Chemical firm BASF has announced it has developed a new formulation for its Ibuprofen DC 85, an active substance in anti-inflammatory and analgesic products, using a nanocoating which, thanks to its resistance to high temperature, can increase production and reduce downtime.
Whereas a standard high-speed tablet press has the capacity to manufacture approximately 200,000 Ibuprofen tablets per hour, BASF claims that during manufacturing trials with the new coating a three-fold increase in production to a rate as high as 700,000 tablets per hour was achieved.
Because the formulation is suitable for direct tabletting even at high doses, it eliminates time-consuming preparation steps such as wet granulation and compacting, reducing production times compared to conventional Ibuprofen formulations and helping customers save money.
The German company will not reveal the nature of its nanolayer but says it protects the active ingredient from the temperature influences which occur during the tabletting process.
This is crucial because Ibuprofen has a fairly low melting point so it can gradually start to melt during tabletting and tends to cause the tablet press punches to stick, grinding production to a halt as the process needs to be stopped to clean each punch.
With the new formulation, production workers do not have to remove distorted tablets stuck to the punches by hand, allowing them to get the most out of the facilities, without the downtimes that conventional Ibuprofen usually involves.
Furthermore, the protective nanocoating reduces the percentage of lubricants used during tabletting, yielding a smaller tablet which is easier for patients to swallow.
"That's a key advantage, especially for patients taking high doses of tablets containing 600 to 800 milligrams of Ibuprofen," said Heinz Einig, responsible for technical service of Ibuprofen with BASF Pharma Solutions.
"Tablets with a total weight above 1,000 milligrams are practically impossible to swallow."
The coating on the Ibuprofen crystals also facilitates rapid tablet dissolution after ingestion by the patient, thus enabling Ibuprofen to work much faster.
The main production locations for ibuprofen powder are the US, India and China, so with this new formulation BASF hopes to increase its customer base of generic companies in those markets.