Issue link: https://www.e-digitaleditions.com/i/922724
8 January 2018 Tablets & Capsules industry news FDA approves digital tablet intended to increase patient compliance SILVER SPRING, MD—The FDA approved Abilify MyCite (aripiprazole tablet with sensor), the first drug product to include a digital ingestion tracking system. After the tablet is ingested, its sensor sends a message to a wearable patch that transmits the information to the patient's smart phone. With the patient's consent, that information can be shared with caregivers and physicians. The tablet treats schizophrenia and acute manic and mixed episodes associated with bipolar disorder and can be used as an add-on treatment for depression in adults. The product is manufactured by Otsuka Pharmaceutical, Tokyo, Japan, and uses sensors supplied by Proteus Digital Health, Redwood City, CA. U of Sheffield to add continuous manufacturing SHEFFIELD, UK—The depart- ment of chemical and biological engi- neering at the University of Sheffield will add an integrated pilot plant to its faculty of engineering's teaching facil- ity. The pilot plant will manufacture pharmaceutical tablets from blends of model APIs and excipients. It will fea- ture crystallization, blending, granulat- ing, and tabletting machines; a contin- uous powder processing plant; and an industrial control room. Students will use the facility to test design models for unit operations and to conduct open-ended research and design proj- ects. It will also be used for continuing education courses. IPEC revises quality agreement guide, addresses co-processed excipients BRUSSELS, Belgium—The IPEC Federation updated its quality agree- ment guide to include ExciPact and ANSI certification standards, as well as a manufacturer's quality statement template. In other news, IPEC-Americas and IPEC Europe published "Co-processed Excipient Guide" for excipient makers and users. The guide facilitates com- munication between excipient users and suppliers about safety informa- tion required for regulatory filing of products containing novel co-pro- cessed excipients. Joe Zeleznik of Meggle discussed the guide in a webinar on December 15. These and all other IPEC guides can be down- loaded for free at www.ipec.org. FDA approves two HIV treatments SILVER SPRING, MD—The FDA approved Juluca (dolutegravir and ril- pivirine) for treatment of adults with HIV-1 infections whose virus is cur- rently suppressed on a stable regimen for at least 6 months, with no history of treatment failure. The tablet, man- ufactured by ViiV Healthcare, Brentford, UK, is the first complete Capsules of Vegetable Origin • Suitable for all types of products • Low moisture content • Ideal for moisture sensitive, hygroscopic and liquid formulations • Resistant to cross-linking • USP/EP compliant dissolution • FDA "GRAS" status • Global regulatory acceptance • Preservative Free • Allergen Free • Kosher and Halal Certified (866) 788-2888 www.capscanada.com info@capscanada.com