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O'Connor, Thomas

Publications and source records attributed to O'Connor, Thomas.

5 records
All sourcesNASA NTRSDOE OSTI
DOE OSTI2022

Application of a headspace GC–MS method to evaluate the product quality of alcohol‐based hand wipe sanitizers

Abstract The investigation of marketed hand wipe sanitizers presented an analytical challenge owing to the need for extraction from the solid matrix of the products. The present work describes the development of a new sample preparation method for the extraction of analytes from the hand wipe sanitizer matrix into dimethyl sulfoxide for analysis using headspace GCMS. Alcohol‐based hand sanitizer (ABHS) wipe products labeled to contain ethanol or isopropanol as active ingredients were tested, varying in the size and weight of the wipes. The spike recovery assay was confirmed using spiking solutions containing impurities at concentrations equivalent to 50, 100 and 200% of the interim concentration limits. All of the tested analytes showed recovery within the allowable limits (80–120%). Six marketed ABHS wipe products were tested and no impurities above the FDA interim limits were observed. One product contained ethanol below the 60% v/v limit and another product was mislabeled for isopropanol and was found to contain ethanol instead. Four of the six ABHS products did not meet the label claim, which may affect the product quality. The analytical method and sample preparation procedures will provide the FDA and ABHS manufacturers with the capability to conduct quality assurance testing of hand wipe sanitizers for active ingredient content and impurities.

Biochemistry & Molecular Biology↗
DOE OSTI2022

Optimization of screw design for continuous wet granulation: A case study of metoprolol succinate ER tablets

This study aimed at understanding the effect of screw design on the critical characteristics of granules and tablets of an extended-release (ER) formulation for twin screw granulation process. The screw design parameters assessed included number of kneading elements (KEs) per kneading zone, distance separating kneading zones, staggering angle (SA) of kneading elements and number of sizing elements (SEs). These input variables were varied using a design of experiment (DoE) approach to manufacture granules. Particle size distribution (PSD), flow and bulk properties of the granules, breaking strength and dissolution of tablets manufactured using these granules were characterized. The results of least square fitting showed that KEs, SA, and SEs of the screws significantly (p -values < 0.05) affected the PSD, cohesion, compressibility (CPS), conditioned bulk density (CBD) and permeability of the granules. The KEs and SEs significantly (p -value < 0.05) affected the dissolution, which was attributed to their effects on CPS and CBD of the granules. The distance between kneading zones had no significant effect on granules and tablet characteristics. Finally, these results may be used to further study the interaction of the identified critical screw design parameters with other processing parameters for continuous manufacturing of this ER matrix-based tablet formulation.

60 APPLIED LIFE SCIENCES↗
DOE OSTI2022

Switching from batch to continuous granulation: A case study of metoprolol succinate ER tablets

Continuous manufacturing (CM) has been used to produce several immediate release drug products. No extended-release (ER) product manufactured employing CM technology has been approved yet. Herein this study investigated the critical aspects of switching from the batch mode of high shear granulation to the continuous operation of twin-screw granulation for extended-release tablets. Metoprolol succinate ER tablets was used as a model ER formulation for this purpose. A central composite design (CCD) was employed to determine the effects of high shear granulator (HSG) parameters, namely impeller speed, granulation time, and binder liquid feeding rate, on the critical granulation characteristics important for product performance. These critical granulation characteristics served as a guide for switching from the batch processing to the continuous operation for achieving the same breaking strength and dissolution for this ER metoprolol tablets. The granulation time was the most critical factor affecting the bulk properties of granules which contributed to tablet dissolution. The higher density and lower compressibility of granules were attained at the longest granulation time of 5.4 min with the fastest liquid feeding rate of 75 g/min. The granules’ density was the primary factor negatively affecting the dissolution of metoprolol tablets. However, the breaking strength of tablets confounded the effect of granules density on metoprolol dissolution. Switching the processing parameters of high shear granulation to twin-screw granulation achieved similar dissolution profiles (F2 greater than 50). The screw speed was not found to affect bulk properties of granules. The root cause of granulation failures in twin-screw granulation, such as premature consolidation, excessive swelling, poor cohesion, inconsistent shearing effects, and formation of deformed agglomerates, were identified. In conclusion, the use of critical granulation characteristics through a performance-based approach of ER tablets facilitated the switching of manufacturing of an ER formulation form batch to continuous operation.

37 INORGANIC, ORGANIC, PHYSICAL, AND ANALYTICAL CH↗