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In this webinar the essential aspects of oral solid dosage forms will be evaluated, especially a comparison between capsules and tablets will help to select the ideal formulation for your scope. You will be guided through the capsule development process from early phase development to larger scale manufacturing, emphasizing the critical process aspects that have to be controlled from a formulation point of view to obtain a successful product.

Capsules and tablets are the most popular oral solid dosage forms for the manufacturing of oral medication and food supplements. Although they often share the same target profile, both have distinct advantages and disadvantages. Understanding the different aspects such as patient compliance, the manufacturing process and the desired release profile of the formulation lead to a better selection of the most suitable oral solid dosage form.

In early phase development, capsules play a significant role in helping the API (active pharmaceutical ingredient) enter Phase I clinical trial as limited formulation (blend) development is required. Furthermore, capsules can be filled with pure API, limiting the consumption of API, avoiding development time and thereby reducing financial investment. Moreover, capsules provide excellent versatility in dose selection, taste masking and blinding properties, which are essential features for clinical studies.

For later stages in clinical trials, a more sophisticated blend in capsule formulation is needed to reduce the manufacturing time and to efficiently produce drug products using (semi-)automatic device. The challenges related to the capsule manufacturing in these phases are mainly linked to the homogeneity of the blend to be filled into capsules, needed to guarantee an accurate dose and scale-up problems related to the transfer from manual encapsulation devices to automated machines.

Giulia Milanesi (Ardena)
Group Leader – Formulation Development and Production
Graduated in Industrial Pharmacy with an additional specialization master in pre-formulation and pharmaceutical development, she started her career in Italy as a Formulation Scientist and later she joined Ardena in Belgium. She grew to Senior Formulation Scientist and she currently holds the position of Group Leader Formulation and Production. Her role is to support the formulation development for new chemical entities to enter the clinical studies. Her expertise is mainly focused on oral solid dosage forms such as capsules and tablets, but also nanosuspensions, lipid formulations, oral solutions, injectable formulations and solubility enhancing technologies.

Marco Bellentani (MG2)
Product Manager, Validation Manager and Project Management Officer for Processing Division
Graduated in Computer Science, he has been working for MG2 for almost 30 years. For the first 11 years he gained experience as a Software Engineer managing Encapsulation Software Projects and Products.
He currently holds the roles of Product Manager for Processing Division, Project Management Officer and Validation Manager. Active member of ISPE for almost 20 years he is also part of GAMP Italia Steering Committee since 2008, co-ordinating and actively participating to national and international ISPE/GAMP Working Groups.

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