Hermes Pharma 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 complex and expensive
In the pharmaceutical industry, 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 sub coating 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.