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.
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In this podcast, we discuss delivery modalities for sterile product development of poorly water-soluble drugs, with our special guest: Dr. Manish Mujal, Director of Product Development and CTM Manufacturing at Frontage Laboratories, Inc.
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.
Frontage’s CMC portfolio of services spans pre-formulation, drug product formulation development, analytical method development and validation, GLP batches, GMP clinical trial materials (manufacturing, labeling, packaging, and distribution), scale up, pilot and pivotal/registration batches, and commercial manufacturing (to be ready Q3 2024).
Our formulation development experience and capabilities cover a wide range of dosage forms for IND, NDA, ANDA and 505(b)(2) filings.