Pharmaceutical Emulsions: A Viable Approach for Ocular Drug Delivery
Ocular disorders can lead to serious sight impairment and irreversible blindness. Generally
simple topical and systemic treatments are recommended for treating these vision …
simple topical and systemic treatments are recommended for treating these vision …
Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products
Abstract The United States Food and Drug Administration (USFDA) demands that the
generic industry prove topical ocular products' pharmaceutical and bioequivalence (BE). In …
generic industry prove topical ocular products' pharmaceutical and bioequivalence (BE). In …
[HTML][HTML] Towards the development of a biorelevant in vitro method for the prediction of nanoemulsion stability on the ocular surface
Ophthalmic oil-in-water nanoemulsions (NEs) are a complex technological platform,
representing an advancement in the treatment of dry eye disease. In addition to enabling the …
representing an advancement in the treatment of dry eye disease. In addition to enabling the …
Clinical ocular exposure extrapolation for ophthalmic solutions using PBPK modeling and simulation
M Le Merdy, F AlQaraghuli, ML Tan, R Walenga… - Pharmaceutical …, 2023 - Springer
Background The development of generic ophthalmic drug products is challenging due to the
complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of …
complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of …
From co-delivery to synergistic anti-inflammatory effect: Studies on chitosan-stabilized Janus emulsions having chloroquine phosphate and flavopiridol in Complete …
For the first time, the co-delivery of chloroquine phosphate and flavopiridol by intra-articular
route was achieved to provide local joint targeting in Complete Freund's Adjuvant-induced …
route was achieved to provide local joint targeting in Complete Freund's Adjuvant-induced …
[HTML][HTML] Using molecularly dissolved drug concentrations in PBBMs improves the prediction of oral absorption from supersaturating formulations
FL Holzem, JP Schaffland, M Brandl… - European Journal of …, 2024 - Elsevier
Predicting the absorption of drugs from enabling formulations is still challenging due to the
limited capabilities of standard physiologically based biopharmaceutics models (PBBMs) to …
limited capabilities of standard physiologically based biopharmaceutics models (PBBMs) to …
[HTML][HTML] Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation
M Le Merdy, J Spires, ML Tan, L Zhao, V Lukacova - Pharmaceutics, 2024 - mdpi.com
The development of generic ophthalmic drug products with complex formulations is
challenging due to the complexity of the ocular system and a lack of sensitive testing to …
challenging due to the complexity of the ocular system and a lack of sensitive testing to …
[HTML][HTML] A high-throughput micro-scale workflow to quantify molecularly dissolved drug concentrations under solubilizing conditions
FL Holzem, RL Mikkelsen, JP Schaffland… - Journal of …, 2024 - Elsevier
Physiological and artificial solubilizing agents usually enhance apparent solubility of poorly
soluble drugs, and in many cases also oral drug exposure. However, exposure may …
soluble drugs, and in many cases also oral drug exposure. However, exposure may …
Product quality research for develo** and assessing regulatory submissions for generic cyclosporine ophthalmic emulsions
Approval of the first generic 0.05% cyclosporine ophthalmic emulsion (COE) in the US
represents a milestone achievement of the science and research program in the US Food …
represents a milestone achievement of the science and research program in the US Food …