Eli Elias
CapsCanada, Miami, USA

Abstract

As the rise in demand for personalised therapies necessitates the increasing complexity of the compounds used to develop them, pharmaceutical manufacturers must take into consideration the full lifetime of the drug—from lab bench to pharmacy shelf—to ensure the quality, safety and efficacy of the end product. Incorporating quality by design (QbD) principles from the earliest stages of formulation development through packaging and transport is essential to producing a stable product that elicits a favourable result in the patient.

A PATIENT-CENTRIC APPROACH

A patient-centred therapy is one that focuses on the patient as a whole, addressing distinguishing factors such as cultural background, lifestyle, personal values and socioeconomic circumstances to develop a comprehensive and effective treatment plan that meets the needs of the individual. This adds a layer of complexity to the development and manufacturing process, as drug makers are faced with the challenge of delivering both in terms of therapeutic value and consumer convenience.

Oral solid dose (OSD) has long been the preferred dosage form among patients worldwide and the one most commonly used to treat a wide variety of therapeutic indications. According to Future Market Insights, OSD formulations held 37 percent of the North American market share in 2017, with that number expected to increase at a compound annual growth rate (CAGR) of 6.5 percent through 2027(I). However, as the formulations pharmaceutical innovators are seeking to commercialize become increasingly complex, so too is the process of optimising them for oral dosage forms.
Stringent measures must be in place to preserve the integrity o ...