Dissolution is a critical quality parameter for oral solid dosage forms. When soft gelatin capsules (SGC) are used as a delivery form, considerations need to be made which not only factors in the API and the dissolution media, but also the fill content and the gelatin shell.
Failures on dissolution of the SGC products are frequently related to the attributes of the API and the formulation of the fill content. However, considerations which also need to be factored in includes the gelatin formulation; the interactions between gelatin and the fill content; the process parameters in encapsulating as well as in drying; and in some cases to the analytical conditions. In addition, some of them occur as a result of stability conditions at further stages of development. The SGC pharmaceutical industry is aware of this general concern and has identified the QbD approach as an aid for the development of new products.
This Webinar offers a general view of the key factors on formulation and process that affect the dissolution of SGC. The first part deals with:
- The identification of these parameters on a QbD framework,
- Their effect on dissolution and the preformulation activities to evaluate some of them.
The second part presents some selected case studies on lipophilic and hydrophilic products as an approach in solving the most common problems related to dissolution in softgel product development.
It also offers some technical insights on the phases of product development and introduces some problem-solving skills as result of our multidisciplinary work, analytical sources and our manufacturer experience.
Once again, we offer a multidisciplinary perspective and our knowledge and expertise on softgel development and manufacturing. We call the R&D, production and QC teams to join us to review and contribute to this interesting topic of dissolution of SCG in order to solve the challenges that represent to the Pharmaceutical Industry.
Claudia Silva,
New Platforms Development Director
Pharmacist from Universidad Nacional (Colombia) and European 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 and leads the Project Management on New Platforms for Research, Design and Development of new delivery systems and new pharmaceutical dosage forms and the evaluation of new materials, equipment and technologies as innovative proposals for product development. Professor Ad Honorem at the Pharmacy Department, Universidad del Atlantico (Colombia). Author of several scientific research papers and attendant to International Congresses in the area of rheology and R&D of thickening systems.
Jose Acosta,
Product Development Director for Latin America
Pharmaceutical Chemist from Universidad del Atlántico and Master in Pharmaceutical Sciences from Universidad de Cartagena in Colombia, with 18 years of experience in the pharmaceutical industry. About 4 years as Professor in the Faculty of Pharmacy at the Universidad del Atlántico. Currently in charge of the development of products, focused on formulation, stability, analytical development, transfer and manufacturing processes and quality control of soft capsules and other pharmaceutical dosage forms.
- To learn some key aspects and strategies to control the dissolution of SGC
- To identify the key factors on formulation that affect the dissolution performance
- To define the process parameters related to dissolution of softgels
- To provide to formulators with tools for the preformulation of SGC based on the QBD methodology
- Formulator
- Senior Scientist
- Formulation Specialist
- Product Development Manager
- Regulatory Affairs
- Quality Operations Manager
- Senior Planner/Buyer
- Director
- New Business Development
- Director R&D Business Development
- Associate Director
