The path to perfect quality
The development of new drugs requires plenty of staying power. According to the Association of Research-Based Pharmaceutical Companies in Germany (Verband der forschenden Pharma-Unternehmen, vfa) the pharmaceutical industry invests an average 13.5 years and up to 1.6 billion US dollars per drug until market approval is granted. These figures factor in failed projects, as well as those which are successfully launched. So it pays off when processes can be shortened en route to commercial production.
This is precisely what pharmacist Dr. Elke Sternberger-Rützel, Head of Pharma Services at Harro Höfliger, and her team are working on. Besides an extensive test program, they count on a database with the department’s pharmaceutical-technological product knowledge. “A true in-house development, implemented across departments by Sabine J. Bohne from Pharma Services and Claudia Schoder from IT”, explains Elke Sternberger-Rützel.
The advantage: “If we develop processes for a new customer product, we compare its physical properties with already known materials. This way, we can pre-define a product specific process window.” Therefore, customers can expect a faster transition from manual tests on laboratory equipment to automated project processes. In addition, smaller sample volumes of the precious new product are needed – sometimes only a few hundred grams.
In the case of our inhalation project with Harro Höfliger, the product database has set the course for our process. With Pharma Service’s support, we were able to decisively and quickly identify the appropriate procedure. For future product development, we will also count on Harro Höfliger’s pharmaceutical expertise and reliable service.
Alexander Malin
CEO Nativa
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Materials containing active ingredients
The technological characterization of active ingredient-containing material is a part of the service portfolio.
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In-house laboratory
Powder characteriziation in Harro Höfliger's in-house laboratory.
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Drum TT for the verification and production of minimum sample quantities
Drum TT for verification of dosing capability and the production of minimum sample quantities.
Data for practical use
Since 2005, the technological characterization and classification of active substance-containing material is a part of Harro Höfliger’s service portfolio. On the one hand, this data facilitates the selection of a suitable, scalable method for the production and filling process. On the other hand, it can be incorporated into the modification and optimization of the formulation. For example: Powder is a complex material and its behavior is determined by many factors, such as particle shape, compressibility, cohesiveness and a tendency to be electrostatically charged. In dry powder for inhalation (DPI), the flow characteristics and compressibility of the carrier material – mainly lactose with different amounts of fine particles – are particularly important for clean and consistent filling into blister strips or capsules.
All of these critical characteristics are systematically examined and documented by the specialists of the Pharma Services department. In the in-house laboratory, besides a digital microscope, the team utilizes a powder rheometer, a vibrating sieve machine, a jolting volumeter for the determination of flowability, particle size and density, as well as a moisture meter and other equipment. In addition, drum and membrane fillers in manual and semi-automatic versions are available for filling tests. Very often, optimizations can be achieved rather quickly, when the customer accepts the Pharma Services recommendations and, for instance, uses an alternate lactose, which already proved to be optimal for filling during preliminary tests. This proves to be a convincing benefit that illustrates the value of Harro Höfliger’s product database.
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Pharma Services
Providing the support needed to develop and improve processes – risk management from the start.