Principles of toxicology applied to nanotechnology: risk assessment

Background: Nanotechnologies are developing very rapidly and nanomaterials (NMs) are increasingly being used in a wide range of applications in science, industry and biomedicine.

A new insight about pharmaceutical dosage forms for benzathine penicillin G

In this work, a micellar system of benzathine penicillin G (BPG) in sodium deoxycholate (NaDC) was developed and evaluated physicochemically. The solubility profile of the drug in water and buffer solutions at various pH was determined, as well as its n-octanol/water partition coefficient. The Critical Micellar Concentration of NaDC and its ability to incorporate BPG were also assessed. The study was carried out at low and high ionic strength which was adjusted by the addition of sodium chloride. The results demonstrated the ability of the micellar system to incorporate BPG, as well as to increase its apparent solubility in water. The enhancement of the solubility of BPG by the presence of NaDC micelles could be analyzed quantitatively within the framework of the pseudo-phase model. Concentration analysis showed that the micellar system could attain up to 90% incorporation of BPG. The incorporated drug is expected to exhibit improved stability, since the antibiotic enclosed in the hydrophobic core of micelles is rather shielded from the aqueous external environment

Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

A New Journal in the Field of Pharmaceutical Technology Is Born

International audience

Is the translational approach becoming a reality in nanomedicine?

International audience

Organizational configuration, fit and performance: The case of the pharmaceutical industry in Portugal

Miles e Snow’s configurational theory has received a great deal of attention from many investigators. Framing the Miles e Snow Typology with the organizational configuration concept, the main purpose of this paper is to make an empirical evaluation of what configurational theories postulate: higher organizational performance is associated to the resemblance to one of the ideal types defined. However, as it is often assumed that an organization can increase performance by selecting the adjustable hybrid type to its own exogenous environment, the relation between the organization’s effectiveness and the hybrid configuration alignment to the respective specific environment types was also analyzed. The assumption of equifinality was also considered because the configurational theory assumes that all the ideal types can potentially achieve the same performance level. A multiple regression model was made to confirm if the misfit related to the ideal and hybrid types has significant impact on the organizational effectiveness. The analysis of variance and the Kruskal-Wallis test were used to verify the equality of performance between the different organization types. In short, the empirical results obtained confirm what is postulated in the theory.

Nanotechnology: radical new science or plus ça change?

Is a radical nanotechnology involving the construction of macroscopic products via software-directed manipulation of single molecules possible? Are we only a few decades away from a technological utopia where virtually any product may be constructed via molecular manufacturing? These and other similarly provocative questions formed the backdrop for a well-attended debate on nanotechnology held in the University of Nottingham last year (26 August 2005).

25 years of knowledge creation processes in pharmaceutical contemporary trends

The pharmaceutical industry is knowledge and research-intensive. Due to technological, socio-political and organisational changes there has been a continuous evolution in the knowledge base utilized to achieve and maintain competitive advantages in this global industry. There is a gap in analysing the linkages and effects of those changes on knowledge creation processes associated with pharmaceutical R&D activities. Our paper looks to fill this gap. We built on an idiosyncratic research approach – the systematic literature review – and looked to unearth current trends affecting knowledge creation in international/global pharmaceutical R&D. We reviewed scientific papers published between 1980 and 2005. Key findings include promising trends in pharmaceutical innovation and human resource management, and their potential implications on current R&D practices within the pharmaceutical industry, from managerial and policy-making perspectives.

Voltammetric determination of isoprenaline in pharmaceutical preparations using a copper(II) hexacyanoferrate(III) modified carbon paste electrode

The electroanalytical determination of isoprenaline in pharmaceutical preparations of a homemade carbon paste electrode modified with copper(II) hexacyanoferrate(III) (CuHCF) was studied by cyclic voltammetry. Several parameters were studied for the optimization of the sensor such as electrode composition, electrolytic solution, pH effect, potential scan rate and interferences in potential. The optimum conditions were found in an electrode composition (in mass) of 15% CuHCF, 60% graphite and 25% mineral oil in 0.5 mol l(-1) acetate buffer solution at pH 6.0. The analytical curve for isoprenaline was linear in the concentration range from 1.96 x 10(-4) to 1.07 x 10(-3) mol l(-1) with a detection limit of 8.0 x 10(-5) mol l(-1). The relative standard deviation was 1.2% for 1.96 x 10(-4) mol l(-1) isoprenaline solution (n=5). The procedure was successfully applied to the determination of isoprenaline in pharmaceutical preparations; the CuHCF modified carbon paste electrode gave comparable results to those results obtained using a UV spectrophotometric method. (C) 2004 Elsevier B.V. All rights reserved.

Flow-injection spectrophotometric determination of dipyrone in pharmaceutical formulations using ammonium molybdate as chromogenic reagent

A simple and rapid flow-injection spectrophotometric method is reported for the determination of dipyrone in pharmaceutical formulations. The method is based on the reaction of dipyrone with ammonium molybdate in acidic medium to produce blue molybdenum, which was detected spectrophotometrically at 620 nm. The analyte was determined in a single-line flow system. The calibration curve obtained was linear in the range of 5x10(-4) to 8x10(-3) mol L-1 for dipyrone concentration and the precision ( s r =1.7%) was satisfactory. The method proved to be selective and adequately sensitive. Application of the method to the analysis of pharmaceutical samples resulted in excellent accuracy; the percent mean recoveries were in the range 95.3%-101% and relative errors less than 5.0% for five pharmaceutical formulations were found.

Comparison of the traditional pharmaceutical validation method versus an assisted pharmaceutical validation in hospitalized patients

Objective: To analyze pharmaceutical interventions that have been carried out with the support of an automated system for validation of treatments vs. the traditional method without computer support. Method: The automated program, ALTOMEDICAMENTOS® version 0, has 925 052 data with information regarding approximately 20 000 medicines, analyzing doses, administration routes, number of days with such a treatment, dosing in renal and liver failure, interactions control, similar drugs, and enteral medicines. During eight days, in four different hospitals (high complexity with over 1 000 beds, 400-bed intermediate, geriatric and monographic), the same patients and treatments were analyzed using both systems. Results: 3,490 patients were analyzed, with 42 155 different treatments. 238 interventions were performed using the traditional system (interventions 0.56% / possible interventions) vs. 580 (1.38%) with the automated one. Very significant pharmaceutical interventions were 0.14% vs. 0.46%; significant was 0.38% vs. 0.90%; non-significant was 0.05% vs. 0.01%, respectively. If both systems are simultaneously used, interventions are performed in 1.85% vs. 0.56% with just the traditional system. Using only the traditional model, 30.5% of the possible interventions are detected, whereas without manual review and only the automated one, 84% of the possible interventions are detected. Conclusions: The automated system increases pharmaceutical interventions between 2.43 to 3.64 times. According to the results of this study the traditional validation system needs to be revised relying on automated systems. The automated program works correctly in different hospitals.