Investigation of influence of process variables on mechanical strength, size and homogeneity of pharmaceutical granules produced by fluidised hot melt granulation

Abstract

Publisher rights This is the author's version of a work that was accepted for publication in Powder Technology. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Powder Technology, vol 272, issue March 2015 doi: 10.1016/j.powtec.2014.11.042. General rightsCopyright for the publications made accessible via the Queen's University Belfast Research Portal is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights.Take down policy The Research Portal is Queen's institutional repository that provides access to Queen's research output. Every effort has been made to ensure that content in the Research Portal does not infringe any person's rights, or applicable UK laws. If you discover content in the Research Portal that you believe breaches copyright or violates any law, please contact openaccess@qub.ac.uk. The overall aim of the project was to study the influence of process variables on the 36 distribution of a model active pharmaceutical ingredient (API) during fluidised melt 37 granulation of pharmaceutical granules with a view of optimising product characteristics. 38Granules were produced using common pharmaceutical excipients; lactose monohydrate 39 using poly ethylene glycol (PEG1500) as a meltable binder. Methylene blue was used as a

Quantitative and qualitative use of thermal analysis for the investigation of the properties of granules during fluid bed melt granulation

“…On the other hand, the loss of crystal water from α-lactose monohydrate did not appear in the same thermal range as in the raw material (Table 3), attributed to the free volume experienced when in contact with the polymer, lowering the crystal vaporization temperature. Also, the normalized integration of the signal intensity demonstrates a decrease when using a higher binder content [8].…”

“…Following particle agglomeration and consolidation, the granules are cooled to room temperature and a solid end product with a granular structure is formed [7][8][9][10]. For this granulation method, the drying step, which is required after wet granulation, is eliminated, hence the process time and energy requirements are significantly reduced.…”

Granulation of teawaste and limestone using sodium-based lignosulfonate and DEM simulation of powder mixing

“…Size enlargement is initiated by the addition of liquid binder which wets the powder material and acts as a bonding agent. Wet granulation manufacturing processes can be complex and controlled by multi-factorial relationships between materials and process parameters [1][2][3][4][5][6]. It has been reported that the granule properties were affected by the relative composition of initial feed materials [3].…”

SeDeM-ODT Expert System: A Solution to Challenges in Characterization of Pharmaceutical Powders and Powdered Material

“…Tablets are the most preferred dosage form with respect to patient acceptability, flexibility in dose adjustment, easy manufacturing, and better stability [1,2]. Irrespective of the nature of the drug and its manufacturing technique, tablets should meet some strict requirements in terms of mechanical strength, disintegration, and drug release [3][4][5]. A variety of techniques are available for tablet preparation among which direct compression is mostly preferred due to simplicity, cost-effectiveness, and less number of involved steps [6,7].…”