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Background: Although a variety of drug delivery devices have been launched in recent years, few studies have comprehensively investigated the market trends of combination drugs and medical devices approved or certified in Japan and the regulatory challenges related to their approval. Among the drug delivery devices, autoinjectors are more convenient than traditional prefilled syringes and are designed with safety features to prevent needlestick accidents, allowing self-injection by patients. Therefore, autoinjectors have been incorporated into the treatment of various diseases and have shown significant growth among drug delivery devices., Aim: This study aimed to investigate the market trends of combination drugs approved in Japan, especially those with autoinjector formulations, and to explore the challenges in the regulatory aspects of combination drugs., Methods: Information on the number of marketed drugs and medical devices was obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) database using specific definitions. We looked at the annual changes in the number of drug delivery devices approved and certified as combination drugs or medical devices and the number of canceled certifications. We also examined the classification and main certification criteria for Japanese medical device nomenclature., Results: The study suggested that the number of combination drugs with autoinjector formulations is increasing, replacing previously approved or certified pen-type medication injectors. Moreover, 53% of all drug products were approved for autoinjector formulations after the initial authorization approval in Japan, and more than half of them obtained approval for additional formulations for autoinjectors within five years of the initial authorization approval, with the largest number of cases obtaining approval for additional formulations two years later., Conclusion: The lack of clear regulatory requirements for autoinjectors may lead to confusion among applicants. Furthermore, there are challenges in filing regulatory applications, thus hindering the rapid launch of combination drug-utilizing devices with superior usability., Competing Interests: MM was employed by MSD K.K. The remaining author declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Mochizuki and Maeda.)

With the advent of antibiotic-eluting polymeric materials for targeting recalcitrant infections, using preclinical models to study biofilm is crucial for improving the treatment efficacy in periprosthetic joint infections. The stratification of risk and severity of infections is needed to develop an effective clinical dosing framework with better outcomes. Here, using in-vivo and in-vitro implant-associated infection models, we demonstrate that methicillin-sensitive and resistant Staphylococcus aureus (MSSA and MRSA) have model-dependent distinct implant and peri-implant tissue colonization patterns. The maturity of biofilms and the location (implant vs tissue) were found to influence the antibiotic susceptibility evolution profiles of MSSA and MRSA and the models could capture the differing host-microbe interactions in vivo. Gene expression studies revealed the molecular heterogeneity of colonizing bacterial populations. The comparison and stratification of the risk and severity of infection across different preclinical models provided in this study can guide clinical dosing to effectively prevent or treat PJI., Competing Interests: O.K.M. declares the following disclosures: Royalties - Corin, Mako, Iconacy, Renovis, Arthrex, ConforMIS, Meril Healthcare, Exactech, Cambridge Polymer Group; Stake/Equity-Cambridge Polymer Group, Orthopedic Technology Group, Alchimist. E.O. declares the disclosures: Royalties-Corin, Iconacy, Renovis, Arthrex, ConforMIS, Meril Healthcare, Exactech; Paid consultant – WL Gore & Assoc; Editorial Board – JBMR; Officer/Committee- SFB, ISTA. None of these are in direct conflict with the study.

We aimed to determine the efficacy of the various available oral, topical, and procedural treatment options for hair loss in individuals with androgenic alopecia. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of the National Library of Medicine was performed. Overall, 141 unique studies met our inclusion criteria. We demonstrate that many over the counter (e.g. topical minoxidil, supplements, low-level light treatment), prescription (e.g. oral minoxidil, finasteride, dutasteride), and procedural (e.g. platelet-rich plasma, fractionated lasers, hair transplantation) treatments successfully promote hair growth, highlighting the superiority of a multifaceted and individualized approach to management.

Dissolution of drug from its solid form to a dissolved form is an important consideration in the design and optimization of drug delivery devices, particularly owing to the abundance of emerging compounds that are extremely poorly soluble. When the solid dosage form is encapsulated, for example by the porous walls of an implant, the impact of the encapsulant drug transport properties is a further confounding issue. In such a case, dissolution and diffusion work in tandem to control the release of drug. However, the interplay between these two competing processes in the context of drug delivery is not as well understood as it is for other mass transfer problems, particularly for practical controlled-release considerations such as an encapsulant layer around the drug delivery device. To address this gap, this work presents a mathematical model that describes controlled release from a drug-loaded device surrounded by a passive porous layer. A solution for the drug concentration distribution is derived using the method of eigenfunction expansion. The model is able to track the dissolution front propagation, and predict the drug release curve during the dissolution process. The utility of the model is demonstrated through comparison against experimental data representing drug release from a cylindrical drug-loaded orthopedic fixation pin, where the model is shown to capture the data very well. Analysis presented here reveals how the various geometrical and physicochemical parameters influence drug dissolution and, ultimately, the drug release profile. It is found that the non-dimensional initial concentration plays a key role in determining whether the problem is diffusion-limited or dissolution-limited, whereas the nature of the problem is largely independent of other parameters including diffusion coefficient and encapsulant thickness. We expect the model will prove to be a useful tool for those designing encapsulated drug delivery devices, in terms of optimizing the design of the device to achieve a desired drug release profile., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

The study in this paper presents a new material that was produced as a thin film by the Pulsed Laser Deposition technique (PLD) using a 532 nm wavelength and 150 mJ/pulse laser beam on the hemp stalk as target. The analyses performed by spectroscopic techniques (Fourier Transform Infrared Spectroscopy-FTIR, Laser-Induced Fluorescence Spectroscopy-LIF, Scanning Electron Microscopy coupled with Energy Dispersive X-ray-SEM-EDX, Atomic Force Microscopy-AFM and optical microscope) evidenced that a biocomposite consisting of lignin, cellulose, hemicellulose, waxes, sugars and phenolyc acids p -coumaric and ferulic, similar to the hemp stalk target was obtained. Nanostructures and aggregated nanostructures of 100 nm to 1.5 μm size were evidenced. Good mechanical strength and its adherence to the substrate were also noticed. It was noticed that the content in calcium and magnesium increased compared to that of the target from 1.5% to 2.2% and from 0.2% to 1.2%, respectively. The COMSOL numerical simulation provided information on the thermal conditions that explain phenomena and processes during laser ablation such as C-C pyrolisis and enhanced deposition of calcium in the lignin polymer matrix. The good gas and water sorption properties due to the free OH groups and to the microporous structure of the new biocomposite components recommends it for studies for functional applications in medicine for drug delivery devices, filters in dialysis and for gas and liquid sensors. Functional applications in solar cells windows are also possible due to the conjugated structures of the contained polymers.

Objective: While interest in the use of wearable large-volume injectors for subcutaneous drug delivery is increasing, it remains unclear whether and under what conditions these emerging dosing options are preferred over more frequent but shorter administration of smaller doses using handheld autoinjectors. Therefore, the objective of this study was to examine the characteristics of patients diagnosed with cancer, diabetes, inflammatory and cardiovascular diseases, and treatment attributes that determine device preferences., Methods: Based on a cross-sectional online choice experiment, 191 participants expressed their preferences without being physically exposed to the devices or performing injections. Logistic hierarchical regression models were used to assess which patient characteristics, and how changes in treatment attributes, drive device preferences., Results: Participant quality of life reduced the likelihood of preferring wearable large-volume injectors to handheld autoinjectors. Moreover, reducing injection frequency from biweekly to monthly to quarterly injections, and shortening injection duration from 33 to 8 min, significantly increased the likelihood of patients preferring large-volume injectors to autoinjectors ( p < 0.001)., Conclusion: The study revealed patient quality of life as predictor of device preference and identified critical inflection points in injection duration and injection frequency, at which patient preferences shift from handheld autoinjectors to wearable large-volume injectors.

Pediatric medication in China is characterized by a lack of child-specific drugs and insufficient types, specifications, dosage forms, and delivery devices. In recent years, new dosage forms with good compliance, such as inhalation preparation, rectal delivery system, and transdermal delivery system, have attracted more attention in pediatric medication. Because of the physiological characteristics of delicate viscera, difference in swallowing ability and psychological characteristics of fear of pain and aversion to bitter taste, it is particularly important to select suitable drug delivery route and drug delivery device according to children's physiological characteristics. With the help of the special drug delivery devices, traditional Chinese medicine and innovative Chinese medicine can be administered according to the expected design path, and drug delivery devices can ensure the accurate dose and improve the complia-nce to achieve the purpose of effective and safe drug delivery. It is also a way to realize the re-innovation of traditional Chinese medicine. The present study summarized the research progress in drug delivery devices for common drug delivery routes and new drug deli-very routes, put forward the innovative design idea of children's drug delivery devices according to the special needs of children, poin-ted out the compatibility of drug delivery devices and other problems in the current development, and prospected the application of intelligent information technology and additive manufacturing technology in drug delivery device innovation. This is expected to provide references for the development of innovative drugs and drug delivery devices suitable for children's multidimensional demand for medication.

In this paper, two mathematical models have been formulated by extending the basic reaction-diffusion model, along with suitable initial and boundary conditions to study the drug delivery and its diffusion in biological tissues from multi-layered capsules/tablets and other drug delivery devices (DDDs), respectively. These devices are either taken orally or through other drug-administration routes. The formulated models are solved using the variational finite element method followed by the fundamental matrix method, to study the drug delivery and its diffusion more efficiently. The main aim of this work is to provide an effective model, using optimal mathematical techniques to help researchers and biologists in medicine in decreasing the endeavours and expenses in designing DDDs. The outcomes obtained are compared with the experimental data to demonstrate the validity and the feasibility of the proposed work.

We demonstrate a novel structure based on smart carbon nanocomposites intended for fabricating laser-triggered drug delivery devices (DDDs). The performance of the devices relies on nanocomposites' photothermal effects that are based on polydimethylsiloxane (PDMS) with carbon nanoparticles (CNPs). Upon evaluating the main features of the nanocomposites through physicochemical and photomechanical characterizations, we identified the main photomechanical features to be considered for selecting a nanocomposite for the DDDs. The capabilities of the PDMS/CNPs prototypes for drug delivery were tested using rhodamine-B (Rh-B) as a marker solution, allowing for visualizing and quantifying the release of the marker contained within the device. Our results showed that the DDDs readily expel the Rh-B from the reservoir upon laser irradiation and the amount of released Rh-B depends on the exposure time. Additionally, we identified two main Rh-B release mechanisms, the first one is based on the device elastic deformation and the second one is based on bubble generation and its expansion into the device. Both mechanisms were further elucidated through numerical simulations and compared with the experimental results. These promising results demonstrate that an inexpensive nanocomposite such as PDMS/CNPs can serve as a foundation for novel DDDs with spatial and temporal release control through laser irradiation.

The 'one-size-fits-all' approach followed by conventional drug delivery platforms often restricts its application in pharmaceutical industry, due to the incapability of adapting to individual pharmacokinetic traits. Driven by the development of additive manufacturing (AM) technology, three-dimensional (3D) printed drug delivery medical devices have gained increasing popularity, which offers key advantages over traditional drug delivery systems. The major benefits include the ability to fabricate 3D structures with customizable design and intricate architecture, and most importantly, ease of personalized medication. Furthermore, the emergence of multi-material printing and four-dimensional (4D) printing integrates the benefits of multiple functional materials, and thus provide widespread opportunities for the advancement of personalized drug delivery devices. Despite the remarkable progress made by AM techniques, concerns related to regulatory issues, scalability and cost-effectiveness remain major hurdles. Herein, we provide an overview on the latest accomplishments in 3D printed drug delivery devices as well as major challenges and future perspectives for AM enabled dosage forms and drug delivery systems., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Pay-load deliveries across the skin barrier to the systemic circulation have been one of the most challenging delivery options. Necessitated requirements of the skin and facilitated skin layer cross-over delivery attempts have resulted in development of different non-invasive, non-oral methods, devices and systems which have been standardized, concurrently used and are in continuous upgrade and improvements. Iontophoresis, electroporation, sonophoresis, magnetophoresis, dermal patches, nanocarriers, needled and needle-less shots, and injectors are among some of the methods of transdermal delivery. The current review covers the current state of the art, merits and shortcomings of the systems, devices and transdermal delivery patches, including drugs' and other payloads' passage facilitation techniques, permeation and absorption feasibility studies, as well as physicochemical properties affecting the delivery through different transdermal modes along with examples of drugs, vaccines, genes and other payloads.

Oral administration is a pillar of the pharmaceutical industry and yet it remains challenging to administer hydrophilic therapeutics by the oral route. Smart and controlled oral drug delivery could bypass the physiological barriers that limit the oral delivery of these therapeutics. Micro- and nanoscale technologies, with an unprecedented ability to create, control, and measure micro- or nanoenvironments, have found tremendous applications in biology and medicine. In particular, significant advances have been made in using these technologies for oral drug delivery. In this review, we briefly describe biological barriers to oral drug delivery and micro and nanoscale fabrication technologies. Micro and nanoscale drug carriers fabricated using these technologies, including bioadhesives, microparticles, micropatches, and nanoparticles, are described. Other applications of micro and nanoscale technologies are discussed, including fabrication of devices and tissue engineering models to precisely control or assess oral drug delivery in vivo and in vitro, respectively. Strategies to advance translation of micro and nanotechnologies into clinical trials for oral drug delivery are mentioned. Finally, challenges and future prospects on further integration of micro and nanoscale technologies with oral drug delivery systems are highlighted., (Copyright © 2020. Published by Elsevier B.V.)

This is an overview of the current drug delivery systems (DDSs) starting with various routes of drug administration. Various drug formulations are then described as well as devices used for drug delivery and targeted drug delivery. There has been a considerable increase in the number of new biotechnology-based therapeutics. Most of these are proteins and peptides, and their delivery present special challenges. Cell and gene therapies are sophisticated methods of delivery of therapeutics. Nanoparticles are important for refining drug delivery. In addition to being vehicles for drug delivery, nanoparticles can be used as pharmaceuticals as well as diagnostics. Most of the advances in targeted drug delivery have occurred in therapy of cancer. Drug delivery to the brain across the blood-brain barrier presents many challenges. Refinements in drug delivery will facilitate the development of personalized medicine. The ideal DDS is defined. Commercial aspects, challenges, and future of DDSs are discussed.

Child-appropriate drug formulations are a prerequisite of successful drug therapy in children. Efficacy and safety must be given for the active pharmaceutical ingredient, but safety also for the used excipients, components of primary packaging materials, and devices. We are presently experiencing exciting times for pediatric drug development, stimulated by previous governmental incentives in both the European Union and the United States. The most important advances in pediatric drug formulation development are reviewed and evaluated in this article. Scientific publications and recent industry strategies indicate a clear shift from liquid dosage forms to novel solid dosage forms. Solid formulations are usually composed from excipients generally regarded as safe, whereas many liquid formulations contain excipients such as preservatives, antioxidants, or taste-masking agents that raise concerns. Further, some recent clinical studies on swallowability, acceptability, and preference indicate superiority for small-sized tablets, so-called mini-tablets, over conventional liquids. In general, multiparticulate solid dosage forms could partly replace the liquids and provide more stable and cheaper alternatives to existing drug products or new developments. Dispersible solid drug dosage forms like orodispersible tablets, mini-tablets and films are even better opportunities for efficient and safe use in pediatrics. Novel measuring and administration devices may facilitate the handling and drug administration of these modern drug dosage forms. Combination products (drug-device combinations) can easily be linked with new e-health technologies in near future to further improve pediatric drug therapy., (© 2018, The American College of Clinical Pharmacology.)

Despite being the fifth most common cancer in the United States, minimal progress has been made in the treatment of bladder cancer in over a decade. Intravesical instillation of Bacillus Calmette-Guerin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) has been in use for over 30 years and remains the standard treatment in cases of intermediate and high risk disease. Despite the relative success of intravesical BCG, unmet needs in the treatment of NMIBC persist. These challenges include disease recurrence and progression even with treatment with BCG, as well as issues regarding its availability and patient tolerability. The inherent properties of the bladder pose the biggest obstacle to developing effective intravesical treatments for NMIBC. Current research is now focusing on methods to improve the delivery of intravesical therapies. The objective of this review is to discuss novel intravesical drug delivery systems and how they are addressing these challenges in the treatment of NMIBC.