Tablets & Capsules


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lan, carboxymethyl cellulose cekol, polyvinyl pyrroli- done, pectin, gelatin, sodium alginate, hydroxypropyl cellulose, polyvinyl alcohol, and maltodextrins. Whatever the film used, manufacturers typically adapt or augment the basic casting process with proprietary methods based on their intellectual property. The methods vary accord- ing to the API to be added, which may be soluble or insoluble and hydrophilic or lipophilic. In fact, the film substrate can accept multiple molecules and compounds, and scientists must work to determine the right ratio. Special mixing techniques ensure even distribution of the API(s) throughout the film. In the final step before pack- aging, the film is cut into precise, identical sizes to ensure uniform doses. One polymer film—what the company calls a dissolv- able matrix—combines polyethylene oxide and other polymers into an ultrathin, single-layer film strip [2]. It delivers APIs directly to the mucous membranes of the mouth, cheek, and under the tongue within seconds without the need for water. The matrix can carry and deliver molecules, proteins, and peptides into the blood- stream and is suitable for both small and large molecules and possibly biologics. It is the only single-layer biocom- patible film currently available and, according to the company, the yields of its process are competitive with those of tablets. The technology is currently used in two commercial products. The first is Zuplenz (ondansetron) for the pre- vention of nausea and vomiting associated with chemotherapy, radiation, and post-operative surgical issues. The other is Suboxone (buprenorphine and nalox- one) for the maintenance treatment of opioid depen- dence in combination with a treatment plan and counsel- ing. The company is also working with partners on three small molecules for migraine and gastrointestinal issues, and five other products. They include insulin for Type 1 diabetes, testosterone for hormone deficiency, a GLP-1 analogue for Type 2 diabetes, teriparatide for osteoporo- sis, and Biondvax, a universal influenza vaccine. The insulin film, developed in partnership with Midatech, is in Phase II trials. T&C Reference 1. "Global Markets and Technologies for Advanced Drug Delivery Systems," BCC Research, Wellesley, MA. January 2014. Accessed August 4, 2014. 2. PharmFilm from MonoSol Rx, Warren, NJ. N.E. Gupta is a freelance writer. 18 March 2015 Tablets & Capsules Tuesday, May 5, 2015 12:00 PM (Noon) – 2:00 PM EDT This is a FREE webinar. Register today at Steve Lee, CapsCanada Moderated by Matthew Knopp, Editor of Tablets & Capsules Gain a greater understanding of the com- mon defect types in two-piece capsules, how they occur, and how they are prevented. We will take an in-depth look at the main defect drivers and learn how root cause analysis tools can be used to identify issues in the capsule fi lling process. W E B I N A R PDH Information: If you are working on a certifi cation or licensing program that allows Professional Development Hours, CSC Publishing Inc. will (upon re- quest) provide a Certifi cate of Participation for educational webinars put on by Tablets & Capsules. One certifi cate per registered participant will be sent if the webinar is viewed. Check with your employer or local agency about what they require. In many cases, our educational webinars count toward professional development hours. Understanding Filling Defects in Two-Piece Hard Shell Capsules

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