This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and thermally, oxidatively, and photolytically unstable active pharmaceutical ingredient (API) for ophthalmic application, specifically for the reduction of intraocular pressure (IOP) and to provide neuroprotection.
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Nanoemulsion has the potential to overcome several disadvantages in drug formulation. Nanoemulsions are nano-sized emulsions that can improve the bioavailability of drug molecules via various routes of administration. The development of nanoemulsion formulation is a challenging and lengthy process. Selecting components such as oil phase, surfactant, an optimum oil-to-surfactant ratio, and ideal process parameters are critical for developing a stable nanoemulsion. Development becomes more complicated when a drug molecule is sensitive to a variety of factors. This webinar discusses, with a case study, a nanoemulsion development process using a microfluidizer, and factors to consider while developing a sterile ophthalmic nanoemulsion formulation for a light, oxidation, and heat-sensitive molecule.
In this webinar, we discuss the strategies to overcome challenges during formulation development, various technologies available for formulation development, and Frontage CMC's unique capabilities.
A number of the abuse-deterrent formulations in development and available on the market utilize hard-to-crush tablet technologies. Frontage possesses wide experience in running studies with controlled substances. Frontage provided full support in developing the protocol, revising study methodology, developing full package for IRB submission, including Informed Consent Form.