1,721,679 research outputs found
Merck KGaA Darmstadt, Germany : Financial case study
No full textComptabilité, Contrôle, FinanceBeing part of the most important industries in the world, the pharmaceutical industry is subject to an increasingly constraining regulation and is also facing a large set of ethical issues. Indeed, while seeking profitability, pharmaceutical companies have a moral obligation toward society to provide drugs to everyone at affordable prices, especially in emerging countries. Considering all the controversies in the last few years, pharmaceutical companies became aware of the need to be proactive in order to restore their reputation, thus they started to integrate the Corporate Social Responsibility (CSR) in their business. Neglecting the CSR arouses vehement criticism by media, NGOs or consumers. This concept takes social, environmental and economic concerns into account but also interactions with all the stakeholders on a voluntary basis. In other words, it is the companies’ contribution to the key sustainable development issues. The oldest pharmaceutical and chemical company worldwide, Merck KGaA, is constantly proving its commitment in CSR by implementing many different actions in developing countries and being more transparent with the stakeholders. The German company is specialized in 3 core businesses of which Healthcare (focused on general medicine, endocrinology and fertility) represents the major proportion of the sales. Within a strategy of dynamic growth, Merck KGaA realized in 2015 its largest acquisition with Sigma-Aldrich for 17 billion dollar. Although being well-known and offering a huge products portfolio developed by a powerful R-D, the company is evolving in a highly competitive market with a strong price pressure given that governments apply austerity measures cutting the health’s budget, thus restricting drugs’ reimbursements. Nevertheless, knowing that drug-based therapies are widely predominant and necessary to treat severe diseases, it doesn’t jeopardize the viability of the company’s activities. In fact, Merck KGaA is performing quite well in terms of financial data. Since the Sigma-Aldrich acquisition, the company benefits from synergy effects by increasing its net sales from 11 363 million € in 2013 to 15 024 million € in 2016 and also manages to cover all its costs (operating expenses, interests, taxes) which leads to create wealth over the 3 years. However, the acquisition upset the consolidated accounts and some key financial indicators. As a matter of fact, the increase of the capital employed with a stable operating profit, has a negative impact of the return on capital employed which falls from 10,75% to 5,46% in 2015. The working capital was also impacted by Sigma-Aldrich by extending the payment terms of receivables and increasing the inventory. Short-term liabilities became higher than current assets which could affect the repayment’s ability of the company. Moreover, the level of indebtedness raised from 0,04 to 0,97 which is a significant increase but still lower than 1. The net debt isn’t alarming because the management board aims to reduce it quickly in the following years. Listed on the DAX, Merck KGaA’s average share price increased from 65,92 € to 91,52 € once the process of acquisition was totally completed. Investors were uncertain and reluctant about the consequences of such an event. One specific point is that the Merck family owns 70% of the capital. The company isn’t distributing too many dividends and the strategy is to reinvest the money in further projects. However, reaching a price-to-book ratio above 1, indicates that the return on equity is higher than the profitability expected by shareholders. Investors are also willing to pay more for a Merck KGaA’s share owing to anticipations concerning earnings rises. Last but not least, it would be advisable for shareholders who seek some safety on their investment to invest in a stable business such as Merck KGaA
Flexoelectric polarisation effects in nematic liquid crystal phase gratings
Get PDFNematic phase gratings have been studied in which a planar nematic layer of thickness 17.2 μm is sandwiched between two glass substrates coated with an alignment polymer. The upper substrate is a continuous earth plane and the lower substrate has a patterned electrode of interdigitated stripes (electrodes and gaps are both 40 μm wide). Reorientation of the nematic liquid crystal occurs in response to d.c. electric fields applied between the interdigitated electrodes. These nematic reorientation regions have been used to investigate the influence of the flexoelectric polarisation in the nematic liquid crystal by observing the resultant (i) movement of tilt fringes in a Mach-Zehnder interferometer, and (ii) optical diffraction patterns. In the Mach-Zehnder interferometer the periodic variation of the refractive index resulting from the periodic distortion profile is measured directly from the displacement of the tilt fringes. The asymmetry in the response to positive and negative polarities of the d.c. voltage for both measurement techniques is directly related to the sum of the flexoelectric coefficients, e1 + e3
Interferometric method for determining the sum of the flexoelectric coefficients (e1+e3) in an ionic nematic material
Get PDFThe time-dependent periodic distortion profile in a nematic liquid crystal phase grating has been measured from the displacement of tilt fringes in a Mach-Zehnder interferometer. A 0.2 Hz squarewave voltage was applied to alternate stripe electrodes in an interdigitated electrode geometry. The time-dependent distortion profile is asymmetric with respect to the polarity of the applied voltage and decays with time during each half period due to ionic shielding. This asymmetry in the response allows the determination of the sum of the flexoelectric coefficients (e1+e3) using nematic continuum theory since the device geometry does not possess inherent asymmetry
Results of urine sample testing before and after treatment of NPF and Merck KgaA praziquantel with respect to gender.
No full textResults of urine sample testing before and after treatment of NPF and Merck KgaA praziquantel with respect to gender.</p
Novel process analytical technological approaches of dynamic image analysis for pharmaceutical dry particulate systems
Get PDFWith the introduction of Process Analytical Technology (PAT) and Quality by Design (QbD) concepts by the Food and Drug Administration (FDA) the pharmaceutical industry is thriving towards improved process understanding. Subsequently, the pharmaceutical industry shifted the focus on the implementation of new technologies for real-time process control of various unit operations. Enhanced process understanding will result in a robust process and eventually enable quality by design into the product.
Inline with this PAT concept of improving process understanding and enhancing manufacturing efficiency, the objectives of this research work were to introduce and implement novel technologies of dynamic image analysis (DIA). The novel DIA approaches would allow for real-time (on-line) particle size and shape monitoring in a pharmaceutical dry milling unit operation and subsequently flowability characterization (at-line) of the milled material for pharmaceutical powders and granules.
For the first objective we employed a pilot-scale conical mill and investigated two DIA sensors, one as on-line mode and the other as in-line mode, for real-time particle size and shape monitoring. We selected different pharmaceutical excipients and placebo granulates, spanning a wide range of particle characteristics, for milling. Various mill parameters such as feeder speed, impeller speed, and screen sizes were considered. The particle size distribution results obtained from both the on-line and in-line modes were compared with a commercially available DIA instrument, which served as an at-line reference. Additionally, the data was also compared with the traditional sieve analysis. The results from the on-line, in-line and at-line DIA measurement modes showed similar particle size distributions for the various materials studied. However, few differences among the different DIA modes were observed that were mainly attributed to sampling and particle dispersion. A high correlation of 0.975 (p<0.001) was observed between on-line d50 and at-line d50 when compared to 0.917 (p<0.001) between in-line d50 and at-line d50. Finally, the on-line sensor was chosen as it provided robust results. A novel concept of time evolving size and shape analysis (TESSA) was successfully proposed for the first time in dry milling. The TESSA approach was found to be useful in detecting changes in milling conditions including the successful detection of a damaged screen when intentionally introduced in the milling process.
In the second objective we introduced a modern instrument, which combines powder avalanching with DIA to enable a comprehensive understanding of the flow behaviour of pharmaceutical powder formulations. The flow characterization of such formulations is essential as they can pose a challenge for upstream solid dosage manufacturing such as tabletting (die filling) and capsulation (weight variation). A commercial powder avalanching instrument existed earlier, but it lacked dynamic image analysis and further provided very few avalanching parameters such as mean time to avalanche and scatter values. The novel instrument used in this study provides image analysis of the motion of a powder inside a rotating drum and results in several parameters associated with powder avalanching such as avalanche time, avalanche angle, and avalanche power in addition to several other parameters. We initially tested the suitability of this modern instrument for flow characterization of binary blends, comprising of a coarse excipient and fine drug particles, and further introduced the concept of critical flow concentrations (CFCs). At least three drug concentrations were identified for which the flow behaviour, of the binary blends, essentially changed. Accordingly, different flow regions were identified, which were explained on the basis of changed particle packing configurations. A theoretical model successfully provided a first estimate of the initial two CFCs. The novel avalanche testing instrument used in this work provided complementary information to conventional flowability methodologies such as flow through an orifice. A thorough assessment of pharmaceutical blends is needed to avoid CFCs in view of a robust formulation development and hence with respect to building quality into the design of the solid dosage forms. Later, we used the powder avalanching instrument for characterizing the flow behaviour of the milled materials produced from the conical mill.
In the third objective we implemented the on-line DIA sensor in the conical mill and further tested the feasibility of the avalanching instrument as a potential at-line PAT tool for powder flow characterization. We conducted a response surface design in combination with robustness testing (Taguchi design). Both of these designs employed the conical mill, together with the on-line DIA sensor and the powder avalanching instrument. The mill process parameters, namely impeller speed and screen sizes significantly affected the particle size distribution and flow rate of the milled placebo granules. Feeder speed did not affect the particle size, but displayed a statistically significant influence on the flow responses. Robustness testing was able to capture the effect of assigned noise factors (different placebo lots and temperature conditions) on the responses and showed clear differences between different lots of the placebo granulates in addition to temperature-dependent changes in flow behaviour. Eventually, the powder avalanching instrument was proved to be a successful at-line PAT tool.
The dynamic image analysis PAT tools investigated in this research work provided a novel source of understanding the particle characteristics (size and shape) and flow behaviour of pharmaceutical powders and dry milled granules. Adequate characterization of particle size as well as shape and flowability is essential for upstream solid dosage form manufacturing. Thus, on-line particle size monitoring and at-line flowability characterization using the presented novel DIA techniques together, as complementary process analytical tools, provides valuable information for industrial characterization of pharmaceutical dry particulate systems, namely powders and granules
Results of urine sample testing before and after treatment of NPF and Merck KgaA praziquantel with respect to the degree of infection.
No full textResults of urine sample testing before and after treatment of NPF and Merck KgaA praziquantel with respect to the degree of infection.</p
Testing Drugs and Testing Limits: Merck KGaA v. Integra Lifesciences I, Ltd. and the Scope of the Hatch-Waxman Safe Harbor Provision
Get PDFHareid, Jonathan A.. (2006). Testing Drugs and Testing Limits: Merck KGaA v. Integra Lifesciences I, Ltd. and the Scope of the Hatch-Waxman Safe Harbor Provision. Retrieved from the University Digital Conservancy, https://hdl.handle.net/11299/155981
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