Topical, Mucosal, and Transdermal CDMO
LLS Health has decades of experience developing topical and transdermal formulations, as well as mucoadhesive dosage forms for nasal, vaginal, and rectal administration. Having grown out of the skin care space more than 20 years ago, we have a unique understanding of complex topical formulations. We also have experience meeting the sterility requirements for topical ophthalmic drug products.
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 functional excipients and advanced drug delivery technologies to increase drug penetration/permeation and overcome the body’s barrier systems. We are expert 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)
Our deep understanding of how excipients – such as emulsifiers, stabilizers, penetration enhancers, and emollients – can affect the physical and chemical properties of drug products allows us to design sophisticated systems that effectively penetrate the target tissue.
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.
Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability. Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.
Analytical Method Validation
Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.
We offer GMP manufacturing for many dosage forms, and our integrated approach creates a smooth transition from pre-clinical activities through clinical validation. We have GMP manufacturing space that is supported by in-house analytical services, bioanalytical services, physicochemical characterization, and ICH-compliant stability programs.
Drug Release Testing
We have over two decades of experience developing and validating release assays for a variety of drug products, including semi-solid formulations, implantable devices, and oral solid dosage forms. Our GMP/GLP facilities are equipped with specialized equipment and seasoned analytical scientists who perform both routine and custom drug release testing.