Published online: "510(k) CLEARED, USER-FILLED MICRODOSING DEVICE FOR OPHTHALMIC AND OTHER APPLICATIONS". Read the full ONdrugDelivery article 👉 https://lnkd.in/ef5Uxiea "Gautam Shetty discusses unmet drug delivery needs in applications requiring accurate and precise microlitre-scale doses,going on to detail how Congruence Medical Solutions’ recently cleared Microliter Dosing Syringe can bring the benefits of advanced syringe materials and performance to these applications."
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Perfluorohexyloctane ophthalmic solution, a pharmaceutical that received U.S. Food and Drug Administration (FDA) approval for treating evaporative dry eye disease (DED) less than 2 years ago, can improve comfort in contact lens wearers without significantly altering the tear film, according to an open-label study published in Clinical Ophthalmology (Dove Medical Press). The drug may improve contact lens wearing ability, leading to less contact lens dropout, the report suggests. Read here: https://bit.ly/3Zg5wlP #PerfluorohexyloctaneOphthalmicSolution #Perfluorohexyloctane #DryEyeDisease #DryEye #TearFilm #ContactLens #ContactLensDropout #Optometry #EyeCare
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The U.S. FDA approved Sun Pharmaceuticals’ LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe #alopecia areata (AA). LEQSELVI is a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata. This is the third JAK inhibitor approved in AA. https://lnkd.in/dFUrVpg4
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FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa: Bimekizumab-bkzx is the first and only approved medication that targets both interleukin (IL) 17F and IL-17A. #finance #pharmacy #lifesciences
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Feminist, grassroots political strategist, federal health policy analyst. Pro-immigrant advocate, pro-union advocate. Voracious reader.
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A little common sense and pragmatism. Very good reading.
President/Owner/Regulatory & Quality Consultant - Black Diamond Regulatory Consulting, LLC
New Pharma TiO2 Study Published - Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet – An industrial case study of attempting to comply with EU regulation 2022/63 Here's the important Conclusions: In this work, the film coating of a commercially available tablet was replaced in order to attempt to comply with EU regulation 2022/63. As TiO2-free alternatives, a coating using CaCO3 was applied in two different amounts, furthermore a clear coating and uncoated tablet cores were also tested. The alternative coatings performed well in the case of moisture absorption, in vitro dissolution and environmental stress. The color of tablets coated with TiO2 was found to be less yellow than the other formulations. Furthermore, in the case of photostability, the alternatives did not yield satisfactory results. Therefore, removing TiO2 from a formulation like this will not result in a safer product due to stability issues. Consequently, even though the formulation complies with the ban of TiO2, it will conflict with other quality regulations. This situation can be solved in two different ways. The first scenario is where pharmaceutical manufacturers conduct intensive research to find viable alternatives to TiO2, deteriorating the competitiveness of this sector in Europe. The second solution is considering that most pharmaceutical formulations contain less than 100 μg of TiO2, therefore the consumer’s exposition to this compound is negligible compared to food products, thus banning TiO2 from pharmaceutical products might not be necessary. This work demonstrates, once again, that any ban of TiO2 for Pharma applications would not improve patient safety but actually make it worse! This would be crazy since there is actually no scientifically credible safety concerns in the first place! You can access this paper in ResearchGate: https://lnkd.in/eCZB-P7k
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OT shared encouraging updates from Glaukos Corporation about their iDose TR implant, a long duration treatment for open-angle #glaucoma and ocular hypertension. In Phase 3 #clinicaltrials, iDose TR 75 mcg showed sustained, substantial IOP reductions. The treatment is designed to help address patient non-adherence to topical regimens.
Glaukos has announced several positive clinical updates for its iDose sustained-release procedural pharmaceutical platform. The iDose TR (travoprost intracameral implant) is a long duration prostaglandin analog approved for a single administration for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). It is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue Read More: https://ow.ly/T3He50UK6pO
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Glaukos has announced several positive clinical updates for its iDose sustained-release procedural pharmaceutical platform. The iDose TR (travoprost intracameral implant) is a long duration prostaglandin analog approved for a single administration for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). It is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue Read More: https://ow.ly/T3He50UK6pO
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PharmaResearch Co. Ltd. has received CE MDR certification for its #Rejuran products and plans to begin a confirmatory clinical trial for its next-generation knee injection, NPNP-001, in January 2025 https://lnkd.in/gR7iqYww
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#RegulatoryUpdate FDA approves Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Following a thorough analysis of the available data, the FDA approved Yesafili and Opuviz, finding that neither drug differs significantly from Eylea in terms of clinical efficacy. Read: https://lnkd.in/etnqmDVe
Founder, CEO at Congruence Medical Solutions, LLC
2moPleased to be part of the 20th anniversary issue.