Roller compaction: Effect of morphology and amorphous content of lactose powder on product quality

Omar, Chalak S.; Dhenge, Ranjit M.; Osborne, James D.; Althaus, Tim O.; Palzer, Stefan; Hounslow, Michael J.; Salman, Agba D.

doi:10.1016/j.ijpharm.2015.06.032

Cited by 27 publications

(13 citation statements)

References 26 publications

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“…26) still has several smaller particles, which are signs of breakage. The fracture and insignificant plastic deformation of the lactose can help explain why no strong ribbon and plastic deformation are produced [12]. The SEM images of CMS-Na (No.…”

Section: The Ribbon Characteristicsmentioning

confidence: 99%

“…Osborne [70] and Omar [12] observed that the strength of the ribbon was dependent mainly on the hydraulic pressure. In this study, the relationship between the ribbon TS and the hydraulic pressure is described by a simple power equation as follows:…”

Section: The Power Modelmentioning

confidence: 99%

“…The ribbon surface of CMS-Na is rough, and the shape of the primary particles could be seen clearly. Due to the limited amount of breakage and deformation, the produced ribbons of CMS-Na are porous and are expected to be weaker than MCC and lactose [12]. The SEM images of two NPPs, i.e., Mume Fructus extracts (No.…”

Section: The Ribbon Characteristicsmentioning

confidence: 99%

“…Compared to wet granulation (WG), RC offers the advantages of avoidance of moisture and heat, as well as the decreased production time and operational cost by reducing manufacturing complexity [8][9][10][11]. The RC equipment consists of two counter rotation rollers, which apply high stress to the incoming powder to produce a compacted material, which is called a ribbon or flake [12]. The ribbons are then milled into granules for die compression or encapsulation [13][14][15].…”

Section: Introductionmentioning

confidence: 99%

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Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Zhang

et al. 2019

Pharmaceutics

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The purpose of this study is to use a material library to investigate the effect of raw material properties on ribbon tensile strength (TS) and solid fraction (SF) in the roll compaction (RC) process. A total of 81 pharmaceutical materials, including 53 excipients and 28 natural product powders (NPPs), were characterized by 22 material descriptors and were compacted under five different hydraulic pressures. The transversal and longitudinal splitting behaviors of the ribbons were summarized. The TS-porosity and TS-pressure relationships were used to explain the roll compaction behavior of powdered materials. Through defining the target ribbon quality (i.e., 0.6 ≤ SF ≤ 0.8 and TS ≥ 1 MPa), the roll compaction behavior classification system (RCBCS) was built and 81 materials were classified into three categories. A total of 24 excipients and five NPPs were classified as Category I materials, which fulfilled the target ribbon quality and had less occurrence of transversal splitting. Moreover, the multivariate relationships between raw material descriptors, the hydraulic pressure and ribbon quality attributes were obtained by PLS regression. Four density-related material descriptors and the cohesion index were identified as critical material attributes (CMAs). The multi-objective design space summarizing the feasible material properties and operational region for the RC process were visualized. The RCBCS presented in this paper enables a formulator to perform the initial risk assessment of any new materials, and the data modeling method helps to predict the impact of formulation ingredients on strength and porosity of compacts.

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Section: The Ribbon Characteristicsmentioning

confidence: 99%

Section: The Power Modelmentioning

confidence: 99%

Section: The Ribbon Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Zhang

et al. 2019

Pharmaceutics

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“…Omar et al [58] described the effect of the type and degree of amorphicity in three different lactoses on the properties of ribbon produced using roller compaction. Similarly, Al-Asady et al [59] investigated different materials (microcrystalline cellulose, hydroxypropyl methylcellulose, Maltodextrin, lactose, sodium carbonate, and calcium carbonate) for nanoindentation hardness produced via a granulation approach.…”

Section: Applications Via Hmementioning

confidence: 99%

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Maniruzzaman

Nokhodchi

2017

Drug Discovery Today

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A c c e p t e d M a n u s c r i p t Highlights  HME can be exploited in a broad range of applications for advanced drug delivery  Unique advantages to be utilised in a solvent free manufacturing platform  A means to explore the potential of continuous manufacture of pharmaceuticals  Scale-up issue considerations, from an FDA compliance point of view  HME regulatory guidelines for the manufacture of novel drug delivery systems Ali NokhodchiAli Nokhodchi is a professor of pharmaceutics and drug delivery at the University of Sussex. He has supervised over 120 Mpharm, PharmD, and MSc students and 15 PhD postgraduate students at several institutions in various fields of pharmaceutical formulations and drug delivery. He is an editorial board member of over 20 peer-reviewed international journals. Ali has published over 185 research articles in various fields of pharmaceutics, including tableting, particle engineering, inhalation, nanoparticles, dissolution, skin delivery, and controlled-release formulations. In addition, he has published five book chapters on skin, controlled-release formulations, particle engineering, and inhalation products. Ali has also been the editor of a book on pulmonary delivery published by Wiley in 2015. He has been the recipient of several prizes in pharmaceutical sciences and has been listed by Essential Science Indicators in the top 1% scientists in the field of pharmacology and toxicology.Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.

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Recent Progress in Roll Compaction Process Development for Pharmaceutical Solid Dosage Form Manufacture

Muliadi¹,

Banda²,

Chen³

2020

Continuous Pharmaceutical Processing

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Roller compaction: Effect of morphology and amorphous content of lactose powder on product quality

Cited by 27 publications

References 26 publications

Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Using a Material Library to Understand the Impacts of Raw Material Properties on Ribbon Quality in Roll Compaction

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Recent Progress in Roll Compaction Process Development for Pharmaceutical Solid Dosage Form Manufacture

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