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If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing. Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.   Read article here  

Article
Outsourced Pharma, 8 September 2014

Are Regulators Providing The Right Quality Incentives?

Sep 08, 2014

Purpose To present a new screening methodology intended to be used in the early development of spray-dried amorphous solid dispersions. Methods A model that combines thermodynamic, kinetic and manufacturing considerations was implemented to obtain estimates of the miscibility and phase behavior of different itraconazole-based solid dispersions. Additionally, a small-scale solvent casting protocol was developed to enable a fast assessment on the amorphous stability of the different drug-polymer systems. Then, solid dispersions at predefined drug loads were produced in a lab-scale spray dryer for powder characterization and comparison of the results generated by the model and solvent cast samples. Results The results obtained with the model enabled the ranking of the polymers from a miscibility standpoint. Such ranking was consistent with the experimental data obtained by solvent casting and spray drying. Moreover, the range of optimal drug load determined by the model was as well consistent with the experimental results. Conclusions The screening methodology presented in this work showed that a set of amorphous formulation candidates can be assessed in a computer model, enabling not only the determination of the most suitable polymers, but also of the optimal drug load range to be tested in laboratory experiments. The set of formulation candidates can then be further fine-tuned with solvent casting experiments using a small amount of API, which will then provide the decision for the final candidate formulations to be assessed in spray drying experiments.   Read article here

Article
Pharmaceutical Research, August 2014

Screening Methodologies for the Development of Spray-Dried ASDs

Aug 01, 2014

A breach in the pharmaceutical supply chain is only the tip of the iceberg. Innovators (Big Pharma and biotech companies) are today a minority player supplying only about 20% of the world’s medicines. At present, the vast majority of medicines are generic—the fruits of the best science of the 20th century can now be enjoyed for a few cents a pill.   Read article here

Article
Pharmaceutical Technology Europe, August 2014

Pharmaceutical Manufacturing and Supply-Chain Trends to 2020

Aug 01, 2014

Here, Eunice Costa, PhD, Scientist, Drug Product Development; Filipe Neves, PhD, Senior Scientist, Group Leader, Drug Product Development; Gonçalo Andrade, PhD, Business Development Manager; and Conrad Winters, PhD, Director, Drug Product Development, all of Hovione, describe the strong position of inhalable products in preclinical and clinical pipelines and make the case for formulation-based approaches to enable and enhance pulmonary product development.   Spray-drying technology in particular is highlighted as a highly favourable, scalable manufacturing technique for inhalable composite particles.   Read article here

Article
ONdrugDelivery, 2014, June, pp. 3 - 8

Scale-up & QbD Approaches for Spray-Dried Inhalation Formulations

Jun 19, 2014

The quality metrics debate needs to recognize the paramount importance of quality culture over and above the mere compliance that results from meeting a quality system. What is needed is a simple reward system that identifies role models. An FDA’s Dean’s List will solve many problems: it will reward those producers that do the right thing for the patient, it will encourage innovation in pharmaceutical manufacturing, it will allow inspection resources to be applied wisely, it will make quality an effective differentiator at a time when the vast majority of manufacturing is done through outsourcing. This paper flags the responsibility of the CEO in driving the organization’s quality culture: the final safety net that assures patients only get good medicines.  

Article
Guy Villax Letter, June 2014

Why Dr. Hamburg Needs Her Dean’s List

Jun 01, 2014

The pulmonary route is gaining increasing popularity as a fast and effective way of delivering drugs to the lungs both locally and systemically. There are several reasons for this interest, noted Conrad Winters, PhD, director, and Filipe Neves, PhD, group leader, both from the Drug Product Development Group at Hovione. “Firstly, advances in device technology have made inhalation drug delivery more convenient and patient-friendly. Secondly, from a therapeutic angle, the lungs provide a high absorption area with extensive vascularisation, leading to rapid delivery of the drug. Moreover, because it circumvents first-pass metabolism, lower doses can be administered compared with the oral route.” Read full article

Article
Pharmaceutical Technology Europe, February 2014

Particle Engineering for Inhaled Therapeutics

Feb 01, 2014

With an increasing number of relatively insoluble drugs in development today, there is a need to develop and use platform technologies capable of addressing solubility issues. Among the different alternatives, the use of stabilised amorphous solid dispersions is becoming increasingly popular, with pharmaceutical spray drying being one of the key technologies used in their preparation. In spray dried dispersions (SDD), the active pharmaceutical ingredient (API) is molecularly dispersed in a polymeric matrix. The polymer is used to stabilise the amorphous, metastable form of the drug and sustain supersaturation of the API in solution/biological fluids, thereby increasing bioavailability. Read article here

Article
European Industrial Pharmacy, December 2013

Scale-up of spray dried amorphous solid dispersions

Dec 01, 2013

In this work, the potential of spray congealing in microencapsulation, taste masking and controlled release was explored and compared to other commonly used technologies, specifically spray drying and hot melt extrusion. The ability to control powder characteristics without the need of subsequent downstream processing methods is a marked advantage over other “particle-engineering” technologies. Moreover, spray congealing is an environmentally friendly process where high throughputs can be achieved. This technology involves some critical stages that should be thoroughly evaluated when establishing the process, namely the atomization, cooling and feed stages. Spray congealing represents a very attractive and promising platform to address some of the challenges related to drug development and drug life cycle management. Read article here

Article
Chemistry Today, September/October 2013

Spray congealing: applications in the Pharmaceutical Industry

Sep 01, 2013

The changing development paradigm resulting from the US Food and Drug Administration’s 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  

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.   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 ...   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.  

Article
Speciality Chemicals Magazine, January 2013

Quality by Design in API process development

Jan 15, 2013

Interview: Colin Minchom, VP, Particle Design Business Unit “An 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 Hovione, that can apply multiple platforms, to increase the probability of solving the  problem, and deliver the desired outcome.” Read article here

Article
Drug Development and Delivery, October 2012

New Technologies in Particle Design

Oct 31, 2012

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