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This research was designed to understand how the processing parameters affect the properties of the microparticles, such as microparticle size distributions, surface and internal morphologies, drug loadings, and drug release kinetics, and thus, to control them. This number decreased slightly in 2018, but still, about 47,000 people died from opioid overdoses. In 2017 alone, more than 70,000 people died of a drug overdose, and more than 50,000 of those deaths were due to opioids. Opioid overdose continues to cause the majority of drug-related deaths in the United States. The in-line approach produced PLGA microparticles with a highly reproducible size distribution, DL, and naltrexone release rate. Then, the micro particles swelled to form smooth surfaces. As PLGA microparticles went through structural changes, the surface showed raisin like wrinkled morphologies within the first 10 days. The changes in morphology of the microparticles during different phases of the in vitro release study were also studied for three types of microparticles made with different PLGA concentrations and molecular weights. A higher drug loading, however, shortened the drug release duration from 56 to 42 days. These increases may be due to a faster shell formulation, enabling PLGA microparticles to entrap more naltrexone into the structure. Increasing the PLGA concentration from 5.58% to 16.85% showed a corresponding rise in the encapsulation efficiency from 74.0% to 85.8% and drug loading from 27.4% to 31.7% for the micro particles made with the homogenization speed of 2000 RPM. As the viscosity of the oil-phase increased from 52.6 to 4046, the span value increased from 1.24 to 3.1 for the microparticles generated at the homogenization speed of 2000 RPM. The uniformity of the microparticles was found to be related to the viscosity of the oil-phase. A high molecular weight PLGA at various concentrations was used to generate oil-phases with a range of viscosities and also to compare with a 64 and 79 kDa at a single, high concentration. The in-line homogenization system was used at high flow rates for the oil- and water-phases, e.g., 100 mL/min and 400 mL/min, respectively, to continuously generate microparticles. That allows the transition from a laboratory scale to scale-up production. The oil-phase included PLGA and naltrexone dissolved in benzyl alcohol and DCM. Benzyl alcohol was used as a co-solvent due to the poor solubility of naltrexone in DCM. The schematic of the in-line naltrexone-loaded PLGA microparticle generation using the emulsification-extraction technique is demon- strated in Fig. 1-A. Two pumps, a gear pump and a syringe pump, were used to flow the aqueous- and oil-phases into the in-line homogenizer, respectively. The schematic of the in-line naltrexone-loaded PLGA microparticle generation using the emulsification-extraction technique is demon- strated in Fig. 1-A. Two pumps, a gear pump and a syringe pump, were used to flow the aqueous- and oil-phases into the in-line homogenizer, respectively. In making PLGA microparticles, there are many variables that need to be controlled to produce them with reproducible properties. Some of the parameters are shown in Fig. 9.
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