Challenges and emerging solutions in the development of compressed orally disintegrating tablets

Areas covered: The review discusses the main challenges of ODT manufacturing process and the emerging solutions featured at early drug development stages. The research specifically describes the methods reported for taste masking/assessment and solubilisation of unpalatable and poorly soluble drugs, respectively. Furthermore, this review highlights the techniques used for developing modified-release ODTs, an emerging area in the field. In addition, it also discusses the poor flowability and segregation problems of directly compressed powders. Moreover, the review describes the tests reported in the literature for ODT disintegration time assessment since a universal technique is still non-existent. Expert opinion: The approaches used to overcome the manufacturing challenges often have a bearing on the price of the end product. However, despite the technical and regulatory challenges, ODTs can offer many advantages over the conventional dosage forms if accompanied by suitable adjuvant technologies and in vitro analytical tools. © 2014 Informa UK, Ltd. Introduction: Orally disintegrating tablets (ODTs) provide several advantages over conventional tablets such as suitability for patients with swallowing difficulties and faster onset of action. The manufacture of ODTs by compression/tableting offers a practical and cost-effective strategy over the freeze drying (lyophilisation) method. Nonetheless, the FDA recommends a disintegration time of 30 s and a maximum weight of 500 mg for a tablet to be labelled as an ODT. These requirements, alongside other desirable product properties, have created a number of challenges for the formulator to overcome while developing compressed ODTs.

A framework for enabling dynamic e-business strategies via new enterprise paradigms and ERP solutions

In the global Internet economy, e-business as a driving force to redefine business models and operational processes is posing new challenges for traditional organizational structures and information system (IS) architectures. These are showing promises of a renewed period of innovative thinking in e-business strategies with new enterprise paradigms and different Enterprise Resource Planning (ERP) systems. In this chapter, the authors consider and investigate how dynamic e-business strategies, as the next evolutionary generation of e-business, can be realized through newly diverse enterprise structures supported by ERP, ERPII and so-called "ERPIII" solutions relying on the virtual value chain concept. Exploratory inductive multi-case studies in manufacturing and printing industries have been conducted. Additionally, it proposes a conceptual framework to discuss the adoption and governance of ERP systems within the context of three enterprise forms for enabling dynamic and collaborative e-business strategies, and particularly demonstrate how an enterprise can dynamically migrate from its current position to the patterns it desires to occupy in the future - a migration that must and will include dynamic e-business as a core competency, but that also relies heavily on ERP-based backbone and other robust technological platform and applications.

The MIMIC model and formative variables:problems and solutions

The use of the multiple indicators, multiple causes model to operationalize formative variables (the formative MIMIC model) is advocated in the methodological literature. Yet, contrary to popular belief, the formative MIMIC model does not provide a valid method of integrating formative variables into empirical studies and we recommend discarding it from formative models. Our arguments rest on the following observations. First, much formative variable literature appears to conceptualize a causal structure between the formative variable and its indicators which can be tested or estimated. We demonstrate that this assumption is illogical, that a formative variable is simply a researcher-defined composite of sub-dimensions, and that such tests and estimates are unnecessary. Second, despite this, researchers often use the formative MIMIC model as a means to include formative variables in their models and to estimate the magnitude of linkages between formative variables and their indicators. However, the formative MIMIC model cannot provide this information since it is simply a model in which a common factor is predicted by some exogenous variables—the model does not integrate within it a formative variable. Empirical results from such studies need reassessing, since their interpretation may lead to inaccurate theoretical insights and the development of untested recommendations to managers. Finally, the use of the formative MIMIC model can foster fuzzy conceptualizations of variables, particularly since it can erroneously encourage the view that a single focal variable is measured with formative and reflective indicators. We explain these interlinked arguments in more detail and provide a set of recommendations for researchers to consider when dealing with formative variables.

Human brain slices for epilepsy research:pitfalls, solutions and future challenges

Increasingly, neuroscientists are taking the opportunity to use live human tissue obtained from elective neurosurgical procedures for electrophysiological studies in vitro. Access to this valuable resource permits unique studies into the network dynamics that contribute to the generation of pathological electrical activity in the human epileptic brain. Whilst this approach has provided insights into the mechanistic features of electrophysiological patterns associated with human epilepsy, it is not without technical and methodological challenges. This review outlines the main difficulties associated with working with epileptic human brain slices from the point of collection, through the stages of preparation, storage and recording. Moreover, it outlines the limitations, in terms of the nature of epileptic activity that can be observed in such tissue, in particular, the rarity of spontaneous ictal discharges, we discuss manipulations that can be utilised to induce such activity. In addition to discussing conventional electrophysiological techniques that are routinely employed in epileptic human brain slices, we review how imaging and multielectrode array recordings could provide novel insights into the network dynamics of human epileptogenesis. Acute studies in human brain slices are ultimately limited by the lifetime of the tissue so overcoming this issue provides increased opportunity for information gain. We review the literature with respect to organotypic culture techniques that may hold the key to prolonging the viability of this material. A combination of long-term culture techniques, viral transduction approaches and electrophysiology in human brain slices promotes the possibility of large scale monitoring and manipulation of neuronal activity in epileptic microcircuits.

Impact of denial of service solutions on network quality of service

The Internet has become a universal communication network tool. It has evolved from a platform that supports best-effort traffic to one that now carries different traffic types including those involving continuous media with quality of service (QoS) requirements. As more services are delivered over the Internet, we face increasing risk to their availability given that malicious attacks on those Internet services continue to increase. Several networks have witnessed denial of service (DoS) and distributed denial of service (DDoS) attacks over the past few years which have disrupted QoS of network services, thereby violating the Service Level Agreement (SLA) between the client and the Internet Service Provider (ISP). Hence DoS or DDoS attacks are major threats to network QoS. In this paper we survey techniques and solutions that have been deployed to thwart DoS and DDoS attacks and we evaluate them in terms of their impact on network QoS for Internet services. We also present vulnerabilities that can be exploited for QoS protocols and also affect QoS if exploited. In addition, we also highlight challenges that still need to be addressed to achieve end-to-end QoS with recently proposed DoS/DDoS solutions. © 2010 John Wiley & Sons, Ltd.