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You will develop an appreciation and understanding of solid dosage form manufacture carried out in industry and the quality control tests performed before a final dosage form reaches the market. You will gain knowledge of the combination of ingredients that make up pharmaceutical and nutraceutical formulations (API & Excipients) and the different types of tests, required at different stages in order to comply with the high standards required by regulatory authorities such as the FDA and MHRA.
In the laboratories, you will gain hands-on analytical experience on industry-standard equipment including HPLC and UV instrumentation. You will become familiar with different types of chromatography and learn how to operate, maintain and troubleshoot these techniques. You will learn how to handle and prepare solid dosage forms for analysis by spectrophotometric and chromatographic analytical procedures and you will maintain GLP/GMP compliant lab books.
You will benefit from guest lectures and workshops from industry-based professionals from CMOs (contract manufacturing organisations) and CROs (contract research organisations) which will give you the insight necessary and preparation for work in the pharmaceutical, health, medical devices and food industry.
Formulated drug products (FDPs); Active Pharmaceutical Ingredients (APIs); and excipients which make up the formulation, binders, disintegrators, solubilizers, taste masking agents. How choice of excipients determines parameters such as PK (pharmacokinetics) and route of administration of the medicine.

A range of batch release tests conducted by the industry defined by the appropriate Pharmacopeia’s; raw material testing, validation batch testing, assay of active content, degradation and stability studies, dissolution profile testing, uniformity of dosage units and physical characterisation.
Instrumental analytical techniques including UV/Vis spectrophotometry, TLC, HPLC and Mass spectrometry. Theoretical and practical knowledge of different types of chromatography.
Practical HPLC operation for analysis of pharmaceutical samples, maintenance and troubleshooting. Mobile phase preparation, standards and sample preparation and API extraction for analysis. Analysis and quantification of multi-component systems.
Knowledge of ICH guidelines and regulatory standards (such as MHRA) and processes for originator, generic and biopharmaceutical industries.
Maintenance of a GLP compliant lab book and knowledge of GMP.

Upon completion of this module you will be able to
LO1: Appraise and understand the differences between an API (Active Pharmaceutical Ingredient) and an FDP (Formulated Drug Product); and critically explore how the final dosage form is formulated.
LO2: Evaluate the fundamental science of the physicochemical properties of selected drugs in their native and formulated dosage forms.
LO3: Critically assess the elements of Quality Control (QC) and Batch release testing procedures on final dosage forms required by the respective Pharmacopeia’s (BP, USP, IP, JP) and the specifications that the products must meet.
LO4: Accurately assess the importance of GLP and GMP in research and manufacturing organisations; critically examine the impact of non-compliant medicines.
LO5: Evaluate the importance of, and perform sample and standard preparation in chromatographic analysis (including HPLC).
LO6: Appraise the theory of HPLC and expedite its operation, maintenance and troubleshooting.