Pharmaceutical properties information collection

The Semantic Web Initiative supports two key needs in pharmaceuticals, first, the need to collect and represent complex forms of information in an intelligent, flexible form so that it is usable by computer tools and by scientists and clinicians and second, the need to gain insights or make decisions based on an aggregation of information that may share common entities, such as molecules, diseases, and intellectual property. 

With these concerns in mind, it is appropriate to outline a comprehensive program for the physical characterization of pharmaceutical solids. A modem industry cannot tolerate the inconsistent practices of the past, where the only physical properties that might be documented were those that could be conveniently measured. It is of extreme importance that investigators measure the parameters that need to be measured and not merely collect the type of data that is convenient to obtain. Proper physical characterization must be systematic in its approach, and it should follow a protocol that is rationally designed to obtain all needed information. 

The optical microscope is a valuable tool in the laboratory and has numerous applications in most industries. Depending on the type of data that is required to solve a particular problem, optical microscopy can provide information on particle size, particle morphology, color, appearance, birefringence, etc. There are many accessories and techniques for optical microscopy that may be employed for the characterization of the physical properties of materials and the identification of unknowns, etc. Utilization of a hot-stage accessory on the microscope for the characterization of materials, including pharmaceutical solids (drug substances, excipients, formulations, etc.), can be extremely valuable. As with any instrument, there are many experimental conditions and techniques for the hot-stage microscope that may be used to collect different types of data. Often, various microscope objectives, optical filters, ramp rates, immersion media, sample preparation techniques, microchemical tests, fusion methods, etc., can be utilized. 

Stability studies on a finished pharmaceutical product should be designed in the light of the properties and stability characteristics of the drug substance as well as the climatic conditions of the intended market zone. Before stability studies of dosage forms are initiated, information on the stability of the drug substance should be sought, collected and analyzed. Published information on stability is available on many well-established drug substances. 

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