[Solubility enhancement with extrusion technology]. / Hatóanyagok oldódásának elosegítése extrúziós technológiával.

The transformation of the stable crystalline form can enhance the bioavailability of poorly water soluble drugs. The molecular dispersion, or solid solution, can be formed by various methods. The thermodynamic and kinetic properties of such compounds are very similar to the amorphous state. Twin-screw melt-extrusion, with controlled pressure, heat and shear stress, is a powerful way for separating the molecules of the active ingredient from each other and distributing them in the matrix homogenously. The extrudate can be processed onward immediately after a required cooling phase. The dependence of the possible effect of extrusion on the process parameters was investigated by Raman-microscopy and X-ray powder diffraction in course of the preparation of solid solution of spironolactone.

[Monitoring the temperature distribution during dielectric drying]. / Mikrohullámú vákuumszárítás során kialakuló hoeloszlás követésének lehetosége.

Microwave assisted vacuum drying offers never questioned advantageous and it is getting more and more popular lately. In spite of its uniqueness there is a rightful resistance and mistrust because the temperature distribution of the workload is far from being homogeneous as a result of the existing inhomogeneous electromagnetic field. The aim of this study is to survey the heat thus field distribution in the workload to prevent local overheating that endangers the quality of the pharmaceutical product. Thermography as a non perturbing thermometrical method was used to map the heat distribution in the workload. To get a 3D information Teflon layers were used to form cross-sectional and photogenic surfaces about the dusty blend and a purpose-developed software to evaluate qualitatively the IR pictures.

[Formulation of a capsule preparation with high active ingredient content using re-crystallized drug compound]. / Nagy hatóanyagtartalmú kapszulázott készítmény formulálása attkristályosított hatóanyag alkalmazásával.

Richter Gedeon Company aimed to manufacture and launch a generic product, that's original is already on market in Hungary. The goal of a generic development is to produce an essentially similar product to the original one. It seems to be simple and routine work, but during the formulation a couple of problems have to be solved. Our active agent was voluminous therefore we could not fill the whole quantity of the active, even without any excipients. In addition the flow property of the powder mixture were very bad, and it may cause inaccurate capsule filling and significant differences in the weight of the filled capsules. During the formulation we managed to assure the appropriate physical properties of the agent by re-crystallisation. We changed the excipients used in the first trials. Chemically these were the same, but with different physical features.

[The generic Research and Development possibilities after Hungary accessed th European Patent Convention]. / A magyar generikus készítményfejlesztés lehetósége az iparjogvédelem tükrében.

January 1, 2003 Hungary became a member of the Munich Convention on the Grant of European Patents (European Patent Convention, EPC). As from January 1, 2003 European patents may be claimed and obtained also for Hungary and European applications may be filed with the Hungarian Patent Office as well. This paper focuses on the exceptional generic R&D possibilities which can harmonize in harmony with all the claims of the Union in spite of the fact that it does not follow general European limitations and practises. Based on the amended Hungarian Patent Law (No. XXXIII of 1995 on the Protection of Inventions by Patents; Article 19 (6)b)) the exclusive right of exploitation shall not extend to acts done for experimental purposes relating to the subject matter of the invention, including experiments and tests necessary for the registration of medicines as well. The national and international legal history and background of the operative Hungarian Patent Law are also presented roughly. The paper deals with the divergence of the originator-generic industry and the EU-USA industry and with the incoherence within the EU itself on the early testing permissions and limitations.