Formulation Development and Testing

Expert Support For Your Pharmaceutical Formulation Development

At iuvo BioScience, our expert scientific team is here to help you develop stage-appropriate formulations for active pharmaceutical ingredients (APIs) in support of your drug development initiatives.

Considering the rising costs of pharmaceutical development, it is imperative that drug development companies apply efficient and effective formulation selection while maintaining a thorough understanding of the drug substance and final product.

Whether you are at the early non-clinical research stage, progressing into GLP pre-clinical toxicology studies, or ready to proceed to clinical testing, iuvo BioScience is ready to assist you with your pharmaceutical formulation development.

The formulation of a pharmaceutical product contains the API and other inactive ingredients (also known as excipients) designed to ensure specific characteristics related to the performance of the product. It is imperative to consider formulation at the earliest stages of drug development, as it can have a great effect on how the drug performs.

Optimizing Your Formulation For Patient Safety and Success

At iuvo, our primary goal is to help you determine the optimal choice, mix and level of excipients in your new product. We understand that any formulation must be able to be consistently manufactured, maintain its stability for the intended use period, and must have the ability to reach the target tissue in the unchanged form – all while ensuring the highest level of patient safety. If you already have a dosage form in mind, iuvo can optimize it for your attribute of interest; enhanced efficacy, bioavailability or minimized side effects.

To establish a successful formulation strategy, the physical, chemical, and pharmacokinetic characteristics of the API – as well as the intended use of the drug – must be considered at the formulation stage. Pharmaceutical formulation is a critical step in ensuring that the right dose of drug is delivered to the right part of the patient’s body. iuvo can help you design and test formulations that are most appropriate for the intended route of administration – whether that be oral, topical or parenteral. Once developed, we can test these formulations in vivo so that they are optimized for the clinical testing.

Pharmaceutical products also need to be formulated in specific dosage forms to be effectively delivered. We can help also you consider the right dosage form to use for your application, and then design the matrix, optimize the type of excipients used, and their concentrations. Typical pharmaceutical dosage forms include tablets, capsules, solutions, suspensions, ointments, gels, and injectables. Each of these diverse dosage forms present different technical challenges for formulation development.

After developing the ideal formulation for your product, we can prepare the formulation, characterize the material, and test drug/excipient interactions and drug release. Ensuring these parameters are met before entering into preclinical and clinical studies will save you both money and time.

Adding Value To Accelerate Your Development Timeline

We will develop a formulation strategy that works best for your indication. What sets iuvo apart in terms of our formulation development expertise, is that iuvo offers a customized formulation screening strategy that allows us evaluate your preclinical formulation(s) for scientific stability, in vivo pharmacokinetic properties, and screen for potential toxicology effects. Through this process we can meet your target goal whether that is optimizing pharmacokinetic parameters, improving bioavailability or mitigating risks to progression into further development.

As your program develops, we have the capability to do regulated testing including registration stability, leachable evaluation as well as GLP testing. Additionally, the iuvo team can address your clinical formulation needs providing continuity in your program and, most importantly, accelerating your development timeline.

From optimizing lipid nanoparticles, to delivering mRNA more effectively and preparing gels that improve transdermal delivery of APIs, the iuvo team offers a wide range of scientific experience that can be used to help you develop a drug delivery strategy that works best for your product.

Meet Anthony Di Pasqua, PhD
Lead Formulation Scientist

Dr. Di Pasqua has over a decade of experience designing drug formulations to enhance efficacy and/or minimize side-effects of therapeutically active compounds. Dr. Di Pasqua has been involved in the design and characterization of solid, semisolid, and liquid dosage forms. To date, Anthony has 39 published peer-reviewed papers and three patents. He submitted two more patent applications in 2023 and is the co-inventor of two drug-delivery technologies that are currently being licensed by companies in the U.S.

From tablets and capsules, to gels, creams, patches, solutions, suspensions and emulsions, Dr. Di Pasqua has the technical know-how to translate basic scientific concepts into therapeutic applications. His expertise also extends to dosing these formulations in animal models via appropriate routes of administration.