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BACKGROUND: Cyltezo® (Adalimumab-adbm) is an FDA-approved interchangeable biosimilar for Humira® (adalimumab reference product [RP]) that helps treat chronic inflammatory conditions. Adalimumab-adbm is administered via an autoinjector, the adalimumab-adbm pen. This study assessed user opinions related to usability, perceptions, convenience, safety features, and acceptability of the adalimumab-adbm pen. METHODS: 98 Humira Pen users, 100 biologics pen naïve patients, and 99 health care professionals simulated use of the adalimumab-adbm pen on injection pads. Opinions were captured with a validated questionnaire using Likert-type scales during moderated interviews. Binomial tests were conducted for top-two ratings percentages. RESULTS: Nearly 90% of participants found the adalimumab-adbm pen 'easy' or 'very easy' to use, handle, and learn how to use. Almost 90% of volunteers thought the pen was 'very' or 'extremely' solid and convenient to use at home. Around 80% found the pen to be 'very' or 'extremely' comfortable. Over 90% of respondents said they would be 'satisfied' or 'very satisfied' with the safety features and the device itself. Nearly 90% of respondents indicated being 'very' or 'extremely' open to adopting the adalimumab-adbm pen. CONCLUSIONS: The adalimumab-adbm pen provided users with a positive experience with features that benefit perceptions of usability, handling, safety, convenience, and acceptability.

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Hydrogels with particulates, including proteins, drugs, nanoparticles, and cells, enable the development of new and innovative biomaterials. Precise control of the spatial distribution of these particulates is crucial to produce advanced biomaterials. Thus, there is a high demand for manufacturing methods for particle-laden hydrogels. In this context, 3D printing of hydrogels is emerging as a promising method to create numerous innovative biomaterials. Among the 3D printing methods, inkjet printing, so-called drop-on-demand (DOD) printing, stands out for its ability to construct biomaterials with superior spatial resolutions. However, its printing processes are still designed by trial and error due to a limited understanding of the ink behavior during the printing processes. This review discusses the current understanding of transport processes and hydrogel behaviors during inkjet printing for particulate-laden hydrogels. Specifically, we review the transport processes of water and particulates within hydrogel during ink formulation, jetting, and curing. Additionally, we examine current inkjet printing applications in fabricating engineered tissues, drug delivery devices, and advanced bioelectronics components. Finally, the challenges and opportunities for next-generation inkjet printing are also discussed.

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Purpose: We evaluate the safety and intraocular pressure (IOP)-lowering effect of 15-µg bimatoprost implant (higher dose than the currently approved product) compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma or ocular hypertension. Methods: Randomized, phase 3, 12-month, multicenter, paired-eye, patient- and efficacy evaluator-masked noninferiority study. Patients with inadequate IOP control were randomized to receive 360° SLT (day 1) or up to 3 administrations of 15-µg bimatoprost implant (day 4, weeks 16 and 32) in the primary eye and the alternative treatment in the contralateral eye. The primary endpoint was IOP change from baseline at weeks 4, 12, and 24. Results: At weeks 4, 12, and 24, mean IOP change from baseline ranged from -7.01 to -6.65 mm Hg in implant-treated eyes (N=138) and -6.45 to -6.26 mm Hg in SLT-treated eyes (N=138). Differences in IOP change from baseline ranged from -0.70 to -0.25 mm Hg favoring implant; the upper limit of the 95% confidence interval of the difference (implant minus SLT) was <1.0 mm Hg at all 3 visits. The probability of requiring no additional (rescue) IOP-lowering treatment in implant-treated versus SLT-treated eyes was 93.6% versus 86.5% at day 180 and 74.6% versus 77.1% at day 360. Corneal endothelial cell loss was more common in implant-treated eyes and typically occurred after repeated implant administration. Conclusion: Bimatoprost implant 15 µg met prespecified criteria for statistical and clinical noninferiority to SLT in lowering IOP, and after 1, 2, or 3 administrations, demonstrated a duration of IOP lowering similar to SLT. Bimatoprost implant 15 µg was associated with corneal adverse events in some patients, especially after repeated administrations at a fixed interval, and has been discontinued from development. A lower dose strength of implant (bimatoprost implant 10 µg, Durysta) is US Food and Drug Administration-approved for single administration.

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Oral delivery of macromolecules remains highly challenging due to their rapid degradation in the gastrointestinal tract and poor absorption across the tight junctions of the epithelium. In the last decade, researchers have investigated several medical devices to overcome these challenges using various approaches, some of which involve piercing through the intestine using micro and macro needles. We have developed a new generation of medical devices called self-unfolding proximity enabling devices, which makes it possible to orally deliver macromolecules without perforating the intestine. These devices protect macromolecules from the harsh conditions in the stomach and release their active pharmaceutical ingredients in the vicinity of the intestinal epithelium. One device version is a self-unfolding foil that we have used to deliver insulin and nisin to rats and pigs respectively. In our study, this device has shown a great potential for delivering peptides, with a significant increase in the absorption of solid dosage of insulin by ∼12 times and nisin by ∼4 times in rats and pigs, respectively. With the ability to load solid dosage forms, our devices can facilitate enhanced absorption of minimally invasive oral macromolecule formulations.

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Drug delivery devices which can control the release of drugs on demand allow for improved treatment to a patient. These smart drug delivery devices allow for the release of drugs to be turned on and off as needed, thereby increasing the control over the drug concentration within the patient. The addition of electronics to the smart drug delivery devices increases the functionality and applications of these devices. Through the use of 3D printing and 3D-printed electronics, the customizability and functions of such devices can also be greatly increased. With the development in such technologies, the applications of the devices will be improved. In this review paper, the application of 3D-printed electronics and 3D printing in smart drug delivery devices with electronics as well as the future trends of such applications are covered.

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A new solution for local anesthetic and antibiotic delivery after eye surgery is presented. A contact lens-shaped collagen drug carrier was created and loaded by Levofloxacin and Tetracaine with a riboflavin crosslinked surface layer, thus impeding diffusion. The crosslinking was confirmed by Raman spectroscopy, whereas the drug release was investigated using UV-Vis spectrometry. Due to the surface barrier, the drug gradually releases into the corneal tissue. To test the function of the carrier, a 3D printed device and a new test method for a controlled drug release, which mimics the geometry and physiological lacrimation rate of the human eye, were developed. The experimental setup with simple geometry revealed that the prepared drug delivery device can provide the prolonged release profile of the pseudo-first-order for up to 72 h. The efficiency of the drug delivery was further demonstrated using a dead porcine cornea as a drug recipient, without the need to use live animals for testing. Our drug delivery system significantly surpasses the efficiency of antibiotic and anesthetic eyedrops that would have to be applied approximately 30 times per hour to achieve the same dose as that delivered continuously by our device.

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The currently available nebulization devices have a slow aerosol flow and produce vapor with large microdrops. Improved devices that achieve higher airflow and produce smaller microdrops are needed to improve the clinical care of patients. To address this critical need, we developed a novel system for the molecular vaporization of liquids. This device vaporizes an active pharmacological substance dissolved in water, alcohol, or a mixture of water and alcohol using two energy sources at the same time: high-frequency ultrasound and thermal induction. Application of energy to a solution contained in the device's tank allows, within tens of seconds, for the vaporization of the solution itself, with the generation of a vapor consisting of microdrops of very small diameter (0.2-0.3 µm). In this article, we illustrate the technology used, the main verification tests performed, and the primary fields of application for this device. In particular, the advantages of both the aerosol delivery system and the administration system are highlighted.

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BACKGROUND: Conventional treatment for eosinophilic chronic rhinosinusitis with nasal polyps (eCRSwNP) is usually limited; consequently, relapses occur frequently, accurate local drug delivery is currently a research area of major interest. METHODS: Based on postoperative nasal sinus computed tomography (CT) images, the 3D printing technique was used to design and fabricate a precise track-guided sinus drug delivery device. The control group was treated with glucocorticoids by nasal spray for 1 year according to the conventional method, while the experimental group received topical nasal glucocorticoids using the 3D-printed track-guided precise sinus drug delivery device for 1 year. Scores on the Sino-Nasal Outcome Test (SNOT-22) scale and the Lund-Kennedy nasal endoscopic scale during reexamination at 1 month, 3 months, 6 months, and 1 year after the operation were used as the basis for evaluation. RESULTS: The follow-up duration was 12 months or more following endoscopic sinus surgery (ESS) with neosinus cavity formation. The two groups showed significant differences in SNOT-22 scores and nasal polyp Lund-Kennedy subscores at 3 months, 6 months, and 1 year (p < 0.001) and no differences in plasma cortisol at 6 months and 1 year (p > 0.05). CONCLUSION: Local drug administration using our 3D-printed precise sinus drug delivery device is superior to conventional nasal cavity administration in controlling eCRS recurrence.

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INTRODUCTION: Electronically powered drug delivery devices enable a controlled drug release route for a more convenient and painless way with reduced side effects. The current advances in microfabrication and microelectronics have facilitated miniaturization and intelligence with the integration of sensors and wireless communication modules. These devices have become an essential component of commercialized on-demand drug delivery. AREAS COVERED: This review aims to provide a concise overview of current progress in electronically powered drug devices, focusing on delivery strategies, manufacturing techniques, and control circuit design with specific examples. EXPERT OPINION: The application of electronically powered drug delivery systems is now considered a feasible therapeutic approach with improved drug release efficiency and increased patient comfort. It is anticipated that these technologies will gradually fulfill clinical needs and resolve commercialization challenges in the future. This review discusses the current advances in electronic drug delivery devices, especially focusing on designing strategies to achieve an effective drug release, as well as the perspectives and challenges for future applications in clinical therapy.

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Background: Self-injection of biologics is a mainstay of chronic disease treatment, yet the process of self-injection often causes persistent apprehension and anxiety, distinct from needle phobia. While literature alludes to the role that routines and rituals play in self-injection, there is no comprehensive study on the routines and rituals self-injectors employ, nor of the process by which they are discovered and ingrained. Methods: We conducted a mixed-method, observational pilot ethnography study of 27 patients with plaque psoriasis, psoriatic arthritis, or ankylosing spondylitis with and without prior biologic self-injection experience. Patients submitted self-made videos, photos, and projective exercises of an actual biologic self-injection and completed validated instruments to assess burden of treatment. Videos and photos containing routine and ritual elements were thematically categorized based on functional and emotional benefit, and analyzed for differences based on current biologic, dosing frequency, time on current biologic, and burden of treatment measures. Results: During patients' initial at-home injections, training gaps became apparent, leading to a process of experimentation aimed at reducing pain/anxiety, increasing confidence, and building a consistent injection process. Routines were present in 27/27 (100%) patients and anchored the time, place, and process for injection, and incorporated approved use steps for the injection device. Ritual elements served as emotional coping strategies for patients and were present in 21/27 (77.8%) of patients. Conclusion: Our findings suggest that providing patients device training using adult learning principles, teaching routines and rituals concurrently, and providing at-home opportunities for practice with a device trainer may be useful strategies to reduce anxiety, avoid unnecessary experimentation, and improve adherence to injection therapy. While further studies are needed to generalize our findings, we posit that routine and ritual elements can be incorporated into existing patient-clinician interactions or novel digital interventions through mobile medical applications, smart training devices, and connected injection ecosystems.

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BACKGROUND: Self-injected biologic therapies have gained significant prevalence across numerous therapeutic areas. A lack of specific guidance on best practices may lead to inadequate biologic initiation and training. We previously conducted a small-sample, qualitative analysis designed to identify gaps in self-injection training. METHODS: A total of 277 HCPs performing routine biologic initiation and 264 patients currently self-injecting biologics completed this quantitative study remotely using an online survey. The primary objective was to validate previous qualitative findings and firmly characterize the current paradigm. As an exploratory objective, the study examined associations that may exist between training experiences and patient-reported outcomes. RESULTS: Most patients (91.7%) reported receiving formal self-injection training, commonly conducted over one or two sessions. The mean overall training time reported was 37.8 and 30.4 minutes by patients and HCPs, respectively. Over one-third of patients reported lacking confidence that they could correctly self-inject during the first 6 months of treatment. CONCLUSION: Current training practices may not be adequate to prepare patients to start their therapies. Considerable attention must be paid to providing patients with multiple opportunities for training sessions, training devices, and medical information for home access. Further studies should prospectively examine the impact of training techniques on patient-reported outcomes.

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Recently, minitablets have been given extensive coverage in literature, as they are perfectly matched to the current therapy individualization trend. Within this scope, special attention is paid to minitablets that enable convenient drug intake for patients with swallowing problem. However, the packaging system, dispensing the necessary amount of drug units and safe administration still remain unsolved problems or are partially overlooked. Although there are many different approaches towards dosing tablets, only a few seem to be tailored to particularly small tablets. Moreover, none of these approaches meets all the user's expectations. This paper comprehensively elaborates and critically discusses the available dosing options like sachets, blisters, home electronic dispensing systems and minitablets manual dispensers. Additional tests have been also conducted to simulate the handling and dosing procedure with 2 mm diameter placebo minitablets. Despite many advantageous inventions, it has been revealed that further efforts are necessary to identify the optimal design that would allow to eliminate the shaking procedure, adjust cavities diameter or provide better protection against humidity. Nevertheless, the current trend may lead to individual therapy becoming more convenient, safe and reliable, especially in pediatric and geriatric patients.

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As medicine advances and physicians are able to provide patients with innovative solutions, including placement of temporary or permanent medical devices that drastically improve quality of life of the patient, there is the persistent, recurring problem of chronic bacterial infection, including osteomyelitis. Osteomyelitis can manifest as a result of traumatic or contaminated wounds or implant-associated infections. This bacterial infection can persist as a result of inadequate treatment regimens or the presence of biofilm on implanted medical devices. One strategy to mitigate these concerns is the use of implantable medical devices that simultaneously act as local drug delivery devices (DDDs). This classification of device has the potential to prevent or aid in clearing chronic bacterial infection by delivering effective doses of antibiotics to the area of interest and can be engineered to simultaneously aid in tissue regeneration. This review will provide a background on bacterial infection and current therapies as well as current and prospective implantable DDDs, with a particular emphasis on local DDDs to combat bacterial osteomyelitis.

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Under the pandemic situation, there is an urgent need to produce and acquire sufficient quantities of prophylactic vaccines. It becomes important to devise a way to achieve reliable immunity with lower doses to distribute limited supplies of vaccines to maximum number of people very quickly. Intradermal (ID) vaccination is one such method to increase the effectiveness of vaccines. However, this method has not been widely used in general clinical practice because it is technically difficult to inject vaccines precisely into the ID tissue. Therefore, new ID delivery systems that allow reliable ID administration are under development. In this paper, we summarize its design and present the results of performance and usability testing for the Immucise™ Intradermal Injection System (Immucise™). This study showed that Immucise™ can reduce dead volume and inject drugs precisely into the ID tissues of subjects from infants to the elderly and can be used correctly and safely by healthcare professionals. This randomized controlled trial compared ID administration with Immucise™ and standard subcutaneous (SC) administration of seasonal influenza vaccine by analyzing the efficacy of the vaccine in the elderly group at 90 days and 180 days after administration. It was found that the vaccine for the ID group was as effective or more effective than that for the SC group up to 180 days later. It was also found that the geometric mean titer values, especially for B strains, were higher in the two-dose ID group than in the two-dose SC group. These findings suggest that Immucise™ is one of the best devices to distribute a small amount of vaccine quickly and widely to a larger number of people with little loss of vaccine during a pandemic.

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Intravitreal injection (IVI) is the most commonly performed intraocular procedure worldwide. Several manufacturers have developed glass prefilled syringe (PFS) devices to increase the ease of performing IVIs and reduce the complications associated with medication preparation. This formative human factors study assessed a novel, polymer PFS alternative to glass syringes to support development of a usable, silicone-free delivery platform for IVI. Thirteen retina specialists (RSs) with experience preparing a minimum of ≥10 IVIs per week completed the study. RSs were presented with the concept device and prototype instructions for use and completed hands-on tasks to simulate IVI. They then evaluated the concept device for ease of use, comfort, safety, and overall preference versus the IVI devices they are accustomed to using. The primary objectives were to assess the ease of use and acceptability of the proposed syringe design, evaluate the corresponding instructions for use (IFU), and identify any potential usability issues. The secondary objectives were to evaluate a new tamper-evident cap design and compare several externally printed dose marking designs. There were 130 total opportunities for use errors that deviated from the IFU. Of these 130 steps, 110 were a Success, 17 were Incomplete or Incorrect, 2 were Resolved, and 1 was the result of a Study Artifact. All 13 participants completed 3 Essential Tasks successfully and at least 10 participants completed each of the 4 Safety-Critical Tasks successfully. A total of 20 errors were made throughout the test simulation, most of which were rooted in unfamiliar use steps or transference behaviors. Overall, the concept device was found to be usable, acceptable, and safe for IVI by experienced RSs. RSs preferred the concept device to IVI products supplied in vials, but there was no notable preference for the concept device design compared to current glass PFSs used for IVI. The unique features of the concept device, including absence of silicone oil and break-resistance, were mostly recognized by participants and may offer an improvement to currently available systems for IVI.

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Substance abuse is a fundamentally dynamic disease, characterized by repeated oscillation between craving, drug self-administration, reward, and satiety. To model nicotine addiction as a control system, a magnetic resonance imaging (MRI)-compatible nicotine delivery system is needed to elicit cyclical cravings. Using a concentric nebulizer, inserted into one nostril, we delivered each dose equivalent to a single cigarette puff by a syringe pump. A control mechanism permits dual modes: one delivers puffs on a fixed interval programmed by researchers; with the other, subjects press a button to self-administer each nicotine dose. We tested the viability of this delivery method for studying the brain's response to nicotine addiction in three steps. First, we established the pharmacokinetics of nicotine delivery, using a dosing scheme designed to gradually achieve saturation. Second, we lengthened the time between microdoses to elicit craving cycles, using both fixed-interval and subject-driven behavior. Finally, we demonstrate a potential application of our device by showing that a fixed-interval protocol can reliably identify neuromodulatory targets for pharmacotherapy or brain stimulation. Our MRI-compatible nasal delivery method enables the measurement of neural circuit responses to drug doses on a single-subject level, allowing the development of data-driven predictive models to quantify individual dysregulations of the reward control circuit causing addiction.

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PURPOSE: To evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) compared with laser photocoagulation in patients with diabetic macular edema (DME). PATIENTS AND METHODS: This Phase 3, multicenter, randomized, efficacy evaluator-masked, parallel-group, 12-month clinical study enrolled adults in China and the Philippines with reduced visual acuity secondary to fovea-involved DME in the study eye. Participants were randomized 1:1 to study eye treatment with laser photocoagulation every 3 months as needed (n = 139) or DEX every 5 months (n = 145). The main efficacy measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and leakage area. The primary endpoint was the average change in BCVA from baseline over 12 months (area-under-the-curve method). Preplanned subgroup analyses evaluated outcomes in Chinese patients. RESULTS: Mean average change in BCVA from baseline during the study (letters) was 4.3 with DEX (n = 145) versus 1.4 with laser (n = 127) overall (P = 0.001) and 4.6 with DEX (n = 129) versus 0.6 with laser (n = 113) in Chinese patients (P < 0.001). At Month 12, mean change in CRT from baseline was -209.5 µm with DEX versus -120.3 µm with laser (P < 0.001) and mean change in total leakage area from baseline was -8.367 mm2 with DEX versus -0.637 mm2 with laser (P < 0.001). The most common treatment-emergent adverse events in the DEX group were increased intraocular pressure and cataract. CONCLUSION: DEX administered every 5 months provided significantly greater improvement in BCVA, CRT, and total leakage area compared with laser treatment. DEX demonstrated an acceptable safety profile, consistent with an intraocular corticosteroid, and similar to that reported in completed global registration studies.

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INTRODUCTION: Currently, there is no effective therapy for mucopolysaccharidosis IIIA (MPS IIIA). Intravenously-administered enzyme replacement therapies, while effective in other forms of MPS without neurological involvement, have not been successful in patients with MPS IIIA, as they are unable to cross the blood-brain barrier to improve neurological symptoms. We evaluated the long-term safety, tolerability, and clinical outcomes of recombinant human heparan-N-sulfatase (rhHNS) administered intrathecally (IT) in children with MPS IIIA in a phase 1/2 extension study. METHODS: Patients aged ≥3 years with MPS IIIA who had previously completed a phase 1/2 study and received ≥5 of the 6 planned rhHNS infusions via IT administration, were eligible for inclusion. Patients who received 10 mg in the phase 1/2 study had their dose increased to 45 mg. Patients who were treated with 45 mg or 90 mg rhHNS IT in the phase 1/2 study remained on this monthly dose in the extension study. rhHNS was administered via an intrathecal drug delivery device (IDDD). Primary endpoints included the type and severity of adverse events, presence of anti-rhHNS antibodies in the CSF and serum, and changes in laboratory values. Secondary endpoints included standardized neurocognitive assessments and brain magnetic resonance imaging. RESULTS: In the extension study, 12 patients with a mean (SD) age of 9.6 (7.3) years continued treatment with rhHNS IT for a median of 264.4 weeks. Ten of 12 patients completed the extension study. rhHNS IT was generally well-tolerated. All patients experienced at least one treatment-emergent adverse event (TEAE), most being mild or moderate in severity. No serious adverse events (SAEs) were considered related to the study drug, and no deaths occurred. Most SAEs were related to malfunctions of the IDDD. Declines from baseline in Bayley Scales of Infant Development, Third Edition or Kaufman Assessment Battery for Children, Second Edition, Nonverbal Index developmental quotient scores were evident at all rhHNS dosing groups: -17.97%, -18.99%, and -12.12% in the 10/45, 45, and 90 mg groups, respectively, at Month 54. CONCLUSIONS: Overall, rhHNS IT was well tolerated in the extension study. However, rhHNS IT was unable to slow the neurocognitive decline of patients with MPS IIIA. This study was subsequently terminated early because pre-specified efficacy criteria were not met, and the study did not yield clinical proof of concept. (Clinicaltrials.gov Identifier NCT01299727).

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Drug delivery devices are attractive alternatives to drugs usually orally administrated. Therefore, this work aimed to produce PLA/PBAT-based nanofibers for the controlled release of cilostazol, evaluating the effect of different drug concentrations (20 and 30%) over the properties of the fibers. The fibers were characterized by scanning electron microscopy (SEM), Fourier Transform Infrared Spectroscopy (FTIR), x-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric (TG/DTG), and mechanical analysis. SEM results indicated a high concentration of drug crystals on the surface of the fibers that contained 20% of cilostazol. These fibers were also thinner, more crystalline, less thermally stable, and less fragile in comparison to the fibers containing 30% of cilostazol, according to the XRD, DSC, TG/DTG, and mechanical results. The controlled release assays indicated that the fibers containing 20% of cilostazol would be attractive for short-term releases, reaching the equilibrium after approximately 6 h, while the ones containing 30% would ensure a slower release (~ 12 h). Despite the differences, both fibers would improve and enhance the efficiency of the treatment, and they would also prevent possible side effects caused by the drug to the gastric system.

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BACKGROUND: Self-injection, particularly of biologics, has become a mainstay of chronic disease management. Despite labeling requirement for healthcare provider (HCP) training, current injection initiation experiences have been shown to be suboptimal. This study characterizes gaps in training and support during initiation and identifies rationales to inform solutions. METHODS: We enrolled HCPs (n = 18) performing routine biologic initiation and patients (n = 24) currently self-injecting biologics. Participants completed activities through an online, remote ethnography tool. We conducted two focus groups with biologic-naïve patients (n = 5). Data was analyzed using thematic frameworks, Q methodology, and quantitative assessments. RESULTS: Our results suggest considerable gaps exist. Analysis revealed five common themes that could explain these gaps: 1) minimal biologic-specific professional instruction is provided to HCPs; 2) nuanced injection use-steps are not universally understood; 3) no one stakeholder currently 'owns' training; 4) support offered by HCPs and manufacturers is perceived as biased; and 5) emotional burden is not accounted for. CONCLUSIONS: Our study suggests optimizing several elements to facilitate successful initiations, including structured sessions, improved HCP injection device knowledge, demo-device practice, and focus on both emotional and mechanical aspects. Aligning these factors has potential to increase patient confidence, reduce burden on HCPs, and improve probability of success on therapy.

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