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The use of novel tools for the assessment of powders and granules flow properties and for the analysis of minitablets compression process.

Published on Mar 4, 2020in Drug Development and Industrial Pharmacy2.367
· DOI :10.1080/03639045.2020.1734020
Hanna Kotlowska (Gdańsk Medical University), Joanna Krotka + 3 AuthorsBuchi N. Nalluri6
Estimated H-index: 6
Abstract
AbstractObjective: The purpose of this study was to apply the rheological measurements to assess the flow properties of powders and granules and to compare the results with the standard pharmacopei...
  • References (27)
  • Citations (0)
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References27
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#1Hui Ping Goh (NUS: National University of Singapore)H-Index: 3
#2Paul Wan Sia Heng (NUS: National University of Singapore)H-Index: 37
Last. Celine Valeria Liew (NUS: National University of Singapore)H-Index: 18
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Abstract Die filling is a critical process step during tablet production as it defines the tablet weight. Achieving die fill consistency during production of mini-tablets, tablets with diameters ≤6 mm, is considerably more challenging. Although die filling in rotary presses had been studied in relation to the feed paddle design, paddle speed, and turret speed, it is unclear how these process variables could impact mini-tablet production and product properties. In this study, 1.8 and 3 mm mini-ta...
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#1Leo Manley (Eli Lilly and Company)H-Index: 3
#2Jon Hilden (Eli Lilly and Company)H-Index: 9
Last. Tim Kramer (Eli Lilly and Company)H-Index: 1
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Abstract The modern rotary pharmaceutical tablet press is capable of accepting or rejecting individual tablets based on the measured compression force of the tablet. Since during steady operation, each tablet is compressed to the same thickness, a larger compression force implies a heavier tablet. Tablets that are too heavy likely contain more than the desired content of drug substance. The measured compression force thus becomes an important input to the overall control strategy, and variabilit...
2 CitationsSource
#1Felipe L. Lopez (UCL: University College London)H-Index: 3
#2Terry B. Ernest (GSK: GlaxoSmithKline)H-Index: 11
Last. Catherine Tuleu (UCL: University College London)H-Index: 21
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Abstract Multiparticulate formulations based on pellets, granules or beads, could be advantageous for paediatrics, geriatrics and patients with swallowing difficulties. However, these formulations may require suitable administration media to facilitate administration. The aim of this work was to investigate the effect of administration media properties on palatability and ease of swallowing of multiparticulates. A range of vehicles were developed using xanthan gum (XG) and carboxymethyl cellulos...
1 CitationsSource
#1Viviane Klingmann (HHU: University of Düsseldorf)H-Index: 1
#2Hannah Linderskamp (HHU: University of Düsseldorf)H-Index: 1
Last. Hans Martin Bosse (HHU: University of Düsseldorf)H-Index: 10
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Objectives To assess the acceptability and swallowability of several minitablets when administered as a unit dose compared with an equivalent dose of syrup in children aged 6 months to 5 years. Study design The acceptability and swallowability of multiple drug-free minitablets in comparison with glucose syrup was assessed in 372 children of 2 age groups (186 in age group 1 [6-23 months of age] and 186 in age group 2 [2-5 years of age]) in a randomized, 3-way, single administration cross-over stu...
1 CitationsSource
#1Anna Sidorchuk (KI: Karolinska Institutet)H-Index: 10
#2Kayoko Isomura (KI: Karolinska Institutet)H-Index: 9
Last. David Mataix-Cols (KI: Karolinska Institutet)H-Index: 66
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Background Pharmacoepidemiological studies have long raised concerns on widespread use of benzodiazepines and benzodiazepine-related drugs (BZDs), in particular long-term use, among adults and the elderly. In contrast, evidence pertaining to the rates of BZD use at younger ages is still scarce, and the factors that influence BZD utilisation and shape the different prescribing patterns in youths remain largely unexplored. We examined the prevalence rates, relative changes in rates over time, and ...
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#1Hamzah M. Beakawi Al-Hashemi (UPM: King Fahd University of Petroleum and Minerals)H-Index: 1
#2Omar Saeed Baghabra Al-Amoudi (UPM: King Fahd University of Petroleum and Minerals)H-Index: 25
Abstract The abundance of granular materials and powders that are being used in several fields, along with their broad applications, requires a comprehensive understanding of both their macro- and micro-mechanical behavior. The fabric and structural properties, or the inter-particle properties, such as the angle of repose, do affect the behavior of granular materials. This comprehensive review indicates that the angle of repose of granular material is an essential parameter to understand the mic...
34 CitationsSource
#1Yasmin Thabet (HHU: University of Düsseldorf)H-Index: 4
#2Jennifer Walsh (BioCity Nottingham)H-Index: 4
Last. Joerg Breitkreutz (HHU: University of Düsseldorf)H-Index: 39
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Abstract Enalapril is an off-patent angiotensin-converting enzyme inhibitor for which no paediatric age-appropriate formulation is commercially available in Europe, and enalapril maleate (EM) orodispersible minitablets (ODMTs) have previously been formulated within the LENA (labelling enalapril from neonates to adolescents) project. In this study, a dilution method has been developed by dispersing the lowest dose strength ODMTs to enable flexible and precise EM dosing during the dose titration p...
4 CitationsSource
#1Junshu Zhao (BMS: Bristol-Myers Squibb)H-Index: 1
#2David Yin (BMS: Bristol-Myers Squibb)H-Index: 1
Last. Preetanshu Pandey (BMS: Bristol-Myers Squibb)H-Index: 13
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Abstract Despite the increasing importance of mini-tablet for its advantages as pediatric formulations and in modified-release applications, its popularity is limited due to the lack of formulation and processing knowledge in developing such dosage forms. In this study, common grades of microcrystalline cellulose and roller compacted granules with a range of powder properties were used to evaluate the critical material properties required for the successful manufacturing of 1.7-mm mini-tablets. ...
4 CitationsSource
#1Hui Ping Goh (NUS: National University of Singapore)H-Index: 3
#2Paul Wan Sia Heng (NUS: National University of Singapore)H-Index: 37
Last. Celine Valeria Liew (NUS: National University of Singapore)H-Index: 18
view all 3 authors...
Abstract Reproducibility of die fill during tablet production is critical to ensure consistent tablet drug content and mechanical attributes. In the production of mini-tablets, tablets smaller than 6 mm, achievement of uniform die fill is much more challenging. Powder flow is often associated with die fill accuracy but this relationship has not been well characterised especially for mini-tablets. In this study, flow properties of different types of granules were characterised. Mini-tablets of 1....
3 CitationsSource
#1Lawrence X. Yu (CDER: Center for Drug Evaluation and Research)H-Index: 44
#2Michael Kopcha (CDER: Center for Drug Evaluation and Research)H-Index: 2
Abstract While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six sigma quality pharmaceuticals with minimal risks of shortages or recalls. We propose that the future of pharmaceutical quality is six sigma, meaning that no more than 3.4 defects occur per million opportunities. We discuss the path to get there, including economic drivers, performance-based regulation, Quality by Design, advanced...
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