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6 September 2019 Tablets & Capsules research Post-HME cryo-milling decreases AD characteristics of matrix tablets SILVER SPRING, MD—Cryo- milling after hot-melt extrusion (HME) changes a tablet formula- tion's compactability and porosity, affecting the tablet's abuse-deterrent (AD) characteristics, according to research published by FDA offi- cials in the June 2019 issue of AAPS PharmSciTech journal. The study took an AD formulation and used HME to create 2.5- and 5.0-milli- meter extrudates. The 2.5-millime- ter extrudates were cryo-milled and compressed, while the 5-millimeter extrudates were cut and compressed for comparison. Researchers found that when the extrudates were cryo- milled and compressed, the tablets could be readily manipulated by milling, leading to a high degree of extractability. Additionally, when the tablets compressed from cryo- milled extrudates were put under high alcohol concentration, burst drug release was observed. markets Global capsule filling machine market to reach $440 million in 2025 DALLAS, TX—The global capsule filling machines market will grow at a compound annual rate of 1.9 percent through 2025, reaching $440 million, according to a report by Markets Research.biz. The market is seg- mented by machine type, including manual capsule fillers, semi-automatic capsule fillers, and fully automatic capsule fillers. Fully automatic cap- sule fillers represented 64.49 percent of the capsule filling machine mar- ket in 2017 and will occupy more of the market going forward. The report identifies IMA Pharma, Bosch Pack- aging Technology, Schaefer Technol- ogies, MG2, and Dott Bonapace as key market players. industry news EU and US implement MRA AMESTERDAM, Netherlands— With the FDA's recent recognition of Slovakia for GMP inspections, the European Union (EU) and the US have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for human medicines. Under the MRA, EU and US regulators will now rely on each other's inspections for human medicines in their own territories, avoiding duplicative work and freeing up resources to inspect facilities in other countries. FDA publishes draft guidance on safety data collection SILVER SPRING, MD—The FDA published the draft guidance, "E19 Optimisation of Safety Data Collec- tion," which was prepared under the International Council for Harmon- 嘀椀猀椀琀 甀猀 愀琀 䈀漀漀琀栀 㔀 ㈀ 一漀瘀⸀ ㌀ 㘀 ∠ 匀愀渀 䄀渀琀漀渀椀漀Ⰰ 吀攀砀愀猀 䠀攀渀爀礀 䈀⸀ 䜀漀渀稀愀氀攀稀 䌀漀渀瘀攀渀琀椀漀渀 䌀攀渀琀攀爀 倀䠀䄀刀䴀匀䌀䤀㌀㘀 䌀漀渀猀椀搀攀爀愀琀椀漀渀猀 昀漀爀 䐀攀瘀攀氀漀瀀洀攀渀琀 漀昀 吀眀漀 倀椀攀挀攀 䠀愀爀搀 䌀愀瀀猀甀氀攀 倀爀漀搀甀挀琀猀 吀甀攀猀搀愀礀Ⰰ 一漀瘀⸀ 㔀 㨀㌀ 愀⸀洀⸀ 倀愀爀琀渀攀爀 倀爀攀猀攀渀琀愀琀椀漀渀 䌀氀愀猀猀爀漀漀洀 Ⰰ 䔀砀栀椀戀椀琀 䠀愀氀氀 ㈀㌀㐀 匀瀀攀挀椀愀氀 瀀愀爀琀渀攀爀 瀀爀攀猀攀渀琀愀琀椀漀渀㨀