In part two of these blog posts, we will discuss the various types of topical products (ointments, creams, gels, sprays, and lotions), detailing their characteristics both in terms of formulation and use. The Challenges As discussed earlier, there has been an increase in the development of topical drug products as a way to deliver drugs locally to those surfaces, rather than systemically. There...
In pharmaceutical contract manufacturing, outsourcing your product to the right Contract Development and Manufacturing Organization (CDMO) can be a daunting and concerning task. After conducting the legwork of determining the best fit for a CDMO from capabilities and organizational fit perspective, the next step is working with that vendor on determining costs. Generally speaking, there is a ton...
There has been increased interest in the development of topical drug products as a way to deliver drugs locally, rather than systemically and for diseases that occur in the skin, mucosal surfaces, the eye, and/or wounds of these surfaces. There are reduced side effects and toxicity to other organs compared to systemic delivery. Topical drug products are typically formulated to enable the...
The Process Validation (PV) Guidance from the FDA (January 2011) adopts the product lifecycle concept, emphasizing the expectation that process validation starts with process design and carries throughout the entire lifecycle of a commercial product. During the process qualification stage, the process design is evaluated to determine if the process is capable of consistently delivering quality...