Oral Drugs Archives

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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.

Presenters
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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Latest Resources

Defining acceptable impurity levels for drug substances in GLP toxicology studies

Enhancing Safety in Drug Substance Synthesis: A Smart Approach to Chemical Design

Insights into Thermogravimetric and Evolved Gas Analysis

Chirality in drug development: from racemic mixtures to enantiopure substances

The importance of polymorph screenings

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(Cross-)Contamination Control through Effective Equipment Cleaning

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Design of Experiments (DoE) and its relevance in API crystallization process development

Preparative HPLC Excellence

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The importance of API Intrinsic Dissolution Rate and how to determine it

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A CDMO’s insight on amorphous solid dispersions

Accelerate Your Path to Preclinical Trials

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On-demand webinar: Advancing Drug Development: Overcoming Bioanalytical Challenges of Nanomedicines and ADCs

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On-demand webinar: Navigating CMC requirements for Spray Drying Processes

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Scientific/CMC Writing and Regulatory Support

Fill & Finish Services

Driving your lead candidate to clinic

Phase-appropriate drug substance manufacturing

Facilitating clinical trial success for drug products

Leading Bioanalytical Competencies

Excellence in solid state research

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Bioanalytical characterization and monitoring of ADCs supporting safety and efficacy from pre-clinical to clinical

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Phase-appropriate development of a phase 1 oral dosage form

Strategies for Effective Cold Chain Packaging and Labelling

Timely Clinical Trial Material Services

Leverage the power of CMC in early drug development

Formulation and Process Considerations for Optimising Spray-Dried Solid Dispersions

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Prevent undesired immunogenicity from becoming the barrier for innovative biotherapeutics

Scientific Advice and Dialogue with EMA during Drug Development

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Applying the science of advanced dissolution testing to accelerate product approval

Discriminatory dissolution test method in late development

Which solubility-enhancing technology should I use to support my early drug development project?

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