Importance of Proper Drug Storage and Recovery with Ethylene Oxide

Assessing the condition of the drug after drying, freeze-drying, stabilization or addition of preservatives is very important. This control, which is based on the monitoring of phytochemical and morphological parameters that determine the quality of a drug, is necessary whenever elements are encountered that indicate poor / incorrect storage or processing. These elements can be macro or microscopic; for example, when the drug is not properly dried, its macroscopic characteristics appear altered compared to the descriptions given in the Pharmacopoeia. Other factors may indicate the poor quality of post-drying, such as the lack of protection from the aggression of microorganisms, animals or insects. Such attacks can rarely occur accidentally, while they are often the consequence of inadequate transport conditions.

To evaluate the quality of a drug, despite its correct storage and despite the fact that it can be attacked by external agents, there are numerical tables and illustrated tables that say how it must appear in a macroscopic sense and what to evaluate, from a phytochemical and chemical point of view / general, to determine the degree of quality (the chemical assay assumes the presence of precise reference printouts). In certain situations the drug must "be rejected, for example in the presence of animal contamination; in others, only the part affected by visible fungal aggressions must" be eliminated; still, in other cases the drug can be recovered entirely, which involves the use of technical strategies that lead us to eliminate the source of contamination while preserving as much as possible the original quality. The recovery operations are in fact very drastic and this drasticity affects the quantity of active ingredients present in the drug. The drug can, for example, be treated with ethylene oxide, closing it in airtight containers saturated with this gas; ethylene oxide eliminates the presence of microorganisms, but it is not suitable for all drugs, since it can cause an excessive deterioration of the active ingredients (when these have chemical / physical characteristics such as not to withstand its presence). Moreover, ethylene oxide is not exactly the best of the healthy expression of a drug (it is carcinogenic); after treatment, therefore, the drug must be stored at a temperature of 30 ° C for several days, allowing the gas to move away from it.

Although ethylene oxide is a suitable means for the elimination of certain microorganisms, it may not be suitable for certain alkaloid drugs (belladonna, henbane) which undergo excessive decay; therefore, one must always be very careful in using this method, in order not to risk losing the drug completely.

If certain precautions are followed, it is possible to reasonably eliminate the contaminant from the drug, preserving its health quality in a stable and dignified way, but spending a lot of time and money to obtain this result. That is why it is important to consider all those technical - artificial manufacturing elements and factors. Often, this correctness refers to common sense, but just as often common sense does not go hand in hand with professionalism; common sense becomes professionalism when it is structured in a knowledge that leads to the knowledge of what you want to know and what you want to use.

The quality of a drug is the expression and economic gain of all the companies that produce, process and market it. When a drug is not treated properly, it loses its quality and market value, which in order to be recovered on the contrary, respecting all these elements leads not only to obtain a quality product, but also to exploit that product from an economic point of view in the most exhaustive way possible.

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