An ideal formulation
As APIs grow more complex and drug developers seek unique ways to differentiate topical, transdermal, and mucosal drug delivery is of growing importance. These routes of administration offer benefits such as bypassing first-pass metabolism, increasing patient compliance, and achieving controlled release.
However, developing topical, transdermal, and mucosal drug products requires a deep understanding of the utilization of advanced drug delivery technologies to increase drug penetration/permeation and overcome the body’s barrier systems. We are experts in solubility and bioavailability enhancement and can help you determine the best route of administration for your API.
Deep formulation knowledge and API handling capability
Our business started out decades ago developing nanoparticulate zinc oxide for sunscreen. Since then, we’ve expanded into a range of complex topical products, including ophthalmics, mucoadhesive tablets and films. With topical expertise in our roots, we have the unique insight needed to create safe and efficacious suspensions, solutions, and emulsions in the form of gels, lotions, ointments, and creams.
We have worked on dozens of topical formulations with a wide variety of APIs, including:
- Small molecules (insoluble compounds, new chemical entities)
- Large molecules (peptides, nucleotides)
- Highly potent APIs (hormones, steroids, cytotoxics)
- Controlled substances (Schedule I-V)
Complex topical and transdermal drug delivery systems
We are equipped with a full suite of supporting services and facilities to handle every aspect of product development. Our seasoned analytical team provides method development and validation to characterize even the most challenging new chemical entities (NCEs) and generics. We can support Q1/Q2 evaluations, and we develop in vitro release testing protocols based on Franz diffusion cell technology. These capabilities are supplemented with state-of-the-art temperature and humidity-controlled and monitored chambers for accelerated and long-term stability testing (both ICH stability and custom programs, including photostability).
Our work in sterile manufacturing and aseptic processing means we are fully equipped to develop and manufacture topical ophthalmic drug products. We have both clinical and commercial GMP manufacturing facilities, and our experienced quality team provides oversight to all manufacturing activities. The close interaction between formulation, manufacturing, analytical, and quality ensures your product makes a seamless transition from concept through commercialization.