Pullach, Germany, September 6, 2012 – Hermes Pharma, the expert in user-friendly solid oral dosage forms, has announced the start of a research project with the Research Center Pharmaceutical Engineering GmbH (RCPE), INNOJET Herbert Hüttlin and the Karl Franzens University. The goal of the project is to jointly develop new pharmaceutical formulations and design manufacturing processes accordingly. The scope of the project includes developing new approaches to masking unpleasant taste and smell of active pharmaceutical ingredients (APIs) which patients often experience when pharmaceuticals dissolve in the mouth.
The four partners plan to develop new technologies to coat APIs with lipids and simultaneously overcome the drawbacks of conventional production processes. The research spans formulation development to the design and implementation of new production processes. A special focus will be on achieving greater efficiency through shorter processing times by developing techniques that eliminate the use of solvents, and by increasing yields.
Lengthy process cycles and elaborate coating make processing today complex and expensive
In the pharmaceutical industry today, coating with polymethacrylate or with modified cellulose is state-of-the-art. The disadvantage of this process is that an enormous amount of solvents must be used, but only for processing purposes. The coating of active agent particles with lipids as part of the hot melt coating process is, in comparison, a less costly and more innovative approach to masking the unpleasant taste inherent in APIs. Because solvents are not needed when coating with lipids, process cycle times are shortened and subcoating of particles or tablets for isolating purposes becomes redundant.
However, coating with lipids presents other challenges: According to Prof. Dr. Andreas Zimmer of the Institute for Pharmaceutical Sciences of the University of Graz (Austria), such coatings are often associated with release and stability problems, as during shelf life unwanted changes in polymorphic form can occur. The characterization of lipids and stability projection are therefore prerequisites for the successful development of pharmaceuticals which incorporate unpleasant substances and dissolve in the mouth.
The goal: To obtain new formulations and develop novel process techniques
“The goal of the research project is to obtain a basic understanding of the crystallization processes during coating and storage of the final products,“ said Dr. Sharareh Salar-Behzadi, Senior Researcher at the RCPE. „As a result, we will be able to predict polymorphic changes better and develop formulations which guarantee not only the required release profile but also effective taste masking over the entire shelf life of the product.”
In addition to highly product-oriented research, the team aims to concentrate on the implementation of new technical processes in production. At the onset of the research project, the selection of the most suitable process technologies was undertaken so that scale up of the formulation from lab settings to larger facilities can be transitioned easily. Part of this technology selection involved the development of a PAT (Process Analytical Technology) solution for direct in-process measurement of critical product attributes.
In conjunction with PAT, the development of a solution is being considered which provides direct real-time information about the chemical composition of the product, for example, the coating layer thickness or water content. It is expected that critical process and quality attributes such as the duration of the process, temperature, spray and release rates could then be predicted more accurately.
The concept of Quality by Design (QbD), the pursuit of a holistic approach to product lifecycle, will serve as the link between product and process development. Appropriate process technologies will be embedded early in order to produce high quality pharmaceutical products profitably. The researchers plan to take production process steps into account - even in the product development phase. The partners aim to substitute to a large extent post production quality control and analytics for in-process measurements with corresponding process control, and expect to obtain related cost savings.
Four specialists intent on achieving one goal
„Hermes Pharma is the expert in the development and production of user-friendly dosage forms,“ said Dr. Detlev Haack, Head of R&D, Hermes Pharma. „In order to provide solutions at every point along the entire pharmaceutical value chain, we engage time and again in the first steps of research and development. We drive innovative technologies which are incorporated into our products and services and provide our customers with a competitive advantage.”
Hermes Pharma has selected three partners for this project: INNOJET Herbert Hüttlin will be supporting the project with its technical expertise in coating and granulation of solid substances, and providing an INNOJET VENTILUS® Fluid Bed System. The latter has already been pre-installed with a hot melt unit. Through linear up-scaling, the advanced equipment will facilitate the implementation of PAT. The underlying internationally-patented Air Gliding Technology was developed by Dr. h.c. Herbert Hüttlin.
As a non-university research organization, the RCPE will be providing technical knowledge related to pharmaceutical process and product development.
The Karl Franzens University Graz will be supporting the development of new formulations with scientific know-how. “Close networking between higher education and industry is important, not only when ground-breaking ideas are developed but when they are implemented for customer solutions,” emphasized Dr. h.c. Herbert Hüttlin, General Manager and founder of INNOJET Herbert Hüttlin.
The research project will be carried out by the partner specialists in Graz at the RCPE and at the Karl Franzens University. The initial findings are expected mid 2013.
About HERMES PHARMA
Hermes Pharma is the expert in the development and production of user-friendly solid oral dosage forms, including effervescent and chewable tablets, lozenges, orally disintegrating granules and instant drinks. The company provides custom solutions along the entire pharmaceutical value chain – from the development of new product ideas and formulations to production and regulatory support. For more than 40 years, leading pharmaceutical and healthcare companies around the globe have been working with Hermes Pharma to expand their product lines and grow their brands.
Hermes Pharma is a division of Hermes Arzneimittel GmbH, a leading German provider of high quality medicines, food and dietary supplements marketed under its proprietary, well-established brands. Further information is available at www.hermes-pharma.com
About INNOJET Herbert Hüttlin
Founded in 1997, INNOJET Herbert Hüttlin is today a technology leader in the development, production and worldwide sales of pharmaceutical processing equipment for coating und granulation. The company’s success is in large measure due to its unique, worldwide patented INNOJET VENTILUS® and INNOJET AIRCOATER® technologies which are based on its internationally-patented Air Gliding Technology.
Both technologies offer marked improvement in previous industry technical standards because of their high, reproducible product quality which leads to significant time and cost savings and increased productivity. INNOJET VENTILUS and INNOJET AIRCOATER equipment is used profitably every day in laboratory settings as well as in large technical facilities. Working collaboratively with its customers worldwide, INNOJET Herbert Hüttlin provides tailor-made approaches, and implements solutions together with its customers. Further information is available at www.innojet.de.
INNOJET VENTILUS® and INNOJET AIRCOATER® are registered trademarks of INNOJET Herbert Hüttlin.
About the RCPE – Research Center Pharmaceutical Engineering GmbH
The Research Center Pharmaceutical Engineering GmbH (RCPE) is a R&D competence center focused on pharmaceutical process and product development in Graz, Austria.
Founded in July 2008, the RCPE has grown quickly, now employing 100 persons. The center focuses on pharmaceuticals, and food and dietary supplements. In addition to Hermes Arzneimittel GmbH and INNOJET® Herbert Hüttlin, it counts more than 60 industrial partners including Novartis Pharma, Bayer Schering Pharma, Asta Zeneca UK, Sanofi Aventis, and Boehringer and Ingelheim. It also collaborates with 12 scientific partners such as the University of Cambridge, the Heinrich Heine University in Düsseldorf, and Rutgers University.
As a K1 competence center of the Technical University of Graz (65% ownership), the Joanneum Research GmbH (15% ownership) and the Karl Franzens University Graz (20% ownership), the RCPE undertakes process and product optimization projects with leading pharmaceutical companies worldwide. Its research focus comprises the development of advanced medication and therapeutic agents, new dosage forms and diagnostic devices as well as the related production processes, based on the most modern scientific principles. Further information is available at http://www.rcpe.at/en.
About the Karl Franzens University Graz
The Institute for Pharmaceutical Science The Karl Franzens University Graz, founded in 1585, is Austria‘s second oldest university and one of the country’s largest. Numerous outstanding scientists including six Nobel Prize winners have taught and researched at the University. The pharmaceutical technology domain is a part of the Institute of Pharmaceutical Sciences which incorporates all pharmaceutical related areas of the University. Over 20 scientists are involved in pure and applied pharmaceutical research in formulation development of new medications. A focus of the Institute is the investigation of nano structures as related to pharmaceutical dosage forms. Further information is available at http://www.uni-graz.at.
Lucy Turpin Communications
Phone: +49 89 417761-0
Manager, Marketing & PR
HERMES ARZNEIMITTEL GMBH -
Division HERMES PHARMA
Vertrieb & Marketing, INNOJET
Herbert Hüttlin katja.grass(at)innojet.de
Mag. Claudia Hudin
Research Center Pharmaceutical Engineering GmbH
Univ.-Prof. Dr. Andreas Zimmer
Institute of Pharmaceutical Sciences -
Department of Pharmaceutical Technology