A Comparison in Patient Comfort Using Conventional Syringe and Needleless Jet Anesthesia Technique in Periodontal Surgery-A Split-Mouth Randomized Clinical Trial.

Background and Objectives: Periodontal surgery requires local anesthetic coverage to alleviate patient discomfort. Needles and injections can engender feelings of fear and anxiety in individuals. This study aimed to assess the level of comfort and anxiety in patients during the administration of local anesthesia using needleless jet anesthesia (JA) when compared to a conventional syringe (CS) in periodontal surgery. Method and Materials: 60 sites were designated for injection in a split-mouth design in 30 subjects who required periodontal surgery. Local anesthesia was administered in two appointments scheduled one week apart using either a JA system or a CS. The Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), and Beck's anxiety inventory were used to report the pain and anxiety levels while injecting local anesthesia. Statistical analysis of the results was performed using the Shapiro-Wilks test and Paired t-test. Results: Patients reported greater comfort with JA. The VAS and VRS values were statistically significant-(p = 0.003) and (p = 0.001), respectively. Patients showed fear and were nervous about receiving a local anesthetic using a CS. A few subjects experienced lingering pain with the CS, whereas greater comfort and no lingering soreness were reported post-operatively at the site of JA administration. Conclusions: This study provides the first comprehensive assessment of using JA for periodontal surgical procedures. Lower pain scores were consistently observed with the use of jet injectors. Patients were at ease and reported lesser anxiety and greater comfort with jet injectors, making it ideally suited for providing local anesthesia in periodontal surgery.

Needle-free jet injection of intact phospholipid vesicles across the skin: a feasibility study.

Needle-free liquid jet injectors are devices developed for the delivery of pharmaceutical solutions through the skin. In this paper, we investigated for the first time the ability of these devices to deliver intact lipid vesicles. Diclofenac sodium loaded phospholipid vesicles of two types, namely liposomes and transfersomes, were prepared and fully characterized. The lipid vesicles were delivered through a skin specimen using a jet injector and the collected samples were analyzed to assess vesicle structural integrity, drug retention and release kinetics after the injection. In this regard, data concerning size, size distribution, surface charge of vesicles and bilayer integrity and thickness, before and after the injections, were measured by dynamic light scattering experiments, cryo-electron microscopy, and X-ray scattering techniques. Finally, the effect of vesicle fast jet injection through the skin on drug release kinetics was checked by in vitro experiments. The retention of the morphological, physico-chemical, and technological features after injection, proved the integrity of vesicles after skin crossing as a high-speed liquid jet. The delivery of undamaged vesicular carriers beneath the skin is of utmost importance to create a controlled release drug depot in the hypoderm, which may be beneficial for several localized therapies. Overall results reported in this paper may broaden the range of application of liquid jet injectors to lipid vesicle based formulations thus combining beneficial performance of painless devices with those of liposomal drug delivery systems.

Investigating skin penetration depth and shape following needle-free injection at different pressures: A cadaveric study.

BACKGROUND AND OBJECTIVES: The effectiveness of needle-free injection devices in neocollagenesis for treating extended skin planes is an area of active research. It is anticipated that needle-free injection systems will not only be used to inject vaccines or insulin, but will also greatly aid skin rejuvenation when used to inject aesthetic materials such as hyaluronic acid, botulinum toxin, and placental extracts. There has not been any specific research to date examining how materials penetrate the skin when a needle-free injection device is used. In this study, we investigated how material infiltrates the skin when it is injected into a cadaver using a needle-free device. STUDY DESIGN/MATERIALS AND METHODS: Using a needle-free injector (INNOJECTOR™; Amore Pacific, Seoul, Korea), 0.2 ml of 5% methylene blue (MB) or latex was injected into cheeks of human cadavers. The device has a nozzle diameter of 100 µm and produces a jet with velocity of 180 m/s. This jet penetrates the skin and delivers medicine intradermally via liquid propelled by compressed gasses. Materials were injected at pressures of 6 or 8.5 bars, and the injection areas were excised after the procedure. The excised areas were observed visually and with a phototrichogram to investigate the size, infiltration depth, and shape of the hole created on the skin. A small part of the area that was excised was magnified and stained with H&E (×40) for histological examination. RESULTS: We characterized the shape, size, and depth of skin infiltration following injection of 5% MB or latex into cadaver cheeks using a needle-free injection device at various pressure settings. Under visual inspection, the injection at 6 bars created semi-circle-shaped hole that penetrated half the depth of the excised tissue, while injection at 8.5 bars created a cylinder-shaped hole that spanned the entire depth of the excised tissue. More specific measurements were collected using phototrichogram imaging. The shape of the injection entry point was consistently spherical regardless of the amount of pressure used. When injecting 5% MB at 6 bars, the depth of infiltration reached 2.323 mm, while that at 8.5 bars reached 8.906 mm. The area of the hole created by the 5% MB injection was 0.797 mm(2) at 6 bars and 0.242 mm(2) at 8.5 bars. Latex injections reached a depth of 3.480 mm at 6 bars and 7.558 mm at 8.5 bars, and the areas were measured at 1.043 mm(2) (6 bars) and 0.355 mm(2) (8.5 bars). Histological examination showed that the injection penetrated as deep as the superficial musculoaponeurotic system at 6 bars and the masseter muscle at 8.5 bars. CONCLUSION: When injecting material into the skin using a pneumatic needle-free injector, higher-pressure injections result in a hole with smaller area than lower-pressure injections. The depth and shape of skin penetration vary according to the amount of pressure applied. For materials of low density and viscosity, there is a greater difference in penetration depth according to the degree of pressure. Lasers Surg. Med. 48:624-628, 2016. © 2016 Wiley Periodicals, Inc.

Jet injection needle-free dental anaesthesia: Initial findings.

OBJECTIVES: We evaluated patient preference and reported levels of anxiety and discomfort of participants treated with a new needle-free electric motor-driven device vs. conventional local anaesthetic for dental extractions in a proof-of-principle study. Healing and response of gingival tissues to injection were also evaluated at 1, 3- and 7-days post-procedure. METHODS: After informed consent, eight participants who required bilateral maxillary extractions were included in the trial. The side and order of placement for the needle-free and conventional anaesthetic were randomized. The same operator delivered anaesthesia and ensured teeth were anaesthetized on both sides. Another operator, unaware of order and type of anaesthesia placed, performed the extractions. RESULTS: Participant's average discomfort scores were low for both techniques, and lower for the needle-free injection at all timepoints. Needle-free local anaesthesia was the preferred technique by most participants at most timepoints. The average volume of anaesthetic dispensed was similar between techniques. Successful anaesthesia with the needle-free device was achieved in 6 out of 8 participants. Healing of the extraction sockets and adjacent oral mucosa progressed normally for all participants, with no evidence of infection, trauma or hematoma in the injection sites of the test and conventional sides. CONCLUSIONS: The needle-free local anaesthetic technique investigated achieved sufficient anaesthesia for tooth extractions in the maxilla in 75% of the subjects. A larger clinical trial is needed to further validate the technique tested and to investigate whether needle-free local anaesthesia can be successfully applied to the provision of restorative therapy. CLINICAL SIGNIFICANCE: The results of this study can be used by clinicians treating patients who suffer from dental anxiety and needle-phobia.

High-pressure plastic injection injury of the hand: case report.

Occupational high-pressure injection injuries are not common but can be devastating, especially to the hand. Most of the time, full recovery does not occur. We present a case of high-pressure injection injury to the hand in a patient who worked in a shoe-making factory. As far as we know, this massive involvement of a limb in a high-pressure plastic injection injury has never been reported in the literature. Better controls are required to prevent injection injuries and when they do occur, a high index of suspicion is required with immediate referral for surgical review.

Needle-free injection: Dental infiltration anesthesia.

This study aimed to develop an optimal Needle-Free Liquid Jet Injection (NFLJI) technique for dental infiltration anesthesia and evaluate its clinical safety and feasibility. The fluid dynamics of NFLJI in the dentoalveolar region were investigated using soft tissue phantoms supported by rigid glass. NFLJIs were performed at different incident angles and recorded using a high-speed camera. Accordingly, an optimal NFLJI for infiltration anesthesia was developed and validated on cadavers, then assessed in two pilot Randomized Controlled Trials (RCT): one for validating the safety of optimal NFLJI technique, the other for evaluating its feasibility and safety. High-speed videos showed that perpendicular NFLJIs induced significantly more regurgitation than oblique NFLJIs, which was confirmed in cadavers. Clinical trials revealed that perpendicular NFLJIs induced a high risk of bleeding (83.3%) and laceration (83.3%), whereas oblique NFLJIs induced a low risk of bleeding (33.3%) and laceration (16.7%). Moreover, the preliminary success rates of oblique NFLJIs and needle injections were both 83.3%. The recruitment took 3-5 weeks with a rate of 100%. Oblique NFLJIs could be a promising approach for dental infiltration anesthesia, causing minimal drug regurgitation with a relatively low risk of complication. The pilot RCTs confirmed the feasibility for conducting a non-inferiority RCT.

Ballistic impact of single particles into gelatin: experiments and modeling with application to transdermal pharmaceutical delivery.

The impact and penetration of high speed particles with the human skin is of interest for targeted drug delivery by transdermal powder injection. However, it is often difficult to perform penetration experiments on dermal tissue using micron scale particles. To address this, a finite element model of the impact and penetration of a 2 µm gold particle into the human dermis was developed and calibrated using experiments found in the literature. Using dimensional analysis, the model was linked to a larger scale steel ball-gelatin system in order to extract key material parameters for both systems and perform impact studies. In this manner, an elastic modulus of 2.25 MPa was found for skin, in good agreement with reported values from the literature. Further gelatin experiments were performed with steel, polymethyl methacrylate, titanium, and tungsten carbide balls in order to determine the effects of particle size and density on penetration depth. Both the finite element model and the steel-gelatin experiments were able to predict the penetration behavior that was found by other investigators in the study of the impact of typical particles used for vaccine delivery into the human dermis. It can therefore be concluded that scaled up systems utilizing ballistic gelatins can be used to investigate the performance of transdermal powder injection technology.

An acoustic microscopy technique to assess particle size and distribution following needle-free injection.

Needle-free injection is a novel technique for transdermal drug and vaccine delivery, the efficacy of which depends on the number density and mean penetration depth of particles beneath the skin. To date, these parameters have been assessed optically, which is time-consuming and unsuitable for use in vivo. The present work describes the development of a scanning acoustic microscopy technique to map and size particle distributions following injection. Drug particles were modeled using a polydisperse distribution of polystyrene spheres, mean diameter 30.0 mum, and standard deviation 16.7 mum, injected into agar-based tissue-mimicking material, and later, as polydisperse stainless steel spheres, mean diameter 46.0 mum, and standard deviation 13.0 mum, injected both into agar and into porcine skin. A focused broadband immersion transducer (10-75 MHz), driven in pulse-echo mode, was scanned over the surface of the injected samples. Recorded echo signals were post-processed to deduce particle penetration depth (30-300 mum). Furthermore, post-injection size distribution of the spheres was calculated using a novel, automated spectral analysis technique. Experimental results were validated optically and found to predict penetration depth and particle size accurately. The availability of simultaneous particle penetration depth and particle size information makes it possible for the first time to optimize particle design for specific drug delivery applications.

Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients.

Needleless devices have been developed to provide anesthesia without injections. Little controlled research has examined the acceptability of needleless devices in pediatric patients. The aims of the study were to compare children's acceptance and preference for one type of needleless jet injection with classical local infiltration as well as to evaluate the efficacy of the needleless anesthesia. Eighty-seven nonfearful children with no previous experience of dental anesthesia were studied using a split-mouth design. The first dental procedure was performed with the classical infiltration anesthesia. The same amount of anesthetic was administered using the INJEX needleless device in a second session 1 week later, during which a second dental procedure was performed. Patients rated their acceptance and preference for the 2 methods, and the dentist recorded data about the need for additional anesthesia. More negative experiences were reported for the INJEX method. Most (73.6%) of the children preferred the traditional method. Among the 87 treatment procedures attempted following the use of INJEX, 80.5% required additional anesthesia, compared with 2.3% of those attempted following traditional infiltration. Traditional infiltration was more effective, acceptable, and preferred, compared with the needleless INJEX.

Is the jet injection effective for teeth extraction?

Pain control is achieved typically by means of injection of local anesthesia for invasive procedures to carry out procedures with as little pain or discomfort as possible. Although this method is highly effective, patients often fear more from the sight of a needle during administration of local anesthetic than from the treatment. Therefore, needleless local anesthesia with a jet injection device has been proposed. With the INJEX®, anesthetic solution is forced under high pressure into the oral mucosa, leading to mechanical infiltration of the compound through the mucosa. With this study, we aimed to show the effectiveness of the needleless injection for infiltrative anesthesia and compare the acceptance and efficacy between jet injection with INJEX and local infiltration anesthesia. 28 adult patients admitted to our department for tooth extraction were included in the study. Two symmetrical teeth in the same jaw were extracted from each of the patients. Jet injection with the INJEX® was performed on one side and classical (needle) infiltration anesthesia on the other side with 0.3 cc Ultracain DS forte (Sanofi Aventis, Istanbul, Türkiye) on buccal and lingual aspects and 0.1 cc on palatal aspects of the teeth. The difference between pain and discomfort scores experienced during tooth extraction was statistically significant (P = 0.026). Accordingly, the pain or discomfort score of the INJEX® method during tooth extraction was significantly higher. Jet injection with the INJEX® was not found to be effective for local infiltrative anesthesia especially teeth extractions. It may be more acceptable when using for previously classical local infiltration anesthesia by patients. The main problem with jet injection was the "pop" sound when the INJEX® device was pressed, and also inadequate suppyling the anesthesia.

Current Progress in Particle-Based Systems for Transdermal Vaccine Delivery.

Transcutaneous immunization (TCI) via needle-free and non-invasive drug delivery systems is a promising approach for overcoming the current limitations of conventional parenteral vaccination methods. The targeted access to professional antigen-presenting cell (APC) populations within the skin, such as Langerhans cells (LCs), various dermal dendritic cells (dDCs), macrophages, and others makes the skin an ideal vaccination site to specifically shape immune responses as required. The stratum corneum (SC) of the skin is the main penetration barrier that needs to be overcome by the vaccine components in a coordinated way to achieve optimal access to dermal APC populations that induce priming of T-cell or B-cell responses for protective immunity. While there are numerous approaches to penetrating the SC, such as electroporation, sono- or iontophoresis, barrier and ablative methods, jet and powder injectors, and microneedle-mediated transport, we will focus this review on the recent progress made in particle-based systems for TCI. This particular approach delivers vaccine antigens together with adjuvants to perifollicular APCs by diffusion and deposition in hair follicles. Different delivery systems including nanoparticles and lipid-based systems, for example, solid nano-emulsions, and their impact on immune cells and generation of a memory effect are discussed. Moreover, challenges for TCI are addressed, including timely and targeted delivery of antigens and adjuvants to APCs within the skin as well as a deeper understanding of the ill-defined mechanisms leading to the induction of effective memory responses.

Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial.

OBJECTIVE: Pain due to administration of local anesthetics is the primary reason for patients' fear and anxiety, and various methods are used to minimize it. This study aimed to measure the degree of pain during administration of anesthesia and determine the latency time and duration of pulpal anesthesia using two anesthetic methods in the maxilla. MATERIALS AND METHODS: A randomized, single-blind, split-mouth clinical trial was conducted with 41 volunteers who required class I restorations in the maxillary first molars. Local anesthesia was administered with a needleless jet injection system (experimental group) or with a carpule syringe (control) using a 30-gauge short needle. The method of anesthesia and laterality of the maxilla were randomized. A pulp electric tester measured the latency time and duration of anesthesia in the second molar. Visual analogue scale (VAS) was used to measure the degree of pain during the anesthetic method. Data were tabulated and then analyzed by a statistician. The t-test was used to analyze the differences between the groups for basal electrical stimulation. Duration of anesthesia and degree of pain were compared using the Mann-Whitney test. A 5% significance level was considered. RESULTS: There was no statistical difference in the basal electrical stimulation threshold (mA) and degree of pain between the two methods of anesthesia (p>0.05). Latency time was 2 minutes for all subjects. The duration of pulpal anesthesia showed no statistical difference (minutes) between the two methods (p<0.001), with a longer duration for the traditional method of anesthesia (median of 40 minutes). CONCLUSIONS: The two anesthetics methods did not differ concerning the pain experienced during anesthesia. Latency lasted 2 minutes for all subjects; the traditional infiltration anesthesia resulted in a longer anesthetic duration compared with the needleless jet injection.

Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial.

BACKGROUND: Peripheral intravenous (PIV) catheter insertion is a frequent, painful procedure that is often performed with little or no anesthesia. Current approaches that minimize pain for PIV catheter insertion have several limitations: significant delay for onset of anesthesia, inadequate anesthesia, infectious disease exposure risk from needlestick injuries, and patients' needle phobia. OBJECTIVE: Comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for PIV catheter insertion. METHODS: A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8 to 15 years old presenting to a tertiary care pediatric emergency department for PIV catheter insertion. All subjects recorded self-reported visual analog scale (VAS) scores for pain at time of enrollment and pain felt following PIV catheter insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV catheter insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV catheter insertion. RESULTS: Of the 70 children enrolled, 35 were randomized to the J-Tip jet injection group and 35 to the ELA-Max group. Patient-recorded enrollment VAS scores for pain were similar between groups (P = 0.74). Patient-recorded VAS scores were significantly different between groups immediately after PIV catheter insertion (17.3 for J-Tip jet injection vs 44.6 for ELA-Max, P < 0.001). Blinded reviewer assessed VAS scores for pain after PIV catheter insertion demonstrated a similar trend, but the comparison was not statistically significant (21.7 for J-Tip jet injection vs 31.9 ELA-Max, P = 0.23). CONCLUSION: J-Tip jet injection of 1% buffered lidocaine provided greater anesthesia than a 30-minute application of ELA-Max according to patient self-assessment of pain for children aged 8 to 15 years undergoing PIV catheter insertion.

Influence of solution viscosity and injection protocol on distribution patterns of jet injectors: application to photodynamic tumour targeting.

Photodynamic therapy of deep or nodular skin tumours is currently limited by the poor tissue penetration of the porphyrin precursor 5-aminolevulinic acid (ALA) and preformed photosensitisers. In this study, we investigated the potential of jet injection to deliver both ALA and a preformed photosensitiser (meso-tetra (N-methyl-4-pyridyl) porphine tetra tosylate, TMP) into a defined volume of skin. Initial studies using a model hydrogel showed that as standoff distance is increased, injection depth decreases. As the ejected volume is increased, injection depth increases. It was also shown, for the first time, that, as injection solution viscosity was increased, for a given injection setting and standoff distance, both total depth of jet penetration, L(t), and depth at which the maximum width of the penetration pattern occurred, L(m), decreased progressively. For a standoff distance of zero, the maximum width of the penetration pattern, L(w), increased progressively with increasing viscosity at each of the injection settings. Conversely, when the standoff distance was 2.5 mm, L(w) decreased progressively with increasing viscosity. Studies with neonate porcine skin revealed that an injection protocol comprising an 8.98 mPas solution, an arbitrary injection setting of 8 and a standoff distance of zero was capable of delivering photosensitisers to a volume of tissue (L(t) of 2.91 mm, L(m) of 2.14 mm, L(w) of 5.10 mm) comparable to that occupied by a typical nodular basal cell carcinoma. Both ALA and TMP were successfully delivered using jet injection, with peak tissue concentrations (67.3 mg cm(-3) and 5.6 mg cm(-3), respectively) achieved at a depth of around 1.0mm and substantial reductions in drug concentration seen at depths below 3.0 mm. Consequently, jet injection may be suitable for selective targeting of ALA or preformed photosensitisers to skin tumours.

The penetration of a soft solid by a liquid jet, with application to the administration of a needle-free injection.

Liquid jet injections have been performed on human skin in vivo and silicone rubber using Intraject needle-free injectors. The discharge characteristics of the liquid jet were measured using a custom-built test instrument. The experiments reveal that a high-speed liquid jet penetrates a soft solid by the formation and opening of a planar crack. The fluid stagnation pressure required for skin penetration decreases with increasing diameter of the liquid jet. These findings are consistent with the slow-speed penetration of a soft solid by a sharp-tipped punch. It is demonstrated that the Shergold-Fleck sharp-tipped punch penetration model [Shergold, O.A., Fleck, N.A., 2004. Mechanisms of deep penetration of soft solids. Proc. Roy. Soc. Lond. A 460, 3037-3058.] gives adequate predictions for the pressure required to penetrate a soft solid by a high-speed liquid jet.

Children's preferences concerning the physical appearance of dental injectors.

PURPOSE: This pilot study was carried out to assess how the physical appearance of dental injectors influenced children's choice. METHODS: The study group consisted of 34 randomly selected children (17 boys, 17 girls) between the ages of 7 and 11 (mean age=8.6 +/- 1.4), who had been registered for treatment at the School of Dentistry, Marmara University. A combination of tests-the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Venham Picture Test (VPT), and facial image scale (FIS)-were used to assess the multi-dimensional character of children's dental anxiety. Dental injectors (Wand, Citoject, traditional metal injector [MI], and plastic injector [PI]) were displayed on a tray and introduced to the children. The children were asked to consider which injectors they would choose "if their tooth had to be put to sleep," and their preferences were noted starting with their first choice. RESULTS: The children's first choice was: (1) the Wand (56%); (2) PI (29%); (3) Citoject (12%); and (4) MI (3%). The anxious children (n= 13) preferred the Wand with significantly higher ratings (Wand=84%; Citoject=8%; MI=8%; PI=0%). CONCLUSION: The physical appearance of dental injectors is important to children and even more important for children who are anxious.

[Comparison of the systems used for providing local anesthesia in dentistry--the Wand (Milestone Scientific) and Injex (Rosch)]. / Analiza porównawcza systemów do znieczulen miejscowych w stomatologii--the Wand (Milestone Scientific) oraz Injex (Rosch).

UNLABELLED: Local anesthesia is one of the basic and the most often executed interventions in dentistry. This procedure is very stressful for the patients because it is combined with pain. The new systems for delivering local anesthesia in dentistry have revolutionized the technique considerably by its simplify as well as reduction in pain. THE AIM: this study presents the comparison between the local anesthesia delivery systems used in dentistry--The Wand and Injex, taking into consideration pain intensity during performing anesthesia and the intensification of fear before executed anesthesia with the given system. MATERIAL AND METHODS: the Visual Analogue Scale (VAS), verbal scale and questionnaires were used to evaluate pain and fear. RESULTS: On the basis of our investigations it can be concluded that there were statistically important differences between men and women in fear intensity combined with the anesthesia procedure--men were less afraid than women. The patients who were anaesthetized with system The WAND declared less fear before similar anesthesia in future. The average value of intensity of pain analyzed with both verbal and visual scales during anaesthetizing with the system Injex (independently from sex) was statistically significantly higher than for system The WAND--respectively 0.57 and 8.55 for The WAND, 2.02 and 32.18 for Injex (p = 0.001). CONCLUSION: on the basis of the results of this study it can be concluded that the less stressful and painful local anesthesia delivery system is the WAND.

Analysis of thin baked-on silicone layers by FTIR and 3D-Laser Scanning Microscopy.

Pre-filled syringes (PFS) and auto-injection devices with cartridges are increasingly used for parenteral administration. To assure functionality, silicone oil is applied to the inner surface of the glass barrel. Silicone oil migration into the product can be minimized by applying a thin but sufficient layer of silicone oil emulsion followed by thermal bake-on versus spraying-on silicone oil. Silicone layers thicker than 100nm resulting from regular spray-on siliconization can be characterized using interferometric profilometers. However, the analysis of thin silicone layers generated by bake-on siliconization is more challenging. In this paper, we have evaluated Fourier transform infrared (FTIR) spectroscopy after solvent extraction and a new 3D-Laser Scanning Microscopy (3D-LSM) to overcome this challenge. A multi-step solvent extraction and subsequent FTIR spectroscopy enabled to quantify baked-on silicone levels as low as 21-325µg per 5mL cartridge. 3D-LSM was successfully established to visualize and measure baked-on silicone layers as thin as 10nm. 3D-LSM was additionally used to analyze the silicone oil distribution within cartridges at such low levels. Both methods provided new, highly valuable insights to characterize the siliconization after processing, in order to achieve functionality.

Jet injection into polyacrylamide gels: investigation of jet injection mechanics.

Jet injectors employ high-velocity liquid jets that penetrate into human skin and deposit drugs in the dermal or subdermal region. Although jet injectors have been marketed for a number of years, relatively little is known about the interactions of high-speed jets with soft materials such as skin. Using polyacrylamide gels as a model system, the mechanics of jet penetration, including the dependence of jet penetration on mechanical properties, was studied. Jets employed in a typical commercial injector, (orifice diameter: 152 microm, velocity: 170-180 m/s) were used to inject fluid into polyacrylamide gels possessing Young's moduli in the range of 0.06-0.77 MPa and hardness values in the range of 4-70 H(OO). Motion analysis of jet entry into polyacrylamide gels revealed that jet penetration can be divided into three distinct events: erosion, stagnation, and dispersion. During the erosion phase, the jet removed the gel at the impact site and led to the formation of a distinct cylindrical hole. Cessation of erosion induced a period of jet stagnation ( approximately 600 micros) characterized by constant penetration depth. This stage was followed by dispersion of the liquid into the gel. The dispersion took place by crack propagation and was nearly symmetrical with the exception of injections into 10% acrylamide (Young's modulus of 0.06 MPa). The penetration depth of the jets as well as the rate of erosion decreased with increasing Young's modulus. The mechanics of jet penetration into polyacrylamide gels provides an important tool for understanding jet injection into skin.