Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Developing the ideal dosage form for pharmaceutical products has long been a priority for drug companies. A poor dosage form decision can lead to costly commercial errors and potentially low medication adherence by patients—an aspect that can be particularly important in the rising numbers of chronically ill patients. Not only should consideration be made to the therapeutic characteristics and potential manufacturability of the finished drug product; but also, whether the dosage form will ultimately be patient-centric and, hence, ensure optimum adherence of a treatment regimen.

“Drug dosage forms have evolved in recent years due to several factors, including the growing demand for custom drug delivery solutions, the increasing complexity of new therapeutic entities (NTEs) entering the development pipeline, and the aggressive competition in the pharmaceutical market,” reveals Ishani Maharaj, Application Development Specialist, Pharma Ingredients, Univar Solutions. “While oral solid dose (OSD) forms remain the preferred choice due to convenience and cost-effectiveness, applying innovative delivery approaches is essential to meet the unique needs of the target patient population.”

Shifting focus
“The pharmaceutical sector is propelled by radical innovations, accelerating the pace of the therapeutic process achieving the transformative shift from life science to healthcare. From personalized medicine, advanced nanotechnology to sustainable formulations, 3D printing, combination therapy, and smart drug delivery, the landscape is undergoing a profound transformation,” asserts Jnanadeva Bhat, vice president, head—Formulation R&D at ACG-Worldwide. “The growing attention to rare diseases has catalyzed a revolution in the field of drug development, reflecting the industry’s responsiveness to unmet medical needs while setting the stage for pioneering advancements.”

In concurrence, Filipe Gaspar, vice president of Technology Intensification at Hovione highlights the growing proportion of orphan drugs—and the need for leaner and accelerated drug development paths along with it—as an important trend. “The change from large volume to small volume drugs, namely by the increased prevalence of rare/orphan drugs and precision medicine, is driving substantial changes in the pharma industry and driving innovation in many areas such as drug discovery, clinical design, supply chain management, development, and regulatory paths,” he says. “A very lean, API-sparing, and accelerated CMC [chemistry, manufacturing, and controls] development approach becomes critical to prevent being the bottleneck in drug approval.”

Therefore, Gaspar continues, continuous manufacturing is being more widely adopted as it provides a more streamlined approach, avoids the need for scale-up, and facilitates debottlenecking pharmaceutical development. However, he warns that despite the advantages brought about by transitioning from batch to continuous manufacturing, there are also challenges, such as a lack of access to continuous manufacturing technology for smaller pharma companies and biotech companies.

“Most small pharma and biotech [companies] do not have [continuous manufacturing technology] as a captive technology and the limited CDMO [contract manufacturing and development organization] network is still developing the expertise and expanding their capacity,” Gaspar adds. “By relying on batch processes, these innovators may incur on additional development costs and, most importantly, delay their drugs to market, sometimes many months, which can be critical to success of many drugs.”

Read the full article at PharmTech.com