Pump Spray Research Articles

Evaluation of droplet velocity and size from nasal spray devices using phase Doppler anemometry (PDA)

To determine aerosol deposition during the inhalation drug delivery, it is important to understand the combination of velocity and droplet size together. In this study, phase Doppler anemometry (PDA) was used to simultaneously characterize the aerosol velocity and droplet size distribution (DSD) of three nasal spray pumps filled with water. Thirteen sampling positions were located in the horizontal cross-sectional area of the nasal spray plumes at a distance of 3 cm from the pump orifice. The results showed droplet velocities near the center of the spray plume were higher and more consistent than those near the edge. The pumps examined showed significant differences in their aerosol velocity at the center of the spray plume, which suggest that this metric might be used as a discriminating parameter for in vitro testing of nasal sprays. Droplet size measurements performed using PDA were compared with results from laser light scattering measurements. The ability of PDA to provide simultaneous measurements of aerosol velocity and size makes it a powerful tool for the detailed investigation of nasal spray plume characteristics.

Recent advances in drying and dehydration of fruits and vegetables: a review

Fruits and vegetables are dried to enhance storage stability, minimize packaging requirement and reduce transport weight. Preservation of fruits and vegetables through drying based on sun and solar drying techniques which cause poor quality and product contamination. Energy consumption and quality of dried products are critical parameters in the selection of drying process. An optimum drying system for the preparation of quality dehydrated products is cost effective as it shortens the drying time and cause minimum damage to the product. To reduce the energy utilization and operational cost new dimensions came up in drying techniques. Among the technologies osmotic dehydration, vacuum drying, freeze drying, superheated steam drying, heat pump drying and spray drying have great scope for the production of quality dried products and powders.

Size-fractionated characterization and quantification of nanoparticle release rates from a consumer spray product containing engineered nanoparticles

This study describes methods developed for reliable quantification of size- and element-specific release of engineered nanoparticles (ENP) from consumer spray products. A modified glove box setup was designed to allow controlled spray experiments in a particle-minimized environment. Time dependence of the particle size distribution in a size range of 10–500 nm and ENP release rates were studied using a scanning mobility particle sizer (SMPS). In parallel, the aerosol was transferred to a size-calibrated electrostatic TEM sampler. The deposited particles were investigated using electron microscopy techniques in combination with image processing software. This approach enables the chemical and morphological characterization as well as quantification of released nanoparticles from a spray product. The differentiation of solid ENP from the released nano-sized droplets was achieved by applying a thermo-desorbing unit. After optimization, the setup was applied to investigate different spray situations using both pump and gas propellant spray dispensers for a commercially available water-based nano-silver spray. The pump spray situation showed no measurable nanoparticle release, whereas in the case of the gas spray, a significant release was observed. From the results it can be assumed that the homogeneously distributed ENP from the original dispersion grow in size and change morphology during and after the spray process but still exist as nanometer particles of size <100 nm. Furthermore, it seems that the release of ENP correlates with the generated aerosol droplet size distribution produced by the spray vessel type used. This is the first study presenting results concerning the release of ENP from spray products.

Flavored anesthetic lozenge versus Xylocaine spray used as topical pharyngeal anesthesia for unsedated esophagogastroduodenoscopy: a randomized placebo-controlled trial

The use of Xylocaine spray has been the common practice in many endoscopy centers, but scientific evidence is not conclusive on its superiority over other forms of topical anesthesia. This study aimed to compare the effectiveness of Xylocaine spray as a topical pharyngeal anesthesia for upper endoscopy and that of anesthetic lozenges with a characteristic flavor. A randomized placebo-controlled trial was performed in a single endoscopy center. For this study, 191 consecutive patients ages 18 to 70 undergoing outpatient esophagogastroduodenoscopy were randomized before the procedure into either a spray group (10% Xylocaine pump spray plus plain Strepsils) or a lozenge group (Strepsils Dual Action anesthetic lozenge plus distilled water spray). The primary outcome was the patient tolerance score, calculated according to the taste of the anesthetic agent, the intensity of numbness, the amount of cough or gag, and the degree of discomfort at esophageal intubation. The secondary outcomes included difficulty of esophageal intubation and the patients' and endoscopists' satisfaction score for the procedure. Randomization assigned 97 patients to the lozenge group and 94 patients to the spray group. The demographic data were similar in the two groups. The spray group had a significantly higher patient tolerance score, a greater intensity of numbness, less gag reflex, and less discomfort than the lozenge group. The lozenge group had a better taste than the spray group. The difficulty of esophageal intubation and the patients' and endoscopists' satisfaction were comparable between the two groups. Topical Xylocaine spray is superior to the flavored anesthetic lozenge as a topical pharyngeal anesthesia in unsedated esophagogastroduodenoscopy.

Efficacy of a Metered-dose 8% Lidocaine Pump Spray for Patients with Post-herpetic Neuralgia

Topical lidocaine patch is effective in the treatment of post-herpetic neuralgia (PHN), but not suited for paroxysmal pain because of the long latency of analgesia. Here, we examined the efficacy of 8% lidocaine pump spray (Xylocaine pump spray, XPS) for PHN. Twenty-four patients with PHN were recruited into a randomized, double-blind, placebo-controlled, crossover study (study 1), and 100 patients with PHN were recruited into an open-labeled study (study 2). In study 1, patients were randomized to receive either XPS or saline placebo pump spray (PPS) applied to the painful skin areas. Following a 7-day period, patients were crossed over to receive the alternative treatment. In study 2, XPS was prescribed for patients who were advised to use the spray anytime, with a 2-hour gap between applications, for 2 weeks. The pain was assessed with a visual analogue scale (VAS). Details of use were noted in the diary. In study 1, greater decreases in VAS of persistent pain followed application of XPS (baseline: 6.1 +/- 1.7 cm, 15-minute post-spray: 2.3 +/- 2.5 cm, mean +/- SD) than with PPS (6.1 +/- 1.7 cm, 5.7 +/- 1.6 cm, [P < 0.01]). The effect persisted for a median of 4.5 hours (range, 2 to 24 hours) after application. In study 2, 13 of 100 patients discontinued the treatment because of mild local side effects or insufficient effect. In the remaining 87 patients, XPS maintained significant pain relief relative to baseline throughout the 2-week period. Satisfaction with the therapy was reported by 79% of patients. In both studies, XPS provided a significant improvement in PHN due to its prompt analgesia, lack of systemic side effects, and convenience of use.

Recombinant Thrombin: Safety and Immunogenicity in Burn Wound Excision and Grafting

This study evaluated the safety, immunogenicity, and hemostatic effect of recombinant human Thrombin (rThrombin), in patients undergoing skin grafting for burns. This was a phase 2 multiple site, single-arm, open-label study in patients receiving partial- or full-thickness autologous grafts. rThrombin was applied using a spray applicator to newly excised wounds of 1 to 4% body surface area at 5 minutes intervals for up to 20 minutes, after point source bleeding was stopped. Adverse events, skin graft survival, and formation of anti-rThrombin antibodies were measured at baseline and Day 29. There were no deaths or study drug discontinuations. Adverse events occurred in 63 of 72 patients (88%), and were typical of sequelae of skin grafting. Hemostasis was achieved within 20 minutes after application of rThrombin in 65 of 71 patients (91.5%). Skin graft failure occurred in 4 patients (6%). At the day 29 evaluation, for those patients who returned, 88.9% had > or =90% graft survival. One patient (1 of 70, 1.4%) had specific, low titer antibodies to rThrombin at baseline, but no increase in titer posttreatment; a second patient (1 of 62, 1.6%), developed antibodies to rThrombin at day 29. None of the antibodies neutralized native human thrombin. In excised burn wounds, hemostasis at 20 minutes was achieved in 91.5% of patients and skin graft survival was excellent. There was a low rate of antibodies to rThrombin at baseline (1.4%) and a low rate of anti-rThrombin antibody formation at day 29 (1.6%). rThrombin was well tolerated when administered with a pump spray.

The Analgesic Effect of a Metered-Dose 8% Lidocaine Pump Spray In Posttraumatic Peripheral Neuropathy: A Pilot Study

A topical lidocaine patch is effective in the treatment of posttraumatic peripheral neuropathy (PTPN), but it is not suited for breakthrough pain because of difficulty with an additional application. Here, we examined the effect of 8% lidocaine pump spray (Xylocaine pump spray, XPS) on peripheral neuropathic pain caused by surgery or injury. Thirty-one patients with PTPN were randomized to receive either XPS or saline placebo pump spray applied to painful skin areas. The optimal dose of up to 30 sprays (0.1 mL/single spray, 30 times) was individually determined as the dose which completely covered the painful site. After a 7-day period, the patients were crossed over to receive the optimal dose of the alternative spray. Pain was assessed with a visual analog scale. XPS, but not placebo pump spray, significantly decreased the visual analog scale for continuing pain and tactile allodynia. The effect persisted for a median of 5 h (range, 2-60 h) after application. Mild side effects were reported in three patients with XPS consisting of local irritation (n = 3) and local flare (n = 1). All adverse events disappeared without medication within a few hours. The present study suggests that XPS provides a significant improvement in PTPN due to its prompt analgesia, lack of systemic side effects and convenience.

8% Lidocaine Pump Spray Relieves Pain Associated With Peripheral Blood Flow Disorders

It is often difficult to reduce pain associated with peripheral blood flow disorders (PBFD) using standard analgesics. We assessed the analgesic effects of a metered-dose 8% lidocaine in patients with PBFD. Twenty-four patients with PBFD-related pain were enrolled in this double-blind placebo-controlled crossover study. Patients were randomized to receive either 8% lidocaine or saline on the painful site with a metered-dose spray. After a 3-day period, patients were crossed over to receive the alternative treatment. Pain was assessed with a visual analog scale (VAS) before and 15 minutes after the treatment. Patients were also asked to record the time at which pain appeared again. The blood concentration of lidocaine was measured at 15, 30, and 60 minutes after lidocaine application. There were no significant differences in VAS before treatment between the placebo and lidocaine treatments. However, lidocaine significantly decreased VAS at rest from 5.5+/-3.1 cm (mean+/-SD) to 0.6+/-0.9 cm and on movement from 8.4+/-2.0 cm to 1.7+/-1.7 cm, resulting in a significant difference between the 2 sprays. The median time to recurrence of pain was 3 hours. The blood concentration of lidocaine was less than 0.3 microg/mL in all patients. A metered-dose 8% lidocaine pump spray produced prompt analgesia in patients with PBFD-related pain without severe side effects.

The Influence of Various Mucoadhesive Polymers on In Vitro Performance of the Resulting Artificial Saliva Pump Spray Formulations

The aim of this study was to investigate the rheological behavior and mucoadhesive nature of saliva substitutes, by incorporating various mucoadhesive polymers into an artificial saliva pump spray formulation. For this purpose various mucoadhesive polymers including cellulosic polymers in the range of 0.1-1.0% and Carbomers such as C974p, C971, C934p and C971 in the range of 0.01-0.1% were added to a formulated aqueous-based artificial saliva pump spray formulation, containing fixed amounts of some essential electrolytes. The pH of the formulations was between 6.3-7.4. The formulations were examined in terms of appearance, taste, odor, spray-ability, short-term thermal and mechanical stability, pH, viscosity and rheological behavior, particle size distribution, as well as invitro mucoadhesive strength (MS). The mucoadhesivity ratio (MR) was also calculated as follows: MR=MS test /MS control , using natural saliva as the control. Natural saliva showed a pseudoplastic rheological behavior, with a viscosity in the range of 12.85-28.15cP. Hence, artificial saliva samples having viscosities within this range were selected. The rheological behavior and viscosity of the test samples as well as the natural saliva were subsequently determined. Similar to that found for the natural saliva, all the prepared formulations showed a pseudoplastic rheological behavior. Among the polymers, C974p had the highest viscosity (25.97±0.11 cp) and mucoadhesive strength (34.84±0.21 mN/cm 2 ) followed by hydroxypropylmethylcellulose which had a viscosity of 25.48±0.11 cp and a mucoadhesive strength of 34.03±0.24 mN/cm 2 . Furthermore, the mucoadhesivity of C974p containing artificial saliva was 1.186 times greater than natural saliva and 1.387 times more than water. In conclusion, it seems that the presence of mucoadhesive polymers within the artificial saliva pump spray formulations could help to improve the adhesive nature of the formulation to mucosal surfaces, making it even more effective than the natural saliva.

Prolonged Efficacy of IR3535 Repellents Against Mosquitoes and Blacklegged Ticks in North America

Here I report the first findings of consistently high, long-duration efficacy of IR3535 (ethyl butyl acetyl aminopropionate) formulations in the United States. I tested novel, controlled-release formulations of IR3535, at 10% in lotion and at 20% in pump spray and aerosol, against mosquitoes in the field and blacklegged ticks in the laboratory. These were also the first studies to be conducted under the authority of the U.S. Environmental Protection Agency's Human Studies Rule of 2006, and the protocols underwent science and ethics reviews by five entities. IR3535 is better known in Europe than in North America, having been marketed in the United States only more recently, and there are comparatively few publications on its efficacy. I began with pretrial studies of dosing behavior to compute formula-specific mean dosing rates for the subsequent efficacy trials. Dosing rates were lower than the 1 ml/600 cm rate commonly used to quantify efficacy. Complete protection times ranged from 7.1 to 10.3 h for mosquitoes and from 9.1 to 12.2 h for blacklegged ticks. Long protection duration resulted in many cases being truncated by darkness or eventual subject withdrawal, which suggests that actual protection times were probably greater.

Assessment of Early Acute Lung Injury in Rats Exposed to Aerosols of Consumer Products: Attempt to Disentangle the “Magic Nano” Conundrum

In Germany in 2006 a series of rapidly developing and sometimes severe cases of pulmonary health impairment were observed after normal use of the “Magic Nano Glass & Ceramic” spray and “Magic Nano Bath” spray. In contrast, the previously marketed “Magic Nano” pump spray product (handheld trigger device without propellants) was unobtrusive. Analysis of particles discharged from these products did not reveal stable (solid) nano-sized particles. The precipitous increase of pulmonary health impairment in humans caused by “Magic Nano Sprays” triggered a comparative assessment of the acute inhalation toxicity of “Magic Nano Glass & Ceramic” spray, “Magic Nano Bath” spray, and “Magic Nano” pump spray in rats. The first two test specimens were examined as spray-can aerosols using an intermittent generation principle, whereas the undiluted liquid content of the pump spray was continuously aerosolized. Groups of Wistar rats were nose-only exposed for 4 h. However, due to mortality occurring already during exposure following exposure to Glass & Ceramic spray, the exposure duration was reduced to ∼ 2 h in some groups. In addition to endpoints called for by contemporary testing guidelines, respiratory tract injury was also probed by respiratory function measurements during exposure supplemented by analyses in bronchoalveolar lavage (BAL) fluid on the first postexposure day, including lung histopathology in rats exposed to Glass & Ceramic spray. The Glass & Ceramic spray caused mortality at 2269 mg/m3 and above, the pump spray was in the beginning lethal range at 81222 mg/m3, while the bath spray was tolerated without mortality up to the maximum tested nominal concentrations of 28100 mg/m3. The time-adjusted 4-h LC50 of Glass & Ceramic spray was 5098 mg/m3. The analysis of respiratory patterns revealed changes indicative of both upper and lower respiratory tract sensory irritation. In addition to clinical signs suggestive of marked lung irritation, especially in the rats exposed to the Glass & Ceramic spray, histopathology revealed lung inflammation, hemorrhages, edema, and focal septal thickening. Lung weights and BAL endpoints (lactate dehydrogenase [LDH], protein, γ -glutamyltransaminase, and neutrophilic granulocytes) were markedly increased. In summary, this comparative study demonstrates that the conventional OECD 403 protocol is suitable to comparatively assess the potential and potency of these types of consumer products in their end-use configuration. Measurements in BAL were most suitable for the identification of acute lung injury. By contrast, lung function measurements during exposure did not demonstrate any conclusive association with lung injury. It does not appear that the particle size per se is a key determinant in the toxicity of “Magic Nano Glass & Ceramic” spray (approximately 100% mortality occurred at a MMAD of ∼ 7 μ m; GSD ≈ 3). This might suggest that more volatile substances or substances contained in the test articles that co-evaporate with solvents or water may be causative for the findings observed. Hence, the findings of this study support the notion that the assessment of the acute inhalation toxicity of complex end-use products is methodologically challenging and cannot be readily anticipated based on compositional or physical (particle size) data. Accordingly, in the absence of predictive and validated in vitro assays, in vivo inhalation testing of potentially toxic commercialized spray products appears to be indispensable for consumer safety. In order to prevent indiscriminant testing of such products in bioassays, the development of standardized in vitro alternatives should be considered with high priority.

Laboratory and Field Evaluation of the Impact of Exercise on the Performance of Regular and Polymer-Based Deet Repellents

Studies were done in Manitoba, Canada, to evaluate the impact of exercise on repellent performance against mosquitoes. Two products containing the active ingredient N,N-diethyl-3-methylbenzamide (deet) were tested; one product was a polymer-based cream (3M Ultrathon Insect Repellent) and the other product was an alcohol-based pump spray formulation (Muskol Insect Repellent). Assessments were done in the laboratory using Aedes aegypti (L.) and in the field with naturally occurring populations of mosquitoes. Repellent was applied to the forearms (laboratory) or a lower leg (field) of test subjects at 1.5 g of test product per 600 cm2 surface area (0.75 or 0.83 mg deet/cm2). For a given test day, subjects exercised or did not. Exposure to mosquito attack was for 1 min at 30-min intervals in laboratory procedures, and it was continuous in field tests. Performance was measured as complete protection time (CPT). Moderate levels of physical activity resulted in a >40% decline in mean CPT, from 468 to 267 min in the laboratory experiments and from 359 to 203 min in field tests. Repellent product did not affect the magnitude of the decline. Mean biting pressure during field trials was 21.3 bites per min, and mosquito collections were made up primarily of Ochlerotatus sticticus (Meigen) and Aedes vexans (Meigen).

Field Evaluation Against Mosquitoes of Regular and Polymer-Based Deet Formulations in Manitoba, Canada, with Comment on Methodological Issues

Studies were carried out in Manitoba, Canada, to evaluate the efficacy of three repellent products for protection of human subjects against mosquito bites. All test substances contained the active ingredient N,N-diethyl-3-methylbenzamide (deet); two were polymer-based creams (3M Ultrathon Insect Repellent and Morflex DEET Insect Repellent 30) and the third (Muskol Insect Repellent) was an alcohol-based pump spray formulation. Application of repellent was to the forearm and lower legs of subjects at 0.75 or 0.83 mg deet/cm2. Exposure to mosquito attack was continuous, and efficacy was determined by measuring complete protection time (CPT). Regardless of whether delivered as a polymer cream or in alcohol, mean CPT was similar for the tested repellents at 623 +/- 107 to 644 +/- 163 min. By contrast, mean CPT for the different test subjects showed significant variation, ranging from 531 +/- 42 to 756 +/- 54 min. Mosquito collections from untreated human test subjects, Centers for Disease Control and Prevention (CDC) light traps and sweep-netting consisted primarily of Ochlerotatus sticticus (Meigen) and Aedes vexans (Meigen). Relative catch of these two species was similar for different sampling methods through much of the day, but not in the evening, when CDC light traps oversampled Ae. vexans relative to untreated human subjects. Results are used to highlight the need to account for intersubject variation when designing repellent studies, and also are used as a basis to discuss limitations associated with using relatively few subjects when testing repellents.

Field Evaluation Against Mosquitoes of Regular and Polymer-Based Deet Formulations in Manitoba, Canada, with Comment on Methodological Issues

Studies were carried out in Manitoba, Canada, to evaluate the efficacy of three repellent products for protection of human subjects against mosquito bites. All test substances contained the active ingredient N,N-diethyl-3-methylbenzamide (deet); two were polymer-based creams (3M Ultrathon Insect Repellent and Morflex DEET Insect Repellent 30) and the third (Muskol Insect Repellent) was an alcohol-based pump spray formulation. Application of repellent was to the forearm and lower legs of subjects at 0.75 or 0.83 mg deet/cm2. Exposure to mosquito attack was continuous, and efficacy was determined by measuring complete protection time (CPT). Regardless of whether delivered as a polymer cream or in alcohol, mean CPT was similar for the tested repellents at 623 ± 107 to 644 ± 163 min. By contrast, mean CPT for the different test subjects showed significant variation, ranging from 531 ± 42 to 756 ± 54 min. Mosquito collections from untreated human test subjects, Centers for Disease Control and Prevention (CDC) light traps and sweep-netting consisted primarily of Ochlerotatus sticticus (Meigen) and Aedes vexans (Meigen). Relative catch of these two species was similar for different sampling methods through much of the day, but not in the evening, when CDC light traps oversampled Ae. vexans relative to untreated human subjects. Results are used to highlight the need to account for intersubject variation when designing repellent studies, and also are used as a basis to discuss limitations associated with using relatively few subjects when testing repellents.

The pH changes of calcium hydroxide mixed with six different vehicles

The aim of this study was to determine the pH values of calcium hydroxide mixed with sterile saline, glycerin, Xylocaine pump spray, Citanest Octapressin, 0.2% chlorhexidine solution, and Ultracaine DS. pH values of all vehicles were measured by a pH microelectrode before calcium hydroxide powder was added to 2 mL of the vehicle until the solutions were saturated (n = 10). After all the saturated samples were prepared, pH was remeasured at 0, 10, 20, 30, and 45 minutes; 1, 24, and 48 hours; and 7 days. When pH changes over the time course were compared, there were no statistically significant differences among mean pH values of 0, 10, 20, 30, 45 minutes, 1 hour, and 24 hours (P = .754) and mean pH values of these groups were significantly lower than the mean pH value of 48 hours and 7 days (P < .05). The highest mean pH value was observed at day 7. When different vehicles were compared, the lowest mean pH value was observed in sterile saline. The mean pH value of Xylocaine was the highest (P < .05). The result of this study indicated that when calcium hydroxide powder was mixed with glycerin, Xylocaine pump spray, Citanest Octapressin, 0.2% chlorhexidine solution, Ultracaine DS, and sterile saline solution, the mixtures became very highly alkaline. However, the pH values of the mixtures increased significantly after 24 hours. When one of these vehicles is used for root canal medication, a calcium hydroxide mixture might be left in place at least 7 days.

Effect Of Nasal And Bronchial Grass Pollen Challenges On Plasma Cytokine Levels

RATIONALE: Few studies have performed nasal and bronchial allergen challenges in the same patients. The aim of our study was to assess the effect of the allergen delivery route (nasal and bronchial) on plasma cytokine levels in grass pollen sensitized patients. METHODS: Twenty-one subjects with seasonal grass pollen rhinitis and/or intermittent asthma underwent outside the grass pollen season one nasal provocation test (NPT) and one bronchial provocation test (BPT) with a grass pollen extract in a randomized order. BPT, performed by using a dosimeter jet nebulizer (Spira Electro 2) producing 10 μm particles, was considered positive when FEV 1 dropped by 20%. NPT, performed by means of a nasal pump spray in both nostrils, was considered positive when nasal flow measured by anterior-rhinometry dropped by 40% or symptom score was ≥ 5. Plasma cytokine levels (IL-4, IL-5, IL-10, IL-2, TNF-α and IFN-γ) were measured before and 3, 6 and 24h after allergen challenge by flow cytometry using a bead array immunoassay. RESULTS: A significant increase in plasma levels of IL-5 was found 24 hours following NPT (0.78 to 2.50 pg/ml; p=0.008) and 6 and 24 hours following BPT (0.95 to 40.69 pg/ml; p=0.029). The increase of IL-5 after BPT was significantly higher than after NPT (p=0.034). IL-4, IL-10, IL-2, TNF-α and IFN-γ plasma levels were undetectable in most of the samples. CONCLUSIONS: Our results suggest that introducing allergens through the bronchi induces significantly higher concentrations of IL-5 than through the nose.

Aptar Group Inc.

AbstractPlastics (MIC: 11.7 SIC: 3089 NAIC: 326199)AptarGroup is a global supplier of a broad range of dispensing systems for the personal care, fragrance/cosmetic, pharmaceutical, household and food/beverage markets. Co.'s operations are divided into two segments: Dispensing Systems and SeaquistPerfect. The Dispensing Systems segment sells primarily non‐aerosol spray and lotion pumps, plastic dispensing and non‐dispensing closures, and metered dose aerosol valves to the fragrance/cosmetic, pharmaceutical, personal care, household and food/beverage markets. SeaquistPerfect sells primarily aerosol valves and accessories and certain non‐aerosol spray and lotion pumps mainly for the personal care, household and food/beverage markets.

Validity ofIn VitroTests on Aqueous Spray Pumps as Surrogates for Nasal Deposition, Absorption, and Biologic Response

This research investigated the impact of the full range of in vitro spray characterization tests described in the FDA Draft Bioequivalence Guidance on nasal deposition pattern, pharmacokinetics, and biological response to nicotine administered by two aqueous nasal spray pumps in human volunteers. Nicotine was selected as a model drug (even though it is not locally acting) based on its ability to alter cardiac function and available plasma assay. Significant differences in pump performance-including mean volume diameters, spray angle, spray width, and ovality ratios-were observed between the two pumps. There were no significant differences in deposition pattern, or pharmacokinetic or pharmacodynamic response to the nasally administered nicotine. Although there were statistical differences in the in vitro tests between the two pumps, these differences did not result in significant alterations in the site of droplet deposition within the nose, the rate and extent of nicotine absorption, or the physiologic response it induced. These results suggest that current measures of in vitro performance, particularly spray angle and spray pattern (ovality), may not be clinically relevant. Additional research is needed to define what spray pump characteristics are likely to produce differences in deposition pattern and drug response.

Study of a combined percutaneous local anaesthetic and the TDS® system for venepuncture

Transdermal Delivery System (TDS) is a liquid formulation which can be applied to the skin via a metered pump spray to deliver drug across skin. This placebo controlled, double blind trial compared anaesthetic properties of two TDS systems (TDS alpha and TDS beta) with placebo. The active and placebo treatments were applied to the dorsum of the hands, bilaterally and simultaneously for 5 min on 100 healthy volunteers. Following cannulation, pain perception was measured using the verbal rating score (VRS) and visual analogue score (VAS). Lidocaine plasma levels were assessed at 0 and 2 h. The VRS and VAS results show that TDS beta significantly decreased pain score compared to placebo (p < 0.02). Blood lidocaine at 2 h post application was also higher for TDS beta than for TDS alpha, suggesting that a 5 min application of TDS beta was effective in delivering local anaesthetic and accelerating the onset of skin anaesthesia prior to venous cannulation in adults.

AptarGroup Inc.

AbstractPlastics (MIC: 11.7 SIC: 3089 NAIC: 326199)AptarGroup designs, manufactures and sells consumer product dispensing systems for the personal care, fragrance/cosmetic, pharmaceutical, household and food/beverage markets. Operations are divided into two segments, Dispensing Systems and SeaquistPerfect. The Dispensing Systems segment sells primarily non‐aerosol spray and lotion pumps, plastic dispensing and non‐dispensing closures, and metered dose aerosol valves to the fragrance/cosmetic, pharmaceutical, personal care, household and food/beverage markets. SeaquistPerfect sells primarily aerosol valves and accessories and certain non‐aerosol spray and lotion pumps mainly for the personal care, household and food/beverage markets.