The efficacy of a transdermal hydrogel patch containing betamethasone dipropionate for treatment of chronic hand eczema: A single-blind, randomized and controlled trial.

BACKGROUND: Topical corticosteroids under occlusion have been used to enhance the treatment of eczema. However, no study has investigated the efficacy of a steroid-containing transdermal patch for the treatment of chronic hand eczema. METHODS: We conducted a randomized, controlled, assessor-blinded trial to determine the efficacy of a transdermal patch containing betamethasone dipropionate compared to topical betamethasone dipropionate ointment in the treatment of mild to moderate chronic hand eczema. The patients were included and assigned to receive either the transdermal patch once daily at night or the ointment twice daily for a period of 8 weeks. The outcomes were assessed using the Hand Eczema Severity Index (HECSI), Physical Global Assessment (PGA) score, self-reported compliance, level of patient satisfaction, quality of life, and side effects. RESULTS: Fifty-six patients completed this study. At 8 weeks, there was a significant reduction in the HECSI scores in both the transdermal patch and topical ointment groups compared to those measured at baseline (14.61 to 1.86, p < 0.001; 18.46 to 3.43, p < 0.001, respectively) without a statistically significant difference between the two groups. Similarly, the two groups did not show any significant difference in the PGA scores, quality of life and side effects. However, the transdermal patch group reported better compliance and a higher level of patient satisfaction than the topical ointment group. CONCLUSION: The transdermal corticosteroid patch has proven to be a safe and effective treatment, comparable to topical corticosteroids, after 8 weeks of use. Its sustained-release properties, along with once-daily use, can improve patient satisfaction and promote greater adherence to the treatment. TRIAL REGISTRATION: This study was registered with the Thai Clinical Trials Registry (www. CLINICALTRIALS: in.th) under registration number TCTR20220413003.

Stability, permeation, and cytotoxicity reduction of capsicum extract nanoparticles loaded hydrogel containing wax gourd extract.

The aim of this study was to develop hydrogel loaded with capsicum extract nanoparticles and wax gourd extract for transdermal delivery of capsaicin. The addition of wax gourd extract was supposed to reduce cytotoxicity of capsaicin in capsicum extract against HaCaT keratinocyte cell line. Capsicum extract nanoparticles were prepared by solvent displacement method using hyaluronic acid as a stabilizer. The physical and chemical stability of capsicum extract nanoparticles were investigated by dynamic light scattering technique and UV-Visible spectrophotometry, respectively. Hydrogel loaded with capsicum extract nanoparticles and wax gourd fruit extract was then formulated by using Carbopol 940® as a gelling agent for transdermal delivery. The skin permeability of capsaicin from the hydrogel was evaluated by Franz diffusion cell approach. The cytotoxicity reduction of capsicum extract nanoparticles and capsicum extract nanoparticles by mixing with wax gourd extract was determined by MTT assay The results showed that capsicum extract nanoparticles exhibited an average diameter of 168.4 ± 5.3 nm with a polydispersity index and zeta potential value of 0.26 ± 0.01 and -45.7 ± 7.1 mV, respectively. After two month-storage, particle size, polydispersity index, and zeta potential values of capsicum extract nanoparticles stored at 4° C, 30° C, and 45 °C did not significantly change. The capsaicin content decreased to 78%, 71%, and 72% when stored at 4 °C, 30 °C, and 45 °C for three months, respectively. The pH values of hydrogel containing capsicum extract nanoparticles were found to be in the range of 5.58-6.05 indicating good stability. The hydrogel exhibited a pseudoplastic character. The rate of permeation flux of capsaicin from hydrogel was 7.96 µg/cm2/h. A significant increase in cell viability was observed when the cells were incubated with capsicum extract nanoparticles mixed with wax gourd, compared to capsicum extract nanoparticles alone. The wax gourd extract in the hydrogel protected HaCaT cells from capsaicin cytotoxicity, thus may provide a new approach for delivery of capsaicin to reduce cytotoxicity to skin cells.

Special issue: Pharmaceutical innovation.

"Pharmaceutical innovation" is an interdisciplinary area of the pharmaceutical sciences including drug development with a focus on manufacturing, process control, and technology, among many other subfields of research. In this special issue, we have invited all participants attended the International Conference and Exhibition on Pharmaceutical Sciences and Technology 2018 under the theme of pharmaceutical innovation and translational research for human health, held in Bangkok during January 24-25, 2018, to submit the research papers and after peer-review process, 10 of them were selected.

Modified biomolecule as potential vehicle for buccal delivery of doxepin.

AIM: Doxepin is a traditional tricyclic antidepressant with analgesic and anesthetic properties when applied topically to the mucosa. Doxepin is one approach in treating insomnia and depression in Parkinson's disease. Patients with Parkinson's disease suffer difficulties in swallowing. Therefore, it was the aim of this study to develop a buccal-adhesive delivery system. METHODS: Pectin was modified with cysteine. Stability assays in form of disintegration assay according to the Ph.Eur were performed. Furthermore, bioadhesiveness on buccal mucosa was investigated incorporating the drug doxepin. RESULTS: The adhesiveness was improved 1.4-fold and revealed a sustained release over 3 h. CONCLUSION: Taking these findings into account, the modifications render this designed excipient fruitful for buccal delivery.

Plasticizing effect of ibuprofen induced an alteration of drug released from Kollidon SR matrices produced by direct compression.

The objectives of this study were to investigate the effect of storage temperature on drug release from matrices containing 10, 40 and 70% w/w ibuprofen in Kollidon® SR (KSR). The matrix tablets were produced by direct compression and then kept at 30 and 45 °C for 3 months. Drug release from the matrix tablets was examined after storage for 0, 1, 4 and 12 weeks. Scanning electron microscope was used to reveal physical appearance of the tablet surface at the respective time intervals. In addition, differential scanning calorimeter was used to investigate glass transition temperature (Tg) of ibuprofen in KSR at 0-100% w/w based on the principle of Gordon-Taylor equation. At 45 °C, the dissolution of ibuprofen in KSR as well as the coalescence of polymer particles were observed to be higher than those of storage at 30 °C. The physical state of ibuprofen dispersed in the polymeric matrix and degree of polymer coalescence led to the variation of drug release. The coalescence of polymer particles was a result of the polymer transition from glassy to rubbery state according to water absorption of KSR and plasticizing effect of ibuprofen. The reduction of the Tg of ibuprofen blended with KSR could be better described by the Kwei equation, a modified version of Gordon-Taylor equation.

Development and characterization of extended release Kollidon SR mini-matrices prepared by hot-melt extrusion.

Kollidon SR as a drug carrier and two model drugs with two different melting points, ibuprofen and theophylline, were studied by hot-melt extrusion. Powder mixtures containing Kollidon SR were extruded using a twin-screw extruder at temperatures 70 and 80 degrees C for ibuprofen and 80 and 90 degrees C for theophylline. The glass transition temperature (T(g)) and maximum torque were inversely related to ibuprofen concentrations, indicating its plasticizing effect. The results of differential scanning calorimetry (DSC) and X-ray diffraction analysis showed that ibuprofen remained in an amorphous or dissolved state in the extrudates containing drug up to 35%, whereas theophylline was dispersed in the polymer matrix. The increase in amounts of ibuprofen or theophylline in the hot-melt extrudates resulted in the increase in the drug release rates. Theophylline release rate in hot-melt extruded matrices decreased as the extrusion temperature increased. In contrast, a higher processing temperature caused the higher ibuprofen release. This was a clear indication of the plasticizing effect of ibuprofen on Kollidon SR and a result from water uptake. Theophylline release rate from hot-melt extrudates decreased with increasing triethyl citrate (TEC) level because of the formation of a denser matrix. By adding of Klucel LF as a water-soluble additive to the hot-melt extruded matrices, an increase in ibuprofen and theophylline release rates was obtained.