Tablets & Capsules


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Tablets & Capsules July/August 2021 7 EFSA revises TiO 2 safety assessment PARMA, Italy—The European Food Safety Authority (EFSA) no lon- ger considers titanium dioxide (TiO 2 ), listed as E171 in the EU, a safe food additive, revising its previous assess- ment of the substance published in 2016. The updated evaluation high- lights the need for more research to fill data gaps on TiO 2 's genotoxicity, that is the chemical substance's abil- ity to damage DNA. Although the absorption of TiO 2 particles after oral ingestion is low, the concern is that the substance can still accumulate in the body. Briefly noted… The FDA approved Tembexa (brincidofovir) tablets and suspen- sion for the treatment of human smallpox disease in adult and pediat- ric patients, including newborns. The drug is manufactured by Chimerix, Durham, NC. The agency also approved Farx- iga (dapagliflozin) to reduce the risk of kidney function decline, kid- ney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease. The product is manufactured by AstraZeneca. The FDA approved the expanded indication of Trikafta (elexacaftor/ tezacaftor/ivacaftor and ivacaftor) to include the treatment of chil- dren with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene. Pradaxa (dabigatran etexilate) oral pellets have received FDA approval to treat children ages 3 months to under 12 years old suffering from venous thromboembolism directly after they have been treated with a blood thin- ner given by injection for at least five days. It is manufactured by Boeh- ringer Ingelheim Pharmaceuticals. It promotes combining knowledge management with quality risk man- agement to enable better risk-based decisions and demonstrates how knowledge management can enhance nearly every element of the PQS across the product lifecycle. The guide can be accessed at publications/guidance-documents/ good-practice-guide-knowledge-man agement-pharmaceutical-industry. Revised Handbook of Pharmaceutical Granulation Technology now available ELLICOTT CITY, MD—The fourth edition of the Handbook of Pharmaceutical Granulation Technol- ogy is now available for purchase. The fully revised edition covers the rapid advances of agglomeration science, process control and mod- eling, scale-up, emerging particle engineering technologies, and cur- rent regulatory changes. The hand- book is the collective work of 50 subject matter experts from around the world and has been edited by Dilip M Parikh of DPharma. You can purchase the revised hand- book at https://www.routledge. com/Handbook-of-Pharmaceutical- Granulation- Technology/Parikh/p/ book/9780367334772. NIH awards Emory University researchers 2.4 million grant to study childhood epilepsy treatment ATLANTA, GA—The National Institute of Health (NIH) awarded $2.4 million grant to pharmacy pro- fessor Martin D'Souza and other researchers at Emory University's Col- lege of Pharmacy to study if oxytocin- encapsulated nanoparticles targeted to the brain can decrease seizures and behavioral deficits in childhood epilepsy in mouse models. The grant will provide D'Souza $284,000 over five years to acquire nanoparticle- encapsulated oxytocin, which has been shown to penetrate the blood- brain barrier and confer sustained resistance to seizures in mice. Visit our website now to watch videos on: Packaging, capsule lling equipment, coating, dedusters, excipients, pneumatic conveying, tablet presses, tooling, and more.

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