Patient-Centric Oral Solid Dose Formulation: Improving Access And Value Across The Product Lifecycle

By Anil Kane, Executive Director, Global Head of Technical & Scientific Affairs, Thermo Fisher Scientific

Safety, efficacy, and quality have been the mainstay objectives of drug development and manufacturing for decades. In recent years, a fourth pillar has emerged that may hold the key to commercial success in today’s increasingly competitive marketplace: patient centricity.

A common theme in healthcare, patient centricity in pharmaceutical manufacturing refers to the integration of patients’ needs and preferences into drug design, development, and lifecycle decisions from early planning to production and delivery. This approach enables pharmaceutical companies to define a development path that will lead to enhanced patient acceptability of the product and, as a result, improve treatment adherence, clinical outcomes, and market access.

The demand for patient-centric drug development is being fueled by multiple considerations: the fact that patients are playing a more central and proactive role in managing their own healthcare, the growth of specialty drugs and personalized therapies, the need to compete for clinical trial participants, and increased regulatory pressure to demonstrate that new drugs can deliver meaningful improvements to patient health outcomes.

Oral solid dose (OSD) formulations are particularly well suited to patient-centric design considerations. In addition to leading the market as a preferred drug form because of their efficiency, cost-effectiveness, shelf stability, and ease of administration, OSDs are uniquely customizable to the needs of specific patient populations. Through strategic selection of excipients, coatings, and delivery technologies, developers can alter and adjust such features as palatability and swallowability while optimizing dosing, bioavailability, release mechanism, and other performance attributes. By identifying specific characteristics of target patient populations that might inhibit safe and proper use of the drug product, developers can also make packaging and delivery decisions that will eliminate obstacles and enhance usability and compliance.

This whitepaper provides insight into the systematic application of patient centricity to the design of OSD products, focusing specifically on the following considerations:

• Patient-related characteristics that should inform drug product design decisions, such as age, swallowing impairment, motor impairment, dentition, cognitive impairment, and patient preference, among others
• Product-related characteristics that can be modified to address the needs of target patient populations, such as swallowability, palatability, dosage form, dosing regimen, release mechanism, and packaging
• The innovative technologies, materials, and processes that can be leveraged to map patient-related characteristics to product performance considerations to deliver a drug product that meets the needs and preferences of a target population