MELAMINE CONTAMINATION IN PHARMACEUTICALS

 

MELAMINE CONTAMINATION IN PHARMACEUTICALS

 

Melamine is a nitrogen based organic compound that is characterized by its high nitrogen content (67%). It is also known by other chemical names, such as triaminotriazine, cyanuramide and cyanuric acid amide.  

Melamine is an industrial based chemical compound used in the production of laminates, glues, dinnerware, adhesives, moulding compounds, coatings and fire retardants. Melamine is illegally added to food products in order to increase the apparent protein content. Melamine is the one of the major component in pigment yellow 150, a colorant in inks and plastics. 

Melamine is harmful if swallowed, inhaled or absorbed through skin. Chronic exposure may cause cancer or reproductive damage. When melamine is absorbed in to the blood stream, they concentrate and interact in urine filled renal microtubules and damage renal cells, causing kidney malfunctioning.

 

History

 Melamine has been used as an adulterant in feed stock for several years (melamine boosts measured nitrogen concentration of material to which it is added, and making them appear more nutritious than they actually were). It has been involved in several food recalls after the discovery of severe kidney damage to children and pests poisoned by melamine-adulterated food. In 2007, dog and cat illness and deaths reported due to melamine contamination in vegetable proteins imported to US from China. Infant formula in China reported to be contaminated with melamine resulted in illness and death.

Melamine contamination in pharmaceuticals

There is  no known instances of Melamine contamination in pharmaceuticals yet. Melamine  contamination of drugs may result in decrease in efficacy or stability and direct toxicity.

FDA identifies 27 at- risk materials derived from milk and animal products for melamine contamination. They are

1.	Adenine
2.	Albumin
3.	Amino acids derived from casein protein hydrolysates
4.	Ammonium salts
5.	Calcium pantothenate
6.	Caseinate or sodium caseinate
7.	Chlorophyllin copper complex sodium
8.	Colloidal oatmeal
9.	Copovidone
10.	Crospovidone
11.	Dihydroxyaluminum aminoacetate
12.	Gelatin
13.	Guar Gum
14.	Glucagon
15.	Hyaluronidase
16.	Imidurea
17.	Lactose
18.	Melphalan
19.	Povidone
20.	Povidone - Iodine
21.	Protamine Sulfate
22.	Protein Hydrolysate for injection
23.	Taurine
24.	Thioguanine
25.	Urea
26.	Wheat bran
27.	Zein

 FDA also recommended testing starting materials than contain more than 2.5% nitrogen in the compound by weight. 

It is important for companies in the supply chain to determine if they are using an at risk material. If a company finds that materials in use are deemed at risk, the FDA guidance recommends the manufacturers of finished drug products test for melamine in the starting materials before they are used in the preparation of the final drug product.