Power Plus Communications (Germany)

PurposeThe use of two-dimensional (2D) printing technologies of drugs on orodispersible films (ODF) can promote dose individualization and facilitate drug delivery in vulnerable patients, including children. We investigated midazolam pharmacokinetics after the administration of 2D-printed ODF.MethodsMidazolam doses of 0.03 and 3 mg were printed on an ODF using a 2D drug printer. We investigated the bioavailability of the two midazolam doses with ODF swallowed immediately (ODF-IS) or delayed after 2 min (ODF-DS) by comparing their pharmacokinetics with intravenous and oral midazolam solution in 12 healthy volunteers.ResultsThe relative bioavailability of ODF-IS 0.03 mg was 102% (90% confidence interval: 89.4–116) compared to oral solution and for 3 mg 101% (86.8–116). Cmax of ODF-IS 0.03 mg was 95.5% (83.2–110) compared to oral solution and 94.3% (78.2–114) after 3 mg. Absolute bioavailability of ODF-IS 0.03 mg was 24.9% (21.2–29.2) and for 3 mg 28.1% (23.4–33.8) (oral solution: 0.03 mg: 24.4% (22.0–27.1); 3 mg: 28.0% (25.0–31.2)). Absolute bioavailability of ODF-DS was significantly larger than for ODF-IS (0.03 mg: 61.4%; 3 mg: 44.1%; both p < 0.0001).ConclusionThis trial demonstrates the tolerability and unchanged bioavailability of midazolam printed on ODF over a 100-fold dose range, proving the suitability of ODF for dose individualization. Midazolam ODF-IS AUC0–∞ in both doses was bioequivalent to the administration of an oral solution. However, Cmax of the therapeutic dose of ODF-IS missed bioequivalence by a clinically not relevant extent. Prolonged mucosal exposure increased bioavailability. (Trial Registration EudraCT: 2020–003984-24, August 10, 2020).

During the last two years, very little progress has been achieved in the field of standardization pertaining to PLC. But since 2006 a New Work Item Proposal has been accepted for CISPR I by the National Committees and two documents have been published. The Joint Working Group ETSI/CENELEC on the network standard has frozen the work due to disagreement on field limits radiated generally by communication networks. However, new initiatives with a New Work Item Proposal have been taken in CENELEC, namely in Working Group 10 of the SC205A. The development of coexistence standards is making good progress, IEEE and ETSI PLT are the most active bodies in this field. The regulatory procedures in the EU for in-house and access PLC are briefly introduced.

European Power Utilities are facing huge changes these days. The liberalization of the energy market leads to decreased margins as well as national regulatory bodies' demand for higher transparency. Utilities are in need to gather more information about the actual status and load of their electricity grid. Information, is only decentralized available on different sites within the whole power grid. A lot of different communication technologies are used today to collect all the demanded data, e.g. Narrowband PLC or GSM for automatic meter reading, copper twisted pair for the control of RTU (Remote Terminal Units) or fibre optical networks for SCADA (Supervisory Control and Data Acquisition) systems. For each of these applications a new communication network has to be build up and operated. With Broadband Powerline Communication Systems (PLC) utilities could set up one communication platform for the data transportation of all the applications mentioned above. The PLC Technology enables various IP-based services by broadband data transfer from and to every point of the electric network. And this technology enables utilities to use their own infrastructure, the distribution network, as a communication network. This Keynote will present implementation and migration strategies for power utilities to IP based Broadband Powerline Communications Systems. It will show the aspects on a technical and user requirement based approach for enhanced utility communication. Intelligent network and grid communication for industrial and household application will be depicted with respect to existing communication media and applications.

The developing of standards for products and networks used for power line communications (PLC) remains one of the main issues connected with this new technology. Due to the difficulty to achieve consensus for limits not much progress was achieved during the last two years. However, the Regulatory Authorities in US as well as in Europe have recognized the role which this technique can play in increasing the competition among telecommunication providers. The paper will present the state of art in the development of standards, the Regulatory environment and an overview of the PLC deployment in different parts of the world.

An important pillar of European Union's Law Structure is the legal instruments of the European Community. It encompasses regulations, directives, decisions, and recommendations. Concerning the European regulation of Telecommunications the New European Regulatory Framework adopted in 2002 is relevant. The package consists of five Directives and one Regulation to replace the many legislative measures previously in force. The scope of the new package covers satellite and terrestrial networks (fixed or wireless), including the public switched telephone network, networks using Internet protocol (IP), cable TV networks and broadcast network infrastructures. Key aspects relate to significant market power, market entry (licensing), number protability and universal service. The new regulatory framework for electronic communications networks and services is applied in all Member States of the European Union from July 25th, 2003. That is the directives are transposed into the different national legal frameworks. This transposing is the regular procedure for directives to come into force. CE conformity marking - The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives, in particular with regard to the protection of users and consumers. The CE mark ensures free movement of products in the Internal Market of the European Union. Thus, CE marking can be regarded as the products trade passport for Europe. For CE-marking and market access of PLC-equipment the EMC directive 89/336/EEC and the Low Voltage Directive 73/23/EEC are relevant.