F.I.P. International Commission on Pharmaceutical Enzymes

In 1960, during the General Assembly of the F.I.P.(acronym for Fédération Internationale Pharmaceutique/International Pharmaceutical Federation) at Copenhagen, a scientific symposium on enzymes used in pharmacy was organized. Although pancreatic enzymes and also pepsin and papain had already been used therapeutically before 1940, the assays to measure the enzymatic activity as described in the different national Pharmacopoeias which were valid around 1960 were often obsolete or inadequate. To cope with this unsatisfactory situation, the Council of the F.I.P. appealed to Prof. R. Ruyssen (University of Gent, Belgium) to form a Commission to study these problems and to formulate proposals for better assay and control methods for pharmaceutical enzymes. At present the F.I.P. International Commission on Pharmaceutical Enzymes is still directly depending on the Council of the F.I.P.

Prof. R. Ruyssen acted as Vice-president of the F.I.P.(from 1955 to 1960) and as President of its Scientific Section (1958-1962). He was founder and first chairman of the International Commission on Pharmaceutical Enzymes of the F.I.P. (1960-1975). Prof. Dr. Pharm. R. Ruyssen, born in 1901, died in 1979 after a very active life.
Enzyme activity is determined by the quantity of substrate transformed or product formed per unit time. The reaction rate that is measured depends on a number of experimental conditions such as temperature, pH, ionic strength, and the presence or absence of inhibitors or activators. It is only under the conditions specified in the prescribed assay procedure that enzyme units are defined.
Assay accuracy and reproducibility are the most stringent requirements for the determination of enzyme potencies in pharmaceutical formulations. Furthermore, the unit value must correspond to an enzyme activity the physician can relate to. Expression of activity in units based on molar concentrations is only possible when the substrate molar concentration, the reaction mechanism, and the resulting rate equation are known. Enzyme preparations for pharmaceutical use can contain various enzymes of unknown molar concentration the activity of which is preferably expressed as total activity.

The biological biopolymeric substrates ( proteins, polysaccharides, bacteria, oil emulsions) often have a molecular complexity and the fact that the potential number of bonds susceptible to hydrolysis is not known and frequently varies over he time course of the assay makes a Good Standardization Practice necessary.
The International Commission on Enzymes F.I.P. (with experts of pharmaceutical companies, universities, control laboratories) improves the assay methods and the guidelines for the preparation of pharmaceutical enzyme reference materials, calculates the potency in terms of the F.I.P. -standard using a unitage expressed in "International F.I.P. -units, organizes meetings and symposia.

The German Pharmaceutical Industry Association publishes annually a doctor's compendium : "Rote Liste ". In 1974 only 10% of the enzymes were expressed in F.I.P. -units and 15 years later almost 80 % .
The Centre for Pharmaceutical Enzyme Standards has a coordination function in organizing collaborative enzyme assays between academic, industrial and national pharmaceutical control laboratories and in distributing F.I.P. enzyme standards. The Centre moved in 1977 from the Laboratories of the Belgian Society of Pharmacy to the Laboratory for General Biochemistry and Physical Pharmacy of the Faculty of Pharmaceutical Sciences ( Ghent University, Belgium). Already in 1986 the methods and standards found their way into 295 firms in 25 countries.
The relationship with the European Pharmacopoeia increased since the first agreement in 1978. F.I.P. assay procedures and standards were adopted for several enzyme systems (e.g.: chymotrypsin in 1983, Pancreatic Pulvis in 1985) and the results acquired a legal status in different European countries.
The responsibilities of the commission increases and problems occur if an enzyme manufacturer stops his production or when active members of the commission must be replaced because of age, promotion, change of personal interest ,etc. The commission must renew itself to remain alert and keen without losing the experience gained. It is a lasting challenge to ensure continuity. New proposals must be put forward to solve the problems related to new enzymatic systems. Advances in this field can be found in " Pharmaceutical Enzymes" a book published by Marcel Dekker, Inc. New York.
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List of members
President: Prof. dr. J. Demeester (also Director of the Centre for Standards)(Belgium)
Honorary President: Prof. Dr. A. Lauwers (Belgium)
Vice-president: Dr. G. Peschke (Germany)
Honorary Vice-President: Drs. Rut Matthijsen (Netherlands)
Secretary: Pharm. J. Dufaux (Belgium) (A.P.B.)
Dr. D. Bizzarri (Switzerland)
Dr. J.J. Descombe (France)
Dr. C. Hofbauer (Germany)
Dr. H. Nagel (Germany)
Dr. A. Potthoff (Germany)
Dr. J.P. Thalhofer (Germany)
Prof. dr. G. Van Dedem (Netherlands)
Dr. R. Vanneste (France)
Prof. dr. S. De Smedt (Belgium)
Dr. Bart Lucas (Belgium)
Eng. J. Haustraete (Belgium)
Dr. H. Raymakers (Netherlands)
Prof. dr. S. Scharpé (Belgium)
Dr. L. Zlodi-Gosnik (Slovenia)
Prof. dr. K. Vercruysse (USA)