Pharmaceutical Materials Science: An Active New Frontier in Materials Research
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Introduction The essence of pharmaceutical materials science is the application of fundamental concepts in the physical sciences to the challenges of understanding the behavior of soft, mostly organic, crystalline, and amorphous materials of relevance to the pharmaceutical industry. Like its parent discipline, pharmaceutical materials science is concerned with connecting phenomena occurring on the molecular scale, such as crystallization and polymorphism, to metrics of macroscopic performance, such as hydration rate and mechanical strength, and their consequences for industrial processes such as powder flow or compaction. The relationships between some of the aspects highlighted in this issue are summarized diagrammatically in Figure 1, which shows the progression
MRS BULLETIN • VOLUME 31 • NOVEMBER 2006
from crystal engineering of active pharmaceutical ingredients (APIs) through processing and manufacturing of particles and powders into dosage forms such as tablets, culminating with therapeutic action in the patient. Some key concepts in materials science with direct pharmaceutical application include the design of custom materials with specific physical and chemical properties, the use of theoretical models to predict material performance in biological environments, and the development of novel characterization techniques for nanoscopic and micron-sized particles. For example, a biocompatible polymer may be required that can control the diffusion of a biologically active protein over a 24-hour treatment period. Likewise, it may be necessary
to predict how inhaled submicron-sized drug particles are deposited in the airways of the lung without the use of costly and time-consuming in vitro and in vivo experimental studies.
Background Although research in pharmaceutical materials science historically has been concentrated in pharmacy departments, the rapid pace of development and highly interdisciplinary nature of the work has meant that it is increasingly becoming delineated as a subject area in its own right, with materials scientists playing a key role in this process. The first documented use of the term “pharmaceutical materials science” that we have been able to locate in the open literature was in a 1991 article by Franks et al.,1 describing the application of materials science concepts to the production of freeze-dried biological molecules for therapeutic uses. Just five years later, Craig was already contemplating the future of the discipline in a paper entitled “Pharmaceutical Material—Resuscitation or Reincarnation?”2 so it is clear that this terminology must have been in popular use well before the 1990s. In fact, scientific articles describing the study of pharmaceutical materials and their unique range of applications and properties have appeared in the chemistry, physics, and pharmaceutical literature for well over a century. One of the first patents on a method for forming tablets by uniaxial die compaction, a process still widely used in the pharmaceutical industry today, was granted in the Unite
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