Development of regulatory science for continuous manufacturing of strip-film based drug dosage forms capable of real-time release

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Project Summary/Abstract: Development of regulatory science for continuous manufacturing of strip-film based drug dosage forms capable of real-time release Polymer films have emerged as a promising platform for the delivery of pharmaceutical products in recent years. They are roughly the size of a postage stamp and can be placed on the tongue for immediate release or under the tongue (sublingual) or on the inside of the cheek (buccal) for sustained release to deliver drugs. These films offer several distinct advantages over traditional orally disintegrating tablets (ODTs), in part due to their small size, ease of administration and more flexibility and less fragility than ODTs. Therefore they are gaining significant interest as an emerging novel oral drug delivery system. However, unlike the vast body of available knowledge to support robust and predictable manufacturing of tablets, the literature related to strip-films is rather sparse and fragmented. Our group has been working on this novel technology for past eight years and has shown that if properly formulated and manufactured in a continuous process, this is a technology that has the potential to modernize pharmaceutical manufacturing due to its many attractive features. We have shown that in contrast to prevalent solvent based casting, engineered drug particles in nano and micro sizes may be incorporated through slurry casting for achieving high quality films that have excellent drug content uniformity and lead to very fast release even from poorly water soluble drugs. Other attractive features include the ability to formulate drugs, including those that are highly water insoluble, for many important therapeutic applications, such as quick-effect pain management, fast-acting remedy for nausea and vomiting, medications for Alzheimer’s disease which often leads to dysphagia (inability to swallow tablets), combination therapies required for treating cancer or AIDS, and most importantly, addressing unmet therapeutics needs in pediatric formulations, e.g., drug delivery in neonates requiring flexible dosages depending on the weight of the infant, and in pediatric cancers. To realize the full potential of this emerging technology, we propose to carry out scientific research to determine the impact of raw and intermediate material properties as well as key manufacturing processes and parameters on critical product quality attributes in continuous strip-film manufacturing. Further, we will develop and validate models for key processes to enable improved product and process development. Thus the proposed work will lead to the development of the important body of knowledge that is necessary to support more robust, predictable, or cost-effective processes for improved manufacturing of film based dosage forms that achieve high quality. It will also support more efficient regulation of the film products by the FDA, thus benefitting patients as well as society.