Press Room

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

Applying Quality by Design to spray drying

May 01, 2013

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design,formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Press Release

Hovione announces a co-promotion and collaboration agreement with Ligand for Captisol®

Apr 03, 2013

Lisbon, Portugal, 3rd April 2013 - Hovione today announced a co-promotion and collaboration agreement with Ligand to provide Hovione’s customers efficient access to Captisol® technology. Captisol, a chemically modified cyclodextrin, is proven to improve the solubility and stability of drugs and is currently used in six marketed products. Hovione offers innovative particle engineering technologies to improve the solubility of modern drugs. The agreement allows Hovione to use Captisol technology in its solubilization programs, which include amorphous solid dispersions, crystal design and size reduction and control of particle size. By adding this new technology, it increases the likelihood of solving the molecule’s bioavailability challenges. “Hovione is delighted to announce the ability to provide access to Captisol.There is no single solution to improving bioavailability and for a customer to access diverse options with a single supplier provides for greater probability of success and speedier outcomes,” said Dr. Colin Minchom, Hovione’s Vice President of Particle Design. “Hovione has manufactured Captisol for more than a decade, and we are very pleased to expand our partnership to help customers succeed. Providing for greater access to Captisol should efficiently enable the successful development of more poorly soluble molecules and further increase our Captisol partnership portfolio,” said Mr. Mathew W. Foehr, Ligand’s Executive Vice President and Chief Operating Officer. About Captisol®  Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists at the University of Kansas' Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis™, Baxter International's Nexterone® and Pfizer's Vfend® IV. There are currently more than 30 Captisol-enabled products in development, including Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's delafloxacin IV program. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design,formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail: ipina@hovione.com . Follow Hovione on Twitter @HovioneGroup and LinkedIn. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia and osteoporosis. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Please visit www.captisol.com for more information on Captisol or www.ligand.com for more information on Ligand. Follow Ligand on Twitter @Ligand_LGND.    

Press Release

Hovione and Solvias announce a collaboration to provide for improved drug solubility

Nov 28, 2012

Loures, Portugal, 26 September 2012 - Hovione today announced the expansion of its solutions to solve issues of poor bioavailability, patient acceptability and the enabling of optimal delivery for non-oral routes of administration. Building on the experience of more than 100 projects and successful commercialization of spray dried dispersions, Hovione’s toolkit of solutions now includes crystal design, particle size reduction to the micro or nano-scale and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II. “We are very pleased to offer our customers these technologies. In response to customers’ needs, Hovione is investing in new technologies, many of them capable of handling highly potent compounds. These will help drive compounds with development challenges from early clinical to market”, said Guy Villax, Chief Executive. Colin Minchom PhD, who has been leading Hovione’s Particle Design business since March, stated: “More than the technologies, the quality of Hovione’s scientists, engineers and their experience in the application of 21st Century methodologies such as QbD, PAT and process modelling are outstanding.” Hovione will be presenting its new offering in detail during the AAPS Annual Meeting and Exposition at McCormick Place, Chicago USA. Hovione scientists and staff will be available to support your queries at booth 3936 from October 15-17. The company will also be exhibiting at Booth 3D39 at CPhI in Feria de Madrid, Spain (October 9-11). For those that are interested in the offering but are not able to attend either event, please visit hovione.com/pd or contact particledesign@hovione.com. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers in the most regulated markets. Hovione offers integrated API, particle design, formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione Expands Particle Design Solutions

Sep 26, 2012

Loures, Portugal, 30 August 2012 - Hovione today announced the appointment of Dr. Mike Ironside as General Manager, TTC in New Jersey. Dr. Ironside was previously with GSK in the UK and AMRI and most recently with Anacor Pharmaceuticals, both in USA, where he held the position of Vice President of Chemical Manufacture and Development. “This is a key appointment at an important time for Hovione. We are certain that Dr. Ironside’s leadership qualities combined with his relevant experience in chemical and analytical process development, scale-up from Pilot Plant to full commercial scale will enable us to further strengthen and enlarge our US operations in New Jersey and add new approaches to solve our customers’ most challenging problems.”, said Dr. Thomas Eisele, Vice President Corporate Research & Development. “I am excited and honoured about this new opportunity to lead the Hovione team in New Jersey. Throughout my career I have had a great respect for Hovione, a company that is recognized as world leader in pharmaceutical manufacture and particle design. I am looking forward to helping further enhance the TTC’s established reputation for offering our customers’ integrated solutions for any molecule “said Dr. Ironside. Dr. Ironside brings over 20 years of experience in the development and scale-up of APIs from lead candidate optimization through to NDA submission and commercialization. He also brings extensive experience in the management of scientific and operational teams in Biotech and Contract Research Organization (CRO) environments. Dr. Ironside is a member of the Royal Society of Chemistry in Great Britain and a member of the editorial board of the ACS Journal Organic Process Research and Development. He trained as an organic chemist at Dundee University, Dundee, UK, and holds a PhD in organic chemistry from the same University. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. Hovione offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com  or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail:ipina@hovione.com     

Press Release

Hovione Announces the Appointment of Mike Ironside, PhD as General Manager TTC

Aug 30, 2012

Loures, Portugal, 23rd August 2012 - Hovione announced the appointment of Dr. Conrad Winters as Director, Drug Product Development. Dr. Winters was previously with Merck in USA and Canada and most recently with Xenon Pharmaceuticals Inc., where he held the position of Senior Director, Compound Properties Group. “We are very pleased to welcome Dr. Winters to Hovione. His experience in particle engineering, solubilisation, drug product development, scale up and commercialization will enable us to solve our customers’ most challenging problems”, said Dr. Thomas Eisele, Vice President Corporate Research & Development. “I am delighted to join the strong team at Hovione. Already the recognized world leader in pharmaceutical spray drying, I am looking forward to leading the team in developing complimentary technologies to enable Hovione to offer customers’ integrated solutions for any molecule”, said Dr. Winters. Dr. Winters is a Senior Director with 18 years experience in the pharmaceutical industry with a focus on managing the development of compounds from lead candidate optimization through to NDA submission and commercialization. He has much experience in rational formulation design, based on fundamental understanding of material properties and the adaptation of particle properties to effect improved bioperformance. Dr. Winters has led cross functional global teams charged with the development of priority new chemical entities. He has contributed to and prepared documentation in support of many successful regulatory submissions. Dr. Winters is a member of the American Association of Pharmaceutical Scientists and of the Royal Pharmaceutical Society of Great Britain. He is author of four patents, ten papers and is a frequent speaker at international conferences. He trained as a pharmacist at the Bradford University, Bradford, UK, and holds a PhD in Pharmaceutical Technology from the same University. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Drug Product Intermediate development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. Hovione offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

Press Release

Hovione Announces the Appointment of Conrad Winters

Aug 23, 2012

Loures, Portugal, June 21st, 2012 – Hovione announced today that the consolidated sales for the fiscal year ended March 2012 amounted to USD 180m, the sixth consecutive year of sales growth, representing a growth of 24% in relation to last year. “Another year of continued strong performance by the Hovione group. During the last five years Hovione has doubled its sales and has made bold strategic steps to both strengthen its ability to serve Innovators and to consolidate its leadership in off-patent contrast agents. Looking forward, and despite the difficult economic environment, we remain confident that 2012 will be another year of solid growth”, said Miguel Calado, Chief Financial Officer. In addition to the financial results, which reflect the quality of the Team’s performance, overall 2011 represented a year of great achievements, namely: Hovione stood behind 3 NDA approvals, these were all major NMEs – and in two cases the approvals were full QbD filings in which Hovione was central to the design and data generation. All Hovione plants underwent several successful GMP inspections by one or more of the major Medicines’ Agencies – a reflection of the large flow of filings and the high standards of compliance. “Getting multiple NDA approvals every year is becoming a habit at Hovione, this reflects well both on our customers, on our team and on the CMO model. Our patient investment in capacity, new technologies and development methodologies is paying off.” said Guy Villax, Chief Executive Officer. About Hovione Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Intermediate Drug Product development and compliant manufacture. With four FDA inspected sites in the U.S., China, Ireland, and Portugal, the company focuses on the most demanding customers, in the most regulated markets. Hovione offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit www.hovione.com  or contact Marketing & Communication, Isabel Pina, + 351 21 982 9362, e-mail:ipina@hovione.com     

Press Release

Hovione’s sales grow 24%

Jun 21, 2012

Contact Us

If you would like to learn more about Hovione, kindly fill in the form below and we will be revert to you soon.