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Formulation Characteristics and In Vitro Release Testing of Cyclosporine Ophthalmic Ointments.

The aim of the present study was to investigate the relationship between formulation/process variables versus the critical quality attributes (CQAs) of cyclosporine ophthalmic ointments and to explore the feasibility of using an in vitro approach to assess product sameness. A definitive screening design (DSD) was used to evaluate the impact of formulation and process variables. The formulation variables included drug percentage, percentage of corn oil and lanolin alcohol. The process variables studied were mixing temperature, mixing time and the method of mixing. The quality and performance attributes examined included drug assay, content uniformity, image analysis, rheology (storage modulus, shear viscosity) and in vitro drug release. Of the formulation variables evaluated, the percentage of the drug substance and the percentage of corn oil in the matrix were the most influential factors with respect to in vitro drug release. Conversely, the process parameters tested were observed to have minimal impact. An evaluation of the release mechanism of cyclosporine from the ointment revealed an interplay between formulation (e.g. physicochemical properties of the drug and ointment matrix type) and the release medium. These data provide a scientific basis to guide method development for in vitro drug release testing of ointment dosage forms. These results demonstrate that the in vitro methods used in this investigation were fit-for-purpose for detecting formulation and process changes and therefore amenable to assessment of product sameness.

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Mycophenolate mofetil therapy in adult patients with recalcitrant atopic dermatitis.

Patients with severe atopic dermatitis (AD) may require potent immunosuppressive therapy to control their disease. Mycophenolate mofetil (MMF) has been suggested as a safe and effective drug in these cases. We have used oral MMF 2-3gr/day in adult patients with severe recalcitrant AD who failed other major systemic drugs, or where other drugs, including cyclosporine, methotrexate and azathioprine, were contraindicated. Of 9 consecutive adult patients, 4 (44%) responded completely, 2 (22%) had partial response and 3 (33%) did not respond at all. The MMF therapy was continued for 5-36 months (average 21 months) without major side effects. Our results demonstrate that oral MMF may be an effective drug in AD. Due to its good safety profile, it may be recommended as a first line systemic therapy, or successive to cyclosporine in the long term.

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Unusual Case of Vogt-Koyanagi-Harada Disease Associated with SAPHO Syndrome: A Case Report.

A 66-year-old Japanese woman who was diagnosed with synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome presented with bilateral blurred vision 4 months prior to visiting our hospital. She had visited a local ophthalmology clinic first. She was diagnosed with conjunctivitis and was prescribed antibacterial eye drops. The symptoms persisted in spite of treatment. She was then referred to our hospital. At her initial visit, the visual acuities were 0.6 in both eyes. A slit-lamp examination revealed bilateral shallow anterior chamber, and intraocular pressures of 18 mm Hg in the right eye and 16 mm Hg in the left eye. There were no cells in the anterior chamber. Fundus examination revealed bilateral annular choroidal detachment and serous retinal detachment. Fluorescein angiography showed leakage of dye from the retinal pigment epithelium (RPE) and indocyanine green angiography showed focal choroidal hypoperfusion. Optical coherence tomography showed wavy RPE line and blurry thick choroid. Systemic investigation by the physician demonstrated bilateral pleural effusions of unknown origin. The patient had a past history of breast cancer; however, no metastasis was identified via malignant cells through cytology, laboratory findings, radiographs, CT, and MRI. After the diagnosis of Vogt-Koyanagi-Harada (VKH) disease was made, the patient was treated with local and systemic steroid including high-dose intravenous corticosteroids, and 150 mg of cyclosporine per day. Seventy days after the second high-dose of intravenous corticosteroids, these medications brought a complete resolution of both choroidal and retinal detachment. VKH disease associated with SAPHO syndrome is rare. The combination of immunosuppressive drug and steroid might be helpful for severe cases of VKH disease.

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Epithelial to mesenchymal transition induces stem cell like phenotype in renal cell carcinoma cells.

Metastatic dissemination of solid tumors is often initiated by reactivation of an embryonic development program, epithelial-to-mesenchymal-transition (EMT). EMT has been associated with acquiring invasiveness and resistance to conventional therapies. However, the precise role of EMT during renal cell carcinoma is still debatable and is under investigation. In this context, our study is designed to evaluate the role of cyclosporine (CsA) and transforming growth factor-β (TGFβ) administration in inducing EMT-like state in renal carcinoma cells. We also studied the associated phenotypic changes which may lead to tumor metastasis.

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Placebo Effects in the Immune System.

Even though knowledge and systematic application of placebo responses in the immune system are sparse, this topic is of particular importance since it may aim at drug-dose reduction while maintaining therapeutic efficacy of treatment in clinical settings. Placebo responses in the immune system are inducible by associated learning paradigms, such as behaviorally conditioned immunosuppression. One established learning paradigm in both rats and humans is conditioned taste avoidance (CTA), where a novel taste as conditioned stimulus (CS) is paired with the administration of the immunosuppressive drug cyclosporine A (CsA) as unconditioned stimulus. By representing the CS alone at a later time point, the conditioned response is reflected by avoidance behavior toward the taste (CTA). Simultaneously, diminished cytokine production and proliferative capacity of T cells are observed, closely mimicking the pharmacological effects of CsA. This chapter provides an overview on placebo responses in the immune system and delineates actual approaches, translational aspects, and limitations of learning paradigms in clinical settings.

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Association of time under immunosuppression and different immunosuppressive medication on periodontal parameters and selected bacteria of patients after solid organ transplantation.

Aim of this study was to investigate the association of the time under immunosuppression and different immunosuppressive medication on periodontal parameters and selected periodontal pathogenic bacteria of immunosuppressed patients after solid organ transplantation (SOT).

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Improving the utility of clinical phenotyping in interstitial cystitis/painful bladder syndrome: from UPOINT to INPUT.

The phenotyping system UPOINT has proven effective in classifying patients with Urologic Pelvic Pain Syndromes in a clinically meaningful way and to guide therapy. While highly successful in men with chronic pelvic pain syndrome (CPPS), UPOINT is more limited in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) since by definition all patients have the urinary and organ specific phenotype. Furthermore, AUA guidelines recommend a sequential tiered approach to therapy rather than the multimodal UPOINT scheme. We sought to modify UPOINT to be more practical and efficacious for IC/PBS.

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Regional variations in immunosuppressive therapy in patients with primary nephrotic syndrome: the Japan nephrotic syndrome cohort study.

The lack of high-quality clinical evidences hindered broad consensus on optimal therapies for primary nephrotic syndromes. The aim of the present study was to compare prevalence of immunosuppressive drug use in patients with primary nephrotic syndrome across 6 regions in Japan.

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Association of CYP3A4*1B genotype with Cyclosporin A pharmacokinetics in renal transplant recipients: A meta-analysis.

Cyclosporine (CsA) is a substrate of cytochrome P450 (CYP) 3A4 with a narrow therapeutic index and large individual difference. CYP3A4*1B is reported to be associated with CsA pharmacokinetics parameters, but the relevance is still in dispute. Therefore, a meta-analysis was employed to evaluate the influence of CYP3A4*1B on CsA pharmacokinetics at different post-transplantation times in adult renal transplant recipients.

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Psoriasis Management in Actual Clinical Practice: A 6-Year Retrospective Study of 845 Patients.

Over the past years, with the availability of relatively well tolerated, very effective but expensive drugs, biologics, treatment of psoriasis has dramatically shifted from inpatient modalities to outpatient ones. Relatively little is known about true life practices regarding psoriasis treatment in our country.

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