title: The potential clinical relevance of visible particles in parenteral drugs.
abstract: Visible particulates (VP) are one subclass of defects seen during the final visual inspection of parenteral products and are currently one of the top ten reasons for recalls 1,2. The risk posed by particles is still unclear with limited experience reported in humans but remains an important consideration during the manufacture and use of parenteral products. From the experimental and clinical knowledge of the distribution of particulate matter in the body, clinical complications would include events occurring around parenteral administration e.g., as a result of mechanical pulmonary artery obstruction and injection site reaction, or sub-acute or chronic events e.g., granuloma. The challenge is to better understand the implication for patients of single vials with VP and align the risk with the probabilistic detection process used by manufacturers for accept/reject decisions of individual units of product.
authors.affiliation: Pharma Development Safety Risk Management, F. Hoffmann-La Roche AG, Basel, Switzerland. lucette.doessegger@roche.com
authors.forename: Lucette
authors.initials: L
authors.lastname: Doessegger
authors.forename: Hanns-Christian
authors.initials: HC
authors.lastname: Mahler
authors.forename: Piotr
authors.initials: P
authors.lastname: Szczesny
authors.forename: Helmut
authors.initials: H
authors.lastname: Rockstroh
authors.forename: Georg
authors.initials: G
authors.lastname: Kallmeyer
authors.forename: Anja
authors.initials: A
authors.lastname: Langenkamp
authors.forename: Joerg
authors.initials: J
authors.lastname: Herrmann
authors.forename: Joseph
authors.initials: J
authors.lastname: Famulare
mesh_terms: D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007263:Infusions, Parenteral; D007267:Injections; D010288:Parenteral Nutrition / Q000009:adverse effects; D010316:Particle Size; D052638:Particulate Matter / Q000008:administration & dosage* / Q000009:adverse effects* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry; D011655:Pulmonary Embolism / Q000139:chemically induced*; D012128:Respiratory Distress Syndrome / Q000139:chemically induced*; D065227:Transfusion Reaction
chemical_list: D052638:Particulate Matter; D004364:Pharmaceutical Preparations