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The changing development paradigm resulting from the US Food and Drug Administration鈥檚 quality-by-design (QbD) initiative and International Conference on Harmonisation (ICH) guidelines requires increased process understanding of the drug substance and drug product throughout development and manufacturing. A lack of information can result in delays in regulatory approval and higher costs. Applying QbD principles leads to greater process understanding, facilitates regulatory approval and streamlines postapproval changes. Case studies on the manufacture of a bulk powder and the development of a tablet show the application of QbD principles, including defining critical quality attributes, implementing risk assessment, optimising process development, developing a design space and performing a criticality analysis. Read article here

Article
Pharmaceutical Technology Europe, September 2013

Optimising Quality by Design in Bulk Powders and Solid Dosage

Sep 01, 2013

The interface between the Active Pharmaceutical Ingredients (API) manufacturing and formulation development is of paramount importance in the pharmaceutical world. Chemists, engineers and formulators are not exposed, by training, to the same challenges. As presented in Figure 1, on the one hand there are API suppliers, characterized by a service orientation mindset, used to addressing synthesis route issues (e.g. impurities, yields), solid state characterization (e.g. polymorphs, polymorph control), raw material sourcing, etc); on the other hand, formulators are used to a different type of language and daily concerns (e.g. bioavailability, patience compliance, administration route, efficacy and processibility). Read article here 聽

Article
European Industrial Pharmacy, June 2013

Bridging API manufacturing and formulation through particle design

Jun 01, 2013

The role of empirical and mechanistic modeling The purpose of this work was to build different models to predict the particle size of spray dried powders and assess their usefulness in the design space establishment. Powders were obtained by spray drying solutions of a known pharmaceutical excipient (hypromellose phthalate). The powders were characterized by image analysis (for particle size and circularity), loss on drying (for residual solvent content) and helium pycnometry (for particles density). A full factorial experimental design was performed and PLS regression was used to establish a statistical model. In addition, mechanistic modeling of droplet formation based on hydrodynamic instabilities was also used to estimate the size of particles. Spherical particles, with average particle size between 3 and 9 ?m, were obtained by spray drying solutions in a lab scale unit. Particle density and residual solvent content did not vary significantly between experiments. Statistical and mechanistic approaches were compared. Both statistical and mechanistic models were able to describe the results observed, although the mechanistic model was the most accurate. The mechanistic description of droplet formation was of great assistance to understand and describe the spray drying process. 聽 Introduction Spray drying is a well-established and widely applied technology to manufacture a wide range of powders. It is an ideal process when the end-product quality comprises attributes such as well-defined particle size distribution, residual solvent content, bulk density and morphology (1). Spray drying involves the atomization of a liquid stream (i.e. dispersion of the liquid into very small droplets) into a chamber where the droplets are contacted with a hot gas stream leading to flash drying and particle formation (2). Efforts to understand the physical principles of spray drying were intensified in the last decade with the aim of improving powders attributes and speed up product and process development. Due to the remarkable flexibility of the technology the use of spray drying is increasing in the pharmaceutical industry. It is being used to produce, among others, amorphous materials with enhanced bioavailability, microencapsulated drugs and powders for inhalation (3). In most of the spray drying applications the particle size is considered a critical quality attribute, e.g. for inhaled or oral drugs where it affects drug aerodynamic or compr ... 聽 Read entire article

Article
Chemistry Today, March/April 2013

Applying Quality by Design to spray drying

May 01, 2013

The concept and terminology of Quality by Design (QbD) have become part of the common language of those working in the pharmaceuticals industry. This ambitious initiative aims to bring the industry to a higher level of innovation and process control through a better process understanding and thus to develop improved processes with positive implications in terms of process capability, sustainability and cost-efficiency. Read article here

Article
Speciality Chemicals Magazine, January 2013

Quality by Design in API process development

Jan 15, 2013

Interview: Colin Minchom, VP, Particle Design Business Unit 鈥淎n issue for customers with a poorly soluble molecule is that any one solubility enhancement technology is likely to have, I believe, a 20% to 40% probability of solving the problem. This means that in order to assure acceptable bioavailability, at least three technologies need to be investigated. The customer would need to contract with three single platform technology companies or be able to engage a single company, such as 四色AV, that can apply multiple platforms, to increase the probability of solving the聽 problem, and deliver the desired outcome.鈥 Read article here

Article
Drug Development and Delivery, October 2012

New Technologies in Particle Design

Oct 31, 2012

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