EXECUTIVE INTERVIEW - Foster Delivery Science: Unmatched History & Uncompromising Focus in Hot-Melt Extrusion

Hot-melt extrusion (HME) has been widely utilized in the development and manufacture of pharmaceutical and combination products, including formation of solid molecular dispersions to increase the bioavailability of poorly soluble drugs and drug/polymer implantable devices. Foster Delivery Science specializes in HME for pharmaceutical and medical device applications offering contract services from formulation development to clinical supplies and manufacturing. Foster Delivery Science is a wholly owned business unit of Foster Corporation, a leader in melt extrusion of biomedical polymers for more than 25 years. Drug Development & Delivery recently spoke to Larry Acquarulo, CEO of Foster Corporation, about the history of Foster Delivery Science, their highly focused strategy in melt extrusion, and future plans for the business.

​Q: What is the history of Foster Delivery Science?

​A: Foster Corporation was founded 25 years ago to provide highly specialized melt extrusion and material blending services to the healthcare market. At that time, interventional catheters were emerging as a primary method for treatment of blockages in the coronary arteries using balloons and, later, stents. We played a key role in formulation development, process development, and contract manufacturing of polymers to make catheters visible under fluoroscopy during these procedures.

​Over time, the demand for highly specialized polymer blending services emerged in other areas, including implantable devices, drug delivery devices, and combination drug/device products. To support the demand for drug delivery applications, we invested in dedicated equipment, cleanroom operations, cGMP capabilities, and highly trained pharmaceutical personnel to complement our polymer processing expertise. This resulted in a dedicated business unit, Foster Delivery Science, to serve these applications. At the same time, there was an increase in newly discovered drugs with high crystallinity and poor solubility within the pharmaceutical industry. Hot-melt extrusion (HME) began emerging as a viable process for enhancing the bioavailablity of these drugs. HME involves twin-screw extrusion processing of active pharmaceutical ingredients (APIs) and water-soluble polymers. Foster Delivery Science was one of the few contract development and manufacturing companies that had extensive expertise in extrusion processing and the facilities to support APIs. Providing contract HME services to pharmaceutical companies is a core competency of our business today.

​Q: What are the services that Foster Delivery Science offers today?

​A: Foster Delivery Science provides contract melt extrusion services throughout the product life cycle, including formulation, analytical characterization, process development, process improvement, scale-up modeling, and optimization for clinical and commercial supply. Our twin-screw extrusion lines range from 16 mm to 27 mm, offering the ability to produce extrudate from lab sample to production quantities.

​We have a variety of post-extrusion equipment that allows us to convert extrudate into shapes that include powder, pellets, film, fiber, and rods. This allows us to support a variety of delivery systems, such as oral dose, patches, implants, and more.

​Q: What are the company’s core areas of expertise?

​A: We offer expertise in engineering critical polymer blending and extrusion processes and providing solutions to complex design engineering requirements. Our strategy has always been to provide the highest quality melt extrusion services to our customers by leveraging the expertise and know-how we have developed during the 2.5 decades in the extrusion blending business. We believe our focus and expertise in melt extrusion results in a premium service to those customers for which the technology is applicable.

​Polymer process design engineering is one of our primary areas of expertise. Our top people have strong backgrounds in extrusion process engineering, which has contributed to our expertise in process development, optimization, and scale-up. This process expertise ideally complements the chemistry background of many of our pharmaceutical customers, and provides for a highly collaborative and effective interaction partnership that maximizes project outcomes.

​Q: How has pharmaceutical HME evolved over the years?

​A: Within the pharmaceutical industry, early HME applications involved extruding rods which were milled into granules for oral controlled drug delivery, which were subsequently tableted or encapsulated. Melt granulation had been investigated for solid dispersions, and HME was a natural fit for the processing technology. Currently, HME has emerged as a standard processing technology to create molecular dispersions of APIs into various polymer or/and lipid matrices for improved bioavailability, controlled release, and targeted drug delivery.

​Pharmaceutical scientists have used HME to produce a range of pharmaceutical dosage forms, such as tablets, capsules, films, and implants for oral, transdermal, and transmucosal routes of administration. HME is now used to prepare commercial pharmaceutical products with enhanced bioavailability (Norvir) and to provide abuse deterrent properties for narcotics (OxyContin).

​Within the medical device industry, melt extrusion of APIs into polymers used in the manufacture of devices are also rapidly evolving. New materials, such as bioresorbable polymers, are ideally suited for drug delivery. These materials have melt temperatures below the degradation temperatures of many drugs such that they can be processed into shapes and provide slow, localized release over time.

​Q: What is your unique approach to solving pharmaceutical HME challenges?

​A: With every project, we seek to leverage our vast experience in melt extrusion to develop the optimal process for the application. Our first step is to develop a clear understanding of clients’ objectives and molecules. With a clear understanding of the desired outcomes and API limitations, we begin our systematic approach to process development. This includes extruder and feeder selection, screw design, die design, processing conditions, pre- and post-blending operations, and design for future scale-up.

​It is not uncommon for APIs to have low degradation temperature, and in some cases, these are below the melt temperature of the polymer. Our technical team is composed of experts in twin-screw extrusion, which allows us to develop process solutions to these complex problems.

​For example, one client asked to incorporate an API that degrades 90°C into a polymer that has a processing temperature of 150°C. Our team was able to develop a process that minimized residence time of the materials in the extruder to achieve good mixing between the drug and polymer yet avoid drug degradation.

​Q: How do you manage projects with your clients?

​A: Our approach to project management is to be pro-active and collaborative. We understand our clients’ success is dependent on the success of the projects we work on for them. Conversely, our success as an organization is dependent upon our clients’ success in developing products to bring to clinical trial and ultimately commercialization. We utilize project management tools, including Gantt charts, to manage the timeline of projects. Our intranet calendar system provides a communication platform for our internal project team and ensures the entire team remains on schedule.

​Q: What are your plans for future growth?

​A: Foster Delivery Science is in the process of constructing a 32,000-sq-ft, cGMP facility, directly across the street from our current building. This facility will provide the necessary resources for development and manufacturing of pharmaceutical and medical device components using highly engineered polymer extrusion technologies. The new facility will be complete with a new Process Manufacturing Area (PMA), equipment wash and clean areas, equipment storage, as well as a designated space for weighing and dispensing. Additional areas will be allocated to research and development, as well as a comprehensive QC laboratory. The new PMA will allow for more efficient handling of equipment and will provide our customers with the confidence to expand orders and entrust Foster Delivery Science as a leading supplier for their unique polymer needs.

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