Chemical Hazards Assessment of Excipients

All drug formulations have the potential to cause harm to humans, therefore, excipients need to have the properties required for their technical function and must also meet necessary safety requirements. An important part of the risk assessment of excipients is the evaluation of chemical hazards of excipients, which usually arise during the incorrect process of excipients production. Examples of known toxicity induced by excipients include renal failure and death caused by diethylene glycol, osmotic diarrhea caused by ingestion of mannitol, hypersensitivity reactions caused by lanolin, and cardiotoxicity caused by propylene glycol. Toxicological considerations are particularly important for drug products administered to certain specific populations. For example, in order to avoid potential toxicity issues, additional risk assessment of excipients is required in the pediatric and geriatric formulation design. In addition, excipients maximize systemic exposure through solubility, but also have the potential to obscure clinical pathological endpoints. Pathology studies involving the use of excipients in the early stages of drug discovery often require the development of an evaluation strategy. Therefore, during the development of a novel excipient, its pharmacology and toxicology should be fully considered.

Chemical Hazards Assessment Services

BOC Sciences' specialized laboratory provide timely support in excipient composition analysis which enable you to perform regular checks to help our clients verify that their excipients are in compliance with current relevant regulations and standards. We perform chemical hazard assessment of your excipients by offering toxicological assessment and pathological assessment services.

Toxicity Assessment of Excipients

Toxicity assessment of pharmaceutical formulation excipients is a daunting and extremely diverse challenge, which involves the combined application of multidisciplinary expertise. BOC Sciences has established a team of experts with extensive experience in pharmacology, drug metabolism and pharmacokinetics, and toxicology, and our services include:

• Specific attention on the identification of compounds of regulatory concern
• Assessment of the inherent risk of excipients according to their source, quantity and function in drug formulations
• Determine toxic effects on the population as a whole or on specific populations
• Calculate safe and allowable levels of excipients for different exposure routes and different target populations
• Good Laboratory Practice (GLP) toxicology studies are used to identify novel excipients

Figure 1. Risk assessment of toxicity and safety of excipients. (Pandey, V.; et al. 2022）

Pathological Assessment of Excipients

To determine whether excipients affect common clinical pathological endpoints, BOC Sciences provides safety assessments of excipients commonly used in preclinical pharmacology and toxicology studies.

Assessment regarding the application:

• Dosage form
• Route of administration (e.g., tablets, parenteral use, etc.)
• Function (e.g., colorant, filler, part of release system)
• Potential impact on critical quality attributes of the drug product
• Quantity, daily intake

Why Cooperate with BOC Sciences?

• Stability and quality testing
• Comprehensive analytical data
• Quality assurance expertise
• Early formulation development support
• Multiple strategies for risk guidance are available.