Pharmaceutical products expert systems

To build a pharmaceutical formulation expert system, the formulation process has to be broken down into a number of discrete elements in order to provide distinct problem-solving tasks, each of which can be reasoned about and manipulated. However, as the formulation process is so complex, none of these tasks can be treated independently. A means of representing interactions and communicating information between tasks is therefore required. For example, one task may result in certain preferences that must be taken into account by subsequent tasks. To achieve this level of communication between tasks, the information in an expert system has to be highly structured and is therefore often represented as a series of production rules. An example of a production rule is as follows ... 

The first recorded reference to the use of expert systems in pharmaceutical product formulation was in the London Financial Times in the spring of 1989 [3], closely followed by an article in the autumn of the same year [4], Both referred to the work then being undertaken by personnel at ICI Pharmaceuticals, UK (now AstraZeneca) to develop an expert system for formulating pharmaceuticals ab initio. Since that time several companies and academic institutions have reported their experiences. 

Although there is a great deal of interest in expert systems, there is still much uncertainty regarding tangible benefits. In a survey of 74 companies in the US in 1993 [28] the main benefits identified were improved productivity, more consistent decision making, increased accuracy, and improved competitiveness. However, it is more pertinent to discuss those benefits found by users of systems in pharmaceutical formulation. These include ... 

Table 1 Published applications of product formulation expert systems in pharmaceuticals...

Expert Systems in Pharmaceutical Product Development / 1663 Expiration Dating / 1685... 

To develop a product from inception to market, the product and process have to be optimised and the process scaled up and transferred to commercial production. Definitions and descriptions of the requirements for all these stages of development are discussed in Chapter 8, although the major discussion is on the preformulation/formulation input to product optimisation. The many factors which a formulator should consider in the selection of pharmaceutical excipients and packaging are discussed. Useful sources of information and techniques for selection such as expert systems and experimental design tools are included. 

Reference to the use of expert systems in pharmaceutical product formulation first appeared on 27 April 1989 in the London Financial Times (Bradshaw 1989). This article was closely followed by one in the same year by Walko (1989). Both these authors were describing the work being undertaken by ICI (now Zeneca) Pharmaceuticals and Logica UK Ltd. to develop an expert system for formulating pharmaceuticals using PFES. Since these first publications, many companies and academic institutions have published on work being conducted in this area, as shown in Table 8.3. 

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