3 resultados para Prescription drugs

em ArchiMeD - Elektronische Publikationen der Universität Mainz - Alemanha


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Pharmacological cognitive enhancement (CE) is a topic of increasing public awareness. In the scientific literature on studentrnuse of CE as a study aid for academic performance enhancement, there are high prevalence rates regarding the use ofrncaffeinated substances (coffee, caffeinated drinks, caffeine tablets) but remarkably lower prevalence rates regarding the usernof illicit/prescription stimulants such as amphetamines or methylphenidate. While the literature considers the reasons andrnmechanisms for these different prevalence rates from a theoretical standpoint, it lacks empirical data to account for healthyrnstudents who use both, caffeine and illicit/prescription stimulants, exclusively for the purpose of CE. Therefore, wernextensively interviewed a sample of 18 healthy university students reporting non-medical use of caffeine as well as illicit/rnprescription stimulants for the purpose of CE in a face-to-face setting about their opinions regarding differences in generalrnand morally-relevant differences between caffeine and stimulant use for CE. 44% of all participants answered that there is arngeneral difference between the use of caffeine and illicit/prescription stimulants for CE, 28% did not differentiate, 28% couldrnnot decide. Furthermore, 39% stated that there is a moral difference, 56% answered that there is no moral difference andrnone participant was not able to comment on moral aspects. Participants came to their judgements by applying threerndimensions: medical, ethical and legal. Weighing the medical, ethical and legal aspects corresponded to the students’rnindividual preferences of substances used for CE. However, their views only partly depicted evidence-based medical aspectsrnand the ethical issues involved. This result shows the need for well-directed and differentiated information to prevent thernpotentially harmful use of illicit or prescription stimulants for CE.

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Iron deficiency is the most common deficiency disease worldwide with many patients who require intravenous iron. Within the last years new kind of parenteral iron complexes as well as generic preparations entered the market. There is a high demand for methods clarifying benefit to risk profiles of old and new iron complexes. It is also necessary to disclose interchangeability between originator and intended copies to avoid severe anaphylactic and anaphylactoid side reaction and assure equivalence of therapeutic effect.rnrnThe investigations presented in this work include physicochemical characterization of nine different parenteral iron containing non-biological complex drugs. rnWe developed an in-vitro assay, which allows the quantification of labile iron in the different complexes and thus it is a useful tool to estimate the pharmaclogical safety regarding iron related adverse drug events. This assay additionally allowed the estimation of complex stability by evaluation of degradation kinetics at the applied conditions.rnrnAn in-ovo study was performed to additionally compare different complexes in respect to body distribution. This in combination with complex stability information allowed the risk estimation of potential local acute and chronic reactions to iron overload.rnrnInformation obtained by the combination of the methods within this work are helpful to estimate the safety and efficacy profile of different iron containing non-biological complex drugs. rnrnPhysicochemical differences between the complexes were demonstrated in respect to size of the inorganic fraction, size and size distribution of the complete particles, structure of the inorganic iron fraction, morphology of the complexes and charge of the complexes. And furthermore significant differences in the biological behavior of different complexes were demonstrated. rnrnThe combination of complex stability and biodistribution as well as the combination of structure, size and stability represent helpful tools for the physicochemical characterization of iron containing non-biological complex drugs and for the estimation of pharmacological safety. This work thus represents an up to date summary of some relevant methods for the characterization of intravenous iron complex drugs in respect to pharmaceutical quality, pharmacological safety and aspects of efficacy. rnrnProspectively, it is worthwhile that the methods within this work will contribute to the development and/or characterization of iron containing nanoparticular formulations with beneficial efficacy and safety profiles.rn

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In this study a novel method MicroJet reactor technology was developed to enable the custom preparation of nanoparticles. rnDanazol/HPMCP HP50 and Gliclazide/Eudragit S100 nanoparticles were used as model systems for the investigation of effects of process parameters and microjet reactor setup on the nanoparticle properties during the microjet reactor construction. rnFollowing the feasibility study of the microjet reactor system, three different nanoparticle formulations were prepared using fenofibrate as model drug. Fenofibrate nanoparticles stabilized with poloxamer 407 (FN), fenofibrate nanoparticles in hydroxypropyl methyl cellulose phthalate (HPMCP) matrix (FHN) and fenofibrate nanoparticles in HPMCP and chitosan matrix (FHCN) were prepared under controlled precipitation using MicroJet reactor technology. Particle sizes of all the nanoparticle formulations were adjusted to 200-250 nm. rnThe changes in the experimental parameters altered the system thermodynamics resulting in the production of nanoparticles between 20-1000 nm (PDI<0.2) with high drug loading efficiencies (96.5% in 20:1 polymer:drug ratio).rnDrug releases from all nanoparticle formulations were fast and complete after 15 minutes both in FaSSIF and FeSSIF medium whereas in mucodhesiveness tests, only FHCN formulation was found to be mucoadhesive. Results of the Caco-2 studies revealed that % dose absorbed values were significantly higher (p<0.01) for FHCN in both cases where FaSSIF and FeSSIF were used as transport buffer.rn