beclometasone dipropionate (EcoBec / Beclazone / Beclazone)

Intravital Monitoring of Psoriasis Treatment Response and Drug Delivery Using Multiphoton Fluorescence Lifetime Imaging.

Nguyen Lynhda L, Mess Christian C, Herberger Katharina K, Schneider Stefan W SW et al.

Multiphoton tomography equipped with fluorescence lifetime imaging (MPT-FLIM) is a novel noninvasive imaging technique for analyzing morphological and metabolic states of skin diseases at a subcellular resolution. The present study is the first to establish MPT-FLIM as an imaging modality to monitor treatment response in psoriasis during topical anti-inflammatory therapy. Patients with psoriasis treated with topical calcipotriol/ betamethasone dipropionate (C/B) or a calcipotriol derivative (C/-) formulation were recruited and monitored using MPT-FLIM. Imaging was performed at baseline on day 0, and during treatment on days 3 and 28. A total of six patients prescribed C/B, six patients prescribed C/- and four healthy controls were recruited. Characteristic histological features were visualized, including acanthosis, parakeratosis, papillomatosis, and thinning of the granular layer. There was a strong correlation between clinical, multiphoton tomographic, and pathophysiological improvement during treatment. Assessment of subclinical metabolic changes was a predictive parameter for treatment outcome. Detection of fluorescence signals from drug components allowed for tracking of drug distribution in intra- and intercellular spaces. MPT-FLIM proved to be a suitable tool for monitoring treatment response in psoriasis patients and tracking drug delivery. It could be a potential method for monitoring other inflammatory skin diseases during treatment to adjust therapy on an individual level.

Symptom Improvement with BDP/FF/G Fixed Triple Inhalation Powder in Moderate to Severe COPD Patients Uncontrolled with Dual Therapies: A Non-Interventional, Open-Label, Single-Arm, Prospective Study (RESPONSE Slovenia).

Harlander Matevž M, Šubic Tjaša T, Eržen Renato R, Maček Cafuta Arjana A et al.

People living with COPD are frequently inadequately treated due to underdiagnosis or misdiagnosis. The aim of this study was to evaluate the real-world performance of the beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed triple combination formulated in a dry powder inhaler (DPI) in improving symptoms, lung function, and adherence in moderate to severe COPD patients uncontrolled on dual therapies. We conducted a non-interventional, open-label, single-arm, multicenter, prospective study across 19 outpatient centers in Slovenia. The primary objective was to measure symptom improvement with the COPD Assessment Tool (CAT). A total of 359 patients with moderate to severe COPD (97% classified as GOLD E, frequent exacerbators) were followed for 24 weeks. There was a significant 6-point reduction in the CAT score after switching from dual therapies to BDP/FF/G inhalation powder (95% CI: -7.0 to -5.5; p < 0.0001). FEV1 increased by 110 mL (95% CI: 90-130; p < 0.0001) and FVC by 95 mL (95% CI: 65-120; p < 0.0001), reaching a statistically significant improvement of 2.5 percentage points in the FEV1/FVC quotient. The net improvement in dyspnea severity was 50.9% (95% CI 44.7%-57.2%), as assessed using the modified Medical Research Council (mMRC) Scale. Treatment adherence improved significantly after 6 months of triple therapy. In our cohort, switching uncontrolled moderate-to-severe COPD patients from dual therapy to BDP/FF/G fixed triple inhalation powder led to significant improvements in symptoms, lung function, dyspnea, sleep quality, and treatment adherence.

Impact of Gamma Irradiation and Ethylene Oxide Sterilisation on the Stability of Crystalline and Amorphous Drug Solids.

Elkhashab Mohamed M, Sartawi Ziad Z, Lynch Denis D, Vucen Sonja S et al.

Terminal sterilisation is a critical process for pharmaceutical products intended for parenteral or invasive administration, yet conventional sterilisation approaches can compromise thermolabile or chemically sensitive drug substances. In this study, the compatibility of crystalline and amorphous solid forms of five drug substances (betamethasone dipropionate (BMD), estradiol (E2), itraconazole (ITZ), vismodegib (VDG), and zolmitriptan (ZMT)) with sterilising gamma irradiation and ethylene oxide (EtO) cycles was evaluated in terms of chemical and physical stability. Physical stability was assessed by visual inspection of crystalline powders and amorphous solids pre- and post-sterilisation and by differential scanning calorimetry (DSC) to characterise the melting behaviour of crystalline drugs, and glass transition and recrystallisation events in amorphous forms. Chemical stability was examined using reverse phase-high-performance liquid chromatography (RP-HPLC), liquid chromatography-mass spectrometry (LC-MS), and proton nuclear magnetic resonance spectroscopy (¹H-NMR). Gamma irradiation and EtO preserved the chemical integrity of BMD, E2, ITZ, and VDG. A reversible colour change observed for ITZ was attributed to radical formation as confirmed by gentle heating, HPLC and LC-MS. E2 demonstrated alterations in crystallinity and thermal behaviour after sterilisation, despite maintaining chemical integrity. ZMT exhibited pronounced sensitivity to sterilisation: gamma irradiation induced physical softening and oxidative degradation, particularly in the amorphous form, while EtO sterilisation induced ZMT hydroxyethylation, as confirmed by LC-MS identification of multiple alkylated derivatives. Overall, sterilisation compatibility was governed primarily by molecular structure rather than the drug solid-state. These findings provide an insight for selecting sterilisation strategies and facilitate the translation of crystalline and amorphous pharmaceutical solids toward clinical application.

Perception and Satisfaction with Calcipotriol and Betamethasone Dipropionate PAD-Cream in Patients with Plaque Psoriasis: Results From a Survey.

Gisondi Paolo P, Brigenti Noemi N, Bellinato Francesco F, Girolomoni Giampiero G