ABSTRACT

The applications of the dose-response models of infection for various pathogens and objectionable microbes have been developed to assess the probability of the infection for specific microbes. The use of such models has been implemented in water safety for human consumption and food industry. But till now, none of these models have been used in assessing the risk of infections from contaminated pharmaceutical products. Multi-dose medicines with significant water activity are especially products that need careful formulation as they are liable to microbial spoilage and proliferation. This deterioration of the multiple-use dosage forms may impacts their quality, efficacy, stability and safety. While manufacturing conditions of pharmaceutical products are controlled and microbiological cleanliness is monitored through quality control tests, the in-use behavior and attitude influenced by the consumers on the dosage forms are beyond the control of pharmaceutical manufacturing firms. The mishandling of drugs by the healthcare professional or the patient himself may affect the health of the both hospitalized and outdoor users. The new methodology provides quantitative evaluation. This review article investigates and highlights the limitations of the reliance on the preservative efficacy test (PET) alone and extends its usefulness by combined application with in-use contamination simulation study of infection model from pharmaceutical products. This imitation study will provide new prospective for the design and evaluation of the new pharmaceutical dosage forms. This novel simulation approach may assume either single or multiple spots contamination models with different intervals using suitable indicator microbe for the route of administration of the drug.

Keywords: Dose-Response Model; Multi-Use; Water Activity; PET; Simulation Stu