The United States Pharmacopoeia (USP) has set up a programme unit team on excipients with a mandate for fiscal 2024 on the specific areas of di-ethylene glycol (DEG) and ethylene glycol (EG). The plan envisages contributing in testing excipients and also helping enhance criticality of testing methods in collaborations with USP headquarters in the US.
This comes close on the heels of the Central Drugs Standard Control Organization (CDSCO) office conducting massive risk-based inspections pan-India following the World Health Organization (WHO) holding Indian pharma companies accountable for exporting contaminated cough syrups in Gambia and Uzbekistan due to the presence of excipients like DEG and EG in the cough syrups.
“Excipients have a direct correlation with patient safety so it becomes very important to test excipients. Traditionally, excipient testing was done keeping in mind the end use in the drug product but that has changed over the past several years. So ideally it should not be tested into the end product but it has to be built in the end product. Quality by Design (QbD) is the way to go when you formulate a particular product so that one can counter and mitigate the risks involved considering that excipients have a lot of functional role to play in several drug products,” said Girish Kapur, vice president (VP), India Site Operations and Site Head, USP on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry between July 5 and July 7, 2023.
“USP as a standard setting organization realized this change and the dedicated expert committees on excipients now focus on excipient characterization, excipient variability, performance and the composition as well. USP has several general chapters which very well elaborate on how you can test different excipients in the lab. Besides this, there are 500 plus excipient monographs in the National Formulary (NF). NF has the maximum number of monographs and more than 60% of them have physical reference standards as well,” informed Kapur.
He further added that Covid has taught us the importance of supply chain. Given that the excipient supply chain is very complex and now with the advent of complex generics in the pharma industry, more excipients which will now be novel and not the regular ones like starch, CMC and HPMC among others. This will make the supply chain more vulnerable for adulteration. It is also important because we will use the excipient in the drug product and this will eventually affect the drug quality.
“USP is very well integrated with its US counterparts with a big lab set up in Hyderabad in India. As a standard setting organisation, USP believes that the public standard setting process has to be based on a robust public input system which can give feedback on monographs published in the USP and the NF. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. USP is an official quality standard for medicines marketed in the US,” Kapur informed.
USP–NF is a combination of two compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.
“Excipients form 90% of the dosage forms available in the market. The role of excipients is very important as they impart a lot of physical characteristics to the drug product in terms of flowability, compressibility, disintegration and controlling the drug release in the product. In some cases, they also influence the organoleptic properties like taste and texture among others. These are the important parameters for evaluating the drug product which is sold in the market,” Kapur concluded.
Tuesday, July 11, 2023