Indian pharma sees immense importance in US FDA guidance on aluminum content and labelling in parenteral nutrition
Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products. There are also exports for the same.
The global regulatory authority noted that aluminum toxicity in parenteral nutrition represents a major safety concern, necessitating labeling. As per the regulation, aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed micrograms per liter (mcg/L).
In contrast, the limits for the aluminum content of small volume parenteral (SVP) drug products and pharmacy bulk packages (PBPs) used in parenteral nutrition are not specified by regulation.
Further, the International Council for Harmonisation (ICH) has not established a permitted daily exposure (PDE) for aluminum. To address this lack of information, the global regulatory authority said that the current draft guidance clarifies the key factors in determining the aluminum content in an SVP drug product and provides its recommendations regarding the aluminum concentration limits in SVPs.
Additionally, this guidance is intended to assist applicants in determining the appropriate content and placement of information on aluminum in SVP and human prescription drug product labeling, including the Prescribing Information and container label and carton labeling.
The intent of this guidance is to help assure that the information is clear and accessible to health care practitioners and guides the safe and effective use of the drug product. The recommendations in this guidance apply to the evaluation of aluminum content and establishment of a recommended aluminum concentration limit in an SVP drug product. The guidance does not alter labelling considerations or recommended concentration limits for aluminum content in LVP drug products.
Parenteral drug products are those intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that the drug products’ active substances are administered directly into a blood vessel, organ, tissue, or lesion.
SVP drug products for parenteral nutrition are used as additives to admixtures. Aluminum, one of the most abundant metallic elements on earth, occurs naturally in several minerals, ores, oxides, and silicates. Humans are exposed to aluminum through drinking water, foods, and drugs.
Aluminum’s oral bioavailability is poor, so healthy individuals typically face little risk of toxicity. The gastrointestinal tract allows less than 1 per cent of ingested aluminum to be absorbed into the bloodstream, and renal excretion removes 99 per cent of that aluminum. Despite that, aluminum toxicity has been documented in medical literature for more than 30 years, with manifestations that include osteomalacia and reduced bone mineralization, neurological dysfunction and dialysis encephalopathy, microcytic hypochromic anaemia, and cholestasis.
Therefore US FDA has issued the draft and insists that the industry engaged in this area need to submit with these comments before February end 2023. Also a long-implicated, major source of aluminum exposure is PN, resulting from contamination of ingredients. These ingredients are contaminated with aluminum in raw materials as well as through byproducts from the manufacturing process and packaging system, during which aluminum may leach from the manufacturing equipment and container closure components like glass vials and stoppers) during autoclave terminal sterilization and shelf-life storage.
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