Tablets & Capsules


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6 January 2017 Tablets & Capsules research Capsule expands into star shape, can reside 2 weeks in stomach CAMBRIDGE, MA—Researchers at the Massachusetts Institute of Technology and Brigham and Women's Hospital developed a cap- sule that deploys a star-shaped struc- ture that remains in the stomach as long as 2 weeks as it gradually releases its payload. The structure has six arms that fold inward so it can fit inside a capsule. After ingestion, the capsule dissolves in stomach acid, allowing the arms to unfold. Because of its size, the structure stays in the stomach until it dissolves. The approach could replace the need for frequent dosing and help overcome obstacles to treating diseases like malaria. A study of the capsule appears in the November 2016 issue of Science Translational Medicine. Method of synthesizing polymers promises new, better excipients MINNEAPOLIS, MN—A new method for creating and incorporating polymer excipients into oral dosages may improve the delivery of poorly soluble APIs, according to research markets Global MCC market to exceed $936 million by 2020 ALBANY, NY—The global market for microcrystalline cellulose (MCC) will reach $936.3 million by 2020, a compound annual rate of 5.8 percent, according to a report by Transparency Market Research. The fastest growth will be in the pharmaceutical industry as the geriatric population grows, increasing demand for products that use MCC. Global blister packaging to grow more than 5 percent annually ELMHURST, IL—The global mar- ket for blister packaging is forecast to grow at a compound annual rate of 5.8 percent, according to a report from Technavio, "Global Blister Packaging Market 2016-2020." The pharmaceuti- cal industry is a leading user of blister packaging because it offers a tamper- evident and convenient format. PVC remains the primary blister film due to its low cost and easy availability. industry news ISPE publishes third edition of OSD guide BETHESDA, MD—The International Society for Pharmaceutical Engineering (ISPE) published the third edition of "ISPE Baseline Guide: Oral Solid Dosage Forms." The new guide expands discus- sions of risk management and product and processing; adds a chapter about product isolation and containment; and provides updates about OSD facilities' architecture, process support utilities, HVAC, controls, and instruments. We're pleased to announce that John Davidson has joined T&C's Technical Advi- sory Board. Davidson is director of supply chain and techni- cal services at Capsugel, Greenwood, SC. In that role, he works with phar- maceutical and nutracetuical compa- nies in North America and Central America to improve operational effi- ciencies. He holds an engineering degree from the Georgia Institute of Technology. His article "Strategies for improving capsule filling efficiency" appeared in the January 2014 issue. Continuus Pharma awarded $4.4 million to study continuous pharma manufacturing WOBURN, MA—Continuus Phar- maceutical, a contract pharmaceutical manufacturer, was awarded a $4.4 mil- lion contract by the FDA and the Biomedical Advanced Research and Development Authority to support its work on monitoring and improving drug quality using integrated continuous manufacturing. The company is a spin- out of the continuous manufacturing collaboration between MIT and Novartis. During the next 3 years, it plans to develop an integrated continu- ous pilot plant to test real- time release and traceability. Guidance addresses quality agreements, self-identification SILVER SPRINGS, MD—The FDA finalized "Guidance for Industry: Contract Manufacturing Arrangements for Drugs," which addresses quality agreements. It states each party, both the owner and the contract facility, are responsible for ensuring compliance with cGMP for the manufacturing activities it performs. Furthermore, quality agreements should clearly describe the materials/services pro- vided, quality specifications, and means of communication between the parties; they should also state that the contractor's services will comply with GMP. The FDA also published a final Guidance clarifying self-identification requirements for generic manufactur- ers. It states that facilities must self- identify if they manufacture generic APIs or finished dosage forms (FDFs), package FDFs, or provide contract ser- vices to API and FDF manufacturers. If a facility fails to self-identify, all APIs and FDFs manufactured there will be labeled misbranded, which could trig- ger an inspection. Pepsi to collaborate on pediatric TB treatment LIVERPOOL, UK—TB Alliance, a nonprofit organization that develops tuberculosis (TB) treatments, will col- laborate with Pepsi to improve patient compliance in children. Many TB treatments are bitter and must some- times be taken for as long as a year, conducted at the University of Minnesota and Dow Chemical. In ani- mal tests, one excipient provided a threefold increase in drug absorption compared to conventional formulations. An article about the research, "High throughput excipient discovery enables oral delivery of poorly soluble pharma- ceuticals," appears in the October 2016 issue of ACS Central Science. new technical advisor

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