Physical and chemical changes: root cause and how to fix them
Stability is a great concern in the industry, since pharmaceuticals must be safe and effective. It is defined as the physical and chemical integrity of a pharmaceutical dosage form and it is tested through all the phases of product development. Critical as well as some non-critical quality attributes must be tested under harmonized stability conditions in order to guarantee the stability of a product and to define its shelf life.
In most of the oral solid forms, the physical and chemical reactions are promoted by factors such as temperature, humidity, air and light and soft gelatin capsules (SGC) are not the exception. Failures on stability in SGC are mainly related to incompatibilities API-excipients as well as to migration phenomena and account for high costs at product development.
This topic as well as some others presented before has been approached through the QbD methodology in order to understand the effect of diverse formulation variables on the stability and minimize the risk of failure at stability conditions.
The first part aims to introduce the main physical and chemical issues in SGC, the key factors involved and the proposed tests. The second part will deal with some case studies aimed to illustrate how to evaluate the stability at the preformulation phase, some of the variables that should be taken into account in a particular case, the risk analysis, the experimental design, the results as well as the conclusions.
Procaps invite you to join us in this webinar and to participate in the task of making the product development a part of the QbD approach to translate the results into new knowledge and costs and time reductions.
Presented by
Claudia Silva,
Director, New Platform Technologies
Pharmacist from Universidad Nacional (Colombia) and PhD in Food Science and Engineering from Universidad de Santiago de Compostela in Spain.
Senior researcher with experience on formulation, development and industrial transference for new products, integrates her background and expertise in rheology of natural hydrocolloids leading the Project Management on New Platforms for Research, Design and Development of new delivery systems and new pharmaceutical dosage forms, the evaluation of new materials, equipment and technologies as innovative proposals and the evaluation of gelatin substitutes for product development.
Author of several scientific research papers and attendant to various International Congresses in the area of rheology and Research and Development of thickening systems.
Diego Monterroza,
Corporate Manager, R&D
Diego holds a degree in Organic Chemistry from Universidad del Atlántico and a Master’s degree in Pharmaceutical Sciences from Universidad Nacional in Colombia. He has more than 15 years of formulation and analytical development experience with soft gelatin capsules products, including products for the US, EP and Canadian markets.
Diego has led formulation development for liquids, semisolids, and suspensions, contained in soft gelatin capsules, including lipid formulations and self-emulsifying drug delivery systems. In his current role, Diego leads the product and analytical development of pharmaceutical products for PROCAPS S.A. covering diverse solid and liquid dosage forms, mainly, soft gelatin capsules and associated technologies.
