Halo-Produced FDC Drugs Already Approved and in Development Benefit Patients,
Reduce Costs, and Can Extend Patent Life and Market Dominance

Whippany, NJ, November 2, 2017 – Halo Pharma (“Halo”) provides its pharmaceutical manufacturing partners the technical expertise, and advanced formulation technology to support the development and manufacturing of fixed-dose combination (FDC) drugs, a rapidly growing market niche that offers significant advantages across the healthcare spectrum. FDC drugs combine multiple active pharmaceutical ingredients (APIs) into a single-dose product, improving patient convenience and the likelihood for medication compliance and appropriate dosing. Pharma companies can realize substantial savings when developing an FDC comprised of previously approved new chemical entities or their generic counterparts. Bringing to market a FDC product is a proven and attractive strategy for extending the market potential of proprietary drugs.

Halo’s many years of experience developing FDC oral solid dosage forms and broad-based technological capabilities ensure Halo clients have access to the widest range of formulation options and production methods to meet their needs. Companies that partner with Halo in the development of FDC’s benefit from the competitive advantages that FDC products offer, leveraging Halo’s skills and infrastructure to enable the production of high quality FDC products that meet their clinical endpoints and may achieve an accelerated regulatory timeline to market approval utilizing the 505.b.2 pathway.

Examples of Halo’s specialized formulation capabilities include not only hot melt extrusion, wet granulation/roller compaction, extrusion-spheronization, and fluid bed technology, but multiparticulate capsule filling and bilayer press capabilities. The flexibility and variety of manufacturing platforms Halo offers allows customers to choose the FDC solid dosage form that is the most suitable for their clinical needs. Many clients choose multi-layer tablets, but others choose mini-tablets that can be compressed together or combined in capsules, sachets, or stick packs. Halo also offers a variety of polymer-coating options to enable controlled release of different drug substances into one tablet as well as taste masking methods that rely on ion exchange technology.

“We have seen a marked interest in FDC products from current and new customers. The capabilities Halo possesses, all under one roof, provide many options for our customers in the development of their products. Halo is one of very few CDMOs who have development and commercial manufacturing experience in FDCs,” says Lee Karras, CEO of Halo Pharma. “we have made and will continue to make significant investments in equipment and technical expertise at Halo to support this platform,” Mr. Karras adds.

For a more detailed understanding of the applications and advantages of FDC products and of Halo Pharma’s expertise and advanced capabilities in the design and manufacturing of FDC drugs, we offer free on our website the White Paper entitled “Fixed-Dose Combination Products: Considerations for Design, Formulation, Manufacturing, and Analysis” and the Case Study “Fixed-Dose Combination Drugs.”

The White Paper details different strategies for the design and formulation of FDCs, and the many benefits of these products for patients, physicians, and the pharmaceutical industry. It also presents important factors to consider in the development and manufacturing of FDCs, such as the physical and chemical compatibility of the APIs being combined, the pharmacokinetic and target release profiles of the component drug substances, target patient populations, and the full range of oral solid dosage form options. Included as well are recommendations for identifying and working with a CDMO partner.

The Case Study describes two pharmaceutical companies that were looking for a CDMO partner that could offer a broad range of formulation options and the flexibility to combine multiple drug substances and create single-dose FDC products. The challenging scenarios included combining three different APIs — one of which was not compatible with the other two — into a single formulation, and combining two drug substances that had different release profiles into one FDC product.

Halo Pharma can help your company develop, test, and bring to market fixed-dose combination drugs products quickly and cost effectively. To learn more about Halo Pharma’s FDC specialty products visit www.halopharma.com/combo.

Halo Pharmaceutical 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 Pharmaceutical’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