Press Room

Hovione and Invion sign development agreement for first inhaled non-steroidal anti-inflammatory for asthma Portuguese API manufacturer Hovione has agreed with Invion to progress the development of inhaled INV104 (zafirlukast) as a potential new treatment for asthma. Hovione and the Australian drug developer will collaborate to develop the proprietary novel technology – a dry powder formulation of the compound INV104 (zafirlukast) delivered by Hovione’s inhaler.   Read the article here

Article
Manufacturing Chemist, 27 July 2015

Hovione and Invion sign development agreement

Jul 27, 2015

Developing an Orally Inhaled Dry Powder Formulation - A Complex Itinerary and a Technological Challenge The delivery of an orally inhaled API to the deep lung can be performed using different drug-delivery platforms, such as nebulizers, pressurized metered dose inhalers (pMDI), and dry powder inhalers (DPI). DPIs are increasingly becoming a more important drug delivery option and are expected to hit double-digit figures, reaching global sales of $31.5 billion in 2018 DPIs are conventionally formulated using a carrier-based approach, in which the API is size-reduced until it reaches an inhalable particle size and is further blended with a lactose carrier to enable dose metering and to improve powder flowability and dispersibility. Even though this formulation approach is the most commonly used, it presents several drawbacks. To overcome the limitations, as well as to address the renewed interest in pulmonary delivery of biotherapeutics and other advanced therapies, several alternative particle engineering approaches have been devised over the years, such as the production of composite particles by spray-drying where the API is embedded in an excipient matrix. Although the development of a DPI seems straightforward, it is a complex area that integrates multiple fields of knowledge. In a general way, the success of a DPI produced using a carrier-based formulation approach will be determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance. In this article, Gonçalo Andrade, business development manager at Hovione, spoke to Pharmaceutical Technology about the key considerations when developing an orally inhaled dry-powder inhalation formulation. Read the article here

Article
Pharmaceutical Technology, June 2015

Developing an Orally Inhaled Dry Powder Formulation

Jun 01, 2015

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: Gonçalo Andrade, PhD, Business Development Manager Peter Villax, 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, Cláudia Moura, PhD Student; Eunice Costa, PhD, Scientist, Drug Product Development; Filipe Neves, PhD, Senior Scientist, Group Leader, Drug Product Development; all of Hovione, 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) 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 here Read the article in Pharmaceutical Technology  here  

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 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

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