Browsing Category
Continuous manufacturing
Investigation of granular dynamics in a continuous blender using the GPU-enhanced discrete element…
Continuous powder blending is an essential operation during continuous pharmaceutical manufacturing. However, the complex granular dynamics in the blender is still poorly understood. This study employs a graphic processor unit (GPU) enhanced discrete element method (DEM) to analyse the granular…
Read More...
Read More...
Continuous Processing of Micropellets via Hot-Melt Extrusion
Microparticulate drug delivery systems, e.g., micropellets (MPs), are used in a variety of pharmaceutical formulations such as suspensions, injectable systems, and capsules. MPs are currently manufactured mainly via batch, solvent-based processes, e.g., spray-drying and solvent…
Read More...
Read More...
Continuous integrated production of glucose granules with enhanced flowability and tabletability
Glucose is widely used in both the food and pharmaceutical industry. However, the application of industrially crystallized glucose in solid dosage forms is challenged by its poor flowability and tabletability. To improve these characteristics continuous twin-screw granulation was tested, which has…
Read More...
Read More...
Specific Excipient Requirements in Continuous Tablet Manufacturing
Abstract
Continuous Manufacturing Technology continues to gain importance in pharmaceutical manufacturing.
Although traditional processes like direct compression, roller compaction, or wet granulation are used within the continuous lines, the requirement for ingredients may differ from…
Read More...
Read More...
Development of a predictive model for gravimetric powder feeding from an API-rich materials…
A model was developed for predicting the feed factor profile of a powder, processed through a gravimetric feeder, as a function of material properties and process parameters. Predictive models proposed in existing literature have often used excipients and active pharmaceutical ingredients (APIs)…
Read More...
Read More...
Development and Use of a Residence Time Distribution (RTD) Model Control Strategy for a Continuous…
Residence-time-distribution (RTD)-based models are key to understanding the mixing dynamics of continuous manufacturing systems. Such models can allow for material traceability throughout the process and can provide the ability for removal of non-conforming material from the finished product. These…
Read More...
Read More...
Control strategy definition for a drug product continuous wet granulation process: Industrial case…
This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based on continuous twin-screw wet granulation. This control strategy has been defined by a multidisciplinary team using an enhanced approach, in alignment with the…
Read More...
Read More...
Optimization of screw design for continuous wet granulation: A case study of metoprolol succinate ER…
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…
Read More...
Read More...
Soft sensor for content prediction in an integrated continuous pharmaceutical formulation line based…
In this study, a concentration predicting soft sensor was achieved based on the Residence Time Distribution (RTD) of an integrated, three-step pharmaceutical formulation line. The RTD was investigated with color-based tracer experiments using image analysis. Twin-screw wet granulation (TSWG) was…
Read More...
Read More...
Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control…
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls…
Read More...
Read More...