Expert API Formulation Development
With decades of practical formulation development experience and a keen attention to detail, we create pharmaceutical formulations that are safe and efficacious. Our development process produces optimal drug product formulations within the boundaries informed by preformulation characterization data, including solid form, solubility, stability parameters, and target pH range.
Our strategies withstand FDA scrutiny and accelerate successful commercialization. With the Design of Experiments (DOE) approach we assess samples under accelerated stress conditions and use these insights to select the most stable formulations with sufficient solubility. Our capabilities tailor your formulation to the desired delivery route, be it oral, parenteral, nasal, inhaled, ocular, intravitreal, or topical.
Our expertise spans sterile and non-sterile products for all dosage forms. Sterile products include injectable solutions, suspensions, emulsions, gels, and lyophilized powders. Non-sterile products include tablets, capsules, solutions, suspensions, topicals, and semi-solids.
Our scientists assess your formulations so you can make informed decisions and prevent lost time if a strategy proves unsuccessful. We evaluate your drug substance’s physicochemical characteristics and determine how different formulations utilize these intrinsic properties.
With a greater understanding of the molecule, our scientists develop prototype pharmaceutical formulations. Finalized lead and backup formulations are detailed and recommended through an iterative process.
Once we identify the target formulation, the team develops scalable processes for robust manufacturing of the bulk formulation and final dosage forms. We then transfer these processes to an appropriate manufacturing facility, typically within our organization. The transfer will utilize stage-appropriate activities such as validation and document control.
We produce high quality batches with complete documentation, including Batch records and Certificates of Testing/Analysis. We evaluate formulations in appropriate container/closure systems on long-term stability. Analytical methods, optimized and validated at the stage-appropriate time, support the formulation development and GMP testing activities.
We design developability assessments for early-stage molecules to guide your upcoming studies. Our expert team evaluates your therapeutic’s chemical structure for potential liabilities, including self-association and aggregation. We also perform solubility and viscosity screening, and thermal stability assessments.
DRUG COMPATIBILITY TESTING
We perform material compatibility testing to evaluate your compound’s drug-drug and drug-excipient reactions on a physical and chemical basis. As a result, you can filter out components that do not meet expectations for the final formulation. Additionally, we assess potential interactions your product might encounter throughout different points in its lifecycle, such as the manufacturing process or route of administration.
We develop formulations using a combination of empirical inquiry and DOE / Quality by Design (QbD) studies. Our team pays strict attention to every detail, including:
- Using Generally Recognized as Safe (GRAS) ingredients
- Identifying potential stability problems
- Ensuring compatibility with container/closure systems
- Maximizing API physical/chemical stability under pharmaceutical manufacturing conditions
We integrate molecular properties with formulation, delivery, and device systems to develop patient-friendly products with optimal market potential. Our team helps you determine the best injection method for your target drug delivery needs, whether it be subcutaneous, intramuscular, or intravenous.
Determine the optimal choice for the select solid form of your drug by partnering with our formulation experts. Solid dosage forms help drive efficacy by enhancing solubility and bioavailability. Extensive preformulation screening of solid form rendering techniques provides you with a choice of potential crystalline forms, salt forms, cocrystals, and non-crystalline materials. Our team selects appropriate techniques to manufacture pharmaceutical materials at scale through processes like crystallization and spray drying. Simultaneously, we assess the characteristics and potential challenges associated with the solid form throughout manufacturing, storage, and administration.
Improve your pharmaceutical product’s stability and long-term potency with our lyophilization formulation development. We prepare your drug formulation for reliable manufacturing, storage, handling, and administration. We also pair your product with the most compatible excipient and ensure your final drug product is prepared for various conditions.
Establish your optimal ophthalmic formulation by identifying the best-suited delivery method and creating a well-balanced dosage form. Whether your drug formulation is a solution, suspension, ointment, or emulsion, our experts are here to aid your development program from clinical phases to commercialization. Our team prioritizes sterility and microbe-resistance while also keeping scalability top of mind.
Oral solid dosage forms are among the most popular approaches to drug delivery; however, it is challenging to develop these drug products to be reproducible, scalable, and physically/chemically stable. Our team offers comprehensive services that solve your pharmaceutical formulation challenges and advance your product to the clinic and beyond.
Solutions and suspension clinical formulations are versatile but come with challenges such as physical and chemical stability. Our team has broad and deep experience in developing these dosage forms no matter if your route of administration is injectable, ophthalmic, or oral. Together, we evaluate your specific challenges and apply a comprehensive approach to pharmaceutical product development.
Effectively manage the complexities of semi-solid dosage formulation by addressing the factors that influence drug development. Whether you plan to use a topical dosage form or transdermal delivery system for a new or existing product, our team applies a comprehensive approach to solve your drug formulation challenges.
Different types of buffers provide pH control for solubility and stability.
Tonicity-modifying excipients help control a drug substance's isotonicity and stability.
Surfactants prevent aggregation during manufacturing, storage, and administration. They also increase solubility and enhance wettability.
Bulking agents are important additives for lyophilized material stability and improved appearance.,
Antioxidants, cryoprotectants, and other additives improve chemical stability in solution and/or lyophilized products.
Effective & Robust
We specialize in developing effective and robust pharmaceutical formulations that are bioavailable, non-toxic, manufacturable, and chemically/physically stable. We approach each formulation project with the eventual commercial product in mind. Our priorities are to:
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.