Semi-Solids and Gels
LLS Health has expertise in the formulation of gels and emulsions for topical applications and mucosal delivery. We work with both new chemical entities (NCEs) and generic drug products, including 505(b)(2) and ANDA applications.
Semi-solid formulations are at the foundation of our company, which started in the personal care industry in the 1990s when we scaled up and sold the first nanoparticulate zinc-oxide formulation along with its IP. Since then we have been leveraging this expertise to produce stable formulations with optimal physical properties, chemical properties, and drug release profiles.
LLS Health places great emphasis on meeting target product profile parameters, such as performance, stability, and fit for purpose. We employ a quality-by-design (QBD) approach to process and product development to ensure success.
We understand that these complex, multi-component formulations require extensive pre-formulation work that examines how each factor affects the finished dosage form.
Full formulation and manufacturing capabilities to take on complexity
LLS Health has in-house capabilities that allow for complete formulation development and characterization of semi-solid dosage forms. We have specialized equipment such as Franz cells that enable in vitro drug release testing of semi-solids, and our in-house physical characterization lab regularly measures critical quality attributes such as rheology and viscosity. When coupled with our seasoned analytical staff and ICH stability programs, it is clear why LLS Health is a preferred partner for semi-solid dosage forms.
As with all the dosage forms we handle, LLS Health embraces complex challenges that cannot be solved by standard techniques. Our team, equipment, and facilities are equipped to handle the challenges of highly potent compounds, poorly water-soluble APIs, and products with unique stability requirements.
Our Carbopol® polymers, Pemulen™ polymeric emulsifiers, and Noveon® polycarbophil have been used extensively in semi-solid and gel commercial applications for over fifty years. These excipients provide critical product attributes, including:
- Tailored rheology modification and viscosity control
- Ideal aesthetics and feel, for the creation of non-greasy creams, exceptionally clear gels, and other optimal semisolid formulations
- Highly efficient thickening capabilities and gel formation at low usage levels in aqueous, hydroalchoholic, and anhydrous systems
- Stable and consistent drug dispersion in semisolid emulsions and suspensions
- Mucoadhesion properties to improve the bioavailability of active ingredients
- Compatible with acidic, basic and neutral drugs
- Thermal stability, which allows for versatility in final product sterilization
LLS Health also offers a wide array of additional inactive ingredients for semisolids, such as humectants, emollients, emulsifiers, and surfactant thickeners that are featured on the FDA’s Inactive Ingredient Database (IID).
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.
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.
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.