The impact of high pressure thermal sterilization on the microbiological stability and formation of food processing contaminants in selected fish systems and baby food puree at pilot scale

Abstract Parameter estimation and wastewater characterization are crucial for modelling of the membrane enhanced biological phosphorus removal (MEBPR) process. Prior to determining the values of a subset of kinetic and stoichiometric parameters used in ASM No. 2 (ASM2), the carbon, nitrogen and phosphorus fractions of influent wastewater at the University of British Columbia (UBC) pilot plant were characterized. It was found that the UBC wastewater contained fractions of volatile acids (SA), readily fermentable biodegradable COD (SF) and slowly biodegradable COD (XS) that fell within the ASM2 default value ranges. The contents of soluble inert COD (SI) and particulate inert COD (XI) were somewhat higher than ASM2 default values. Mixed liquor samples from pilot-scale MEBPR and conventional enhanced biological phosphorus removal (CEBPR) processes operated under parallel conditions, were then analyzed experimentally to assess the impact of operation in a membrane-assisted mode on the growth yield (YH), decay coefficient (bH) and maximum specific growth rate of heterotrophic biomass (µH). The resulting values for YH, bH and µH were slightly lower for the MEBPR train than for the CEBPR train, but the differences were not statistically significant. It is suggested that MEBPR simulation using ASM2 could be accomplished satisfactorily using parameter values determined for a conventional biological phosphorus removal process, if MEBPR parameter values are not available.

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Dexamethasone-Loaded Nanostructured Lipid Carriers for the Treatment of Dry Eye Disease

Pharmaceutics ◽

10.3390/pharmaceutics13060905 ◽

2021 ◽

Vol 13 (6) ◽

pp. 905

Author(s):

Sangeeta Kumari ◽

Madhuri Dandamudi ◽

Sweta Rani ◽

Elke Behaeghel ◽

Gautam Behl ◽

...

Keyword(s):

Dry Eye ◽

Ocular Surface ◽

Pilot Scale ◽

Dry Eye Disease ◽

Rapid Screening ◽

Eye Disease ◽

Topical Steroids ◽

Nanostructured Lipid Carrier ◽

The Impact ◽

Ophthalmic Formulation

Dry eye disease (DED) or keratoconjunctivitis sicca is a chronic multifactorial disorder of the ocular surface caused by tear film dysfunction. Symptoms include dryness, irritation, discomfort and visual disturbance, and standard treatment includes the use of lubricants and topical steroids. Secondary inflammation plays a prominent role in the development and propagation of this debilitating condition. To address this we have investigated the pilot scale development of an innovative drug delivery system using a dexamethasone-encapsulated cholesterol-Labrafac™ lipophile nanostructured lipid carrier (NLC)-based ophthalmic formulation, which could be developed as an eye drop to treat DED and any associated acute exacerbations. After rapid screening of a range of laboratory scale pre-formulations, the chosen formulation was prepared at pilot scale with a particle size of 19.51 ± 0.5 nm, an encapsulation efficiency of 99.6 ± 0.5%, a PDI of 0.08, and an extended stability of 6 months at 4 °C. This potential ophthalmic formulation was observed to have high tolerability and internalization capacity for human corneal epithelial cells, with similar behavior demonstrated on ex vivo porcine cornea studies, suggesting suitable distribution on the ocular surface. Further, ELISA was used to study the impact of the pilot scale formulation on a range of inflammatory biomarkers. The most successful dexamethasone-loaded NLC showed a 5-fold reduction of TNF-α production over dexamethasone solution alone, with comparable results for MMP-9 and IL-6. The ease of formulation, scalability, performance and biomarker assays suggest that this NLC formulation could be a viable option for the topical treatment of DED.

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Process Modeling and Simulation of Tableting—An Agent-Based Simulation Methodology for Direct Compression

Pharmaceutics ◽

10.3390/pharmaceutics13070996 ◽

2021 ◽

Vol 13 (7) ◽

pp. 996

Author(s):

Niels Lasse Martin ◽

Ann Kathrin Schomberg ◽

Jan Henrik Finke ◽

Tim Gyung-min Abraham ◽

Arno Kwade ◽

...

Keyword(s):

Raw Materials ◽

Pilot Scale ◽

Physical Models ◽

Agent Based Simulation ◽

Validation Data ◽

Agent Based ◽

Industrial Processing ◽

Digital Twins ◽

Product And Process ◽

The Impact

In pharmaceutical manufacturing, the utmost aim is reliably producing high quality products. Simulation approaches allow virtual experiments of processes in the planning phase and the implementation of digital twins in operation. The industrial processing of active pharmaceutical ingredients (APIs) into tablets requires the combination of discrete and continuous sub-processes with complex interdependencies regarding the material structures and characteristics. The API and excipients are mixed, granulated if required, and subsequently tableted. Thereby, the structure as well as the properties of the intermediate and final product are influenced by the raw materials, the parametrized processes and environmental conditions, which are subject to certain fluctuations. In this study, for the first time, an agent-based simulation model is presented, which enables the prediction, tracking, and tracing of resulting structures and properties of the intermediates of an industrial tableting process. Therefore, the methodology for the identification and development of product and process agents in an agent-based simulation is shown. Implemented physical models describe the impact of process parameters on material structures. The tablet production with a pilot scale rotary press is experimentally characterized to provide calibration and validation data. Finally, the simulation results, predicting the final structures, are compared to the experimental data.

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