- Title
- Optimisation of a legacy product with a history of tablet friability failures utilising quality by design
- Creator
- Watkins, Eric
- Subject
- Pharmaceutical chemistry
- Subject
- Pharmaceutical industry Pharmacy -- Research
- Date Issued
- 2018
- Date
- 2018
- Type
- Thesis
- Type
- Masters
- Type
- Degree
- Identifier
- http://hdl.handle.net/10948/36398
- Identifier
- vital:33938
- Description
- The concept of Quality by Design (QbD) was introduced as a method of building quality into the product during the initial stages of manufacturing. This study explores the suitability of utilising QbD to optimise a legacy product. With the aid of QbD, a higher level of quality assurance and product knowledge was achieved. Sound scientific and risk-based decisions allowed for a robust manufacturing process with inherent operational quality and flexibility. By the establishment a quality target product profile (QTPP) and determining the influence of the critical processing parameters (CPP's) on the product's critical quality attributes (cQA's) the process understanding of Product X can be more accurately defined. The relationships between several explanatory variables will be explored by using a sequence of Design of Experiments (DoE) to obtain an optimal response. The DoE were performed and analysed using Minitab® statistical software version 17.0 (Minitab Inc., United Kingdom). A Response Surface Methodology (RSM) using a central composite experimental design (CCD) was utilised to capture the data. The data was analysed using the collection of statistical models (ANOVA) to analyse the differences between the means and their associated procedures. Input variables investigated were: compression machine tooling shape, hardness, and loss on drying LOD (post drying). The significant value (α) of 0.05 helped to determine if the null hypothesis would be accepted or rejected. The DoE identified the factors that had the highest risk of affecting the output variables and helped to establish the design space. Post completion of the DoE, a confirmatory batch was made which served as a diagnostic tool for evaluating the effectiveness of the generated model. The establishment of a strategy to control the variables and responses is of critical importance in order to appropriately use the flexibility given to products developed or optimised using QbD principles. This study show that the structured approach used in Quality by Design methodology can be successfully applied to optimise a commercialised legacy product.
- Format
- xii, 68 leaves
- Format
- Publisher
- Nelson Mandela University
- Publisher
- Faculty of Science
- Language
- English
- Rights
- Nelson Mandela University
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NMU School of Medicinal Sciences
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Eric Watkins.pdf | 964 KB | Adobe Acrobat PDF | View Details Download |