Browsing Category
Continuous manufacturing
Directly compressible hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing
This work was undertaken to evaluate a novel hydroxypropyl methylcellulose excipient used in the manufacture of hydrophilic matrix tablets for oral controlled release. This material was coprocessed with a small amount of silicon dioxide to provide improvements over the standard material and was…
Read More...
Read More...
Process Design of Continuous Powder Blending Using Residence Time Distribution and Feeding Models
The present paper reports a thorough continuous powder blending process design of acetylsalicylic acid (ASA) and microcrystalline cellulose (MCC) based on the Process Analytical Technology (PAT) guideline. A NIR-based method was applied using multivariate data analysis to achieve in-line process…
Read More...
Read More...
Towards better understanding of the influence of process parameters in roll compaction/ dry…
A key quality attribute for solid oral dosage forms is their hardness and ability to withstand breaking or grinding. If the product is to be manufactured continuously, it can be of interest to monitor the hardness of the material at different stages of manufacturing. Using the controlled process…
Read More...
Read More...
Residence time distribution modelling and in line monitoring of drug concentration in a tablet press…
The presence of a ‘significant dead zone’ in any continuous manufacturing equipment may affect the product quality and need to be investigated systematically. Dead zone will affect the residence time distribution (RTD) of continuous manufacturing and thus the mixing and product quality.
Tablet…
Read More...
Read More...
Optimization of residence time distribution in RCDG and an assessment of its applicability in…
Knowledge of residence time is a critical aspect in developing control and material diversion strategies for continuous manufacturing processes in pharmaceutical manufacturing. Dry granulation is a promising continuous granulation technique as it is fast and economical. In this study, a step-change…
Read More...
Read More...
Investigation into powder tribo-charging of pharmaceuticals. Part I: process-induced charge via…
Powder feeding is a crucial unit operation in continuous manufacturing (CM) of pharmaceutical products. Twin–screw feeders are typically employed to ensure the accurate mass flow of pharmaceutical materials throughout the production process. Here, contact and separation of particles can give rise to…
Read More...
Read More...
A solution for low-dose feeding in continuous pharmaceutical processes
Continuous feeding of small quantities of powder is increasingly applied in pharmaceutical manufacturing. With that regard, what is crucial is not only the feasibility, but also the accuracy and stability. To enable stable processing, low amounts of various agents, e.g., lubricants, can be used.…
Read More...
Read More...
Lubrication Empirical Model to Predict Tensile Strength of Directly Compressed Powder Blends
A new approach is proposed to support prediction of tablet tensile strength as a function of both solid fraction (and/or compression pressure) and extent of lubrication by using empirical data to parameterise the model. This is a pre-requisite for simulation of the compaction unit operation where a…
Read More...
Read More...
Towards a Continuous Manufacturing Process of Protein-Loaded Polymeric Nanoparticle Powders
To develop a scalable and efficient process suitable for the continuous manufacturing of poly(lactic-co-glycolic acid) (PLGA) nanoparticles containing ovalbumin as the model protein. PLGA nanoparticles were prepared using a double emulsification spray-drying method. Emulsions were prepared using a…
Read More...
Read More...
Process Control of Drug Product Continuous Manufacturing Operations—a Study in Operational…
The purpose of this manuscript is to demonstrate that implementation of gravimetric measurements provides the same assurance of product quality and process control as spectroscopic measurements (1) for control of drug content in a fixed-dose combination (FDC) tablet and (2) for identification of…
Read More...
Read More...