Open Alliance

In early 2012, BASF and Catalent formed an open alliance aimed at providing solutions for bioavailability. To understand the details of the collaboration and its goals, we spoke to representatives at each company. Participating in the round table were: Martin Widmann, Senior Vice-President of Pharma Ingredients & Services at BASF and Ian Muir, PhD, President of Modified Release Technologies at Catalent.

Q. Can you explain what each company is contributing to the alliance and how the collaboration functions?

Widmann: BASF and Catalent have complementary offerings and knowledge that address the same customer needs: the enhancement of solubility and bioavailability of poorly soluble drugs. BASF has the broadest portfolio of solubilizers in the industry.

Muir: Together, we will build efficiencies for our customers along the value chain from formulation development and ingredient selection through manufacturing process selection to the finished dosage form—bringing more products and better treatments faster to the market. Catalent has 75 years of heritage enhancing bioavailability with our Softgel technology and has recently expanded its OptiMelt™ hot-melt extrusion capabilities in the US and its Schorndorf, Germany, facility.

Below left to right: Ian Muir, Catalent, and Martin Widmann, BASF.

Q. The collaboration joins two companies with formulation development and manufacturing expertise. How does the collaboration go beyond a traditional supply relationship? What is meant by an open alliance?

Widmann: "Open" means that both partners have joined forces on a nonexclusive basis, because we think that this is the most efficient approach to the market and one that maximizes the reach of both companies. The idea is to provide support in excipient selection for a particular customer need and to provide access to Catalent's formulation and manufacturing experts and leading drug delivery technologies.

Muir: Catalent wants to keep full flexibility in the choice of excipients for its customers, and the open alliance arrangement ensures that customers are not limited to the excipient portfolio of one supplier. The major advantage of the BASF portfolio is the access to its different chemistries, which makes matching to optimize solubility all the more likely. The open alliance will provide customers with formulation expertise across BASF and Catalent and in turn offer seamless bioavailability enhancement solutions from molecule to market.

Q. The alliance was specifically formed to respond to client problems in resolving problems of bioavailability of BCS Class II and IV poorly soluble compounds. What are the potential solutions that can be used to resolve these challenges from an excipient and technology perspective?

Muir: Catalent is the leading industry partner in the development and formulation of drugs, biologics and consumer health products and a world leader in drug delivery technology. Bioavailability enhancement can be addressed through multiple approaches, including optimizing the API, formulation, processing technology, and/or drug delivery dosage form. Our technologies range from OptiForm™ high throughput screening to Softgel technology and OptiMelt™ hot-melt extrusion to highly differentiated controlled release tableting technologies such as OSDrC OptiDose™.

Widmann: Our Kolliphor® range of products, including poloxamers, hydrogenated castor oil, TPGS and others offers a wide variety of properties that match the physicochemical properties of active ingredients. The latest innovation in this field is Soluplus®, which won the Silver CPhI Innovation Award in 2010.

Q. Hot-melt extrusion is one potential solution for resolving bioavailability issues. Can you provide details on the companies' expertise in this area?

Widmann: BASF is a recognized world-leading manufacturer and innovator of pharmaceutical excipients. We offer a line of polymers designed specifically to increase solubility in general and for use with hot-melt extrusion in particular. We have significant investments year on year in the development of pharmaceutical excipients because we believe that today's formulation challenges can not be solved with yesterday's excipients. Furthermore, BASF has decades of experience in the hot-melt extrusion technology in plastics as well as in pharmaceutical applications.

Muir: Catalent is the world-leading solubility solutions provider, with Softgel and OptiMelt™ hot-melt extrusion. Its capabilities range from development, formulation, pilot, commercial manufacturing to differentiated drug delivery on a global scale.

Q. Will BASF and Catalent staff jointly work on a project for a given client?

Muir: Catalent will cooperate with BASF to optimize solubility from excipient selection, formulation, process technology to drug delivery and dosage form for customers desiring an integrated approach. By providing our customers with the option of working with a team of experts across our companies, we will increase efficiencies for them from development to scale-up to commercial, hence enabling them to deliver more products to market.

Widmann: Nobody knows our products better than we do. This know-how in the application of our excipients is brought into the alliance by training and supporting the Catalent formulation experts. Where appropriate, experts of both companies will work together on customer projects to find optimal solutions.

Q. What feedback have you received since the collaboration began?

Widmann: The announcement generated a lot of interest in the market because every formulator is concerned about the solubility challenge.

Muir: Not only in the market, but also internally, everybody is excited about the opportunity to jointly cover the whole pharmaceutical value chain from excipients to finished drugs.