New pyrogen free organic salts from Roquette
and sodium gluconate products for applications in the
pharmaceuticals industry, reports Phil Taylor.
Highly purified sodium lactate and sodium gluconate are used by the drug industry as physiological buffers in the preparation of products such as solutions for dialysis and infusion therapies.
Roquette said that the new sodium lactate product is a heat stable pharmaceutical grade, exhibiting improved organoleptic properties. It has a low endotoxin content to ensure suitability for use in parenterals. This product is now available for large-scale distribution.
Roquette said the new 60 per cent product is intended as a physiologically compatible electrolyte for pharmaceutical injectable preparations and for dialysis solutions, a buffering agent for the correction of metabolic acidosis in intravenous and dialysis solutions. It also acts as a natural occurring bacteriostatic agent and can be used as an emollient and pH regulator for cosmetics.
Meanwhile, the sodium gluconate pproduct is also a highly purified grade and is currently in development for pharmaceutical and cosmetic applications. This product is undergoing International Conference on Harmonisation (ICH) stability testing and is currently available for sampling.
The new products - both manufactured from natural starch - extend Roquette's established range of excipients for parenteral products, which includes a pyrogen-free dextrose monohydrate (LYCADEX PF); pyrogen-free mannitol (PEARLITOL PF); pyrogen-free sorbitol (NEOSORB PF); and KLEPTOSE HPB, a pyrogen-free beta cylodextrin (hydroxypropyl-beta cyclodextrin or HPBCD).
