Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars

Abstract

Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many regulations drug products need to comply with is the elution rate of the active ingredient. Due to the importance of this performance metric, regulations are becoming stricter regarding tolerances and the compliance with these. Combination products have the complexity of many different manufacturing processes that could have an impact on the elution performance, hence the challenge for medical device manufacturers, to get a good understanding of the different process variables that influence this metric and to establish the appropriate controls. The development work and the costs associated to testing, specification setting and lot release make this particular understanding to be critical for the future and success of the business. Key Terms - Dissolution Rate, Elution Rate Mass Fraction, Potency, Steroid Collar.