Contract development and manufacturing organization (CDMO), Halo Pharma will be discussing its capabilities in topical drug products at CPhI NA, Booth 1549, at the Pennsylvania Convention Center, April 24-26.

Topical drug products, which Research and Markets predicts will reach global sales of $194.2 billion by 2024, target localized skin sites or offer systemic penetration by formulations that are easily applied and conveniently packaged. They are complex to formulate as they typically mix oil and water phases in various ratios with an active pharmaceutical ingredient and other ingredients to create a semi-solid or liquid formulation that is safe, efficacious, and patient friendly.

With topical centers of excellence in its Whippany, NJ and Mirabel, Quebec, Canada facilities, Halo Pharma provides a one-stop-shop for global pharmaceutical companies looking to develop and manufacture compliant, high-quality gels, creams, lotions, and sterile and non-sterile ointments for a range of indications. Because Halo Pharma can formulate, develop, scale-up, manufacture, and package topical drug products in contiguous, end-to-end production areas, it eliminates unnecessary changes in process and equipment, as well as knowledge gaps, that can occur when topical products are transferred.

“Halo covers the full breadth of equipment, technologies, skills, and expertise when it comes to taking a topical drug product from formulation to market,” said Lee Karras, chief executive officer, Halo Pharma. “Our manufacturing and packaging facilities are co-located for seamless transition to commercial supply; we handle the bioequivalence (IVRT), chemistry, and microbiology testing that are essential for today’s dermatological markets. Further, we have the supply chain expertise to source the best and lowest cost materials; our equipment and processes are state-of-the-art; and we offer a packaging range that includes tubes, jars, and bottles in various sizes, including trial or sample sizes that many customers desire.”

For a detailed analysis of Halo’s topical development and manufacturing capabilities, download a complimentary white paper, Aim for Quality, Simplicity, and Cost Efficiency in the Development, Scale-up, and Manufacturing of Semi-Solid Dosage Forms. The paper covers formulation selection, five key physical characteristics of product formulation, in vitro release testing (IVRT) and bioequivalence, bioburden and microbial testing, and technology and site transfer considerations.

A case study, Technology and Site Transfer of a Semi-Solid Product for Commercial Launch, is also available to learn how Halo Pharma was recently able to successfully transfer and scale-up a topical  ointment. Using a variety of analytical methods including IVRT, Halo was able to demonstrate bioequivalency with a reference drug without reliance on additional clinical studies. Halo manufactures the finished drug product in 900kg quantities that are packaged in 45g tubes and 2g sample packets.