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news.APR, a drug developer and drug delivery technology provider, and its partner Labtec have submitted anti-migraine drug Zolmitriptan Oral Dispersible Film (ODF) for approval in Europe.
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APR said Zolmitriptan ODF is a very thin polymeric film strip with a size of 3sqcm and 6sqcm for the 2,5mg and 5mg dosage strengths, respectively.
Zolmitriptan ODF once placed in the mouth, dissolves in a few seconds and is swallowed with the saliva without the need of water.
APR and Labtec said the oral dispersible film strip formulation containing anti-migraine drug Zolmitriptan is the second prescription product based upon their RapidFilm technology and is co-developed in collaboration with the Warren, New Jersey based Monosol Rx.
The product will be manufactured for Europe at Labtec´s production site in Hamburg, Germany.
Concurrently, the same partners are proceeding in the US to complete the required steps to obtain Marketing Approval by the FDA.