We use concepts and active ingredients to create technically robust, regulatory-compelling and patient-friendly products whose exclusiveness is best protected.
Together with our customers, we develop individual, customized solutions to achieve the best value for the resources used.
We pursue a “rational design” approach in order to develop formulations and analytical methods in a targeted and robust manner, thus providing solutions that reduce risks and costs.
Semi-solid formulations are often complex and generally less well understood in their critical quality attributes than, for example, typical solid dosage forms. Therefore, such formulations are usually still developed empirically, i.e. by testing known approaches, until an acceptable way is found. In contrast to this “quality by trial and error” approach, we pursue a rational design based on a systematic understanding of the formulations in terms of chemical and physical stability, skin penetration and cosmetic properties, which provides “quality by design”. Experience has shown that this approach leads more quickly to a robust, marketable product that can be modified in a targeted manner if required. It also allows systematic risk minimization from a technical, regulatory and economic point of view.
Creams are classical dosage forms, but their potential has not yet been fully exploided. We have achieved deeper insights into emulsion systems through systematic studies which allow us to solve a variety of formulation challenges.
We offer solutions for formulation challenges such as solubilization, chemical stabilization as well as modification of release and skin penetration in the form of creams, i.e. viscosity stabilized emulsion systems. Over the past decades, there have been many attempts to solve these challenges with “Special/Novel Delivery Systems”, but these only led to very few marketed products. Also, such particle-based systems are typically regulatory complex, more difficult to convert into robust commercial processes and often associated with higher investment and manufacturing costs.
Based on a comprehensive understanding of emulsions with regards to their thermodynamic principles, we are able to offer specifically developed creams – as “Cream 2.0” – for many of these challenges, which can be brought to market maturity much faster, more cost-effectively and with less risk.
A basic study of RaDes scientists in cooperation with the Technical University of Braunschweig, Germany, on the systematic optimization of preservative systems in creams was recently published (https://www.sciencedirect.com/science/article/abs/pii/S0939641118308026). The publication of a paper on the systematic stabilization of hydrolysis-sensitive active ingredients in creams is currently in preparation.
Nevertheless, we are not only focussed on creams, but are committed to identify the best formulation solution for the respective challenge. We also offer also extensive experience on other systems such as hydro- or oleogels, ointments and (film-forming) solutions.
Prototype development is only the beginning of the life-cycle of a formulation. Right from the start, we take into account the impact on future potentials, risks and costs.
In relation to the total development costs of a medicinal product, the exploratory development of a formulation is generally inexpensive. However, with the selection of a final prototype, a strategically and economically significant decision is made. The sum of future expenses with regards to investment, operating and production costs as well as the expenditure for release testing and regulatory support for various prototypes can differ by several million euros. We are able to evaluate such future-projected aspects of prototypes and create risk-based scenarios that allow our customers to develop optimized and sustainable solutions together with us.
In liquid and semi-solid formulations, active ingredients are often dissolved and can react in a variety of ways, which often requires stabilization. Similarly, the unfavorable drug to matrix ratio and quantitative extraction from the matrix often present challenges for which we provide solutions.
We have leading expertise in analytical method development and validation, especially for semi-solid products that are difficult to analyze (e.g. problematic extraction, low doses, low UV activity), and for structural elucidation of complex degradation pathways. We combine this with extensive experience in chemical stabilization (reduction of oxidation, hydrolysis or isomerization) as well as with regards to the interaction of actives and excipients with packaging materials. We are also able to provide risk assessments of secondary degradation phenomena, such as reactions of or with degradation products of active ingredients and excipients. These often follow non-linear, complex kinetics and are not predictable from the routine assessment of short-term stability data.