Journal of Pharmaceutical Care & Health Systems
Open Access
ISSN: 2376-0419
ISSN: 2376-0419
Mostafa Essam Eissa
HIKMA Pharmaceuticals PLC, Egypt
Posters & Accepted Abstracts: J Pharma Care Health Sys
Water activity is very critical aspect in assessing the risk of microbial contamination of medicinal products. Multi-dose pharmaceutical preparations are prone to spoilage due to growth and proliferation of microorganisms, if they were not well preserved either physically or chemically. There have been several reports about infections due to consumption of contaminated drugs by the patients observed worldwide. Due to this challenge, an approach for assessing the microbiological risk hazard of infection from the contaminated multi-dose medicinal products was established based on the dose-response models of infections using an appropriate indicator microbe per route of administration. This new method of evaluation for pharmaceutical formulae has broader view and scope than the conventional Preservative Efficacy Test (PET). Moreover, it takes into consideration the misuse of the product by the customer at short intervals of use rather than the long intervals of the standard Antimicrobial Efficacy Test (AET). The risk evaluation takes into consideration not only the preservation power of the formula, but also the dose size, dose frequency, physical geometry with the integrity of the primary package, the indicator microbe chosen, the characteristic nature of the probability of infection, number of infecting particles and the route of administration. This new methodology may provide a promising method for the assessment of the newly designed and established pharmaceutical formulae in a quantitative manner using the probability risk of the infection. The value of this method can be extended to cover other multi-dose products such as cosmetics and other items that may impact human health.
Email: mostafaessameissa@yahoo.com