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Subutex (buprenorphine product for opioid addiction)
Sudafed (phenylephrine or pseudoephedrine product for nasal congestion)
Suppress
TheraFlu (combination product of pain reliever, anti-pyretic and decongestant)
Triaminic (children's anti-tussive product)
On July 2, 2010, Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical, received approval from the US FDA for Zuplenz (ondansetron) oral soluble film (OSF) for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.[7]
[edit] Advantages
The design of thin film, often referred to as PharmFilm, as an oral drug delivery technology offers several advantages over other modes of drug delivery, such as ingestible tablets, chewable tablets, orally dissolving tablets, softgels, liquids or inhalants:[8]
- The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing, and enhance the efficacy and safety profile of the medicament.
- All tablet dosage forms, softgels and liquid formulations primarily enter the blood stream via the gastrointestinal tract, which subjects the drug to degradation from stomach acid, bile, digestive enzymes and other first-pass effects. As a result, such formulations often require higher doses and generally have a delayed onset of action.
- Conversely, buccal and sublingual thin-film drug delivery can avoid these issues and yield quicker onsets of action at lower doses.
- Thin film is more stable, durable and quicker dissolving than other conventional dosage forms.
- Thin film enables improved dosing accuracy relative to liquid formulations since every strip is manufactured to contain a precise amount of the drug.
- Thin film not only ensures more accurate administration of drugs but also can improve compliance due to the intuitive nature of the dosage form and its inherent ease of administration. These properties are especially beneficial for pediatric, geriatric and neurodegenerative disease patients where proper and complete dosing can be difficult.
- Thin film's ability to dissolve rapidly without the need for water provides an alternative to patients with swallowing disorders and to patients suffering from nausea, such as those patients receiving chemotherapy.
- Thin film drug delivery has the potential to allow the development of sensitive drug targets that may otherwise not be possible in tablet or liquid formulations.
- From a commercial perspective thin film drug delivery technology offers an opportunity to extend revenue lifecycles for pharmaceutical companies whose drug patent is expiring and will soon be vulnerable to generic competition.
- Sublingual film delivers a convenient, quick-dissolving therapeutic dose contained within an abuse-deterrent film matrix that cannot be crushed or injected by patients, and rapidly absorbs under the tongue to ensure compliance.
[edit] References
- ^ Buccal Drug Delivery Systems
- ^ "Oral Thin Films," in Orally Disintegrating Tablet and Film Technologies, 5th ed. (Technology Catalysts International, Falls Church, VA, 2008)
- ^ "Drug Delivery Via Dissolving Strips.". Drug Discovery & Development 10 (7): 10. 2007. ISSN 1524783X.
- ^ Dixit, R.; Puthli, S. (2009). "Oral strip technology: Overview and future potential.". Journal of Controlled Release (Mumbai,India) 139 (2): 94–107. doi:10.1016/j.jconrel.2009.06.014. PMID 19559740.
- ^ "FDA Office of Regulatory Affairs, Sec. 460.600 Content Uniformity Testing of Tablets and Capsules". Fda.gov. ora/compliance_ref/cpg/cpgdrg/cpg460-600.html. Retrieved 2009-09-21.
- ^ Le Person, S; Puiggali, J.R.; Baron, M.; Roques, M. (1998). "Near infrared drying of pharmaceutical thin films: experimental analysis of internal mass transport". Chem. Eng. & Processing 37: 257–263. doi:10.1016/S0255-2701(98)00032-4.
- ^ articles/194180.php
- ^ Biradar, S.; Bhagavati, S; Kuppasad, I (2006). "Fast Dissolving Drug Delivery Systems: A Brief Overview.". The Internet Journal of Pharmacology (Ispub.com) 4 (2). ostia/index.php?xmlFilePath=journals/ijpharm/vol4n2/drug.xml. Retrieved 2009-09-21.