RESUMO
The drug loading efficiency was evaluated using a binder-jet 3D printing process by incorporating an active pharmaceutical ingredient (API) in ink, and quantifying the printability property of ink solutions. A dimensionless parameter Ohnesorge was calculated to understand the printability property of the ink solutions. A pre-formulation study was also carried out for the raw materials and printed tablets using thermal analysis and compendial tests. The compendial characterization of the printed tablets was evaluated with respect to weight variation, hardness, disintegration, and size; Amitriptyline Hydrochloride was considered as the model API in this study. Four concentrations of the API ink solutions (5, 10, 20, 40 mg/mL) were used to print four printed tablet batches using the same tablet design file. The excipient mixture used in the study was kept the same and consists of Lactose monohydrate, Polyvinyl pyrrolidone K30, and Di-Calcium phosphate Anhydrate. The minimum drug loading achieved was 30 µg with a minimal variation (RSD) of <0.26%. The distribution of the API on the tablet surface and throughout the printed tablets were observed using SEM-EDS. In contrast, the micro-CT images of the printed tablets indicated the porous surface structure of the tablets. The immediate release properties of the printed tablets were determined using a dissolution study in a modified USP apparatus II.
Assuntos
Amitriptilina/química , Fosfatos de Cálcio/química , Excipientes/química , Lactose/química , Povidona/química , Impressão Tridimensional , Tecnologia Farmacêutica/métodos , Liberação Controlada de Fármacos , Tinta , Comprimidos , Microtomografia por Raio-XRESUMO
"Margination" refers to the movement of particles in flow toward the walls of a channel. The term was first coined in physiology for describing the behavior of white blood cells (WBCs) and platelets in blood flow. The margination of particles is desirable for anticancer drug delivery because it results in the close proximity of drug-carrying particles to the endothelium, where they can easily diffuse into cancerous tumors through the leaky vasculature. Understanding the fundamentals of margination may further lead to the rational design of particles and allow for more specific delivery of anticancer drugs into tumors, thereby increasing patient comfort during cancer treatment. This paper reviews existing theoretical and experimental studies that focus on understanding margination. Margination is a complex phenomenon that depends on the interplay between inertial, hydrodynamic, electrostatic, lift, van der Waals, and Brownian forces. Parameters that have been explored thus far include the particle size, shape, density, stiffness, shear rate, and the concentration and aggregation state of red blood cells (RBCs). Many studies suggested that there exists an optimal particle size for margination to occur, and that nonspherical particles tend to marginate better than spherical particles. There are, however, conflicting views on the effects of particle density, stiffness, shear rate, and RBCs. The limitations of using the adhesion of particles to the channel walls in order to quantify margination propensity are explained, and some outstanding questions for future research are highlighted.