OSD SUPPLEMENT
Discussing the latest oral solid dosage challenges and trends with two leading players in the industry.
Quick Questions with John Ross, president at Metrics Contract Services & Maria Lundberg, vice president Product Development at Recipharm. Q: Can you outline the key challenges and growth opportunities that have happened in the OSD market recently? ROSS: The major challenge for the market lies in the misalignment of installed capacity compared with the contemporary needs to produce today’s OSD drug products. Many large-scale installations that were used for producing blockbuster drugs, for example, simply do not fit or fulfil the requirements for producing most new drug products. The rising demand for orphan drugs and personalised medicine requires smaller scale batch sizes. Companies will have to invest substantially to remediate or retrofit legacy equipment
and sites; alternatively, they can choose to work with more niche contract partners. The growth in highly potent active pharmaceutical ingredient (HPAPI) programmes is seeing an increased need for installed contained operations. Regulatory controls concerning HPAPIs have become more stringent, requiring companies to rely on engineering controls rather than simply standard work practices and personal protective equipment (PPE) to keep workers safe. Installing contained equipment, such as isolators, bag-in/bag-out filters and split butterfly valves, requires significant investment. As the number of poorly soluble and poorly bioavailable APIs in development continues to rise, so too do the challenges for formulation scientists trying to develop pharmaceutical dosage forms. It is these qualities that contribute to poor attrition rates of drugs in development, which translates into longer development times to formulate new products and delays in getting them to market. Companies need to invest in installing solutions that enhance
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solubility and bioavailability properties of new drugs; for example, multi-particulate drug delivery, spray drying, hot melt extrusion, and extrusion spheronization. Controlling impurities in APIs and drug products remains a critical issue for the industry. Greater evaluation and understanding of impurities — such as trace metals or nitrosamine — in APIs and drug products can be achieved by installing appropriate analytical instrumentation and expertise. LUNDBERG: While oral solid dose (OSD) products may seem unfashionable compared with the steep increase in new biopharmaceutical products, they remain extremely popular. There are many reasons why OSD forms remain the strongest in the market, most notably for their effectiveness, patient-friendly nature, and ability to extend product lifecycles by implementing extended, controlled, and rapid release formulations. However, there are, of course, many challenges to overcome when developing these different formulations.
