Thermal analysis methods are well-established techniques in research laboratories of pharmaceutical industry. The robustness
and sensitivity of instrumentation, the introduction of automation and of reliable software according to the industrial needs
widened considerably the areas of applications in the last decade. Calibration of instruments and validation of results follow
the state of the art of cGMP as for other analytical techniques. Thermal analysis techniques are especially useful for the
study of the behavior of the poly-phasic systems drug substances and excipients and find a unique place for new delivery systems.
Since change of temperature and moisture occur by processing and storage, changes of the solid state may have a considerable
effect on activity, toxicity and stability of compounds. Current requirements of the International Conference of Harmonisation
for the characterization and the quantitation of polymorphism in new entities re-enforce the position of thermal analysis
techniques. This challenging task needs the use of complementary methods. Combined techniques and microcalorimetry demonstrate
their advantages. This article reviews the current use of thermal analysis and combined techniques in research and development
and in production. The advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.
The aim of this paper is to review current applications for thermal methods within the pharmaceutical industry as well as
to present some early work on potential applications for two new thermal methods: Hi-Resolution Thermogravimetric Analysis
and Modulated Differential Scanning Calorimetry.
This study is a count of the publications of a sample of the major pharmaceutical multinational companies. These firms have been divided into three geopolitical groups: Europe, the United States and Japan. Results obtained show that research activities in this industry have been subjected to some changes between 1965 and 1979. Among these changes is the growing importance of fundamental research, the erosion of the leadership of U.S.-based firms and the growing importance of overseas research.
Authors:Tuong Van Le Doan, Petr Stavárek, and Claude de Bellefon
A methodology that may be applied to help in the choice of a continuous reactor is proposed. In this methodology, the chemistry is first described through the use of eight simple criteria (rate, thermicity, deactivation, solubility, conversion, selectivity, viscosity, and catalyst). Then, each reactor type is also analyzed from their capability to answer each of these criteria. A final score is presented using “spider diagrams.” Lower surfaces indicate the best reactor choice. The methodology is exemplified with a model substrate nitrobenzene and a target pharmaceutical intermediate, N-methyl-4-nitrobenzenemethanesulphonamide, and for three different continuous reactors, i.e., stirred tank, fixed bed, and an advanced microstructured reactor. Comparison with the traditional batch reactor is also provided.
Immobilization of the bacteria A. simplex by-2-13 was obtained by irradiation polymerization with an electron beam and gamma-radiation at 0°C. Prednisone acetate (P. A.) was derived from cortisone acetate (C. A.) by 1,2-dehydrogenation, catalyzed by immobilized A. simplex by-2-13. The immobilized bacteria were used 10 times in succession with a transformation percentage ranging from 77 to 86% for electron beam radiation and 79 to 99% for gamma radiation. Dehydrogenation, was carried out at pH 7.2, 34°C, 180–200 r.p.m. for 24 hours. 3% (v/v) anhydrous alcohol was added to the system at onset. Scanning electron micrographs documented the structure of the immobilized bacteria. In this work, the effect of absorbable doses of radiation and the reaction time of non-immobilized bacteria on dehydrogenase activity were studied. The effect of pH, temperature and concentration of substrate were also studied.
Authors:Clara Calero, Thed van Leeuwen, and Robert Tijssen
Bio-pharmaceutical R&D is increasingly an international affair. Research articles published in the peer-reviewed international
scientific and technical journals represent quantifiable research outputs of bio-pharmaceutical firms. Large-scale systemic
measurements of worldwide trends and sectoral patterns within bio-pharmaceutical science can be gauged from these articles,
where coauthored research papers are assumed to reflect research cooperation and associated knowledge flows and exchanges.
We focus our attention on the largest science-based multinational enterprises (MNEs), those that produce relatively large
quantities of research articles. The study deals with the worldwide output of research articles that are co-produced by corporate
researchers during the years 1996–2001.
We employ these publications to examine structural factors characterizing research cooperation networks within industry at
the level of major geographical regions (North America, Europe, Pacific-Asia), with a breakdown by within-MNE and between-MNE
network linkages. The descriptive statistics on publication output and results of network analyses of co-publication linkages
not only indicate regional differences, with a central role for US companies in biopharmaceutical research, but also a variety
of firm-specific research cooperation networks which enabled us to develop a tentative typology of MNEs in terms of their
intra- and interorganizational patterns of research cooperation linkages.
A transzlációs medicina az utóbbi évtizedben kialakult tudományág, amely a közeljövő meghatározó szemléletmódja lesz a gyógyszeripari kutatásban és fejlesztésben, felöleli a kezdeti számítógépes, majd laboratóriumi kutatástól, a fejlesztésnek a preklinikai és klinikai (humán) szakaszán át, a gyógyító eljárás beépülését a terápiába és annak folyamatos követését a mindennapi gyakorlatban. A szerzők célja ezzel a betekintéssel az volt, hogy a maguk szerény módján megpróbálják röviden összefoglalni ennek a kifejlődő új megközelítésnek az alapjait, jelenét és talán jövőjét, felhívják a figyelmet az előtte álló kihívásokra, feladatokra, és rávilágítsanak néhány ígéretes megoldásra, lehetőségre, trendre, modellfejlesztésre és -alkalmazásra. Orv. Hetil., 2011, 152, 1894–1902.