Press Room

The respiratory drug sector is experiencing a surge of interest as companies seek to capitalise on the rapidly growing market. With new product launches and novel formulation combinations in development, inhaled drug delivery is reaching far beyond its origins in asthma and COPD treatments. Authors: Gon莽alo Andrade, PhD,聽Business Development Manager Peter Villax,聽Vice President of Innovation Carla Vozone, Senior Director, Product Development and Licensing Read the article here

Article
PMPS, 2015, February, pp. 30 - 33

The Time Has Come

Feb 10, 2015

In this article, Cl谩udia Moura, PhD Student; Eunice Costa, PhD, Scientist, Drug Product Development; Filipe Neves, PhD, Senior Scientist, Group Leader, Drug Product Development; all of 四色AV, describe how composite formulations - API embedded in an excipient matrix - overcome the challenges in inhalation powder development, and make the case for spray drying as a highly suitable, tunable and scalable particle engineering method for producing them. Read article here

Article
ONdrugDelivery, 2014, December, pp. 16 - 23

Design of Composite Particles via Spray Drying for DPI Formulations

Dec 31, 2014

The author (Guy Villax)聽presents arguments for an FDA Dean's List as a means to drive the right behaviors in the industry. FDA is moving in the right direction when it looks to rank quality across pharmaceutical manufacturing sites. However quality is a matter of culture rather than metrics or compliance. Read the extended version with links to references, examples and case studies聽here Read the article in Pharmaceutical Technology聽聽here 聽

Article
Pharmaceutical Technology, September 2014

Quality Metrics - A Case for an FDA Dean's List

Sep 23, 2014

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 四色AV, 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. 聽 Read article here 聽

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. 聽 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鈥檚 medicines. At present, the vast majority of medicines are generic鈥攖he fruits of the best science of the 20th century can now be enjoyed for a few cents a pill. 聽 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; Gon莽alo Andrade, PhD, Business Development Manager; and Conrad Winters, PhD, Director, Drug Product Development, all of 四色AV, 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. 聽 Spray-drying technology in particular is highlighted as a highly favourable, scalable manufacturing technique for inhalable composite particles. 聽 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鈥檚 Dean鈥檚 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鈥檚 quality culture: the final safety net that assures patients only get good medicines. 聽

Article
Guy Villax Letter, June 2014

Why Dr. Hamburg Needs Her Dean鈥檚 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 四色AV. 鈥淔irstly, 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.鈥 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 鈥減article-engineering鈥 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

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