Storage excipients

Part I (A) contains information which identifies the product, its pharmaceutical form and strength, route of administration and details of the manufacturer. The summary of product characteristics summarizes the qualitative and quantitative composition of the product, its pharmaceutical form, details of pre-clinical and clinical observations, as well as product particulars, such as a list of added excipients, storage conditions, shelf-life, etc. The expert reports contain written summaries of pharmaceutical, pre-clinical and clinical data. 

Molecule/ trade name/ company/ date of initial marketing Chemical structure Indication Dose Commercial oral formulation Excipients Storage... 

Pharmaceutical particulars (excipients, major incompatibilities, shelf life, storage precautions, nature and contents of container, disposal precautions)... 

The choice of the excipients and their concentration, including their function (e.g., antimicrobial preservatives, antioxidants. ..). In the case of antimicrobial preservatives, data are expected on the preservative efficacy in products on storage, including after reconstitution or dilution and during the period of use. 

The aggregate-specific ELISAs could be used to monitor the aggregate-inducing processes during IFN-a formulation and storage in an early phase and the development of aggregate-free IFN-a formulations. The ELISAs were highly sensitive, needed low protein concentrations, worked in the presence of excipients, and required no pretreatment.6... 

The key objective of our efforts has been to develop a vaginal formulation that optimizes spermicidal and antiviral activity while enhancing spreading and true bioadhesiveness. Utilization of strict design principles for an excipient delivery vehicle, which included substantivity to vaginal mucosa, saline compatibility, compatibility with a wide range of spermicidal and antiviral compounds, low irritation potential, sperm impedance, system stability, and efficacy after stressed storage conditions, resulted in the development of DCE s [11,12,13]. Based on the results from in vitro studies, the DCE vehicle was selected for clinical development. 

The properties of tablets are also influenced by temperature and humidity fluctuations, e.g., during storage. Is it possible to select excipient compositions that minimize the effect of temperature and humidity fluctuations on the quality of tablets These questions are raised and treated in a small example in Chapter 2 and extensively in Chapter 8. 

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