positioning the product in the "triptan" market, which includes GlaxoSmithKline's "Imitrex" (sumatriptan) and AstraZeneca's "Zomig" (zolmitriptan). The product has passed the initial formulation phase and is due to commence scale-up manufacturing trials in the second half of 2007, according to the company. The product is planned for submission to US and European Union regulatory authorities during 2008.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ, 08830, tel. 732.346.3072,

References

1. W. Pfister and T. Gosh, "Orally Disintegrating Tablets: Products, Technologies, and Development Issues," Pharm. Technol. 29 (10), 138–150 (2005).

2. FDA, Guidance for Industry: Orally Disintegrating Tablets draft guidance, (Rockville, MD, April 2007).

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

4. A. Clarke and J. Jankovic, "Selegeline Orally Disintegrating Tablet in the Treatment of Parkinson's Disease," Therapy 3 (3), 349–356 (2006).

5. R. Bohnacker et al., "Determination of the Disintegration Time of Mouth Melt Tablets with Texture Analyzer Method," Pharm. Ind. 67 (3), 327–335 (2005).


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