1. Solid Dosage Form Manufacturing

Published in European Pharmaceutical Review - October 2012

Erik Skibsted, Principal Scientist -Novo Nordisk

The Quality by Design (QbD) paradigm is being introduced to more and more R&D and manufacturing units in the pharmaceutical industry.

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2. The Attraction And Challenge Of Continuous Manufacturing

Published in Pharmaceutical Online Magazine - Spring 2012

Jamie Clayton, Operations Manager - Freeman Technology

Moves toward greater processing efficiency and continuous manufacturing are intertwined. The practices associated with quality by design (QbD) and defining the design space are being applied to bring knowledge-led practice to batch process development.

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3. Controlling the impact of humidity

Published in Process Industry Informer - September 2012

Tim Freeman, Managing Director, Brian Armstrong, Powder Technologist, Jamie Clayton, Operations Manager - Freeman Technology

The properties of dry and damp powders can be as dissimilar as those of chalk and cheese. The uptake of even small amounts of moisture can transform powder properties, making humidity and its impact a critical issue for powder processors.

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

Published in AAPS News Magazine - September 2012

Tim Freeman, Freeman Technology, Zhenqi Shi Lilly and David E Reed, Research Laboratory, George L Read Pfizer, Worldwide Research & Development

The Food and Drug Administration (FDA) issued the Process Analytical Technology (PAT) guidance in September 2004,1 which stated, “PAT is defined as a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” Per FDA’s definition, PAT is composed of three components: designing, analyzing, and controlling.

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5. Optimising Tabletting Processes with Quality by Design

Published in Pharmaceutical Technology Europe Digital - May 2012

Tim Freeman, Managing Director Freeman Technology & Carl Levoguer, Product Marketing Manager (Laser, Particle Sizing and Imaging), Malvern Instruments

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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6. Dynamic Testing Methods Pinpoint Parameters Suitable for Further Insight into In-process Powder Behavior

Published in Processing Magazine - April 2012

Jamie Clayton, Freeman Technology & Michael Mayer, AZO GmbH + Co. KG.

Use of a Powder Rheometer has enhanced powder-testing capabilities at the research center of AZO GmbH + Co. KG, Osterburken, Germany. Gains include not only dynamic powder testing, but also fully automated shear- and bulk-property measurement.

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7. The Attraction and Challenge of Continuous Manufacture

Published in Pharmaceutical Online - May 2012

Jamie Clayton, Freeman Technology.

Across the pharmaceutical industry, continuous manufacturing is seen to have valuable benefits. Global efforts are transforming the efficiency of the pharmaceutical industry, with continuous manufacturing viewed as a strategy for success.

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8. Effective Powder Processing Across The Pharma Life Cycle

Published in Pharmaceutical Online - Spring 2011

Tim Freeman, Freeman Technology.

The key to success in any market is finding the right balance between performance and cost. When dealing with commodity products, brand differentiation tends to be low, with cost arguments dominating and forcing lean, highly efficient manufacturing. In more specialized areas, including pharmaceuticals, profit is often derived from unique patented performance that commands a premium price, well above the cost of production. Historically, this position has shielded pharmaceutical manufacturers from many of the rigors faced by, for example, bulk chemical producers, where the legacy is relatively inefficient production. In the prevailing economic and regulatory climate this is rapidly becoming unsustainable and significant pharmaceutical industry resources are being pushed towards process understanding and establishing better manufacturing practices.

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

Published in Innovations in Pharmaceutical Technology - June 2011

Tim Freeman, Freeman Technology.

The pharmaceutical industry is currently focusing significant resources into the area of process development and design. An aspiration is to emulate, at least to some extent, the manufacturing gains already achieved in other sectors where efficiencies as high as 99 per cent are already a daily reality. For manufacturers the cost base is a key driver, but the regulatory perspective brings other benefits into focus. Fully defined, well-understood products, manufactured in efficiently monitored, closely controlled processes present a relatively low risk. For those who can demonstrate such practice there is the potential for a lighter regulatory touch, to complement financial gains.

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10. Modern Pharmaceuticals interview: Tim Freeman discusses the importance of efficient powder processing, and how the FT4 can help solve challenges in formulation and product development

Published in Modern Pharmaceuticals - April 2011

Chandreyee Bhaumik & Tim Freeman, Freeman Technology.

Efficient powder processing is essential for the production of many different materials including foodstuffs, cosmetics, metal powders, minerals and, of course, pharmaceutical formulations. However, when compared with handling liquids and gases, the less predictable nature of powder behaviour complicates formulation, plant design and day-to-day operation alike. This makes the development and production of quality products challenging. During the past 10 years Freeman Technology has worked with powder processors from all areas of industry and academia in order to understand the difficulties that they face. In this interview, Tim Freeman discusses Freeman Technology’s approach to characterising powders, and the unique benefits the FT4 Powder Rheometer provides in measuring process-relevant powder behaviour.

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11. 10 years in powders. Making powders and processes fit

Published in Processing Magazine - March 2011

Tim Freeman, Director of Operations at Freeman Technology

The last decade has been a pivotal one for powder testing. Leaving behind the simplistic idea of trying to define the complexities of powders with just a single number, developers of powder testing instrumentation have combined powerful complementary techniques to bring to industry the toolkit it needs to tackle the considerable challenges of solids processing. Key to the development of new methodologies has been the recognition that they must reflect the environment to which a powder is subject within manufacturing processes.

Significant efforts have been made to understand how the powder properties measured by modern universal powder testers relate to in-process behavior. This ‘work in progress’ holds the key to a better powder processing future across all industry sectors.With reproducible, relevant powder characterization now a reality, there is an opportunity to understand how to formulate and tailor powder blends, and select and design process equipment, that have the compatibility necessary for long-term, efficient manufacturing.

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12. Powder testing techniques for QbD

Published in International Labmate - September 2010

Quality by Design, the new way of working enshrined in guidance from the FDA, raises the profile of pharmaceutical manufacturing and process development. More specifically it 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 that ease communication across the traditional formulation/process development/production boundaries can help.

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13. Powder Testing for Better Formulation

Published in Innovations in Pharmaceutical Technology - Issue Number 34 - October 2010

Almost all pharma 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.

The prevailing commercial and regulatory environment exerts apparently conflicting demands on the pharmaceutical formulator. Cutting time to market in order to realise a return more rapidly demands the acceleration of product development. However, there is an increasing emphasis on getting the manufacturing process right from the outset. As the seeds of reliable and successful manufacture are sown during formulation - the concept of Quality by Design - this broadens the scope of information gathering at the earlier stages of a project. Formulators need to understand how their decisions affect ease of manufacture in order to develop products that are not only clinically efficacious but can also be routinely and reliably manufactured to the necessary standard.

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14. Pharmaceutical Technology Europe - Analytical techniques today and tomorrow

Published in Pharmaceutical Technology Europe - May 2010

The pharmaceutical industry relies on analytical technologies for many testing and monitoring purposes, including formulation analysis, quality control and the identification of counterfeit products. The use of analytical instrumentation has also increased with the FDA’s PAT initiative and a growing emphasis on Quality by Design.

Given the wide range of applications for analytical instruments in the pharmaceutical industry, Pharmaceutical Technology Europe has dedicated both this month’s special feature and the May issue of PTE Digital to analytical technologies. We spoke with experts to identify the main challenges facing analytical scientists and what future advances are waiting on the horizon. Experts discuss the innovations and hurdles in bioanalysis, powder testing and NIR chemical imaging, as well as dissolution testing and the opportunities for improving sample preparation techniques.

Topics covered:

Bioanalysis: hurdles and hopes

Patrick Bennett, Strategic Marketing Director, Pharma, Thermo Fisher Scientific

Innovations in dissolution testing

Tony Copley, Managing Director, Copley Scientific

When and why should the pharmaceutical industry use NIR chemical imaging?

Janie Dubois, PhD, Product Manager Analytical Imaging in the Americas at Malvern Instruments

Understanding powder behaviour

Tim Freeman, Director of Operations at Freeman Technology

Industry must improve sample preparation techniques

Rob Darrington, Marketing & Business Development Manager at Genevac

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15. Ask the Expert: Why is effective powder characterisation so important for the pharmaceutical industry?

Published in Pharmaceutical Technology Europe - June 2010 - Title: The importance of powder characterisation

Effective powder characterisation can lead to better powder understanding and control, which is crucial in the pharma 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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16. Measuring powder properties

Published in Inhalation Magazine - June 2010

Achieving consistent behavior of powders for inhalation, especially during dosing and aerosolization, presents a unique engineering challenge for the pharmaceutical industry, in part because the industry lacks a thorough understanding of the mechanisms that underpin successful drug delivery. Methods such as angle of repose, Hausner ratio, and Carr’s Index all provide some insight into the behavior of micronized pharmaceutical powders but have limitations in their reproducibility, sensitivity, and ability to capture diverse aspects of behavior, especially with respect to characterizing the response of a formulation to air.

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17. Characterising Powders for Better Solids Processing

Published in Pharma Magazine - May 2010

The pharmaceutical industry is moving towards greater emphasis on efficient manufacture. In simple terms, the regulators aim to reduce risk by encouraging developers to design product quality into the manufacturing process from the outset (ICH Q8, Q9 and Q10 - Quality by Design). For producers, this approach also addresses tough industry challenges, such as waste, time-to-market and capital utilization. It is clear, however, that the foundations for successful manufacture must be laid during the early stages of product development

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18. Enhancing dose consistency

Published in Manufacturing Chemist - March 2010

The right material and surface finish on filling equipment can be key to consistent capsule filling. Tim Freeman, Freeman Technology, and Dr Karlheinz Seyfang, Harro Höfliger, look at technology helping to get it right.

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19. Optimizing Ceramic Powder Specification

Published in Ceramic Industry magazine - December 2009

Powder characterization that is both reliable and relevant to the process makes it easier to develop a blend or granulate suitable for ceramic powder processing applications.

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20. Measuring powder behaviour in relation to QbD

Published in European Process Engineer - November 2009

Characterising and understanding a powder’s flowability is critical, particularly in relation to the pharmaceutical industry’s Quality by Design (QbD) and PAT initiatives.

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21. Dynamic powder characterization for DPI formulation

Published in Drug Delivery Technology - May 2009

Tim Freeman, Director of Operations, Freeman Technology Limited & Dr Robert Price, Pharmaceutical Surface Science Group

Formulating pharmaceutical blends for dry powder inhalers (DPI) is challenging, even for an industry with well-established powder processing skills. For a DPI, the active pharmaceutical ingredient (API) is usually a fine cohesive powder, which is then blended with a coarser carrier excipient to improve flow properties. During inhalation, the API is stripped from the surface of the carrier and delivered to the lungs, leaving the excipient to be ingested. With a passive DPI, the motive force for this aerosolization/elutriation process is provided by the patient, with inhalation activating the device.

The inclusion of excipient fines in the blend has been shown to improve drug delivery, a finding that has been explained by a number of hypotheses. 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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22. Quantifying experience in powder processing

Published in Pharmaceutical Technology Europe - March 2009

Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.

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23. Process relevant powder characterization - a powerful tool for development and troubleshooting

Published in Pharmaceutical Online Magazine - Spring 2009

This article examines modern strategies for powder characterization in the pharmaceutical industry, with reference to commonly used technologies. It explores the value of systems that offer multiple methodologies in a single instrument, examining the way they provide a cost- and time- effective route to generating data that support product development and process operation.

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24. Fine tuning DPI formulas

Published in Manufacturing Chemist - June 2008

Various researchers have found that the inclusion of excipient fines in a formulation enhances Dry Powder Inhaler drug delivery. Jagdeep Shur and Robert Price from the University of Bath and Tim Freeman of Freeman Technology believe they can explain the reasons why.

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25. Formulation Optimization For Tableting Applications

Published in Pharmaceutical Solutions Update - November 2007

Tablet production is an essential operation for the pharmaceutical industry, considering the majority of drugs are being delivered in this form. Tablet presses operating on the principle of direct compression have been developed over several decades and it is now possible to make in excess of one million tablets per hour. Developing formulations that process well in these units to consistently deliver uniform tablets with the required properties, remains an ongoing challenge.

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26. Powder Testing for QC Applications

Published in Powder Handling & Processing - Vol.19,01 2007

QC is a vital part of any manufacturing process. Verifying the properties and consistency of both feed materials and products is critical in ensuring efficient process operation and customer satisfaction.

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27. Going with the Flow

Published in Polymers Paint Colour Journal (PPCJ) - October 2006

Powder Coatings - the importance of specifying, monitoring and controlling powder flow properties.

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28. Understanding Powder behaviour by measuring Bulk, Flow and Shear Properties

Published in Pharmaceutical Technology Europe - September 2006

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

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29. Testing Powders in Process Relevant Ways

Published in Powder Handling & Processing - Vol. 18, No 1, March/April 2006

A review of some everyday processing issues and how knowledge of key powder properties can be correlated with processing experience to improve productivity and product quality.

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30. The Importance of Air Content on the Rheology of Powders: An Empirical Study

Published in American Laboratory News - November 2004

Powders are sometimes considered to be relatively stable entities like the individual solid particles that make up their mass. This is not the case however, since their rheological properties can change by factors of between 100 and 1,000 in the presence of air. This paper describes how a powder can be characterized in relation to air content using methods that provide reproducible data from which databases on powder flow properties can be created.

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31. Measuring the Rheology of Difficult Materials

Published in Applied Rheology - November 2000

'Difficult materials', FT4 principle and data analysis and the comparison of different types of materials including Newtonian, pseudo plastic, dilitant and many types of powders.

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