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Module Code - Title:

CH4417 - PHARMACEUTICAL FORMULATION

Year Last Offered:

2025/6

Hours Per Week:

Lecture

3

Lab

0

Tutorial

0

Other

2

Private

5

Credits

6

Grading Type:

N

Prerequisite Modules:

Rationale and Purpose of the Module:

Pharmaceutical formulation is central to transforming active chemical entities into safe, effective, and manufacturable medicines. This module serves to integrate prior learning in physical chemistry, biochemistry, materials science, and process engineering within the applied context of biopharmaceutical product development. It provides a coherent approach linking molecular properties, material behaviour, biological performance, and industrial manufacture, thereby providing insights into real-world therapeutic applications. The module informs students by bridging laboratory-scale understanding with regulated pharmaceutical practice, equipping graduates with the integrated perspective required in contemporary biopharmaceutical and related process industries.

Syllabus:

The module will inform students on a wide range of topics pertinent to pharmaceutical formulation including the underlying principals required to pursue such formulations. Indicative examples are as follows: - The drug development pathway. - Physical chemical principles of dosage from design. - Particle science and powder technology. - Dosage form design and manufacture. - Physical chemical principles of dosage from design. - Particle science and powder technology. - Biopharmaceutics - upstream and downstream unit operations. - Drug delivery approaches. - Dosage form design and manufacture.

Learning Outcomes:

Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)

On successful completion of this module students should be able to: • Analyse how the physicochemical properties of active pharmaceutical ingredients influence dosage form design, performance, and manufacturability. • Justify the choice of appropriate formulation components to achieve targeted drug release, stability, bioavailability, and patient acceptability. • Evaluate how particle and powder properties affect processing behaviour and product performance during pharmaceutical manufacture. • Defend a designed integrated dosage form development strategy, including appropriate unit operations and process considerations from laboratory to industrial scale.

Affective (Attitudes and Values)

On successful completion of this module students should be able to: • Articulate an informed perspective on the scientific, technical, and translational challenges that contribute to attrition in the progression of therapeutic molecules from discovery to market. • Value the integration of scientific and engineering principles in the design, formulation, and manufacture of safe, effective, and high-quality medicines.

Psychomotor (Physical Skills)

n/a

How the Module will be Taught and what will be the Learning Experiences of the Students:

This module is delivered through a student-centred approach combining structured lectures with interactive tutorials and collaborative, challenge-driven group work. Teaching integrates physical chemistry, particle science, biopharmaceutics, and dosage form design within the applied context of pharmaceutical product development, linking molecular properties to therapeutic performance and industrial manufacture. Lectures provide core scientific and engineering foundations, while tutorials emphasise discussion and problem-solving, and group work functions as an integrative, research-led learning experience, The learning environment is interactive and inclusive, enabling students to develop their ability engage critically with drug delivery technologies (Curious), adapt solutions to practical constraints (Agile), and reflect on safety and quality considerations in pharmaceutical practice (Responsible). Recent developments are embedded through the integration of current drug delivery strategies, advances in particle engineering, biopharmaceutical challenges, and evolving regulatory and manufacturing practices.

Research Findings Incorporated in to the Syllabus (If Relevant):

Prime Texts:

G.P. Bunn (2026) Good Manufacturing Practices for Pharmaceuticals , CRC Press
L. Endrenyi, P. Declerck, S.C. Chow (2017) Biosimilar Drug Product Development , CRC Press
L.V. Allen (Jr), T.B.McPherson (2021) Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems , Lippincott Williams & Wilkins
M.E. Aulton, D.M. Collett (2002) Pharmaceutics: The Science of Dosage Form Design , Churchill Livingstone
K.M.G. Taylor, M.E. Aulton (2021) Aulton's Pharmaceutics: The Design and Manufacture of Medicines , Elsevier
M. Rhodes (2008) Introduction to Particle Technology , John Wiley & Sons
P.J. Sinko (2016) Martin's Physical Pharmacy and Pharmaceutical Sciences , Lippincott Williams & Wilkins
G. Walsh (2026) Pharmaceutical Biotechnology: Concepts and Applications , John Wiley & Sons

Other Relevant Texts:

E. Kwong (2017) Oral formulation roadmap from early drug discovery to development , John Wiley & Sons
G.D. Tovey (2018) Pharmaceutical Formulation: The Science and Technology of Dosage Forms , Royal Society of Chemistry
M. Morishita, K. Park (2010) Biodrug Delivery Systems Fundamentals: Applications and Clinical Development , CRC Press
S.A. Hout (2022) Sterile processing of pharmaceutical products: engineering practice, validation, and compliance in regulated environments , John Wiley & Sons

Programme(s) in which this Module is Offered:

BSPICHUFA - PHARMACEUTICAL AND INDUSTRIAL CHEMISTRY
BECBENUFA - CHEMICAL AND BIOCHEMICAL ENGINEERING
MSCBENTFA - CHEMICAL AND BIOCHEMICAL ENGINEERING

Semester(s) Module is Offered:

Autumn

Module Leader:

Maryam.Karimijafari@ul.ie