A new product in BASF's Lµtrol range of poloxamer excipients, designed to improve the solubility of poorly-soluble actives, will be introduced at the CPhI exhibition.
Two grades of the new product, called Lµtrol micro, will be launched at the CPhI meeting later this month under the trademarks Lµtrol micro 127 and Lµtrol micro 68, according to Thorsten Schmeller, the global product manager for the new line.
Poorly-soluble drugs need to have solubilisers added to the formulation in order to improve their bioavailability. Poloxamers have a long history of use in this setting, and BASF is now able to offer micronised grades with a range of advantages over other solubilisers.
The company noted that the micronised product has low toxicity and comes in a particle size similar to most active substances. This results in homogeneous mixtures for tabletting or granulation, and removes the need for micronising the actives.
"Due to the low average particle size that is in the same range as for active ingredients, a direct blending with the active is possible with a low tendency of demixing," said BASF. This allows for cost- and time-saving production, it added.
Both Lµtrol micro 68 and Lµtrol micro 127 are are block copolymersof polyoxyethylene-poly-oxypropylene and have an average particle size of approximately 50 µm. At room temperature they appear as white powders and are soluble in water and ethanol, according to the company.
BASF noted that the products have several pharmaceutical applications, including: dissolution enhancing of actives in tablets and capsules; use as lubricants for actives incompatible with magnesium stearate, e.g. ibuprofen; polishing agents for film-coated tablets; dispersing/wetting agents; and acting as water-soluble lubricant for effervescent tablets.