Ophthalmic and otic preparation are a form of parenteral dosage forms which are sterile, liquid or semi solid formulations that are to be instilled into eye cavity and ear respectively for local and systemic delivery of dosage forms. Aurigene supports customers with services of Ophthalmic and otic solutions development and clinical manufacturing. Ophthalmics and otic solutions both have their respective formulation requirements which can act effectively when instilled into eye and ear. All these formulation aspects are well understood by the technical team at Aurigene which allows to cater the customers with both development and clinical manufacturing aspects and resolve technical and scale up challenges.
Aurigene focuses mainly on end to end development of solutions of Ophthalmic and otic formulations including Stress studies Order of addition studies, pH, osmolality and viscosity optimization studies, Preservative/ anti-oxidant effectiveness studies, Oxygen sensitivity studies, Selection of sterilization process (Filtration/Moist heat), Water loss studies, Gum and Ink migration studies, drop size studies, Bulk Hold time studies, Product part compatibility studies, Photo-sensitivity studies, Thermal sensitivity studies but not limited to.
Services across the product lifecycle
USFDA inspected lab and manufacturing facilities
3Core technical expertise with ophthalmic and otic dosage forms
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