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PubMed2007

Is it possible to improve the patch-test diagnostics for isocyanates? A stability study of petrolatum preparations of diphenylmethane-4,4'-diisocyanate and polymeric diphenylmethane diisocyanate.

We have previously shown that the concentration of diphenylmethane-4,4'-diisocyanate (4,4'-MDI) in commercial test preparations was so low that patch testing with the same was not reliable. The stability of 4,4'-MDI in petrolatum (pet.) was compared with pet. preparations of polymeric diphenylmethane diisocyanate (PMDI), which consists of a complex mixture of monomeric isomers and oligomers of MDI. Preparations of 4,4'-MDI and PMDI were stored under 3 different conditions, i.e. at room temperature, refrigerated and frozen. They were analysed continuously during 1 year with regard to the content of 4,4'-MDI, 3-ring oligomers and 4-ring oligomers using liquid chromatography-mass spectrometry. PMDI preparations kept frozen were stable for a year. All other preparations failed to fulfil the requirements of stability, i.e. +/-20% of the initial concentration. Storage in a freezer prolonged the lifetime for 4,4'-MDI. The decrease in concentration for preparations kept at room temperature and refrigerated was less rapid in PMDI preparations than in 4,4'-MDI preparations. PMDI preparations are better suited for patch testing patients exposed to MDI because they are more stable and homogeneous than 4,4'-MDI preparations. They better reflect possible allergens that workers are exposed to because products used in industry contain both monomers and oligomers.

Chromatography, Liquid↗

PubMed1993

Chemical and physicochemical characterization of petrolatums used in eye ointment formulations.

Petrolatums from different manufacturers were characterized by viscosity measurements, oil number and ratio of low to high mol. wt components (capillary gas chromatography). Viscosity measurements and oil numbers of original materials did not correlate with the viscosity of the processed material in eye ointments. The ratio of high carbon number components to the low carbon number components was a reliable predictor for the viscosity of the formulation.

Chemical Phenomena↗

PubMed1975

Efficacy of the inactivation of bacterial spores in white petrolatum and a hydrophilic ointment by gamma irradiation.

To evaluate the possibilities of using gamma irradiation for the sterilization of ointments, the effect of irradiation on spores of Bacillus pumilus and Bacillus sphaericus in dry material and in two different kinds of ointments was studied. The results indicate that for sterilization purposes irradiation was less effective in white petrolatum as compared to irradiation in the dry state. No such protective effect was found in a hydrophilic ointment. Accordingly, the sterilization dose needed for the sterilization of an ointment can be decided upon only after inactivation experiments with suitable test organisms in the actual preparation.

Bacillus↗

PubMed2000

Systemic candidiasis in extremely low birth weight infants receiving topical petrolatum ointment for skin care: a case-control study.

BACKGROUND AND OBJECTIVE: An increase in the incidence of systemic candidiasis (SC) followed a change in skin care for extremely low birth weight (ELBW) infants in our neonatal intensive care unit (NICU). We sought to determine whether the use of topical petrolatum ointment (TPO) for skin care of ELBW infants was associated with risk for SC. STUDY DESIGN: Case-control study. SETTING: A 48-bed NICU in a private hospital in Houston, Texas. PATIENTS: Ten ELBW infants with and 30 without SC admitted to the NICU from December 1, 1997 through July 31, 1998. METHODS: ELBW infants with SC were identified using hospital microbiology and infectious disease consultation databases. A case was defined as an infant weighing </=1000 g at birth with Candida spp isolated from a normally sterile body site. Three infants without SC were matched to each case by birth weight, admission date, and survival to the age of SC onset for the case. Data were collected by retrospective medical record review. Molecular analysis of Candida isolates was performed by karyotyping and restriction fragment length polymorphism using pulsed-field gel electrophoresis. RESULTS: Case infants had a mean (+/- standard deviation) age of onset of 21.5 +/- 24 days. Infants with SC and controls did not differ in birth weight, gestational age, or duration of therapy with steroids, antibiotics, insulin, or total parenteral nutrition. Although cases were more likely to be born vaginally and had a longer duration endotracheal intubation than controls, these differences were not significant. The odds ratio for skin care with TPO in case infants versus control infants was 11 (95% confidence interval: 1.9-63). Skin care with TPO was discontinued and the incidence of SC decreased to baseline. Several Candida spp and genetic profiles were identified, suggesting that there was not a common source outbreak. CONCLUSIONS: We conclude that the use of TPO promoted an increase in the incidence of SC in ELBW infants. Additional investigation of potential infectious risks for ELBW infants receiving TPO skin care is warranted.

Administration, Topical↗

PubMed1996

In vitro release of betamethasone dipropionate from petrolatum-based ointments.

The purpose of this research was to develop new in vitro methodology for measuring release from petrolatum-based semisolids and to determine whether two ointments, both of which contained betamethasone dipropionate, 0.05%, but with different formulations, could be distinguished by release measurements. Several receptor media were explored to optimize the procedure utilizing Franz-type cells. Analysis was by HPLC. The release slope was 1.5 to 6 times greater from the ointment than the "augmented" ointment (which had greater clinical potency). Release was highest with a receptor consisting of a 5% solution of hexane in acetonitrile. Even so, it was necessary to subject samples of receptor from the augmented ointment to evaporation followed by reconstitution with a smaller volume of mobile phase to bring corticosteroid concentrations up to quantifiable levels. In another series of experiments, the HPLC mobile phase was used as the receptor and a relatively large volume (100 microliters) was injected onto the column. With the second approach, measured concentrations were lower but more reproducible. Quantifiable levels of betamethasone dipropionate were obtained for both formulations beginning from the first data point (at 1 hr), with satisfactory linearity of plots of amount released per unit area of membrane versus the square root of time. Using this methodology, it was possible to distinguish the effect of formulation differences in two ointments containing the same drug in the same concentration.

Administration, Topical↗

PubMed2005

Chemical analysis of 2,4-toluene diisocyanate, 1,6-hexamethylene diisocyanate and isophorone diisocyanate in petrolatum patch-test preparations.

BACKGROUND: Isocyanates with the general formula R-(N=C=O) are theoretically contact sensitizers. However, allergic contact dermatitis (ACD) from isocyanates is seldom reported. In previous reports, patients reacted to their isocyanate-based work materials but not to commercial patch-test preparations of isocyanates. Therefore, we suspected that the low frequency of reported ACD from isocyanates was partly due to inadequate commercial preparations. A past study also showed the concentrations of diphenylmethane-4,4'-diisocyanate (4,4'-MDI) in petrolatum preparations to be much lower than declared. OBJECTIVE: In this study, 2,4-toluene diisocyanate (2,4-TDI), 1,6-hexamethylene diisocyanate (1,6-HDI), and isophorone diisocyanate (IPDI) were investigated in a similar fashion. METHODS: In preparations from 12 dermatology departments and two suppliers of patch-test allergens, we determined the isocyanate content as the isocyanate-dibutylamine derivative, using liquid chromatography and mass spectrometry. The preparations were considered stable if the ratio between the stated and found concentrations was within the range of 0.8 to 1.2. RESULTS: Although 28 of 36 investigated preparations had ratios outside of the stable range, they were in its vicinity, which indicates that preparations of 2,4-TDI, 1,6-HDI, and IPDI are more stable than are preparations of 4,4'-MDI where previously reported results showed ratios far outside of stable range. CONCLUSION: As opposed to preparations of 4,4'-MDI, preparations of 2,4-TDI, 1,6-HDI, and IPDI can be considered to be stable.

Cyanates↗

PubMed1990

Nystatin allergy. Petrolatum is not the optimal vehicle for patch testing.

Testing with various bases in a case of contact allergy to nystatin showed that polyethylene glycol is preferable to petrolatum as a test vehicle. The literature on nystatin allergy is reviewed.

Administration, Topical↗

PubMed1970

Sterility test method for petrolatum-based ophthalmic ointments.

A sensitive sterility testing procedure for the detection of microbial contamination in petrolatum-based ointments is described. The method involves dissolving the ointment in filter-sterilized isopropyl myristate and filtering through a membrane filter. Improved sensitivity is obtained by blending the membrane in Trypticase Soy Broth before incubation. Filter-sterilized isopropyl myristate is shown to be less toxic to microorganisms than heat-sterilized isopropyl myristate. The isopropyl myristate method is more sensitive than the polyethylene glycol-ether method for the detection of microbial contamination.

Bacillus subtilis↗

PubMed1964