apt. Andi Hermansyah, M.Sc., Ph.D.
In October 2022, the public was shocked by the news regarding the many findings of cases of kidney failure, especially in children, which ended with the ban on distribution of drugs in syrup form by the Ministry of Health (Kemenkes). To answer the public's curiosity, one of the lecturers and Chair of the Department of Practical Pharmacy, Faculty of Pharmacy, Airlangga University (FF UNAIR), Mr. apt. Andi Hermansyah, M.Sc., Ph.D. talk about the case.
According to Mr. Andi's explanation, his nickname, paracetamol, which is widely circulating in the market, is now formulated into tablets and syrup. One of the reasons why paracetamol is formulated in syrup form is because it provides a faster drug action than solid forms such as tablets. Besides that, this syrup is also easier to consume and tastes sweeter, so it's no wonder that this form of syrup is in demand among the public and is preferred by children.
In the manufacture of syrup-shaped drugs, additional ingredients or excipients are needed that are able to "carry" the active substance paracetamol into paracetamol syrup. One thing that is needed is a solvent. In cases that are circulating, the cause of kidney failure is suspected due to the use of diethylene glycol and ethylene glycol as solvents. In fact, similar cases caused by diethylene glycol and ethylene glycol have occurred in several countries such as the United States (1937), Nigeria (1990), Haiti (1996), and India (1998). In Indonesia alone, diethylene glycol and ethylene glycol are prohibited from being used in medicinal syrup formulations.
Unfortunately, diethylene glycol and ethylene glycol contamination may still be found in the final drug syrup product as a result of using other solvents such as glycerin and propylene glycol. However, these adverse effects can be avoided because the level of contamination has been regulated in various guidelines.
Based on these risks, the manufacture of a drug must go through a series of rigorous tests before being released on the market. Quality assurance must also be continued when the drug has been circulated. In addition, pharmacists must play an active role in considering the risks and benefits of giving syrup medication and educating patients regarding all possible side effects.
Source:
https://www.jawapos.com/opini/24/10/2022/sirup-parasetamol-dan-penjaminan-mutu-obat/
