Spray Dried Lactose (NF,Ph. Eur.,JP) CAS# 64044-51-5
Glyceryl Monostearate (NF, JP) CAS# 123-94-4Product Application: Direct tableting
Product Certification: Gluten-free
Pharmaceutical Category: Self Lubricating Excipient
LubriTose SD is a co-processed excipient consisting of Spray Dried Lactose and Glyceryl Monostearate. The co-processed formula is 96% Spray Dried Lactose as the compressible ingredient and 4% Glyceryl Monostearate as a lubricant. The co-processing process results in a uniform physical dispersion of the Glyceryl Monostearate and the chemical attributes of both ingredients remain in tact. A drug master file (DMF) is in place for the product.
LubriTose SD is meant to be used in standard direct tabletting applications . It is only necessary to add the API (active pharmaceutical ingredient), any other desired ingredient, and proceed to tabletting. The Glyceryl Monostearate is co-processed in to act as a lubricant and therefore it is not necessary to add a lubricant such as Magnesium Stearate to the tabletting formulation. By using LubriTose™, you get a true direct tabletting operation as the lubricant addition step is removed. LubriTose™ is ideal for continuous systems and also for QbD.
Tablet Weight Uniformity at Increased Press Speed
Due to the improvement in flowability of LubriTose™ formulations compared to the excipient/lubricant blend, these formulations should be optimal for operating at high tablet press speeds. LubriTose™ was compared to an excipient/lubricant blend at increasing press speeds. The testing was completed at press speeds of 25, 50, and 75 rpm’s. At each speed, ten random tablets were collected, weighed, and the average calculated. No adjustments were made to the fill weight as the speed was increased. As observed in the below figure, LubriTose SD, show minimal weight variation across various tablet speeds, which is indicative of a very uniform excipient blend that enables even and consistent flow. With the excipient/ lubricant blend, the decrease in average tablet weight was more pronounced. The tablet press fill weights could be adjusted, but as observed, only minor adjustments would be necessary with the LubriTose™ formulations. This may result in a more robust process where adjustment may not even be necessary.
Improved tablet weight uniformity across various press speeds
- Optimal for operating at high tablet press speeds
- Minimal weight variation across various tablet speeds
- A very uniform excipient blend that enables even and consistent flow