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Influence of tartaric acid on the bioadhesion and mechanical properties of hot-melt extruded hydroxypropyl cellulose films for the human nail.

The objective of this study was to investigate the influence of tartaric acid (TTA) on the bioadhesive, moisture sorption, and mechanical properties of hot-melt-extruded (HME) hydroxypropyl cellulose (HPC) films containing polymer additives. Two Klucel EF and LF batches (HPC, MW: 80000 and 95000, respectively) containing the model antifungal drug ketoconazole (one batch of each MW with and without TTA 4%) were prepared into films by HME using a Killion extruder (Model KLB-100). The bioadhesive properties of the HPC films, with and without TTA, were investigated ex vivo on the human nails. The parameters measured were work of adhesion and peak adhesion force (PAF). A statistically significant increase in both the area under the curve (AUC) and PAF was seen for the HME films containing TTA than those without TTA. Moisture content of hot-melt extruded HPC films was determined using thermogravimetric analysis (TGA). TGA data collected at the two-week interval (25 degrees C/60% RH), measured higher moisture content for the TTA-containing films than those without TTA. Tensile strength and percent elongation were determined utilizing a TA.XT2i Texture Analyzer(R) equipped with a 50-kg load cell, TA-96 grips, and Texture Expert software. TTA functioned as an effective plasticizer, increasing percent elongation and decreasing tensile strength of the HPC films. TTA could potentially be a candidate for transnail applications in film devices prepared by hot-melt extrusion technology.

Antifungal Agents↗

Circular dichroism of amino acid films in UV-VUV region.

Circular dichroism (CD) spectra of sublimated films of alanine and alanine dipeptide were measured in UV-VUV region. When a film has some linear anisotropy, the apparent CD signal is known to be strongly distributed by linear anisotropy. In order to obtain the true CD spectra, we examined this disturbance for L-alanine films. We measured linear dichroism spectra and CD spectra as a function of the sample rotation angle, turning the sample over. On the basis of these measurements, we concluded that the linear anisotropy contribution to CD was sufficiently small for carefully prepared films. In addition, we revealed that it is essential for accurate measurement to prepare thin film of which thickness is smaller than 100 nm for the case of alanine films. CD of amino acid films was compared with that of aqueous solution. Sign of CD signal of solid films was observed to be the same for aspartic acid, but it was reversed from that of aqueous solution for alanine and alanine dipeptide.

Alanine↗

Absorption of dimethylacetamide (DMAC) following application of a polymer film to the skin of rabbits.

Kapton Film is a polymer with high strength and thermal resistance finding use in a wide variety of applications. In the preparation of this film, the uncured material could contain up to 30% dimethylacetamide (DMAC). Note that the final product Kapton Film has been thermally cured with the DMAC removed. During processing, dermal contact with the film is anticipated, and the possibility exists of DMAC transfer from the uncured film, to and through the skin. In this study, 2 x 2-inch pieces of film were applied to the skin of a group of rabbits and secured in place for a single 4-hour contact time. An amount of liquid DMAC corresponding to the amount contained in the 2-inch square was applied to the skin of a separate group of rabbits for 4 hours. Urine samples were collected over the intervals of application to 4 hours post application (8 hours total) or 4 to 20 hours post application (16 hours). The amount of the urinary metabolite monomethylacetamide (MMAC) was determined analytically in these samples. Urine from 2 untreated rabbits was collected at the same time to serve as controls. The amount of urinary MMAC found in the rabbit rine from animals exposed to uncured Kapton Film at both ollection intervals was similar to the amount seen in the controls (background). Rabbits treated with DMAC liquid had measurable urinary MMAC levels that were approximately 100 times background. It is concluded that, under the conditions of this study, very little, if any, DMAC from the uncured Kapton Film was absorbed through the skin (and excreted in the urine as MMAC).

Acetamides↗

Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion.

Hydroxypropylcellulose (HPC) films containing drugs or hydrophilic or hydrophobic plasticizers were prepared by a hot melt extrusion process. Polyethylene glycol 8000 (PEG 8000) 2%, triethyl citrate (TEC) 2%, acetyltributyl citrate (ATBC) 2%, and polyethylene glycol 400 (PEG 400) 1% were the plasticizing agents studied. In addition, either hydrocortisone (HC) 1% or chlorpheniramine maleate (CPM) 1% was incorporated into the films as a model drug. The physical-mechanical properties of the films that were investigated included tensile strength (TS), percentage elongation (%E), and Young's modulus (YM). Differential scanning calorimetry (DSC) was utilized to determine glass transition temperatures (Tg's). These parameters were studied as a function of time and temperature. The glass transition temperatures initially decreased with the inclusion of the drugs and plasticizers. However, after 6 months aging, films containing PEG 400 and HC showed a marked increase in Tg. The films containing PEG 400 showed physical-mechanical instability in all parameters studied. All extruded films exhibited a marked decrease in TS in contrast to a large increase in %E when testing was performed perpendicular to flow versus in the direction of flow. In addition, a consistent film of HPC in the absence of drugs or plasticizers could not be extruded due to the excessive stress on the equipment. Although the theoretical percentage of CPM on aging remained fairly constant over the processing temperature ranges in this study, the HC levels remaining in the extruded films during storage were a function of time and temperature.

Cellulose↗

Characterization of film-coated aerosol canisters using electrochemical impedance spectroscopy.

Drug adhesion to the walls of an aerosol canister can be prevented/reduced by coating the canister with a hydrophobic polymer (e.g., a fluoropolymer). In this study, three batches of fluoropolymer-coated canisters were investigated by electrochemical impedance spectroscopy (EIS) and scanning electron microscopy (SEM). The EIS technique showed that only one of the batches presented as a monolithic, non-porous film. The other two batches were either partially porous or highly porous. Scanning electron micrographs showed evidence of cracks, within the films, but could not alone establish the porous nature of these defects. For the non-porous and partly porous films it was possible to use the EIS data to determine the approximate film thickness. Estimates of 2-4 microm were obtained for the mean film thickness. These values compared favorably with micrometer estimates obtained following acid dissolution of the aluminum canister. It remains to be seen whether the properties of the films (i.e., the porosity and film thickness, determined by EIS) translate to differences in drug adhesion. Nevertheless, the EIS technique was shown to be a powerful, non-destructive method that lends itself to the rapid analysis of batch-to-batch variation in film-coated canisters.

Aerosols↗

Effect of heat on characteristics of chitosan film coated on theophylline tablets.

The effect of heat on the characteristics of chitosan film coated on theophylline tablets was studied. Chitosan of high viscosity grade with molecular weight in the range of 800,000-1,000,000, 80-85% degree of deacetylation was used as a film former by dissolving in 1% v/v acetic acid solution. The coated tablets had been cured at 40, 60, and 100 degrees C for 6, 12, and 24 hr. The morphology of the film at the edge and surface of coated tablets was investigated using scanning electron microscopy. Film cracking was increased and clearly observed in the coated tablets cured at 100 degrees C for 24 hr. As a result, more water could be absorbed into the tablets, followed by faster disintegration and faster drug release. The evidence of partial conversion of chitosonium acetate to chitin in the 13C nuclear magnetic resonance (NMR) spectra of chitosan films cured at 40, 60, and 100 degrees C was observed, but it had no effect on drug release behavior. Theophylline tablets coated with chitosan films gave sustained release behavior in various media, i.e., distilled water, 0.1 N hydrochloric acid, pH 4.5 acetate buffer, and pH 6.8 phosphate buffer. In addition, the film coating temperature at 55-60 degrees C and curing process at 40 and 60 degrees C had no effect on the drug release from theophylline tablets coated with chitosan polymer. Finally, it might be concluded that both the physical and chemical properties of chitosan films were affected by heat.

Biopolymers↗

Optical properties of poly(2,6-dimethyl-1,4-phenylene oxide) film and its potential for a long-term solar ultraviolet dosimeter.

The optical properties of poly(2,6-dimethyl-1,4-phenylene oxide) (PPO) film have been characterized in order to develop an alternative method for UV dosimetry with a focus on long-term human exposure measurements. The dynamic range of PPO film was found to extend to 2 MJ m(-2) of broadband UV exposure independently of film thickness, providing an exposure range of roughly four summer days at subtropical latitudes. The sensitivity of the film to UV exposure was positively related to film thickness in the 20-40 microm range. Films of 40 microm thickness proved to be the most suitable for long-term human UV exposure measurements. The temperature independence of the response of 40 microm PPO film was established from 1.5 degrees C to 50 degrees C within a dosimeter response uncertainty of 6.5%. Dose-rate independence was also demonstrated within 8% of the mean dosimeter response. The spectral response approximates the CIE erythemal action spectrum between 300 and 340 nm, with a peak response at 305 nm. A large deviation from this action spectrum was observed at shorter wavelengths. Investigation of the angular response in both the azimuth and altitude planes showed a cosine error of less than 6.2% between 0 degrees and 40 degrees, and did not exceed 13.3% at any angle greater than 40 degrees. These results indicate that PPO film satisfies the requirements for use as a UV dosimeter, and may be employed in long-term human exposure measurements.

Humans↗

Small-diameter porous poly (epsilon-caprolactone) films enhance adhesion and growth of human cultured epidermal keratinocyte and dermal fibroblast cells.

Autologous keratinocyte grafts provide clinical benefit by rapidly covering wounded areas, but they are fragile. We therefore developed biocompatible hexagonal-packed porous films with uniform, circular pore sizes to support human keratinocytes and fibroblasts. Cells were cultured on these porous poly (epsilon-calprolactone) films with pore sizes ranging from novel ultra-small 3 microm to 20 microm. These were compared with flat (pore-less) films. Cell growth rates, adhesion, migration, and ultrastructural morphology were examined. Human keratinocytes and fibroblasts attached to all films. Furthermore, small-pore (3-5 microm) films showed the highest levels of cell adhesion and survival and prevented migration into the pores and opposing film surface. Keratinocyte migration over small-pore film surface was inhibited. Keratinocytes optimally attached to 3-microm-pore films due to a combination of greater pore numbers (porosity), a greater circumference of the pore edge per unit surface area, and greater frequency of flat surface areas for attachment, allowing better cell-substrate and cell-cell attachment and growth. The 3-microm pore size allowed cell-cell communication, together with diffusion of soluble nutrients and factors from the culture medium or wound substrate. These characteristics are considered important in developing grafts for use in the treatment of human skin wounds.

Biocompatible Materials↗

Support film in transmission electron microscopy: experiences with polyvinyl butyral Pioloform BM 18.

Microscopic work with single-slot grids requires high-quality support films to span the relatively large gap. The imminent unavailability of the polyvinyl formal Pioloform FN 65, which to date has been used as the standard polyvinyl formal for the generation of support films in transmission electron microscopy (TEM), has necessitated the finding of a substitute material to produce such films. Therefore, we compared the polyvinyl butyral Pioloform BM 18 with the polyvinyl formal Pioloform FN 65 for the production of TEM support films, using operational criteria for assessment. Pioloform BM 18 with the solvent chloroform resulted in support films of unacceptable quality compared with Pioloform FN 65. Adding the softener dibutyl phthalate to the chloroform solvent for Pioloform BM 18 markedly improved the film quality, resulting in support films with high transparency and flexibility, and even greater stability in the electron beam when compared with films of Pioloform FN 65. Pioloform FN 65 also had the disadvantage of requiring highly toxic 1,2-dichloroethane as a solvent, whereas Pioloform BM 18 can be used with chloroform.

Collagen Type IV↗

Reading radiographs in chronological order, in pairs or as single films has important implications for the discriminative power of rheumatoid arthritis clinical trials.

OBJECTIVE: To determine the influence of reading series of films in chronological order, in pairs with unknown time sequence, or as single films, on precision and sensitivity to change. METHODS: Two studies were performed with 10 and 12 patients fulfilling the American College of Rheumatology criteria. In Study 1, two sets of films with a 1 yr interval were scored in chronological order, in pairs, and as single films. In Study 2, four sets of films, with a 1 yr interval each, were scored in chronological order, as single films and as single-pair (right and left together). All films were scored with the Sharp/van der Heijde method by two independent observers. Data were analysed with a repeated measures ANOVA using a full mixed effects model. Two generalizability (G) coefficients were constructed for reliability and for change. RESULTS: Study 1: the interobserver reliability was similar for the three methods (G(reliability) chronological 0.94, paired 0.88, single 0.93); progression was a mean increase (averaged over patients, observers and methods) from 26 to 37 (P=0.046). The sensitivity for change was greater for the chronological than for the paired and single scoring (G(change) 0.39, 0.22 and 0.24, respectively). Study 2: the interobserver reliability was 0.86 for chronological, 0.76 for single-pair and 0.91 for single readings. Significantly more progression was measured with the chronological compared with the single-paired and single methods (15.9 vs 8.5 and 8.3; P=0.0001). A constant progression was suggested by chronological reading, in contrast to a stabilization in the other two methods after 1 yr. CONCLUSION: Reading films in chronological order is most sensitive to change in a time period up to 3 yr follow-up; this was already present after 1 yr, but even more pronounced with longer follow-up.

Analysis of Variance↗

Phase 1 trial of nonoxynol-9 film among sex workers in South Africa.

OBJECTIVES: To assess the acceptability and safety of a vaginal nonoxynol-9 film in a group of sex workers at a truck stop in South Africa. DESIGN: A randomized double-blinded crossover trial was conducted between April 1995 and July 1995. INTERVENTION: Seventy-two mg nonoxynol-9 film and an identical glycerine placebo film. METHODS: Following informed consent, each study participant was randomly assigned the designated pre-coded film for 1 month. The second month was a film-free washout period and the participants used the alternate film in the third month. Besides measuring behavioural and clinical outcomes, colposcopy examination for genital lesions, serology and microbiology investigations for sexually transmitted diseases and semi-quantitative PCR for vaginal HIV load estimates were performed. RESULTS: Twenty women participated in the study. The women reported, on average, 19 sexual encounters per week. Vaginal intercourse was protected 25% of the time by condoms. On average, 11 vaginal films, either nonoxynol-9 or placebos were inserted per week. There were no statistically significant differences between the two treatment groups for genital lesions (P = 0.29), reported side effects (P = 0.73), and viral load (P = 0.9). However, the proportions of clinically detected genital lesions (six out of eight versus two out of eight) and self-reported side-effects (five out of eight versus three out of eight) were higher in the nonoxynol-9 group when compared with the placebo group. Incident sexually transmitted diseases occurred more frequently in the placebo group. An increased viral load was associated with the development of a genital lesion (relative risk, 6.0; 95% confidence interval, 0.81-44.4). CONCLUSIONS: The 72 mg film formulation of nonoxynol-9 was an acceptable product for use in this population of sex workers. Although no statistically significant differences in adverse outcomes were detected, clinically there appeared to be an increase in minor lesions and self-reported side-effects with nonoxynol-9 and less protection against sexually transmitted diseases with the placebo. Furthermore, HIV shedding was correlated with the presence of incident vaginal or cervical lesions. This brings into question the potential narrow margin of safety for this product; additional Phase 2 studies are therefore required.

Administration, Intravaginal↗

Temperature response of two photographic films and TLDs suitable for patient dosimetry of high dose fluoroscopic procedures.

When making direct measurements of skin entrance dose for patients undergoing interventional x-ray procedures the dosimeter may be placed near or in direct contact with the skin. The response of such dosimeters to heating during x-ray exposure must be known for accurate dosimetry. Two photographic films and MgB4O7 TLDs used for patient dose monitoring were exposed under different temperature conditions. Film dose response curves were obtained at room temperature and body temperature (22 degrees C and 38 degrees C). The TLD response at room and body temperature was also checked at 14 Gy. Dose response curves of FGP film show at most a 22+/-2% increase in predicted dose at 37 degrees C in the range of 0.3 to 2.8 Gy. LOC4 film showed less than a 2% difference in response between 22 and 37 degrees C over a range of 1 to 11 Gy. The TLDs showed less than a 2% difference at a dose of 14 Gy. Uncertainty in skin dose estimation is less than 2% using LOC4 film and MgB4O7 TLD arrays. Uncertainty in temperature during exposure of Kodak fine grain positive film may lead to errors in dose estimates of +/-11%. Arrays of TLDs and copy film are more suitable for measurements of high doses and are less sensitive to temperature changes during exposure than the fine grain film.

Dose-Response Relationship, Radiation↗

Physical characteristics of modern radiographic screen-film systems.

The most important characteristics that determine the performance of a screen-film system are system sensitivity (speed), slope or the average gradient of the characteristic curve, latitude of the film, system resolution (MTF) and system noise. In addition to these, one has to consider secondary characteristics such as the base plus fog level, the base tint, safelight sensitivity, reciprocity law failure and film granularity while evaluating performance. A comprehensive study of many of these characteristics has been made for a number of film-screen systems on the market. The data has been tabulated in the form of what are called "characteristic tables of radiographic film-screen systems." In these tables, characteristics such as average gradient, base plus fog level, etc. which depend on film alone, appear along the horizontal axis and MTF values which essentially depend on screens only appear along the vertical axis. The body of the table contains the absolute speeds in units of mR-1 at 80 KVP (heavy filtration) and a quantum mottle index of the various film-screen combinations tested, since these depend both on the film as well as on the screens.

Evaluation Studies as Topic↗

Use of retroillumination to visualize optical aberrations caused by tear film break-up.

PURPOSE: The aim of the current study was to develop quantitative methods to assess optical aberrations caused by tear film disruption. METHODS: We used standard fluorescein imaging (FL) and a novel retroillumination (RI) method to image tear film disruption in 12 eyes. Using a clinical slit lamp biomicroscope, we alternated between widefield blue and narrow-beam white light to obtain an interleaved series of FL and RI images of the time course and pattern of tear film break-up. We developed an optical analysis that indicates that the RI image should be proportional to the spatial derivative of the FL image. Intensity fluctuations in the RI images are due to thickness changes in the tear film, whereas intensity fluctuations in FL images are directly determined by tear film thickness. RESULTS: As predicted by optical analysis of RI, the spatial distribution of gaps in the tear film seen with fluorescein appeared as pairs of light and dark contours in the RI images, and a precise correspondence between the spatial derivative of the FL image (slope) and the RI image was found. Both methods showed a gradual spreading of the tear disruption during blink suppression that varied tremendously among eyes in both time and spatial pattern. Resumption of normal blinking did not produce an immediate reconstitution of the normal tear film, and areas of tear break-up created during blink suppression remained abnormal for up to several minutes of normal blinking. CONCLUSIONS: Our analysis indicates that both FL and RI have the potential to quantify optical changes occurring during tear break-up. These results support an interpretation of RI as an intensity-based method for mapping the highly irregular optical aberrations of the eye produced by tear film disruption.

Adult↗

Investigating the functionality of diamond-like carbon films on an artificial heart diaphragm.

In this study, the authors used diamond-like carbon film to coat the ellipsoidal diaphragm (polyurethane elastomer) of artificial hearts. The purpose of such coatings is to prevent the penetration of hydraulic silicone oil and blood through the diaphragm. To attach diamond-like carbon film uniformly on the diaphragm, the authors developed a special electrode. In estimating the uniformity of the diamond-like carbon film, the thickness was measured using a scanning electron microscope, and the characteristics of the diamond-like carbon film was investigated using infrared spectroscopy, Ar-laser Raman spectrophotometer, and x-ray photoelectron spectrometer. Also, to estimate the penetration of silicone oil through the diaphragm, in vitro testing was operated by alternating the pressure of silicone oil for 20 days. The authors were able to successfully attach uniform deposition of diamond-like carbon film on the ellipsoidal diaphragm. In this in vitro test, diamond-like carbon film was proven to have good stability. The amount of silicone oil penetration was improved by one-third using the diamond-like carbon film coating compared with an uncoated diaphragm. It is expected that through the use of the diamond-like carbon film, the dynamic compatibility of an artificial heart diaphragm will increase.

Carbon↗

Casimir effect in critical films of binary liquid mixtures

We present experimental evidence for the Casimir effect within critical films of binary liquid mixtures possessing opposite boundary conditions (+-) by studying the thickness of these vapor-adsorbed films on a silicon wafer as a function of temperature near the critical temperature. Our results for two different critical mixtures demonstrate that the critical Casimir pressure scaling function vartheta(+-)(y) scales with y=L/xi, where L is the equilibrium film thickness and xi is the bulk correlation length. Additionally, on approaching the critical temperature T(c) an increase in the film thickness L is observed, implying that the sign of the universal Casimir amplitude Delta(+-)=vartheta(+-)(0)/2 at T(c) is positive, consistent with theoretical predictions. However, the magnitude of the Casimir amplitude that we measure is approximately two orders of magnitude smaller than that given by prevailing theories. In the two-phase region of the liquid mixture, preliminary evidence suggests that the adsorbed film undergoes a surface phase transition from a film near the critical composition at T less, similarT(c) to a film near one of the bulk phases at T<<T(c). This low temperature film composition most likely corresponds to the bulk phase rich in the component that preferentially adsorbs at the silicon surface.

Journal Article↗

Hysteresis and the dynamic phase transition in thin ferromagnetic films.

Hysteresis and the nonequilibrium dynamic phase transition in thin magnetic films subject to an oscillatory external field have been studied by Monte Carlo simulation. The model under investigation is a classical Heisenberg spin system with a bilinear exchange anisotropy Lambda in a planar thin film geometry with competing surface fields. The film exhibits a nonequilibrium phase transition between dynamically ordered and dynamically disordered phases characterized by a critical temperature T(cd), whose location is determined by the amplitude H0 and frequency omega of the applied oscillatory field. In the presence of competing surface fields the critical temperature of the ferromagnetic-paramagnetic transition for the film is suppressed from the bulk system value T(c) to the interface localization-delocalization temperature T(ci). The simulations show that in general T(cd)<T(ci) for the model film. The profile of the time-dependent layer magnetization across the film shows that the dynamically ordered and dynamically disordered phases coexist within the film for T<T(cd). In the presence of competing surface fields, the dynamically ordered phase is localized at one surface of the film.

Journal Article↗

Coarsening dynamics of dewetting films.

Lubrication theory for unstable thin liquid films on solid substrates is used to model the coarsening dynamics in the long-time behavior of dewetting films. The dominant physical effects that drive the fluid dynamics in dewetting films are surface tension and intermolecular interactions with the solid substrate. Instabilities in these films lead to rupture and other morphological changes that promote nonuniformity in the films. Following the initial instabilities, the films break up into near-equilibrium droplets connected by an ultrathin film. For longer times, the fluid will undergo a coarsening process in which droplets both move and exchange mass on slow time scales. The dynamics of this coarsening process will be obtained through the asymptotic reduction of the long-wave PDE governing the thin film to a set of ODEs for the evolution of the droplets. From this, a scaling law that governs the coarsening rate is derived.

Journal Article↗