Application of Quality by Design principles in the development of the gelatin shell formulation of softgels
The use of soft capsules as a drug delivery route is becoming more and more prevalent within the current pharma sphere.
Soft capsules can overcome various challenges which enable delivery to wider patient profiles and use of different APIs - this includes:
- The ability to formulate liquid drugs.
- Incorporating APIs with low solubility and permeability characteristics.
- The ability to contain high potent compounds.
Traditionally, people involved in the development of products in this dosage form, are more concerned about the fill content formulation since the API is included in that part of the finished product. Challenges that are encountered include not just physical issues such as clumping, nesting, leaking etc, but also chemical interactions between shell and fill content that can affect the chemical stability of the drug in the finished product.
This webinar is intended to present a general view of softgel pre-formulation based on gelatin as a key raw material of the system, and will discuss:
- Various characteristics of gelatine, and the tests that could predict its performance on the preformulation phase and the effect of the parameters in some CQAs of the product.
- Considerations of shell formulation developed on the QbD (Quality by Design) frame in order to offer a guideline to solve some common problems in softgel product development, such as rupture time and clumping.
- A commentary on technical insights into problem-solving skills as a result of our multidisciplinary work; analytical sources; the experiences of our manufacturers and the efforts to overcome the key issues that face the Pharmaceutical Industry.
Please join this webinar to learn about why softgels, as a dosage form should be considered as a delivery medium (and how to save money, time and team effort if you intend to incorporate it within your portfolio) - and why QbD will be the standard for Product Development all over the Pharmaceutical Industry.
Presented by
Diego Monterroza,
Corporate R&D Manager
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.
Claudia Silva,
New Platforms Development Director
Claudia graduated from Universidad Nacional (Colombia) gaining a degree as a Pharmacist. She also holds a European PhD in Food Science and Engineering from Universidad de Santiago de Compostela in Spain.
Claudia went on to become a senior researcher with experience in formulation, development and industrial transference for new products. This 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.
Claudia has authored several scientific research papers and attendant to various International Congresses in the area of rheology and research and development of thickening systems.
