Issue link: https://www.e-digitaleditions.com/i/1218534
6 March 2020 Tablets & Capsules research Increase in generic approvals may mean less thorough regulations CAMBRIDGE, MA—New generic drug approvals have increased over time, spurring competition, but according to experts at Harvard Med- ical School, this may be a result of the FDA accepting less data and short- ened review times. Since 1983, several legislative and regulatory initiatives have come into effect, including the Hatch-Waxman Act, the Generic Drug User Fee Act, and the Orphan Drug Act, all of which played a part in increasing the annual number of generic approvals. Additionally, the use of accelerated approval, fast-track, and priority reviews for new drugs has increased over time, with 81 per- cent of new drugs in 2018 benefiting from one or more of these expedited programs. The authors conclude that Congress and other government offi- cials should consider the effects of less rigorous clinical outcomes while still maintaining policies that encourage efficient review. The full study can be found in the January issue of The Jour- nal of the American Medical Association. Researchers create naproxen tablet without GI tract side effects AUCKLAND, New Zealand— Tablets made of naproxen-loaded polymer hybrid enteric micro- spheres (NP-loaded PHE-Ms) can effectively reduce common NP side effects in the gastrointestinal (GI) tract, including irritation, bleed- ing, and duodenal ulcers, accord- ing to a study published in the journal Drug Design, Development, and Therapy. The study's purpose was to characterize PHE-Ms using an integrated experimental and molec- ular modeling approach and to develop a modified-release solid dos- age form with improved bioavail- ability. The researchers produced NP-loaded PHE-Ms using a modi- fied solvent evaporation technique coupled with molecular modeling. The microspheres were character- ized, optimized, and then developed into tablets that were subjected to stability studies and comparative in vitro-in vivo evaluations. This resulted in a modified-release tablet with an improved dissolution rate and enhanced oral bioavailability due to the stronger polymer-drug relationship in the microspheres due to the molecular modeling. markets US CRO market to grow by 9.4 percent through 2027 SEATTLE, WA—The US mar- ket for contract research organiza- tions (CROs) is forecast to grow at a compound annual rate of 9.4 percent through 2027, according to a report by Coherent Market Insights. A factor of this market's growth is the increasing adoption of regulatory outsourcing services by the pharmaceutical industry to