3). This ability to control particle size, shape, and uniformity should also find advantageous use in many dosage forms, including oral, topical, and PD184352 manufacturer parenteral products. Microfabrication techniques such as PRINT offer the advantage of deterministic control of particle geometry that is inherent from the use of semiconductor manufacturing techniques. In the case of PRINT Inhibitors,research,lifescience,medical technology, the same master template can be used to create each batch of micromolds and particles for a particular size and shape. Thus, each batch of particles possesses high uniformity and batch-to-batch consistency, regardless of the batch size. In
addition, the uniform particle populations that are produced lend themselves to straightforward in-process characterization using a number of standard particle sizing methods, such as microscopy Inhibitors,research,lifescience,medical and light scattering. These
features make the PRINT technology attractive from the perspective of compliance with Quality-by-Design directives from the FDA. From a formulation perspective, PRINT technology has been shown to be a versatile approach to deliver many classes of therapeutic compounds and excipients. Particle size can be controlled over Inhibitors,research,lifescience,medical several orders of magnitude, from the sub-100nm scale to hundreds of microns. In traditional fabrication methods, particle chemical composition and physical characteristics such as geometric or aerodynamic size are inherently coupled, for example, the molecular properties of a small molecule pharmaceutical ingredient are known to impact the particle size distribution of micronized particles, whereas Inhibitors,research,lifescience,medical the solubility and drying kinetics of precursor solutions can impact the particle size distribution of spray-dried particles [8]. In contrast, micromolded particle engineering has the ability to define the particle size and
shape independent of the input material properties, which was demonstrated by fabricating particles of identical geometry yet comprising hydrophilic and hydrophobic small molecules, proteins, or nucleic acids (Figures 2(d)–2(i)). While Inhibitors,research,lifescience,medical particularly relevant for aerosol lung delivery, this ability to independently control particle composition and physical size should find utility in multiple dosage forms and routes of administration. Calpain Small molecule drug compounds can be formulated as drug alone or drug/excipient mixtures with tunable loading. Enlow et al. demonstrated the production of PLGA/docetaxel PRINT nanoparticles with up to 40% chemotherapeutic loading [13]. This finding is in contrast to typical polymer nanoparticle drug delivery systems produced by emulsion [24], nanoprecipitation [25], and ultrasonication [26] that have theoretical drug loading of less than 15% and variable encapsulation efficiency. Furthermore, the authors demonstrated the ability to independently tune particle size, shape, and drug loading.