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Pharmaceutics Jun 2024A classical emulsion formulation based on petrolatum and mineral oil as the internal phase with emulsifier wax as a typical topical emulsion cream was investigated for...
A classical emulsion formulation based on petrolatum and mineral oil as the internal phase with emulsifier wax as a typical topical emulsion cream was investigated for the effect of process parameters on drug product quality and performance attributes. The Initial Design of Experiment (DoE) suggested that an oil phase above 15%, coupled with less than 10% emulsifying wax, resulted in less stable emulsions. Different processing parameters such as homogenization speed, duration, cooling rate, and final temperature showed minimal influence on properties and failed to improve stability. The final DoE suggested that the optimal emulsion stability was achieved by introducing a holding period midway through the cooling stage after solvent addition. Within the studied holding temperature range (25-35 °C), a higher holding temperature correlated with increased emulsion stability. However, the application of shear during the holding period, using a paddle mixer, adversely affected stability by disrupting the emulsion microstructure. IVRT studies revealed that the release of lidocaine was higher in the most stable emulsion produced at a holding temperature of 35 °C compared to the least stable emulsion produced at a holding temperature of 25 °C. This suggests that a holding temperature of 35 °C improves both the stability and active release performance. It appears that a slightly higher holding temperature, 35 °C, allows a more flexible and stable emulsifying agent film around the droplets facilitating stabilization of the emulsion. This study offers valuable insights into the relationship between process parameters at various stages of manufacture, microstructure, and various quality attributes of emulsion cream systems. The knowledge gained will facilitate improved design and optimization of robust manufacturing processes, ensuring the production of the formulations with the desired critical quality attributes.
PubMed: 38931894
DOI: 10.3390/pharmaceutics16060773 -
Eplasty 2024Postsurgical pyoderma gangrenosum (PSPG) is a highly uncommon and unpredictable wound healing complication. Rapid progression of ulcers at incisions can cause unfettered...
BACKGROUND
Postsurgical pyoderma gangrenosum (PSPG) is a highly uncommon and unpredictable wound healing complication. Rapid progression of ulcers at incisions can cause unfettered dehiscence. Most commonly, PSPG involves breast procedures; however, in this work, we detail a case of a patient who developed PSPG 10 days postoperatively after penile inversion vaginoplasty.
METHODS
The patient in this case underwent a penile inversion vaginoplasty with orchiectomy in the standard fashion. She had no risk factors for PSPG. Following an uncomplicated hospital stay, the patient developed difficulty with pain control and increasing serous drainage on the 10th postoperative day. On readmission, the patient was found to have developed large, mildly purulent ulcers throughout the perineal wound edges. On exam under anesthesia, the neovaginal canal was found to be patent and intact. The dehisced portions of the incisions were left open and redressed with occlusive bismuth-petrolatum dressing. Dermatology was promptly consulted with suspicion for PSPG. The patient was started on an 18-day prednisone taper with cyclosporine, along with doxycycline and ciprofloxacin.
RESULTS
After 5 days of immunosuppressive treatment, the ulcers visibly converted to healthy granulation tissue and were no longer actively purulent. Following another washout, the dehisced wound edges were reapproximated. At follow-up, the patient had no evidence of PSPG recurrence and continued dilating on schedule. Our patient recovered from PSPG without further complications and a satisfactory aesthetic result.
CONCLUSIONS
This unique case highlights the importance of prompt dermatological consultation, immunosuppression, and avoidance of further pathergy in the setting of suspicion for PSPG.
PubMed: 38846503
DOI: No ID Found -
Indian Journal of Dermatology 2024Retinoids are used topically as well as orally, and the most commonly used oral retinoids are isotretinoin and acitretin. Mucocutaneous adverse effects are frequently...
Retinoids are used topically as well as orally, and the most commonly used oral retinoids are isotretinoin and acitretin. Mucocutaneous adverse effects are frequently seen with the use of systemic retinoids, the most common being cheilitis, which is dose-dependent and seen in almost all patients using it. To study the comparative effect of topical tacrolimus 0.1% ointment versus topical white soft petrolatum jelly in the treatment of cheilitis due to retinoids. A total of 26 patients with cheilitis post-treatment with isotretinoin were enrolled in this cross-sectional study conducted over a period of 6 months. They were randomized into two groups of 13 patients each to receive topical tacrolimus 0.1% ointment and soft petrolatum jelly twice daily, respectively. Patients were followed up weekly with clinical photographs. Resolution of cheilitis was assessed on the basis of photograph and ICGS score. About 84.6% of patients of group A and 53.8% of patients of group B showed resolution of symptoms within 1 week of treatment. A significant difference was seen in duration for complete cheilitis resolution and relapse rate in the two groups. Our study concludes that oral retinoid-induced cheilitis shows faster and more significant resolution with twice-daily topical tacrolimus 0.1% ointment application compared to twice-daily topical petrolatum jelly.
PubMed: 38841226
DOI: 10.4103/ijd.ijd_67_23 -
Analytica Chimica Acta Jul 2024Mineral oil aromatic hydrocarbon (MOAH) analysis in foods is a major analytical challenge. Quantification is associated with a high uncertainty. The sources of...
BACKGROUND
Mineral oil aromatic hydrocarbon (MOAH) analysis in foods is a major analytical challenge. Quantification is associated with a high uncertainty. The sources of uncertainty are multiple, but the major one is related to data interpretation and integration, which is partially derived from insufficiently efficient sample preparation. Recently, an updated ISO method for the analysis of mineral oil in fats and oils and a standard operating procedure for infant formula analysis have been published. Both methods reported significantly different (up to 1.25) distributions of the internal standards used for quantification (i.e., tri-tert-butyl benzene (TBB) and 2-methyl naphthalene (2-MN)) over the different solvent phases used in the saponification step.
RESULTS
In this work, a microwave-assisted saponification and extraction method was optimized for MOAH analysis to solve the problem related to the MOAH internal standards partition. The paper examines the impact of the solvent mixture used, the concentration of KOH on the partition of TBB and 2-MN, and the effect of the matrix and the washing step to extract the unsaponifiable fraction containing the mineral oils.
SIGNIFICANCE
The optimized procedure achieved a TBB/2-MN ratio of 1.05 ± 0.01 tested in five different fats and oils, namely, sunflower, rapeseed, coconut, palm, and extra virgin olive oils. The method can significantly contribute to reducing the uncertainty of the MOAH quantification when saponification is applied.
Topics: Microwaves; Hydrocarbons, Aromatic; Mineral Oil
PubMed: 38834273
DOI: 10.1016/j.aca.2024.342788 -
Allergologie Select 2024Allergic contact dermatitis is one of the most frequent occupational skin diseases. Targeted allergen avoidance can only be achieved by identification of the causative... (Review)
Review
Allergic contact dermatitis is one of the most frequent occupational skin diseases. Targeted allergen avoidance can only be achieved by identification of the causative allergen. Therefore, patch testing is of utmost importance in occupational dermatology, not only in terms of assessing causal relationships but also regarding the implementation of prevention measures and evaluation of the legal criteria for an occupational skin disease in Germany (statutory occupational disease BK 5101). The lack of commercial patch test preparations poses a great diagnostic challenge. Patch testing of patient's own materials from their workplace is therefore very important to reduce diagnostic gaps. The performance and documentation of the patch test should be in line with current guidelines and recommendations to ensure the necessary test quality and comprehensibility of the test results.
PubMed: 38756208
DOI: 10.5414/ALX2483E -
Journal of Chromatography. A Jul 2024On-line coupled high performance liquid chromatography-gas chromatography-flame ionisation detection (HPLC-GC-FID) was used to compare the effect of hydrogen, helium and... (Comparative Study)
Comparative Study
Comparison of carrier gases for the separation and quantification of mineral oil hydrocarbon (MOH) fractions using online coupled high performance liquid chromatography-gas chromatography-flame ionisation detection.
On-line coupled high performance liquid chromatography-gas chromatography-flame ionisation detection (HPLC-GC-FID) was used to compare the effect of hydrogen, helium and nitrogen as carrier gases on the chromatographic characteristics for the quantification of mineral oil hydrocarbon (MOH) traces in food related matrices. After optimisation of chromatographic parameters nitrogen carrier gas exhibited characteristics equivalent to hydrogen and helium regarding requirements set by current guidelines and standardisation such as linear range, quantification limit and carry over. Though nitrogen expectedly led to greater peak widths, all required separations of standard compounds were sufficient and humps of saturated mineral oil hydrocarbons (MOSH) and aromatic mineral oil hydrocarbons (MOAH) were appropriate to enable quantitation similar to situations where hydrogen or helium had been used. Slightly increased peak widths of individual hump components did not affect shapes and widths of the MOSH and MOAH humps were not significantly affected by the use of nitrogen as carrier gas. Notably, nitrogen carrier gas led to less solvent peak tailing and smaller baseline offset. Overall, nitrogen may be regarded as viable alternative to hydrogen or helium and may even extend the range of quantifiable compounds to highly volatile hydrocarbon eluting directly after the solvent peak.
Topics: Chromatography, High Pressure Liquid; Chromatography, Gas; Mineral Oil; Hydrocarbons; Nitrogen; Helium; Hydrogen; Flame Ionization; Gases
PubMed: 38744185
DOI: 10.1016/j.chroma.2024.464946 -
International Journal of Pharmaceutics Jun 2024The present study systematically investigates the impact of active pharmaceutical ingredient (API) variables and oleaginous base characteristics on the in vitro release...
Impact of active pharmaceutical ingredient variables and oleaginous base on the in vitro drug release from ophthalmic ointments: An investigation using dexamethasone as a model drug.
The present study systematically investigates the impact of active pharmaceutical ingredient (API) variables and oleaginous base characteristics on the in vitro release (IVR) performance of ophthalmic ointments, utilizing dexamethasone as a model drug. The interplay between selected attributes (i.e., particle size distribution, crystallinity, and polymorphic form for API, and rheological factors for compendial-grade white petrolatum) and IVR performance was investigated. APIs from different vendors exhibited variations in crystallinity and polymorphism. Ointments containing amorphous dexamethasone presented higher release amounts/rates compared to crystalline counterparts, emphasizing the role of physical state in release kinetics. Variations in particle size of this lipophilic API (5.4 - 21.2 µm) did not appear to impact IVR performance significantly. In contrast, white petrolatum's rheological attributes, which varied substantially within USP-grade petrolatum, were found to critically affect the drug release rate and extent of the ointment. The study's comprehensive analysis establishes a coherent connection between the quality attributes of both API and petrolatum and IVR, delineating their intricate interdependent effects on ophthalmic ointment performance. These findings provide reference to formulation design, quality control, and regulatory considerations within the pharmaceutical industry, fostering a robust foundational understanding of commonly overlooked quality attributes in ophthalmic ointments.
Topics: Dexamethasone; Ointments; Drug Liberation; Petrolatum; Particle Size; Rheology; Administration, Ophthalmic; Crystallization; Chemistry, Pharmaceutical
PubMed: 38692497
DOI: 10.1016/j.ijpharm.2024.124184 -
Contact Dermatitis Apr 2024Allergic contact dermatitis (ACD) to salicylic acid (SA) is widely unreported. Furthermore, cross-reactivity between SA and other salicylates has not been reported...
INTRODUCTION
Allergic contact dermatitis (ACD) to salicylic acid (SA) is widely unreported. Furthermore, cross-reactivity between SA and other salicylates has not been reported despite well-documented in-group salicylate cross-reactivity.
OBJECTIVE
To describe our clinic's experience patch testing to SA, highlighting seven cases of relevant reactions and concomitant reactivity with other salicylates.
METHODS
Results of patch testing to 5% SA in petrolatum between 1 January 2020, and 9 February 2024, are reported. Seven cases of relevant reactions to SA are detailed.
RESULTS
A total of 489 patients (27.5%) were tested to SA, 21 of which were positive: 7 doubtful (+/-), 14 weak positive (+), and no strong/extreme positive reactions. Four irritant reactions were documented. Of the 14 weak positive (+) reactions, 7 had definite or probable clinical relevance, 5 of which also reacted to other salicylates.
CONCLUSIONS
ACD to SA is likely underreported due to a lack of testing. In our experience, testing SA 5% petrolatum is tolerable without significant irritation. Cross-reactivity between SA and other salicylates is probable. Though SA appears to be the primary sensitizer in some cases, more studies are needed to understand its possible role as a marker for salicylate allergy.
PubMed: 38686774
DOI: 10.1111/cod.14573 -
Contact Dermatitis Jul 2024Contrary to Ni- and Co-induced allergic contact dermatitis (ACD), reactions against Pd are rare. However, Pd activates a larger T cell fraction in vitro, suggesting an... (Comparative Study)
Comparative Study
BACKGROUND
Contrary to Ni- and Co-induced allergic contact dermatitis (ACD), reactions against Pd are rare. However, Pd activates a larger T cell fraction in vitro, suggesting an inefficient skin penetration.
OBJECTIVES
This study compares Ni, Co and Pd skin penetration from commonly used diagnostic patch test preparations (PTPs) and aqueous metal salt solutions.
METHODS
Using Franz diffusion cell assays, we applied the metals in PTPs (5% NiSO, 1% CoCl, 2% PdCl and 3% NaPdCl) and in solution to pigskin for 48 h, thereby mirroring the time frame of a patch test. The different compartments were analysed individually by inductively coupled plasma mass spectrometry.
RESULTS
Metal ions were mainly retained in the upper stratum corneum layers. After application of PTPs, concentrations in the viable skin were lower for Pd (1 and 7 μM) compared to Ni and Co (54 and 17 μM).
CONCLUSIONS
Ni and Co penetrated the skin more efficiently than Pd and thus may sensitize and elicit ACD more easily. This was observed for ions applied in petrolatum and aqueous solutions. We hypothesize that the differently charged metal complexes are responsible for the varying skin penetration behaviours.
Topics: Cobalt; Nickel; Palladium; Patch Tests; Animals; Swine; Dermatitis, Allergic Contact; Allergens; Skin Absorption; Skin
PubMed: 38676576
DOI: 10.1111/cod.14569