Ophthalmic Drug Products – Recent Webinar and Velesco’s Capabilities

The Velesco team recently attended an ophthalmic drug product webinar.  The training titled ‘Ophthalmic Products – Quality and Performance Tests’ was presented by Margareth R.C. Marques, M.Sc., PhD., USP Senior Scientific Liason.  This webinar was of interest to us due to our extensive experience with ophthalmic drug products which includes analytical method development, small scale manufacture and stability testing.

The focus of this webinar was to provide an overview of the planned revisions to USP General Chapter <771> Ophthalmic Preparations – Quality Tests and the new General Chapter <1771> Ophthalmic Preparations – Performance Tests.  The webinar also covered the following topics:

  • Eye Physiology
  • Routes of Administration into the Eye
  • Overview of the Types of Dosage Forms for Ophthalmic Products
  • Special Requirements for Dosage Forms
  • Quality Tests for Ophthalmic Products
  • Dissolution Tests for Ophthalmic Products

The webinar began with an overview of the physiology of the eye and discussed some of the challenges that need to be overcome in order to get a drug substance into the eye.  The eye is a very protective structure and has several mechanisms to guard it against foreign matter, including tear production which can dilute the drug substance and drainage by the nasolacrimal system which can take the drug substance out of the eye.  Static barriers to drug delivery include layers of the cornea and the blood-retinal barrier.  This webinar focused heavily on the quality tests that are required for ophthalmic products based on dosage form.  Topical applications (solutions and suspensions) are the most common, but the USP chapter now includes all dosage forms that are currently approved by the FDA.

Velesco has non-GMP small scale ocular solution capabilities.  We have extensive experience with ophthalmic solutions and performing the required quality tests including description, identity, assay, impurities, pH, and osmolality.  Several of the formulations that we have manufactured have also required viscosity testing due to their composition.  Although we have not yet expanded to offer GMP ocular delivery manufacture capabilities, we can perform release testing of manufactured ophthalmics.

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