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In recent years, continuous manufacturing techniques, such as twin screw wet granulation, have gained significant momentum. Due to the large diversity of the (model) formulations and equipment, it is often difficult to generalize conclusions about the importance of process settings. As only limited knowledge is available on the importance of formulation variables, this study focused on the systematic quantification of both process as formulation effects on critical quality attributes of granules from several model formulations. Apart from conventional process and formulation variables, also non-conventional process factors such as nozzle diameter, nozzle orientation and inclusion of a new type of size control elements were evaluated using a Plackett-Burman screening design. Although effects were often formulation-dependent, liquid-to-solid ratio proved the most influential variable for all formulations. Furthermore, binder concentration had a clear effect on granule characteristics, whereas barrel fill level and barrel temperature were less influential. The novel type of size control elements improved granule size distribution and density. The impact of nozzle diameter and wet binder addition proved negligible towards granule properties. Overall it was apparent that lactose/MCC-based formulations correlated better than lactose-based formulations, indicating the possible process robustness of the first filler combination to accommodate API and excipient variability and to handle APIs with different characteristics.
This article was published in the following journal.
Name: International journal of pharmaceutics
The use of Continuous Manufacturing has been increasing within the pharmaceutical industry over the last few years. Continuous direct compression has been the focus of publications on the topic to dat...
Due to the numerous advantages over batch manufacturing, continuous manufacturing techniques such as twin screw wet granulation are rapidly gaining importance in pharmaceutical production. Since a lar...
The use of native starch as in situ binder in a continuous twin screw wet granulation process was studied. Gelatinization of pea starch occurred in the barrel of the granulator using a poorly soluble ...
Many studies on continuous twin-screw granulation only focus on the granulator without linking this process step to the upstream and downstream unit operations. Product critical quality attributes (CQ...
In this work a cocrystal of Theophylline and 4Aminobenzoic acid was successfully produced and formulated using a hydrophilic binder with a novel continuous melt granulation approach. This melt granula...
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when c...
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
Humanitarian use device (HUD): Use of the fetoscopy instrument sets for selective laser photocoagulation in the treatment of Twin to Twin Transfusion Syndrome (TTTS).
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior...
Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common problem seen in the pediatric surgery population. There is no standard treatment that has been ide...
Passage of blood from one fetus to another via an arteriovenous communication or other shunt, in a monozygotic twin pregnancy. It results in anemia in one twin and polycythemia in the other. (Lee et al., Wintrobe's Clinical Hematology, 9th ed, p737-8)
A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.
Spindle-shaped cells with characteristic CONTRACTILE PROTEINS and structures that contribute to the WOUND HEALING process. They occur in GRANULATION TISSUE and also in pathological processes such as FIBROSIS.
Methods of detecting genetic etiology in human traits. The basic premise of twin studies is that monozygotic twins, being formed by the division of a single fertilized ovum, carry identical genes, while dizygotic twins, being formed by the fertilization of two ova by two different spermatozoa, are genetically no more similar than two siblings born after separate pregnancies. (Last, J.M., A Dictionary of Epidemiology, 2d ed)
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