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SEMMELWEIS UNIVERSITY / FACULTY OF PHARMACY
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INDUSTRIAL PHARMACEUTICAL TECHNOLOGY I:
Dosage form and product development
Department of Pharmaceutics
Director: Prof. Dr. Imre Klebovich
Tutor: Dr. István Antal
First semester
The subject is recommended for the students interested in several fields of industrial
pharmaceutical technology such as research and development of new dosage forms and medicinal
preparations.
Topics:
History of industrial pharmacy. Profiles of the pharmaceutical industry, career for pharmacists.
Pharmaceutical technological aspects of product authorization. Evolution of dosage forms.
Innovation and intellectual property. Preformulation and formulation studies. Optimization of
dosage form composition. Control of active substance and excipients, physic-chemical and solid
state characterization. Novel drug delivery systems. Design of the manufacturing process. Critical
formulation attributes and process parameters. Comparison of scaling-up methods.
INDUSTRIAL PHARMACEUTICAL TECHNOLOGY II:
Operations and procedures
Department of Pharmaceutics
Director: Prof. Dr. Imre Klebovich
Tutor: Dr. István Antal
Second semester
The subject is recommended for the students interested in several fields of industrial
pharmaceutical technology such as operations and procedures in the manufacture of medicinal
preparations.
Topics:
Evolution of pharmaceutical manufacturing operations and procedures. Novel technologies for the
production of dosage forms. Quality by design, manufacturing related to quality assurance and
quality control. Critical parameters in the production. In-process control methods. Process
Analytical Technology. Novel analytical methods for testing production and product quality.
Validation of the manufacturing method. Methods for statistical process control. Current Good
Manufacturing Practice.