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Navigating Wet Granulation in Tablet Manufacturing

Here we explain how comprehensive, process relevant characterization of wet granules can lead to control of tablet CQAs and assist Design Space definition in the manufacture of an OTC medicine.

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预测螺旋加料器中的流动性能 (Predicting Flow Performance in Screw Feeders)

准确、均匀地将材料送入反应系统、混合机和其它处理设备是维持最佳条件、匀速高质量生产的关键。

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制粒过程相关的粉体流动性测试

本手册我们将考察制粒工艺所面临的挑战，研究成功应用所需的分析方法，重点是粉体整体表征方法的价值。案例研究中的数据也验证了此表征方法的优势。

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Batch-to-Batch Comparison of Lactose

In this study, three milled lactose products from DFE Pharma: Pharmatose 200M EU, Pharmatose 200M NZ and Lactochem Fine Powder (LCFP), were evaluated and compared to three competitor products all intended for tabletting applications.

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Applications of the FT4 Powder Rheometer for Dry Powder Inhalers (DPI)

Identifying the properties of a powder or blend associated with optimised performance allows compatible formulations to be developed, without the significant financial and time implications associated with running samples through the process.

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粉体特性对加药性能的影响 (Influence of Powder Properties on Dosing Performance)

干粉吸入剂（DPI）通过患者吸入的方式向肺部深处递送控制剂量的药物活性成分（API）。乳糖作为常用的赋形剂，加载API细颗粒，从胶囊中吸出后API持续进入肺部。粗乳糖通常截留于喉部随后吞咽。在填充、加药和药物释放等过程中，乳糖的特性将影响DPI的性能。

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采用粉体流变学研发仿制粉雾剂 (Using Powder Characterisation to Develop Generic Dry Powder Inhalers)

DPI的表现性能将取决于粉体的性能，包括对气流的响应、渗透性、颗粒间机械咬合及摩擦。通过测量DPI制剂的流变性能，能够使得仿制产品的性能与品牌产品相匹配。

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Using Powder Characterisation to Develop Generic Dry Powder Inhalers

DPI performance will be dependent on several powder properties, including the response to air, permeability, inter-particular mechanical locking and friction. By measuring the rheological properties of DPI formulations, the properties of generic products can be matched to their branded counterparts.

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Manufacturing Support using the FT4 Powder Rheometer

By measuring and understanding powder behaviour, these challenges can be overcome, and effective decisions on changing raw materials or production methods can be made.

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应用FT4 粉体流变仪多功能粉末性质测试仪及GEA ConsiGma双螺杆高剪切造粒机，通过QbD方法实现连续式片剂生产

将本研究拓展到片剂生产后，发现制粒的性质与片剂的关键质量属性之间亦存在明显的对应关系。这种对应关系正是真正的质量源于设计（QbD）方法所需要的信息。

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松装辅料中无关粒径的差异应用笔记 (Particle Size-Independent Variation of Bulk Excipients)

微晶纤维素 (MCC) 来源丰富，易于生产，不易降解，多年来一直被用作药用辅料。但与其它辅料一样，不同材料批次之间的差异也将导致加工时出现类似的差异，最终致使产品与技术规范不符，需要返工，甚至报废。最新的质量源于设计 (QbD) 举措对优化生产工艺提出了要求，以确保最终产品的一致性和可靠性。

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胶囊填充 (Capsule Filling)

在制药行业中，将少量药物活性成分 (API) 与辅料混合，经过各种单元操作完成后续加工—这是诸多生产过程的关键部分。 混合物在下游过程中的行为随混合物不同成分的属性而变化。

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Ein QbD-Ansatz fuer die kontinuierliche Tablettenherstellung - mit dem FT4-Pulver-Rheometer und dem GEA ConsiGma Doppelschnecken-Schnellmischgranulierer

Die Studie wurde anschließend auf die Tablettenherstellung ausgeweitet, wo Korrelationen zwischen den Granulateigenschaften und den kritischen Qualitätsmerkmalen der Tabletten identifiziert wurden, die die für eine echte Quality by Design (QbD) erforderlichen Informationen liefern.

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QbDアプローチ ‒ GEA ConsiGma Twin Screw High Shear Granulatorでの連続錠剤生産におけるパウダーレオメータ FT4による粉体流動性の評価 (A QbD approach to Continuous Tablet Manufacture)

本研究ではフリーマンテクノロジー 社とGEA 社が共同で、粉末設計と連続生産におけるプロセスパラメータの変更が顆粒特性に与える影響を調査しました。

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粉体特性が投薬パフォーマンスに与える影響 (Influence of Powder Properties on Dosing Performance)

1種類の粉体や混合物を均一に充填できるような特性とは何かを明らかにすれば、膨大な金銭的および時間的コストをかけてサンプルをプロセス全体に投入することなく、最適化された新しい配合組成を特定することができます。これにより、含有量における均一性の低下や重量におけるばらつきの増大を抑えることができます。

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粒径に関係しないバルク賦形剤のばらつき (Particle Size Independent Variation of Bulk Excipients)

結晶セルロース(MCC)は豊富で生産しやすく、かつ耐劣化性に優れていることから、製薬用賦形剤として長年使用されてきました。ただし、あらゆる賦形剤と同様に、供給される大量の材料にばらつきがあると製造工程にも同様にばらつきが生まれ、結果的に規格外の製品が生産されることになります。

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ローラーコンパクターのプロセスにおける顆粒特性への影響 (The Influence of Roller Compactor Process Parameters on Granule Properties)

本アプリケーションノートはフリーマンテクノロジーTM 社（FT）とGerteis Maschinen+Processengineering 社（GMP）の共同研究でどのようなプロセスパラメータがプラセボによる乾式造粒に影響を与えるのか調査した。

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カプセル充填 (Capsule Filling)

良い性能を得ることができ、設計上の検討余地を与える。また物性を特定することは品質の高い製品を作ることになる。これらは生産性を高め、廃棄を減らす意味ではビジネス上の重要な要素となる。

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Influence of Powder Properties on Dosing Performance

In this study five lactose powders, with varying particle size distributions, were run through a dosator using four different size outlets.

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The Influence of Roller Compaction Process Variables on Granule Properties

This application note details the joint study undertaken by Freeman Technology and Gerteis Maschinen+Processengineering, to investigate how process parameters influenced the properties of the dry granulate of a placebo formulation.

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Particle Size Independent Variation of Bulk Excipients

A robust method of quantifying the variations in batches of excipients that contribute to differences in downstream process behaviour enables a design space of acceptable raw material properties to be established.

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A QbD Approach to Continuous Tablet Manufacture

This study summarises initial work between Freeman Technology and GEA which has explored the relationship between granule properties and variation in forumulation and processing parameters in a continuous manufacturing environment.

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Capsule Filling

In the pharmaceutical industry, the blending of a small fraction of active pharmaceutical ingredient (API) with a bulk excipient, and then subsequent processing though various unit operations, is an essential part of many manufacturing processes. The way that the blend behaves in downstream processes will be a function of the properties of the components of that blend.

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Using the FT4 Powder Rheometer to Characterise DPI Formulations and to Understanding Dosing and Aerosolisation Performance

Developing powders that exhibit predictable and reliable behaviour in an inhalation process presents a genuine challenge for formulation scientists. Active ingredients tend to be highly cohesive and rarely flow freely making both dosing and dispersion problematic. Addressing these issues requires an understanding of the mechanisms that contribute to successful drug delivery along with the ability to quantify the relevant properties.

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Filling of Powders for Dry Powder Inhalation Using a Vacuum Drum Filler

This study investigates the influence of powder properties on the filling behavior of a vacuum drum filler for DPI application.

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A Investigation into the Effects of Formulation, Vessel Scale and Method of Water Addition on Batch Granulation

It has been demonstrated that there is a link between the quality of a wet mass/dry granulate (as measured by certain flow properties) to critical quality attributes of the resultant tablet. This study extends this work by identifying and quantifying the flow properties of granulation wet masses in relation to their batch manufacture using different vessel scales, formulations and water addition methods.

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Testing for Tableting

Powder testing has progressed significantly since the turn of the millennium, delivering major benefits in tableting applications. At a time when greater efficiency is required, and continuous manufacturing is becoming commonplace, process-relevant powder characterisation is gaining importance.

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Powder Rheology as a Tool to Determine Optimum Blending Time

Powder Rheology can be utilized to characterize powder behavior and provide data on key properties such as compressibility, permeability, and basic flow energy. Uniformity of extra granular actives in a final blend comprised of a dry granulation is critical and is achieved by milling the active with excipients and/or mixing for extended periods. The purpose of this study is to understand the application of powder rheometry as a tool to predict the optimum blending time leading to uniform tablets. Presented at AAPS 2012.

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PAT In-Depth Focus - Correlation between Powder Rheology Data and Processability in Solid Dosage Form Manufacturing

The Quality by Design (QbD) paradigm is being introduced to more and more R&D and manufacturing units in the pharmaceutical industry. This article will show some preliminary results from powder characterisation and how the data correlates to process performance and drug product quality in solid dosage form development projects.

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The Next Wave of PAT: Advancing Process Understanding to Process Control

This article aims to discuss process control and implementation in pharmaceutical development and manufacturing. It will also convey the importance of PAT in pharma and help encourage and spur ongoing efforts on development, implementation, and disclosure of process control to enable FDA’s vision of PAT.

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The Flowability of Wet & Dry Powders

This paper looks at why powder characterisation is important, and that whilst powders are used so extensively throughout the pharmaceutical industry, they are amongst the most difficult materials to characterise.

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Optimising Tabletting Processes with Quality by Design

We all know the importance of particle size distribution when it comes to processing the perfect tablet, but there are also many other factors that must be considered. Authors from Freeman Technology and Malvern Instruments step forward to give you their insight on enhancing tabletting with quality by design and analytical techniques.

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The Attraction And Challenge Of Continuous Manufacturing

This article looks at the potential benefits of continuous manufacturing, highlights the way analytical practice may need to change to support new manufacturing models, and discusses the need for techniques, including dynamic powder testing, that support intelligent processing.

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The Impact of Loaded Drug Dose and the Surface Roughness of the Coarse Lactose Carrier to the Fluidisation Characteristics of Dry Powder Inhaler Formulations

This study shows how to develop a method for measuring the pressure drop across the powder bed during fluidisation experiments with DPI formulations. Presented at Powder Flow 2011.

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Powder Rheology Analysis as Tool for the Characterisation of Interactive Powder Mixtures

In this study powder rheology analysis has been used to characterise interactive inhalation powder mixtures. With the diverse techniques provided by the Freeman FT4 Powder Rheometer, especially the possibility of collecting data during air entrainment, it was expected to gain a better understanding of interactions within the powder blends. It was of particular interest to investigate how the measured forces are affected by the induction of air through the powder and how this data can be correlated to the results of other dispersion measurements. Presented at DDL 2011.

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Powder Rheology as a Tool to Predict Impact of Different Sources of Excipient on Tablet Compression

Powder rheology is utilized to characterize powder behavior and provide data on key properties such as compressibility, permeability, and basic flow energy. Excipients in a tablet formulation could strongly influence process scaleup, optimization, blend, and compression properties. Switching sources of excipients could profoundly impact processing. The impetus for this work is to evaluate if powder rheometry can be used as a tool to predict the impact of using an alternate source of raw material on compression characteristics of tablets. Presented at AAPS 2011.

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Measuring Meaningful Powder Flow Properties – the Limitations of ‘Compressibility Index’ Data

The Compressibility Index (the relationship between a poured bulk density and tapped bulk density), developed by Carr, is still widely used within the pharmaceutical industry as the main, and often only, measure of powder flowability. This comparison of the powder’s poured and tapped densities, although a pragmatic solution for its day, can be too simplistic and not sufficiently sensitive to describe the changes that can occur within the powder bed. It therefore also has the potential to provide misleading information.

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The Application of QbD to Pharmaceutical Powder Processing

In order to better understand the relationship between powder properties and in-process behaviour, modern instrumental methods – such as powder rheometry and shear cell testing – have been employed to provide data on powder behaviour over a wide range of stress conditions. This poster gives an example of how powder characteristics and processing environments can be evaluated to generate the ‘Design Space’ necessary for the implementation of Quality by Design. Presented at UK PharmSci 2010.

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The Influence of Powder Flow Properties on the Filling of Dies and Capsules

This paper describes an approach to evaluating the suitability of powder properties based on Process Analytical Technology and Quality by Design principles. A model die filling rig, a real pocket dosing machine and a dosing disc type capsule filling machine are investigated respectively. The results clearly show how die filling effectiveness, as characterised by powder filling ratio, filling weight uniformity and plug ejection force, is dependant on a range of powder flow characteristics, with respect to individual machine and machine geometry.

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Capsule Filling Performance of Powdered Formulations in Relation to Flow Characteristics

This study examines the ejection force and the dosing weight variation during a capsule filling process for twelve different formulations and shows how the results correlate with the powder characteristics obtained using a Powder Rheometer.

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The Characterisation of Powder Properties in the Pharmaceutical Industry - The Implications of QBD for Solids Dose Manufacture

This paper illustrates how recent advances in powder characterisation allow process engineers to predict material behaviour during processing and how best to configure equipment settings for optimal powder / process / delivery system compatability with respect to tableting and inhalation systems. Furthermore, it also demonstrates how this information can then be fed back in at the development stage to provide processability specifications which generate true 'Quality by Design'.

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Powder Characterisation for Efficient Processing: Moving to a New Manufacturing Model

As the pharmaceutical industry works to transform manufacturing practice, it is timely to examine the role of supporting technologies. One such technology is powder testing, which holds the key to more efficient powder processing.

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Powder Characterisation for Inhaled Drug Delivery

Manipulating and controlling powder behaviour is a demanding but essential element of pharmaceutical manufacturing. The development and production of dry powder inhalers (DPIs) exemplifies and highlights the difficulties faced, arguably presenting the industry with its toughest powder engineering challenge. Fine by necessity, to ensure deposition in the lung, dry powder formulations tend to be highly cohesive and difficult to handle. The need to understand the aerosolisation processes that ensure successful drug delivery adds an additional and substantial layer of complexity.

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Effective Powder Processing Across the Pharma Life Cycle

Learn how using strategies for effective process development ensures manufacturing experience and expertise are appropriately applied at every stage of the product life cycle. Robust powder processes help support these goals. The application of powder rheology encourages a two-way dialogue between manufacturers and formulators.

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The Relationship Between Powder Flow Properties and Dosing Machine Geometry for Pharmaceutical Die Filling Applications

Filling machines have complex geometry through which powder has to flow and a significant requirement for filling processes when manufacturing pharmaceutical solid doses is to ensure weight uniformity. The characteristics of powdered formulations considerably affect their behaviour in filling processes and hence affect the ability to generate consistent filling masses. The results in this study have shown that the powder flow characteristics have to be compatible with the conditions imposed in the process and equipment geometry in order to achieve the target weight uniformity.

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Novel Applications of Traditional Lubricants Using a Dry Particle Coating Technique to Improve the Functionality of Cohesive Drug or Excipient Powders

Powder bulk functionalities such as flow, fluidization and aerosolization are fundamental to the handling and performance of many pharmaceutical products. This study investigated the ffect of surface engineering via mechanical dry coating with a traditional lubricant on the bulk functionailities of either a milled cohesive excipient powder or micronized drug powders.

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To Develop and Evaluate New Methodology for Excipients Compatibility Together with API’s using Rheology

Most of the Drug Dosage Forms are made from solid powder state (Tablets & Capsules) the flow of which can result in variability in dosage unit and production.The aim of this study is to give better understanding of the flow energies related to powder with the addition of different API's at different concentration levels. Presented at AAPS 2010.

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Powder Testing Techniques for Quality by Design (QbD)

Quality by Design demands the detailed consideration of processing issues during the earlier stages of development. This poses the question of how best to inject the necessary expertise from the outset. Analytical tools, such as modern powder testers, that ease communication across the traditional formulation/process development/production boundaries can help.

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Ask the Expert: Why is Effective Powder Characterisation so Important for the Pharmaceutical Industry?

Effective powder characterisation can lead to better powder understanding and control, which is crucial in the pharmaceutical industry where the majority of APIs are delivered as powders. Tim Freeman explains why powder characterisation is not always an easy task and offers advice on how best to obtain rich data sets that can be used to predict powder behaviour in different situations.

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Measuring Powder Properties

Characterization of DPI formulations using a powder rheometer helps developers understand volumetric dosing and aerosolization performance.

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Powder Testing for Better Formulation

Almost all pharmaceutical products exist in powder form at some point on their way to finished product, so an understanding of powder behaviour is critical to the development of an optimal formulation. Effective powder characterisation is one of the foundations of formulation. As the demands on formulators increase, there is a growing need for more efficient, information-rich testing strategies that can support a knowledge-led approach with the necessary manufacturing focus. Instruments that combine shear, bulk and dynamic test methods are one solution. Such systems are cost- and time-efficient, and quantify powder behaviour using a number of complementary parameters that in combination maximise insight. The resulting information accelerates formulation towards optimised and efficient long-term manufacture.

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Understanding Powder Behaviour

The pharmaceutical industry relies on analytical technologies for many testing and monitoring purposes, including formulation analysis, quality control and the identification of counterfeit products. Manufacturers of modern powder testing equipment, such as the FT4 Powder Rheometer, have extended their application and added new, dynamic methodologies, bringing into one system a set of complementary techniques that together are able to better reflect a powder’s response to processing conditions.

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Characterising Powders for Better Solids Processing

The pharmaceutical industry is moving towards greater emphasis on efficient manufacture. The foundations for successful manufacture must be laid during the early stages of product development. This analysis illustrates how considering processing from the start can eliminate the root cause of long-term manufacturing problems. It also serves to highlight the way precise powder characterization leads to understanding that informs every stage of the product life cycle.

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The Characterisation of the Physical Properties of Wet Masses

For this work, a grade of lactose (food grade, Dairy Crest) and a microcrystalline cellulose (PH101, FMC) were used to create four mixtures - 0:100, 50:50, 70:30 and 85:15 Lactose:MCC. The mixtures were then granluated using a range of moisture contents by means of a fixed processing methodology in terms of low shear mix time, water addition rate and high shear granulation time. The properties of the resultant wet masses were then immediately evaluated using some of the methodologies available with the FT4 Powder Rheometer (universal powder tester) - dynamic testing, permeability, compressibility and shear testing. Presented at WCPT6 2010.

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Enhancing Dose Consistency

Selecting the best construction material is an important element of plant design. For powder handling applications, choosing a surface finish that promotes smooth, controlled flow through the process is key to trouble-free production and will enhance operability over the long term. In this article, Tim Freeman, Freeman Technology, and Dr Karlheinz Seyfang, Harro Höfliger, look at technology helping to get it right.

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Choosing the Best Construction Material for Powder Processing Equipment

Selecting the best material of construction is a crucial part of the plant design process, the aim being to balance performance and cost to best advantage. For powder processors, choosing a material that eases flow can pay dividends throughout the lifetime of the plant, but there is limited data on which to base this decision. A study by Freeman Technology highlights the role of the FT4 Powder Rheometer, a universal powder tester, for such studies and provides some valuable comparative data for a wide range of commercially available materials and finishes.

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Measuring Powder Behaviour in Relation to QbD

Characterising and understanding powder flowability is critical, particularly in relation to the pharmaceutical industry’s Quality by Design (QbD) and PAT initiatives. Correlating processability ranking with measured flow properties enables the identification of acceptable process behaviour for each of these parameters, thus defining the design space.

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Implementing QbD: Powder Characterization for Design Space Definition

For those seeking to adopt a Quality by Design approach to pharmaceutical development and manufacture, effective definition of the ‘design space’ is a key activity. This paper considers the role of modern powder testers such as the FT4 Powder Rheometer from Freeman Technology, within this context.

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An Investigation into the Wall Friction Angle of a Range of Low Friction Materials Used in the Manufacture of Pharmaceutical Processing Equipment

Using the FT4 Powder Rheometer this study evaluated a total of 15 coupons, with different wall material, surface roughness and surface treatment, in conjunction with a common pharmaceutical excipient, Respitose ML001. The geometry of a mass flow hopper was calculated using the Hopper Design Software supplied with the FT4.

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The Effect of Fluid-Bed Granulation Process on the Physical and Mechanical Properties of Powders and Granules

The objectives were to compare and characterize the physical and mechanical properties of powders and granules after the fluid-bed granulation process. To investigate and identify the critical process parameters (CPPs) for fluid-bed granulation.By understanding the granulation process and the interactions between the process variables, both process efficiency and critical quality can be achieved in ensuring consistency of granule flowability, tabletability and product bioavailability.

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Determining Endpoint for Wet Granulation Using Rheological and Effusivity Measurement

Though wet granulation is a common unit operation its accurate end-point determination still remains a challenge in pharmaceutical industry.The objective of this study was to determine wet granulation endpoint using microcrystalline cellulose (Avicel 101) by solid state rheological and effusivity measurements. It was determined that powder rheology, using the FT4 Powder Rheometer, measurements are a useful tool to determine the end point in wet granulation. Presented at AAPS 2009.

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Flow and Compaction Characteristics of A Direct Compression Formulation

The flow properties of blends, a very important factor of tableting process, affects the characteristics of powder transfer and die filling consistency, hence, the quality of the final products. In this study, a model formulation containing Titanium Dioxide, as a simulated water insoluble API was used to evaluate the effect of common pharmaceutical glidants on the flow characteristics. Presented at AAPS 2009.

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Flow and Compaction Characteristics of A Direct Compression Formulation (2)

Direct compression is one of the major process technologies for tablet manufacture in industry. It shows advantages compared to other processes including labor and cost saving, fewer manufacturing steps, and greater suitability for moisture sensitive API, etc. In this process, the flow properties and compaction properties of dry blends affect the final quality of compressed tablets, such as hardness and weight variation, etc. So, the characterization of these properties are critical in tableting process development. In this study, a 3x2 DOE was used to study the effect of excipients on the compaction properties (Yield Pressure) and flow properties of the blends. Presented at AAPS 2009.

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To Measure the Additive Effect of Magnesium Stearate and Stear-O-Wet on Wet Granulation

The purpose of this study was to determine the effects of magnesium stearate and stear-o-wet on wet granulation while adding lubricants during wet granulation and measuring their rheological and thermal properties. The FT4 Powder Rheometer was used to measure compressibility, basic flowability energy (BFE), specific flow energy (SFE), bulk density and permeability (measured as pressure drop).

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Characterisation of the Flow Properties of a Novel Spray Dried Tobramycin Powder For Dry Powder Inhalation (DPI)

In this study, the FT4 Powder Rheometer was used to characterize a novel spray dried powder of tobramycin developed for dry powder inhalation, in particular with respect to evaluation of the powder flow behaviour under moderate/low stress conditions.

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Better Wet Granulation: Development, Scale-up and Manufacture

Wet granulation is a common unit operation in the pharmaceutical industry yet accurate endpoint detection remains a challenge. Here we examine the contribution that dynamic powder testing can make, highlighting its ability to detect the transition from wet mass to granulate with the required sensitivity. Quantification of this transition point, with a measure that is independent of process scale, accelerates development and scale-up and improves manufacture.

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Dynamic Powder Characterization for Dry Powder Inhalers (DPI) Formulation

In this discussion, we consider the way powders behave in DPIs and examine the dynamic and bulk powder properties that help to explain the mechanisms that dominate performance. Experimental studies illustrate the impact of blending on the in situ formation of fines and the effect this has on powder properties and aerosolization characteristics.

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A Critical Evaluation of Two Commercial Shear Cell Instruments for Determining the Flow Properties of Powders

In this study, the performance of two commercial rotational shear cell instruments is compared with respect to cell geometry and test procedure. Presented at AAPS 2008.

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Development of a Material Sparing Method to Determine Powder Permeability to Air

A study to develop a material sparing method to detemine the air permeability of powders as a function of consolidation load. To better understand relationships between permeability and powder properties and flowability.

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Evaluating the Impact of Particle Size Reduction Techniques on the Powder Properties of Pharmaceutical Solids

The objective of this study was to evaluate the impact of different particle size reduction techniques on the particle characteristics and powder flow properties.

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Evaluation of Stear-O-Wet as a Lubricant for Making Tablets

The objective of this study was to determine the effects of Stear-O-Wet on powder flow, tableting process parameters, tablet wetting characteristics, and tablet quality and comparing the results with a mixture of MgSt/SLS (94/6, w/w) for a model powder blend consisting of acetaminophen, microcrystalline cellulose, and spray dried lactose. Presented at AAPS 2008.

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Effects of Lubricants at Different Operating Speeds in the Tableting Process on Quality of Tablets Containing High-loading of Acetaminophen

The objective was to evaluate the effects of magnesium stearate mono hydrate (MgSt-M) and magnesium stearate dihydrate (MgSt-D) at two operating speeds in the tableting process on the quality of tablets containing a high-dose of direct compressible acetaminophen (CompapTM L). Presented at AAPS 2008.

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Evaluation of Lubricants for Making Tablets Containing High-loading of Acetaminophen

The objective of this study was to evaluate five lubricants - Magnesium Stearate Monohydrate (MgST-M), Magnesium Stearate Dihydrate (MgST-D), Stear-O-Wet M (SOW), Sodium Lauryl Sulfate (SLS) and Sodium Stearyl Fumarate (SSF) on powder flow characteristics and tableting process parameters parameters for making 450mg flat round tablets containing a high loading of direct compressible acetaminophen (APAP), COMPAP L. Presented at AAPS 2018.

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Characterisation and Functionality of Anhydrous Inhalation Lactose

The aim of this study was to characterise the physiochemical properties of several different grades of inhaltion lactose to further understand the relationships between lactose functionaility and DPI formulation performance, with particular pmphasis on a new commercial inhalation grade of anhydrous lactose. Presented at DDL Edinburgh 2008

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Developing Powder Processing Expertise for the Implementation of Quality by Design

Powder characterization techniques have improved significantly in recent decades, developing well beyond the simplistic methods traditionally used. This paper examines the changes in approach encouraged by QbD and the contribution modern powder testers can make.

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Fine Tuning Dry Powder Inhaler (DPI) Formulas

Various researchers have found that the inclusion of excipient fines in a formulation enhances Dry Powder Inhaler drug delivery. With a DPI, delivery of the defined dose to the lung, relies on control of the aerosolisation proess initiated by the inhaling patient. Here, the impact of fines on powder properties is explored with reference to the effect this has on behaviour within the DPI.

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Formulation Optimization For Tableting Applications

Tablet production is an essential operation for the pharmaceutical industry. Developing formulations that process well in these units to consistently deliver uniform tablets with the required properties, remains an ongoing challenge. This article looks at how dynamic powder testing can optimise this process.

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Volumetric Dosing Efficiency in Relation to the Bulk, Flow and Shear Properties of Powders

This study examines the efficiency of volumetric dosing for a number of different powders and shows how the results correlate with the powder properties measured using the FT4 Powder Rheometer. Presented at Partec 2007.

Pharmaceutical
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Understanding Powder Behaviour by Measuring Bulk, Flow and Shear Properties

A review of pharmaceutical processing and the relevance of powder flow properties in relation to four types of lactose varying from finely milled to spray dried.

Pharmaceutical
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Characterizing Powders for Optimized Pharmaceutical Processing

A review of powder characterisation and some of the ways in which manufacturers can use the data produced to cost effectively increase the efficiency of production processes and more closely control product quality.

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