Solid Dose: Under-hyped but not under-represented

The buzz may be around biologics, but the oral solid dose sector is still going strong

By Karen Langhauser, Chief Content Director – Jun 13, 2019 – pharmamanufacturing.com

Tablets may not be as glamorous or cutting-edge as emerging sectors of the biologics markets, but they have their upsides. Oral solid dose formulations are efficient and cost-effective to manufacture, shelf stable and easy to administer. Perhaps most importantly, they are understood and accepted by patients worldwide.

While it is true that the pharma pipeline is monopolized by new biologic hopefuls implementing novel scientific approaches such as gene therapies, small molecule drugs still dominate the U.S. market in terms of quantity. In fact, when it comes to new molecular entities (NMEs), oral solid dose products still lead the charts. In 2018, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record-high 59 NMEs. Oral solid dose products accounted for 31, or 53 percent, of the NMEs approved by the FDA in 2018. This percentage of OSD approvals is higher than previous years (50 percent in 2017 and 32 percent in 2016). Continue reading on pharmamanufacturing.com