Granulation Characterization
Dilip M. Parikh in Handbook of Pharmaceutical Granulation Technology, 2021
The arrowhead-shaped crystals may behave the same as the agglomerates when comparing flowability but may behave differently when comparing their compressive behavior. Note that the granules are made up of primary particles, crystals that are visible and relatively small compared to the non-agglomerated arrowhead-shaped crystals. Identifying structures and separately evaluating their influence on performance are important. Imaging methods used to identify types of structures present in a sample are visual, thermal, and/or analytical imagings. Visual imaging consists mainly of light obscuration methods, scanning electron microscope images (SEMs), and/or photomicrographs. Thermal analysis is a profile of bond energy and changes of state with temperature. Differential scanning calorimetry (DSC) can be used for structural identification. A review of thermal analysis applications is given by Duncan [4]. Analytical imaging is a set of morphological along with material composition and location data used to describe the granulation structure and/or composition.
Ultrastructure of Human Gastrointestinal System. Interactions Among Mast Cells, Eosinophils, Nerves and Muscle in Human Disease.
William J. Snape, Stephen M. Collins in Effects of Immune Cells and Inflammation on Smooth Muscle and Enteric Nerves, 2020
MC are mononuclear cells filled with secretory granules1 (Figures 20 & 21). Other cytoplasmic organelles include mitochondria, intermediate filaments, lipid bodies, Golgi structures, small vesicles, and ribosomes. Surface processes are narrow folds. The granules are filled with dense materials, assuming several patterns. These include homogeneously dense material, scrolls, crystals, particles, and mixtures of these patterns.1 These granule patterns in aggregate are unique to human MC. MC that are present in situ in normal gastrointestinal tissues,5 as well as those examined after isolation from human colons,29 are well-preserved cells which generally contain scroll-filled and particle-filled granules. MC that are present in, or isolated from, the gut contain more particle-filled granules than do MC from other locations.1,5,29 MC from the lung, for example, contain more scroll granules;6,7,22 those from skin contain more crystal granules.30,31
Lingual Lipase
Margit Hamosh in Lingual and Gastric Lipases: Their Role in Fat Digestion, 2020
As described later in this section, the serous glands were shown to be the sole source of lingual lipase in the rat.6 We studied the fine structure of the human von Ebner’s gland in postmortem specimens of adults.55 The specimens were removed at autopsy 4 to 8 hs after death. We identified the areas containing predominantly glandular structures by thick sections examined in the electron microscope (Figure 10). The electron micrographs revealed the usual portmortem artifactual distortions of the tissue as evidenced by degenerative changes of many of the cytoplasmic organelles. The glandular areas were composed of cells containing round or elongated nuclei and multiple electron-dense granules which appeared to extend completely to a limiting membrane. The granules varied in size, but ranged between 400 and 1400 nm in diameter. Some granules demonstrated less electron density, whereas others showed dark central portions with paler, somewhat hazy, peripheries (Figure 11). Those granules resemble the serous granules described by Tandler and Erlansson94 in human submaxillary glands and by Ichikawa95 in the submandibular gland of the rhesus monkey.
A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation
Published in Pharmaceutical Development and Technology, 2019
Simon Grote, Peter Kleinebudde
The behavior of alpha-lactose monohydrate in RCDG and tableting depends on the particle morphology. Granulation of all materials resulted in granules of sufficient particle size at higher SCFs. Nevertheless, the extent depends on the raw material morphology. The specific surface area increased during roll compaction/dry granulation, the largest influence of this enlarged surface area on further results was obtained for agglomerated lactose. For the tabletability of all lactose monohydrate types a clear influence of the raw materials particle size and morphology was shown. Nonetheless, tabletability of granules from primary particles resulted in tablets of comparable strength. Tabletability of granules from secondary particles was influenced by the SCF applied during RCDG. With higher SCFs, the tensile strength of tablets compressed from granules was increased. The granule size showed in some cases a small influence on tabletability of LM granules of all particle morphologies.
Influence of processing methods on physico-mechanical properties of Ibuprofen/HPC-SSL formulation
Published in Pharmaceutical Development and Technology, 2018
Kaushalendra Chaturvedi, Bhavin Y. Gajera, Ting Xu, Harsh Shah, Rutesh H. Dave
Specific aims of this study are (1) to evaluate the effect of processing methods on physical and mechanical properties of Ibuprofen/HPC-SSL formulations, (2) to determine the nature of the interactions between Ibuprofen and HPC-SSL using Fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), and powder X-ray diffraction studies. Tablets were produced by direct compression of the uniformly mixed powder and granules from wet granulation (WG) and melt granulation (MG). Granules were manufactured by different techniques: (1) melt granulation technique using hot melt extrusion (HME) and (2) wet granulation technique using high shear mixer (Gajera et al. 2016). These two methods were selected because of their wide acceptance in pharmaceutical industry for large-scale manufacturing. Hence, processing these techniques to get intermediate products will be the best way to get useful insights.
High-shear granulation of high-molecular weight hypromellose: effects of scale-up and process parameters on flow and compaction properties
Published in Drug Development and Industrial Pharmacy, 2018
Peter Grdešič, Tamás Sovány, Ilija German Ilić
The most common way to produce granules is by wet granulation, where a liquid is used to achieve agglomeration of the primary powder particles into a granulate [1,2]. Wet granulation is commonly used in many industrial sectors, and most notably for the production of pharmaceuticals. The main objective of the process is to improve the material properties, such as their flow and compaction, handling and to reduce the dustiness, and segregation tendency [3–5]. The formulation and process parameters as well as scale of operation are known to influence granule properties and considerable efforts have been made to gain better understanding of the effects that these can have on granule properties, such as morphology, particle size, porosity, density, strength, flowability, and other critical quality attributes (CQAs) [3,6–17].