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Colloidal forms include liposomes, nanoparticles and niosomes. These carriers are biodegradable and can be an alternative to implants that have to be removed surgically. On the Horizon In general, the next push of innovation involves chemical modifications of established carriers to revise or improve their formulation enhancing properties. For example, Novaliq Heidelberg, Germany is developing an innovative pharmaceutical formulation platform based on semifluorinated alkanes. One such application, CyclASol, is a novel, non-aqueous and preservative-free formulation designed to enhance cyclosporine efficacy in dry eye.
SFA in an aqueous formulation allows for delivery of the hydrophobic cyclosporine as a clear liquid, and is designed to improve tolerability and potentially reduce any blurring associated with emulsion-based formulations. Another example of a new type of inactive ingredient comes from Kala Pharmaceuticals Waltham, Mass. When applied to the surface of the eye, the particles spread out on the ocular surface and embed into the mucin layer, creating a depot of drug to diffuse into ocular tissues.
Atopic Dermatitis Treatment & Management
Kala has conducted trials using a number of agents as treatments for conditions including postop cataract surgery inflammation, dry eye and meibomian gland disease, so this formulation technology should be in the pharmacy soon. Drug development will always be a process of iterative refinement. There are many paths to success, and all have value. Abelson is a clinical professor of ophthalmology at Harvard Medical School. Rimmer is a medical writer at Ora Inc.
What do bleaching creams contain?
Hollander is chief medical officer at Ora, and assistant clinical professor of ophthalmology at the Jules Stein Eye Institute at the University of California, Los Angeles. Preservative-free artificial tear preparations. Assessment of corneal epithelial toxic effects. Arch Ophthalmol ; Impact of short-term exposure of commercial eyedrops preserved with benzalkonium chloride on precorneal mucin. Molecular vision ; Enhancement in corneal permeability of riboflavin using calcium sequestering compounds.
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International journal of pharmaceutics ; Nisha S, Deepak K. An insight to ophthalmic drug delivery system. Schoenwald RD. Ocular drug delivery. Clinical pharmacokinetics ; The AAPS journal ; Advances in ophthalmic drug delivery. Ther Deliv ; Reduction of quaternary ammonium-induced ocular surface toxicity by emulsions. Inv Ophthalmol Vis Sci ; Effect of a mixture of caffeine and nicotinamide on the solubility of vitamin B 2 in aqueous solution.
Eur J Pharm Sci ; Cyclodextrin-mediated enhancement of riboflavin solubility and corneal permeability. Molecular pharmaceutics ; Hydrotropic solubilization—mechanistic studies. Pharmaceutical research ; Ali Y, Lehmussaari K. Industrial perspective in ocular drug delivery. Advanced drug delivery reviews ; A comparative review on conventional and advanced ocular drug delivery formulations.
International Journal of PharmTech Research ; Thermosensitive self-assembling block copolymers as drug delivery systems. Polymers ; Yang H, Leffler CT. Patients with mild or moderate psoriasis at baseline as defined by PGA-C who were randomized and received at least one dose of study medication tofacitinib or vehicle were included in the analyses.
Data at Week 8 and Week 12 were evaluated separately. A stratified analysis was conducted by summarizing the difference in proportions adjusted for the baseline PGA-C disease severity using the Cochran-Mantel-Haenszel approach [ 20 , 21 ]. Patients with missing values were considered non-responders. PASI75 and PGA-C response of clear or almost clear were analyzed using a marginal logistic regression model fit by pseudo-likelihood generalized linear mixed model for repeated measures. All analyses used observed data without imputation. All statistical analyses were performed using SAS Software [ 22 ].
Patient disposition. Note that the subjects includes subjects with mild, moderate, and severe psoriasis; subjects randomized are those that met the mild to moderate psoriasis eligibility criteria. Following database release, it was discovered that five subjects were randomized, but did not have any record of study drug dosing and were assessed in the clinical database as non-treated subjects; as a consequence, these subjects were excluded from all analyses.
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BID twice daily, QD once daily. Only those treatment groups and time points that were statistically significant are described within the text. Patients who were discontinued or with missing values were considered non-responders. BSA excluded the head, neck, palms, and soles, even if these areas were being treated with study drug. Change from baseline in Itch Severity Item score through Week 2. Summary of adverse events, patients discontinued due to adverse events and deaths. Categories of adverse events experienced include treatment-emergent, application site and serious adverse events.
A total of 11 SAEs were experienced by 10 2.
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Overall, 21 4. His final application of tofacitinib ointment was on Study Day 74 and he died on Study Day Relevant medical history included prior myocardial infarction and stent placement, dyslipidemia, hypertension, and year history of tobacco use. The event was considered unrelated to study treatment by the investigator. Application site AEs were reported in 35 of the A total of 12 2. The most common application site AE leading to discontinuation was psoriasis, which was reported by six 1.
Tofacitinib concentrations were above the lower limit of quantification of 0. Across tofacitinib treatment groups, The maximum observed plasma concentration of 9. Based on the post-dose PK obtained in a limited number of patients, the PK had a flat profile with limited fluctuation in concentrations between doses, as would be expected after topical application. Total exposure based on area under the plasma concentration time profile from time zero to the time tau AUC tau in patients with post-dose PK was higher with the higher dose strength, while the relationship between exposure and dose regimen was not clear Additional file 1 : Table S3.
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Greater efficacy of tofacitinib compared with vehicle was seen for more primary and secondary efficacy endpoints at Week 8 than Week Explanation for the increase in vehicle responses between Week 8 and Week 12 was not evident after thorough review of the study data for potential contributing factors, although it is possible this could be related to the small sample size of the study. This is a much more challenging threshold than the achievement of a PGA-C score of clear or almost clear alone, when a patient need only change from mild 2 to almost clear 1 to be considered a responder.
This more stringent criterion is used, as a change from the low end of the mild range to the high end of the almost clear range may not represent a clinically meaningful change. The clinical significance of objective changes in disease severity were confirmed by the improvement in patient-reported measures. Previous studies have shown oral tofacitinib improved patient-reported pruritus in moderate to severe psoriasis [ 19 , 24 , 25 ].
This is a direct effect, independent from improvements in clinician-reported signs of psoriasis severity [ 24 ], with a statistically significant improvement occurring as early as the second day of dosing [ 26 ]. Topical tofacitinib also improves pruritus in patients with atopic dermatitis [ 27 ]. Although pruritus is a common feature of psoriasis, the underlying pathogenesis is not understood. Tofacitinib inhibition of JAK may suppress pruritus by blocking signaling via IL [ 30 , 31 ] and reducing expression of IL-2 [ 32 ].
As neuropeptides have a role in the pathogenesis of both psoriasis and pruritus, increased expression of substance P receptor, high-affinity nerve growth factor receptor or calcitonin gene-related peptide receptor may be involved [ 29 ]. Overall, topically administered tofacitinib had an acceptable safety profile, with no clinically meaningful differences in the incidence of AEs or SAEs between tofacitinib and vehicle treatment groups.
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The incidence of AEs coding to the MedDRA Infections and Infestations system organ class was higher in patients receiving vehicle than patients receiving tofacitinib. None of the side effects associated with topical application of potent corticosteroids were observed.