05. September 2018
As Pfanstiehl approaches its 100th anniversary in 2019, the company has launched a new high purity, low endotoxin, and low metal L-Arginine (USP, EP, JP, ChP), manufactured in the United States under strict cGMP, ICH Q7 compliant conditions. This is the first amino acid Pfanstiehl has launched and they have others in development.
20. August 2018
Material properties are known to have a significant impact on pharmaceutical manufacturing performance, particularly for solid product processes. Evaluating the performance of a specific material, for example an active pharmaceutical ingredient or excipient, is critical during development stages in order to determine the impact of material properties on the process. However, materials may be scarce during the early stages of process development due to high cost, unavailability, import...
17. August 2018
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100 raw material descriptors related to particle size and shape distribution, specific surface area, bulk, tapped and true density, compressibility, electrostatic charge, moisture content, hygroscopicity,...
06. August 2018
Spherical pellets for pharmaceutical applications are widely produced by an extrusion-spheronization process. To achieve an equal, spherical pellet shape with a spheronization process, it is crucial that all pellets are exposed to similar stress conditions. However, in a spheronizer the pellets close to the friction plate are subjected to much higher stresses than pellets at the top of the torus, resulting in a strongly inhomogeneous stress distribution within the particle bed. Therefore, the...
23. May 2018
Flavors are blends of aroma chemicals that are developed for specific end-use applications. The exact composition of flavors is proprietary – it’s the intellectual property of the flavor supplier (“flavor house”). The exact makeup of a flavor is vigorously protected as trade secrets, and not by patents. This is common practice in the food industry, where the sales of popular brands can continue to grow for decades. It’s the secret recipe for Coca Cola that has enabled it to thrive...
17. May 2018
Pharmaceutical excipients that may affect gastrointestinal (GI) drug absorption are called critical pharmaceutical excipients (CPEs), or absorption-modifying excipients (AMEs) if they act by altering the integrity of the intestinal epithelial cell membrane. Some of these excipients increase intestinal permeability, and subsequently the absorption and bioavailability of the drug. This could have implications for both the assessment of bioequivalence and the efficacy of the absorption-enhancing...
07. April 2018
It has been shown that dry coating cohesive active pharmaceutical ingredients (APIs) with nano-silica can improve packing and flow of their blends, facilitating high speed direct compressiontableting. This paper examines the broader scope and generality of previous work by examining three fine APIs; micronized Acetaminophen (mAPAP), coarse Acetaminophen (cAPAP) and micronized Ibuprofen(mIBU), and considers dry coating with both hydrophobic or hydrophilic nano-silica to examine the effect not...
29. November 2017
Meloxicam (MLX) is a non-steroidal anti-inflammatory cyclooxygenase (COX) inhibitor that is used to relieve inflammation and pain. MLX has a preferential affinity for COX-2, which is associated with a lower incidence of gastrointestinal side effects. The drug belongs to Class II of the Biopharmaceutical Classification System (BCS) in which dissolution is the limiting step of its bioavailability. In view of this classification, carrying out further studies regarding the compatibility of MLX with...
03. November 2017
Kaolinite Al2Si2O5(OH)4 is an abundant and inexpensive geomaterial regarded as one of the most common clay minerals in the earth's crust and the most widespread phase among the other kaolin polymorphs (halloysite, dickite and nacrite). Structurally, it is a hydrous aluminum phyllosilicate member belonging to the dioctahedral 1:1 kaolin mineral group. The particle size of the pseudohexagonal kaolinite platelets is normally <2 μm (if compared to a human red blood cell of a typical diameter...
07. October 2017
In the context of continuous pharmaceutical oral dosage manufacturing, a control system is essential to ensure that the critical quality attributes (CQAs) are maintained within the regulatory constraints by mitigating variations generated in upstream operations. Such a system is essential to the Quality by Design (QbD) paradigm shift, which can ensure predefined end quality attributes are achieved within an optimal economic and time bracket. In this work, an advanced model predictive control...