Evonik offers a wide array of preformulation services including feasibility studies and proprietary systems to support pharmaceutical, biotechnology and nutraceutical companies prepare for the development and manufacturing of oral solid dosage forms that are ready for human clinical trials. From the time of your initial concept for a novel or generic formulation, our expert team of scientists and chemists can be by your side to help minimize risk and streamline your entry into a full formulation development program. Regardless of the project stage, we adhere to a strict Quality-by-Design (QbD) process that is intended to optimize the performance, stability, quality and manufacturing robustness of the final product. Through this approach, our preformulation services will ensure formulation development and optimization programs, as well as the manufacturing of preclinical and clinical trial materials, can proceed with minimum risk of delays.

In recognition of our decades of technical expertise and leadership in the development of complex oral solid dosage forms for small molecules, proteins peptides and other drug products, pharmaceutical companies from around the world often reach out to us to conduct their feasibility studies. Often, these discussions will start with the need to solve specific technical challenges surrounding their oral formulation concept for a new or existing drug product. Such challenges may include:

• the esthetics or quality of the coating
• high batch-to-batch variability
• an unsatisfactory rate of batch failure
• inadequate performance of the product

In most cases, we are able to draw upon a wide array of successful case studies conducted with customers that have experienced similar challenges. Where applicable, our expertise and laboratory equipment can also be leveraged for the 3D printing of oral solid dosage forms utilizing a variety of EUDRAGIT® polymers. To best meet your requirements, our team can either travel to your offices for an initial consultation and troubleshooting, or you may visit one of our formulation and application laboratories located across Europe, the U.S. and Asia.

To ensure successful outcomes from preformulation studies, it is important that a range of factors including various excipient, process technology and dosage form options are taken into account. Our experts will review whether your target process technologies, such as drum coaters or fluid bed coaters, are best positioned for use with the target dosage form, such as multiparticulates or matrix tablets, as well as anticipated batch manufacturing requirements. We will also rapidly assess a range of single or combination coating options from our EUDRAGIT® portfolio, as well as other proprietary drug delivery technologies where applicable, to develop a recommendation on the best formulation approach. Such processes will not only leverage our deep process understanding and development know-how, but our expertise across a range of drug products including those with highly potent active ingredients and controlled substances.

Our feasibility studies will review the current or proposed formulation and manufacturing processes to identify the right formulation composition, functional excipients, manufacturing process and process parameters. Studies that we may undertake during the preformulation process includes:

• an evaluation of product appearance to identify potential coating defects,
• plus scanning by electron microscopy to assess film quality and thickness
• as well as polymer distribution.

Additional tests that can be undertaken during the preformulation stage include an evaluation of weight uniformity to review coating homogeneity, and disintegration and dissolution testing across various pH values to characterize product performance. Based upon these outcomes, as well as other analytical data, we will also review the formulation and manufacturing process to increase yield, reduce costs, and ensure product quality and reproducibility can be maintained at any scale.

If you are seeking to accelerate the screening of formulations and processing conditions at the earliest stages of solid dispersion development for your poorly soluble APIs, our MEMFIS® (Melt Extrusion Modeling and Formulation Information System) is ready to help. This proprietary system leverages decades of expertise to help you avoid time-consuming, costly and repetitive experiments that could otherwise be required to identify the most appropriate solid solution or dispersion formulation. The system considers solubility as well as a range of other physical parameters to predict the most suitable polymers as well as maximum drug concentrations.