This webinar will discuss the main critical quality attributes that should be monitored and controlled during product development and/or for the shelf life of products applied to the skin. These products include, but are not restricted to, ointments, creams, gels, lotions, solutions, pastes suspensions, and passive transdermal systems (TDS).

Further discussion will also focus on parameters such as uniformity of dosage units, microbial limits, antimicrobial preservative and antioxidant content, apparent viscosity/rheology, and uniformity in containers. For TDS, the audience will gain insight into parameters such as cold flow, peel adhesion, release liner peel test, and leak test. A brief discussion will be provided on drug release testing of drug products applied to the skin, as well as ophthalmic products.

The live version of this webinar took place on March 3, 2015

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Identify the main critical quality attributes of drug products applied to the skin
– Understand the importance of the evaluation of uniformity of dose unity and container
– Gain awareness of the challenges related to the evaluation of certain parameters, such as cold flow and leak tests, for transdermal systems

Target Audience (If applicable):
– Product development
– Analytical methods
– Stability studies
– Regulatory affairs