November / December 2022 Archives

Are agile supply chain management and blockchain beneficial to industry and patients? Focus group with healthcare and pharmaceutical professionals. Part 2

6 December 2022 No Comments

Healthcare and pharmaceutical companies daily deal with a variety of corporative use cases with downstream impacts on patients that also have upstream effects on performance and innovation. There is an unmet need in this industry for supply chain management, as it is only recently emerging. Pilot projects are already underway, and some have already been adopted by some companies.
By using a focus group method with industry professionals and subject matter experts, this paper will examine whether blockchain and agile supply chains can contribute to healthcare and pharmaceutical innovation.
In this study, data collected and analyzed was used to evaluate the degree to which industry leaders and professionals are aware of blockchain and its role in supporting and generating innovation in agile supply chains.
Using network analysis to uncover respondents’ relationships and connections, we can determine how blockchain and agile supply chain management are interconnected.

Tapinarof

6 December 2022 No Comments

Plaque psoriasis is a common, chronic, immune-mediated disease characterized by scaly, erythematous, and

Survey finds high levels of early adoption of EMA’s centralized clinical trials information system

6 December 2022 No Comments

Early feedback from European and US pharma companies using the EMA’s new clinical trials information system (CTIS) is remarkably positive, according to an Arriello survey. Arriello’s Kieran O’Donnell and Nicola Kidman reveal the survey findings.

Integrating Quality into production to drive cost-effective innovation

6 December 2022 No Comments

As innovative biotech products and personalised therapies progress from lab-based scientific research to human clinical trials and full-scale production, companies are being forced to adapt their Quality processes. Dr. Eduard Cayón of Rephine/ TDV explains how reimagining Quality processes can help get these potentially expensive emerging therapies to market.

Particle Engineering to Optimise the Performance of Inhaled Therapeutics

6 December 2022 No Comments

Aerosol dispersion and deposition performance from dry powder inhalers are dependent on drug particle aerodynamic diameter and size distribution, formulation composition (including surface modification and bulking agents), inhaler device and patient operation. This review will focus on ‘bottom-up’ particle engineering technologies for providing drug delivery by dry powder inhalation. By ‘designing-in’ performance of drug particles and/or drug composite systems, emerging commercial ‘bottom-up’ particle formation technologies allow for the generation of powders that exhibit good aerodynamic performance, excellent inter- and intra-batch variability with less dependence on the delivery device, as well as enhanced physical and chemical stability. There is an opportunity to obtain co-deposition of drug and carrier materials, surface acting agents and / or multiple drugs at the same site of dissolution / absorption that can lead to an improved clinical outcome for both local and systemic delivery.

REACH REGULATION: What’s new about polymers

5 December 2022 No Comments

FOREWORD People and the environment are widely exposed to polymers, the main constituents of

Progress in flow chemistry

5 December 2022 No Comments

The inventory in a flow reactor at any point is a small fraction of the total material being processed. This is an inherently better solution than batch methods in virtually all respects. Capability, however, is dictated by the flow reactor type and size. Current devices generally fall into three areas of use: micro reactors for research, specialised reactors for difficult or dangerous chemistry and large dedicated flow reactors for bulk chemicals. Despite progress, over 90% of industrial chemicals by type are still made in batch reactors. Large parts of the process industries rely on high volume reactors capable of handling different operations. The underlying principles for equivalent capability in flow are well established but as yet, underexploited.

Topical drug delivery and the role of excipients

5 December 2022 No Comments

It is widely accepted that excipients play a crucial role in efficacy, safety and quality of medicinal products. For topical drug delivery, there are particular aspects to consider. Excipients are responsible for the perception of the product by the patient and directly impact on well-being and adherence to the therapy. They can have a direct impact on the efficacy, e.g. through moisturizing or antimicrobial effects. Indirectly, they can influence efficacy through chemical penetration enhancement. More than 500 excipients are approved for topical drug delivery by the FDA. Many of them are complex and show substantial variability in potentially critical material attributes, which may affect the quality of the resulting drug product. Therefore, appropriate characterization is essential for the development of robust products.

Titanium Dioxide: updates

5 December 2022 No Comments

This article provides some insight on the following question: why is Europe on a course that will require the removal of titanium dioxide (TiO2) from 91,000 medicines in the EU at the estimated cost of €32bn, with potentially significant delays to the approval of new medicinal products and the potential to impact the availability of medicines in the EU?
An insight into this topic can be found in the Interim Position Paper from the Committee on Toxicology (COT) (1) which provides a useful summary of the titanium dioxide story over the last 6 years.

Applications of polymeric resins in medical devices for life saving treatments

5 December 2022 No Comments

Polymeric chromatographic resin beads are extensively used in life-saving and life-supporting medical devices. Applications include liver and kidney dialysis, for detoxification relating to hepatitis, alcohol/drug misuse, cirrhosis, fatty liver or cancers or for treating kidney chronic diseases. Other application where polymeric resins find application as medical devices is enteral nutrition for patients suffering from Cystic fibrosis, or for treatment of patients before organ transplantation, to ensure higher rates of survival, or as a treatment for several autoimmune disorders by therapeutic removal of antibodies and molecules from plasma, used. Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proven safe and effective before regulating bodies permit the device to be marketed in their country. This paper will explore applications of chromatographic separation resins in medical devices, differentiations of classifications of medical devices, and typical regulatory compliance requirements for polymeric beads when incorporated into medical devices or diagnostics.

Issue: November / December 2022

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