Issue link: https://www.e-digitaleditions.com/i/1112785
Tablets & Capsules May 2019 7 ability and food effects on medicines, including recommendations on new drug development. "Bioavailability Studies Submitted in NDAs or INDs —General Considerations," provides recommendations to sponsors submit- ting bioavailability information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA sup- plements. The draft guidance "Assess- ing the Effects of Food on Drugs in INDs and NDAs—Clinical Pharma- opment for Treatment," provides general recommendations on the development of antiretroviral drug products to treat pediatric patients with HIV infections. The guidance specifically addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into studies to help facilitate drug product development. The agency also published two revised draft guidances on bioavail- and semi-solid liquid and gaseous dos- age form classifications. The solid dosage form segment accounted for the largest share of revenue in 2018 and is expected to grow at a com- pound annual rate of 4 percent from 2018 to 2025. Stick pack market to grow by more than 5 percent annually A L BA N Y, N Y—T he need for portion control and exact dosage in the pharmaceutical and food and beverage industries is expected to fuel the global stick packaging mar- ket, which is forecast to grow at a compound annual rate of 5.2 percent from 2019 through 2027, according to a report by Transparency Market Research. Stick packs are a preferred packaging form because of their sus- tainabilit y and convenience. Key market player s identif ied in the report include Amcor, Bemis, GSC Packaging, T.H.E.M., Sonic Packag- ing, GreenSeed Contract Packaging, Aristo Pharma Aaron Thomas, Ion Labs, Hearthside Food Solutions, GFR Pharma, Glenroy, Nellson Ana- heim, Label Impressions, and Con- tract Pharmacal. industry news FDA publishes two finalized guidances, two revised drafts SILVER SPRING, MD—The FDA finalized two guidances that focus on HI V prevention and t reat ment. "Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophy- laxis" addresses the agency's current thinking on the overall development program and clinical trial designs to support the development of pre-expo- sure prophylaxis (PrEP) medications, which are long-acting systemic drug products used to prevent sexually acq uired HI V-1. T his g uid ance includes nonclinical and clinical rec- o m me nd at ion s s p e c if ic t o th e development of systemic drug prod- ucts like PrEP. The final guidance "Pediatric Human Immunodeficiency Virus Infection: Drug Product Devel- NILFISK CAPSULE CONVEYORS Transfer empty capsules without dispersion or contamination The Nilfi sk 9505 pneumatically conveys empty capsules at a preset speed. The capsules pass from the container to the fi lling machine hopper damage free. Small footprint Multiple confi gurations Three fi ltration stages AISI 316L stainless steel construction Capsule level sensors Learn more at Nilfi skIndustrialVacuums.com INCREASE automation and REDUCE load times!