Semicontinuous granulation - The process of choice for the production of pharmaceutical granules?

Powder Technology

Volumn 140, Issue 3, 2004, Pages 163-168

  Werani, Juergen ^a   Grünberg, Mads ^a   Ober, Christian ^a   Leuenberger, Hans ^b  

^a PFIZER INC   (United States)

^b UNIVERSITY OF BASEL   (Switzerland)

Author keywords

An optimized organizational business model; Batch type versus semicontinuous processes; Cost saving; Process Analytical Technology (PAT); Reduction of development time and time to market

Indexed keywords

DRUG PRODUCTS; MATHEMATICAL MODELS; PROCESS CONTROL; PRODUCTIVITY;

PHARMACEUTICAL GRANULES; SEMICONTINUOUS GRANULATION;

GRANULATION;

MEDICAL APPLICATION;

CONFERENCE PAPER; COST CONTROL; DEVICE; DRUG COST; DRUG DELIVERY SYSTEM; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY; FOOD INDUSTRY; PROCESS DESIGN; PROCESS TECHNOLOGY; SCALE UP; STANDARDIZATION; TABLET FORMULATION;

EID: 2342614829     PISSN: 00325910     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.powtec.2004.01.021     Document Type: Conference Paper

References (13)

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11. Dörr B., Leuenberger H. Leuenberger H. Development of a Quasi-Continuous Production Line - A Concept to Avoid Scale-Up Problems, Preprints First European Symposium on Process Technologies in Pharmaceutical and Nutritional Sciences, PARTEC 98 Nürnberg. 1998;247-256 Nürnberg Messe, Nürnberg, Germany
12. Johnson A. Six sigma in R&D. Res. Technol. Manag. 45(2):2002;12-16
13. Hussain A.S. Levin M. A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Intermediate-Release Solid Oral Dosage Forms in Pharmaceutical Process Scale-Up. 2002;325-352 Marcel Dekker, New York, Basel. ISBN:0-8247-0625-0 Glossary and further explanations Biostudies In case that there is a doubt that the quality of the larger scale batch may be biologically not identical to the early batches produced on a small equipment, an expensive bioequivalence study is needed. Delivery system Meet the new customer needs, improve patient compliance, provide exclusivity in principle of operation, provide controlled release of the active substance and meet low-manufacturing cost strategy. Development costs The development of a new medication costs in the average 800 million USD. Drug characteristics include physicochemical as well as biopharmaceutical properties, ready-to-use properties, enhanced water solubility, feasible for innovative drug administration/delivery systems. FDA Food and Drug Administration, regulatory agency, Bethesda, USA. Manufacturing process taking care of quality, environmental, health and safety standards, best practices of supply chain management concepts, continuous process flow and lights-out operation, optimal use of capital employed. NIR Near infrared technology becomes increasingly important for in-line and in-process test methods such as measuring the content of drug substance in each tablet, etc. Lödige 900 Large scale high shear mixer PAT Process Analytical Technology, Initiative of the FDA to increase the quality of the product by developing and implementing more in-line test procedures especially to manage critical processes such as optimal mixing of particles of a low dose of a highly potent drug substance with auxiliary substances used, e.g. in tablets. The PAT initiative has as a goal to improve pharmaceutical process technologies to achieve higher quality standards if possible as high as in the chip industry with a performance of six sigma quality [5]. The six sigma approach became also an issue in R&D [11]. Phase I, II, III, IV studies Clinical studies with increasing number of medical treatments and increasing amount of the new medicine needed (see: scale-up and Fig. 2