Halo Pharma Shares Expertise on Fixed-Dose Combination Products as an Effective Approach to Simplified Dosing

Anthony Qu, PhD, Vice President Scientific Affairs, Presents at CPhI NA

Whippany, NJ, April 5, 2018Halo Pharma (Halo), a rapidly growing contract development and manufacturing organization, will share its expertise in fixed-dose combination (FDC) products as an effective approach for simplified dosing at CPhI NA 2018. CPhI North America’s is a leading conference for the entire pharmaceutical ecosystem. Dr. Anthony Qu, Halo’s vice president of scientific affairs, is scheduled to speak at 3:15 p.m., Wednesday, April 25, Room 119A at the Pennsylvania Convention Center in Philadelphia.

Dr. Qu will discuss challenges and solutions in the manufacturing and testing of FDCs as well as the potential benefits of FDCs compared to two or three separate drug products. FDCs are drug products that contain multiple active ingredients in a single dose.

“Fixed-dose combination products offer several advantages for both pharmaceutical companies and their patients,” says Dr. Qu. “For patients, this includes more convenient dosing for better compliance and associated improved clinical performance, as well as the potential for reduced side effects, and fewer copayments and prescription refills. For pharmaceutical companies, FDCs can improve patient compliance, lower production and testing costs, and in some cases offer additional intellectual property protection and market share.”

FDCs are normally composed of previously approved molecules and, as such, a shorter 505(b)(2) pathway is commonly used for these approvals. A low therapeutic dose of two drugs may prove more effective than a higher dose of a single drug.

Dr. Qu’s presentation will include:

  • Several case studies where fixed-dose combinations were developed at Halo and used in adult and pediatric products
  • Scientific approaches to overcoming processing challenges associated with FDC development

“Producing safe and effective FDC products requires thoughtful product design, access to state-of-the-art manufacturing technology, and advanced analytical tools,” says Lee Karras, CEO at Halo Pharma, which is exhibiting at CPhI NA at Booth 1549. “Halo possesses the experience, know-how, and skilled professionals, alongside the specialized equipment and technologies, to ensure FDC targets meet our clients’ clinical endpoints and regulatory requirements.”

Halo Pharma is a rapidly growing contract development and manufacturing organization (CDMO) that provides scientific and development expertise as well as a wide spectrum of manufacturing services from its locations in Whippany, New Jersey USA and Montreal, Quebec Canada to its international client base. Halo offers fully integrated capabilities in a variety of dosage forms including tablets, capsules, powders, liquids, creams, sterile and non-sterile ointments and suppositories. The company is registered to work with any of these dosages in the CI-CV DEA designations. Halo Pharma’s capabilities in the areas of tech transfer, process and product development, production, scale-up/validation and analytical method development allow us to partner with clients from development through commercialization or at any point along the way. For more information please contact services@halopharma.com.

Debra Harrsch
Brandwidth Solutions