module specification

This module will introduce students to scientific principles underlying the formulation, industrial manufacture and quality assurance of commonly used pharmaceutical solid and semi-solid formulations. Students will learn a body of technical knowledge and acquire practical skills in the design, manufacture and quality evaluation of various pharmaceutical products.

The module aims to consolidate and expand on concepts introduced at prerequisite module CY5083 to ensure students have (a) a solid scientific grasp of physicochemical and biopharmaceutical factors that influence formulation, manufacture and stability of pharmaceutical solid and semi-solid products (b) enable students to understand the characteristics and rationalise the design of major pharmaceutical drug dosage forms highlight in the latter (c) expand the students’ practical skills in pre-formulation studies, physical and chemical testing, bioavailability considerations, excipient selection and production methods to ensure quality, safety and drug efficacy (d) encourage critical awareness of the pharmacopoeia and regulatory requirements associated with the manufacture of pharmaceutical solid and semi-solid.

Principles of Pharmaceutical Science and Drug Delivery (CY5083)

Available for Study Abroad? NO

The different stages of drug formulation and development: laboratory to industrial manufacture; regulation of drug use, drug safety and pharmacovigilance (LO 1 – 6).

Pharmaceutical formulation and manufacturing procedures of various types of pharmaceutics, the rationale behind their selection, composition and testing, with emphasis on quality, safety and efficacy for (LO 2 – 4):
• Solid dosage forms.
• Semi-solid dosage forms.

Pharmaceutical formulation development (process development and scale up) which include (LO 1 – 6):
• Quality Assurance (QA).
• Good Manufacturing Practice (GMP).
• Introduction to pharmaceutical regulatory agencies (European Medicines Agency (EMA); Medicines and Healthcare products Regulatory Agency (MHRA) and Food and Drug Administration (FDA)).
• Standard operating procedures (SOPs).
• Pharmacopoeia standards for drug substances and drug products.
• Good Manufacturing Practice (cGMP).
• Quality control of selected pharmaceutical formulations (solutions, suspensions and simple emulsions).

Contemporary pharmaceutical formulation and manufacture of nanoparticles and microcapsules (LO 4 – 5).

Concepts and design of drug packaging (LO 3, 6).

Students will be provided with a range of activities to accommodate different learning styles. The module delivery will consist of lectures/tutorials (21 hours) and practical classes (16 hours).

Lecture and tutorial sessions will include ‘punctuated lectures’ and ‘minute papers’ thus providing opportunities for ‘active engagement’ and to reflect on what has or has not been understood during the sessions. In-class verbal feedback will be provided and students encouraged and directed towards relevant subject matter material. The tutorial sessions will include various types as well descriptive/discussion elements. Students will be expected to prepare in advance for these sessions.

Workshops will discuss case studies of typical formulations, with emphasis placed on interpretation of information and problem solving. Students will be expected to reflect on the learning experience and develop their own understanding of the topics covered in a study group environment.

Practical sessions will stress the importance of organisational proficiency by group working and will augment practical skills to produce reliable experimental data. Students will be expected to interpret the experimental data within context. These sessions will be summative assessed via two written exams (16 hours – directed).

On successful completion of this module, a student will be able to:
1. Describe and critically analyse the different stages of drug development.
2. Explain the strategies behind the preparation and usage of solid and semi-solid pharmaceutical formulations.
3. Attain a critical overview of the compliance behind method development of medicines regarding impurities, excipients, manufacturing procedures and packaging.
4. Design basic formulations, specifying the materials used and their roles.
5. Critically discuss issues related to the design, manufacture and performance of drug formulations by stablishing relationships between formulation, drug delivery and therapeutic effectiveness.
6. Critically appraise the importance of Pharmacopoeia monographs, Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines.

The module will be summative assessed in the following order: two unseen written exams (30% per exam) and one coursework presentation (40%). 

All unseen written exams will assess the specific materials covered during a particular part of the semester (e.g. exam 1 will cover materials delivered between TW 1 – 5 and exam 2 between TW 7 – 12). The exams will be comprised of SAQs for a period of 30 minutes.

A coursework presentation exercise (40%) will summative assess the student ability to interpret and manipulate industrial pharmaceutical formulation control and development. This will be preceded by exercises designed to provide formative feedback.

To pass the module, students need to achieve a minimum aggregate mark of 40%. If the module is passed on reassessment, then the maximum mark awarded will be 40%.

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