RATIONAL FORMULATION DESIGN - 2028/9

Module Overview

In this module, you will learn how to design pharmaceutical formulations that meet product, quality, and regulatory requirements. You will explore formulation strategies, pre-formulation studies, risk assessment, and the use of QTPP, CQAs, and BSC classification to guide decision-making. The module will also introduce Quality by Design, solubility and bioavailability strategies, and design tools such as DoE to support systematic, evidence-based formulation development.

Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2028/9 academic year.

Module provider

Chemistry

Module Leader

ZARMPI Panagiota (Chst Chm Eng)

Number of Credits: 15

ECTS Credits: 7.5

Framework: FHEQ Level 6

Module cap (Maximum number of students): N/A

Module Availability

Semester 1

Prerequisites / Co-requisites

N/A

Module content

Indicative content includes:

Introduction to formulation strategy: role of formulation in product development, QTPP, CQAs, design rationale

Initial risk assessment: defining, QTPP, deriving CQAs, risk assessment tools

Pre-formulation and BSC classification: overview of pre-formulation and BSC classification

Formulation strategies: BSC-based, BioRAM, QbD, design space and DoE, solubility and bioavailability enhancement strategies, selecting appropriate route based on drug properties and QTPP, regulatory strategies

Assessment pattern

Alternative Assessment

N/A

Assessment Strategy

The assessment strategy is designed to provide you with opportunities to demonstrate understanding of core principles while developing practical and analytical skills essential for a career in pharmaceutical sciences.

Thus, the summative assessment for this module consists of:

• Coursework: addresses learning outcomes: 2, 3, 4, 5 and 6

• Examination: addresses learning outcomes: 1, 2, 3, 4 and 5

Formative assessment is designed to support your learning and development by providing ongoing feedback and opportunities to consolidate knowledge, develop practical skills, and link theory to practice. It includes activities such as in-class quizzes, problem-solving exercises, workshops, and group discussions. In laboratory sessions, formative assessment is provided through guided worksheets, and informal feedback from instructors, enabling you to prepare for experiments, interpret results, and refine practical techniques before submitting summative lab reports. These activities are intended to help you identify areas for improvement, enhance critical thinking, and develop transferable skills such as teamwork, scientific communication, and data analysis, ensuring you are well-prepared for the summative assessments and for progression to more advanced pharmaceutics content in later years.

Feedback will be provided throughout the module during lectures, through interactions in laboratory and workshop sessions, and on individual laboratory reports. This will include general guidance to the whole group as well as specific feedback on work to support learning and development. In addition, one-to-one feedback can be requested by appointment with the module leader or relevant lecturer, providing opportunities for further discussion and clarification of concepts.

Module aims

• Develop understanding of the role of formulation design within pharmaceutical product development
• Introduce systematic and risk-based approaches used to design robust formulations
• Apply pre-formulation principles and biopharmaceutic considerations to formulation decision-making
• Develop understanding of QTPP, CQAs, QbD and DoE approaches in formulation optimisation
• Enable students to evaluate formulation challenges and propose scientifically justified solutions and communicate effectively

Learning outcomes

Methods of Teaching / Learning

The learning and teaching strategy is designed to: provide you with a solid theoretical foundation in the subject matter while also developing practical, cognitive, and transferable skills essential for future careers.

The learning and teaching methods include:

Lectures: delivered primarily through PowerPoint and led by experienced members of academic staff with subject-specific expertise. The lectures will focus on introducing key formulation concepts, Sessions will be interactive, with regular opportunities for students to ask questions, engage in guided problem-solving and reflective thinking, and receive timely feedback from staff and peers.

Workshops: delivered by experienced academic staff with subject-specific expertise and will adopt a problem-based learning approach centred on relevant, real-world scenarios. Students will be provided with structured exercises that encourage application of core concepts, critical thinking, and professional judgement. Dedicated time will be allocated for students to work through tasks individually and collaboratively, with ongoing opportunities to interact with the lecturer, ask questions, and engage in discussion. Each session will conclude with lecturer-led feedback, including worked solutions and guided reflection, to consolidate learning and support the development of transferable skills relevant to future academic study and professional practice.

Indicated Lecture Hours (which may also include seminars, tutorials, workshops and other contact time) are approximate and may include in-class tests where one or more of these are an assessment on the module. In-class tests are scheduled/organised separately to taught content and will be published on to student personal timetables, where they apply to taken modules, as soon as they are finalised by central administration. This will usually be after the initial publication of the teaching timetable for the relevant semester.

Reading list

https://readinglists.surrey.ac.uk
Upon accessing the reading list, please search for the module using the module code: CHE3077

Other information

The school of Chemistry and Chemical Engineering is committed to developing graduates with strengths in Employability, Digital Capabilities, Global and Cultural Capabilities, Sustainability, and Resourcefulness and Resilience.

In this module, you will develop key skills that enhance your employability, including problem-solving, decision-making, and the ability to justify formulation strategies; essential skills for careers in pharmaceutical research and industry. You will build your digital capabilities by using software to analyse data, design experiments, and interpret formulation outcomes. You will also develop resourcefulness and resilience, learning to make informed decisions even when data are limited or uncertain. Sustainability is embedded in your learning, as you will use existing information effectively to reach robust formulation decisions without carrying out unnecessary experiments.