In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing pro...
To produce high-quality pharmaceuticals, a real-time monitoring method for the high-shear wet granulation process (HSWG) was developed based on near-infrared spectroscopy (NIRS). Samples consisting of lactose, potato starch, and hydroxypropyl cellulo...
Background/Objectives: The pharmaceutical industry demands stringent regulation of product characteristics and strives to ensure the reproducibility of granules manufactured via the wet granulation process. A systematic model employing the discrete e...
This article highlights the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion. The different melt granulation process options and excipients are described and compared, and a case is made for expanded use of twin-screw...
Continuous manufacturing (CM) is a promising strategy to achieve various benefits in the context of quality, flexibility, safety and cost in pharmaceutical production. One of the main technical challenges of CM is that the process needs to handle tra...
Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and a...
The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral...
The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should...
The article deals with the removal of 20 selected drugs from drinking water by sorption on granulated activated carbon. Two different sorption materials were used, and the efficiency of removing these micropollutants was compared. Experiments were pe...
The development of robust and scalable tablet manufacturing methods remains a key objective in pharmaceutical technology, especially when dealing with active pharmaceutical ingredients (APIs) and excipients that exhibit suboptimal processing properti...
The granulation process of pharmaceutical standard formulation in a high-speed shear wet granulation (HSWG) was measured by in-line near-infrared spectroscopy (NIRS) and agitation power consumption (APC) methods. The F-1, F-2, and F-3 formulations (5...
Solid pharmaceutical formulations with class II active pharmaceutical ingredients (APIs) face dissolution challenges due to limited solubility, affecting in vivo behavior. Robust computational tools, via data mining, offer valuable insights into prod...
Background/Objectives: Tablet is the most popular oral solid dosage form, and high-shear wet granulation and tableting (HSWGT) is a versatile technique for manufacturing tablets. The conventional pharmaceutical development for HSWGT is carried out in...
Almost alone among the process industries, the pharmaceutical industry has tended to rely on batch operations. [...]
A continuous-spray granulator (CTS-SGR) is a one-step granulation technology capable of using solutions or suspensions. The present research objectives were, (1) to reduce the manufacturing operations for solid dosage formulations, (2) to make amorph...
In the last decade, twin-screw wet granulation became an essential technology for continuous pharmaceutical tablet production. Consequently, interest in (semi-)continuous fluidized bed drying systems as a subsequent processing unit has grown. In para...
In view of growing interest and investment in continuous manufacturing, the development and utilization of mathematical model(s) of the manufacturing line is of prime importance. These models are essential for understanding the complex interplay betw...
Background/Objectives: This study aimed to establish a predictive model for critical quality attributes (CQAs) related to tablet integrity, including tablet breaking force (TBF), friability, and capping occurrence, using machine learning-based models...
Experimental characterization of solid-liquid mixing for a high shear wet granulation process in a twin-screw granulator (TSG) is very challenging. This is due to the opacity of the multiphase system and high-speed processing. In this study, discrete...
Granulated active carbon (GAC) is commonly used as a chemical barrier for the removal of organic micropollutants (OMPs) in drinking water treatment plants (DWTPs). However, little is known about the impact of dissolved organic carbon (DOC) and its lo...
Twin-screw granulation (TSG) is an emerging process technology that allows both wet and dry granulation of powders with a wide range of properties [...]
Toward further implementation of continuous tablet manufacturing, one key issue is the time needed for start-up operation because it could lead to lower product yield and reduced economic performance. The behavior of the start-up operation is not wel...
Fungal biosorption is an environmental biotechnology based on the ability of the fungal cell wall to concentrate harmful water pollutants. Among its advantages are its simplicity, high efficiency, flexibility of operation, and low cost. The biosorpti...
Lactose and mannitol are some of the most commonly used powders in the pharmaceutical industry. The limited research published so far highlights the effects of process and formulation parameters on the properties of the granules and the tablets produ...
Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms. The technology has evolved rapidly due to the flexibility of the...
As important parameters in the characterization of aerobic granulation, the shape and average diameter were related to substrates. The previous studies disclosed that the morphology change in aerobic granules was the result of growth and the relative...
Wet granulation is a frequent process in the pharmaceutical industry. As a starting point for numerous dosage forms, the quality of the granulation not only affects subsequent production steps but also impacts the quality of the final product. It is...
Several studies have demonstrated the feasibility of in situ co-crystallization in different pharmaceutical processes such as spray drying, hot melt extrusion, and fluidized bed granulation (FBG) to produce co-crystal-in-excipient formulations. Howev...
In the pharmaceutical industry, the transition to continuous manufacturing of solid dosage forms is adopted by more and more companies. For these continuous processes, high-quality process models are needed. In pharmaceutical wet granulation, a unit...
Granulators play a key role in many pharmaceutical processes because they are involved in the production of tablets and capsule dosage forms. Considering the characteristics of the production processes in which a granulator is involved, proper mainte...
This study explores the influence of blade design on the low-pressure extrusion process, which is relevant to techniques like spheronization. We investigate how blade geometry affects the extruded paste and final product properties. A model paste was...
The manufacturing of solid pharmaceutical dosage forms composed of cocrystals requires numerous processes during which there is risk of dissociation into parent molecules. Resonant acoustic wet granulation (RAG) was devised in an effort to complete t...
Continuously operated pharmaceutical manufacturing lines often consist of a wet granulation unit operation, followed by a (semi-) continuous dryer. The operating conditions of the dryer are crucial for obtaining a desired final granule moisture. Comm...
Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compa...
We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LVODT) to find a new usefulness of low frequency (LF) Raman spectroscopy. LVODT contained dispersed granules with diameters in the order o...
Twin-screw granulation has emerged as a key process in powder processing industries and in the pharmaceutical sector to produce granules with controlled properties. This comprehensive review provides an overview of the simulation techniques and appro...
Eggs are among the most nutritious foods in the world, a versatile ingredient in many food applications due to their functional attributes such as foaming, emulsifying, and coloring agents. Many studies have been reported on egg yolk fractionation an...
Aerobic granules are dense three-dimensional microbial aggregates which are known for their excellent settling ability, high biomass retention, and simultaneous biological reaction due to their multilayered structure. All these features enable the ae...
During the operation of a high-speed shear wet granulator, the rotation of the granulation components leads to the emergence of the phenomenon of particle breakage, which results in changes in particle size. To simulate the breakage process of pharma...
Wet fluidized bed granulation and coating processes have been widely used in the pharmaceutical and food industries. The complex gas–solid flow coupled with heat and mass transfer in such processes made it hard to form complete control over the...
The drying unit of a continuous from-powder-to-tablet manufacturing line based on twin-screw granulation (TSG) is a crucial intermediate process step to achieve the desired tablet quality. Understanding the size reduction of pharmaceutical granules b...
The production of nanosuspensions of poorly soluble active pharmaceutical ingredients (API) is a popular technique to counteract challenges regarding bioavailability of such active substances. A subsequent drying of the nanosuspensions is advantageou...
This study evaluates the feasibility of Near-Infrared (NIR) spectroscopy combined with chemometric modeling for monitoring twin-screw melt granulation. Lactose monohydrate was used as a model excipient and polyethylene glycol (PEG 6000) (Sistemas Ana...
Background: High shear wet granulation (HSWG) is a shaping process for granulation that has been enhanced for application in the pharmaceutical industry. However, study of HSWG is complex and challenging due to the relatively poor understanding of HS...
We present a systematic and automatic approach for integrating tableting reduced-order models with upstream unit operations. The approach not only identifies the upstream critical material attributes and process parameters that describe the coupling...
The consumption of fiber in the human diet is a global recommendation to ensure a healthy diet. Quinoa (Chenopodium quinoa Willd.), a gluten-free grain, and chia (Salvia hispanica), a seed, contain a high fiber content, and both have the potential to...
Melt granulation for improving material handling by modifying particle size distribution offers significant advantages compared to the standard methods of dry and wet granulation in dust reduction, obviating a subsequent drying step. Furthermore, cur...
Tablet manufacturing involves the processing of raw materials through several unit operations. Thus, the mitigation of input-induced variability should also consider the downstream processability of intermediary products. The objective of the present...
Pellet production is a multi-step manufacturing process comprising granulation, extrusion and spheronisation. The first step represents a critical control point, since the quality of the granule mass highly influences subsequent process steps and, co...
In this study, we established a robust feed-forward control model for the tableting process by partial least squares regression using the near-infrared (NIR) spectra and physical attributes of the granules to be compressed. The NIR spectra of granule...
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