Frequently asked questions for PEARLITOL® mannitol and its applications
PEARLITOL® C is the crystalline form of mannitol which typically undergoes further granulation before tableting. PEARLITOL® SD and DC grades are designed for direct compression. The granular powders of PEARLITOL® SD and PEARLITOL® DC are prepared by spray-drying and extrusion respectively.
PEARLITOL® 100 SD and PEARLITOL® 200 SD have different particle sizes but are otherwise exactly the same product. The mean particle size of PEARLITOL® 100 SD and PEARLITOL® 200 SD are 100 µm and 170 µm respectively.
PEARLITOL® 300 DC, PEARLITOL® 400 DC and PEARLITOL® 500 DC have different particle sizes but are otherwise exactly the same product. The mean particle size of PEARLITOL® 300 DC, PEARLITOL® 400 DC and PEARLITOL® 500 DC are 250 µm, 360 µm and 520 µm respectively.
PEARLITOL® SD consists of both alpha and beta crystals of mannitol which have been shown to be stable under practical conditions.
Even though PEARLITOL® has a sweet taste (approximately half the sweetness of sucrose or xylitol), it is non-cariogenic and hence, a tooth-friendly option for sugar-free formulations.
PEARLITOL® SD and DC grades are designed for direct compression due to its superior flow and tabletability. They are available in various mean particle size grades (100 µm to 500 µm) and densities to accommodate and complement other excipients/API(s) in the formulation.
Due to its brittle fracture behavior during compaction, a minimum amount of 1.2% lubricant (e.g., magnesium stearate) is recommended. If other excipients are used, the concentration may be adjusted accordingly.
As mannitol has a brittle fracture nature, new "unlubricated" surfaces are created during compaction which gives higher and robust tablet strength. However, this potentially also leads to higher ejection forces. From our studies, a minimum amount of 1.2% lubricant (e.g., magnesium stearate) is sufficient to lower the ejection force to about 150 N to 300 N depending on the compression force and tablet shape/size.
PEARLITOL® mannitol is an excellent filler for moisture sensitive APIs due to its non-hygroscopicity and stable nature. DC grades are available as PEARLITOL® SD and PEARLITOL® DC depending on your particle size and density requirements.