Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions
| Autor: | Dennis Jenke, Barrett E. Rabinow |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Time Factors Surface Properties Chemistry Extraction (chemistry) Reproducibility of Results Pharmaceutical Science Mineralogy Equipment Design Chemical Fractionation Pulp and paper industry Partition coefficient 03 medical and health sciences Drug Delivery Systems 030104 developmental biology Models Chemical Pharmaceutical Preparations Volume (thermodynamics) Surface-area-to-volume ratio Technology Pharmaceutical Drug product Drug Contamination Plastics Drug Packaging |
| Zdroj: | PDA Journal of Pharmaceutical Science and Technology. 71:225-233 |
| ISSN: | 1948-2124 1079-7440 |
| DOI: | 10.5731/pdajpst.2016.007195 |
| Popis: | When drug products contact plastic manufacturing components, packaging systems, and/or delivery devices, leachables from the plastics can accumulate in the drug product, potentially affecting its key quality attributes. Given practical issues associated with screening drug products for leachables, potential leachables are frequently surfaced as extractables revealed in extraction studies. To facilitate extractables discovery and identification and to shorten extraction times, extraction studies can be exaggerated and/or accelerated. One means of exaggerating an extraction is to increase the test article9s extracted surface area to extraction solution volume ratio (SA/V), as it is generally accepted that an extractable9s concentration in an extract is proportional to SA/V in a 1 to 1 manner. However, as the relationship between an extractable9s concentration and SA/V depends on the extractable9s plastic/solvent partition coefficient (kp/l), the effect of SA/V on the extractable9s concentrations can be either under- or over-estimated if a 1 to 1 proportion is used. This article presents the theoretical relationship between SA/V, concentration, and kp/l; illustrates theory with a case study; and suggests proper exaggeration strategies. LAY ABSTRACT: When drug products are manufactured, stored, or delivered in systems that contain plastics, substances can be leached from the plastics and remain in the drug product, where they might affect the product9s key quality attributes. To discover and identify these leached substances, the plastics are extracted under laboratory conditions and the extracts are appropriately tested. To facilitate this process, extracts may be generated under laboratory conditions that exaggerate or accelerate the drug product9s clinical conditions of manufacturing or use. The proper use of the ratio of the extracted item9s surface area to the volume of the extracting solution as an exaggeration parameter is discussed in this paper. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|