Huettlin GmbH

Schopfheim, Germany

Huettlin GmbH

Schopfheim, Germany
SEARCH FILTERS
Time filter
Source Type

Hartung A.,Johannes Gutenberg University Mainz | Hartung A.,Huettlin GmbH | Knoell M.,Huettlin GmbH | Schmidt U.,Huettlin GmbH | Langguth P.,Johannes Gutenberg University Mainz
Drug Development and Industrial Pharmacy | Year: 2011

Background: Granulation and tableting are closely related process steps in the supply chain of pharmaceutical products. Even today, these steps are still optimized independently by trial and error. On the framework of a process analytical technology approach, these processes were evaluated in an integrated approach. Enalapril maleate is a low-dose drug substance with poor granulating and tableting behavior. In order to verify how granulation influences tableting properties, different granulation experiments were performed. Methods: Granulation experiments with fast spraying rate and fast drying as well as fast spraying rate and slow drying, and also combinations of both were run. The obtained granules were then promptly compressed into tablets in a rotary press and subjected to hardness testing. The progress of spraying and drying was controlled by a continuous near-infrared spectroscopic measuring setup. This study confirms that the tablet characteristics. Result/Conclusion: after compression of the granules in comparison to placebo granules are dependent not only on the residual moisture content of the granules but also on the moisture profiles during the entire fluid bed granulation process. © 2011 Informa Healthcare USA, Inc.


Hartung A.,Johannes Gutenberg University Mainz | Hartung A.,Huettlin GmbH | Knoell M.,Huettlin GmbH | Schmidt U.,Huettlin GmbH | Langguth P.,Johannes Gutenberg University Mainz
Drug Development and Industrial Pharmacy | Year: 2012

Background: In the production of enalapril maleate tablets, the granulation process is the most crucial step. Numerous variables are known to influence the fluid bed granulation process and thus the final granule quality. In this study a novel descriptor for the nozzle parameter "air-to-liquid mass ratio" is presented. Granules manufacturing processes were designed by application of statistical experimental design. Aim: The influence of the critical process parameter (CPP)air-to-liquid mass ratioon pharmaceutic properties of granules was studied. Air-to-liquid mass ratio can be considered as important variable influencing the droplet size of atomized liquid binder solution. Results/Conclusion: A significant influence of air-to-liquid mass ratio on granule final particle size distribution was found. Increasing air-to-liquid mass ratio resulted in increased granules particle size distribution. Decreasing air-to-liquid mass ratio led to granules with reduced tapped density. Thus, it can be concluded that the parameter "air-to-liquid mass ratio" is a critical process parameter in the production of enalapril maleate granules. © 2012 Informa Healthcare USA, Inc.

Loading Huettlin GmbH collaborators
Loading Huettlin GmbH collaborators