SPI Pharma promises ‘fewer failures and higher yield’ with Mannogem XL
Headquartered in Delaware, US, the company will showcase its Mannogem XL mannitol product at the AAPS PharmSci 360 event in Washington DC.
The newly released product delivers a formulation of mannitol that provides improved compression and disintegration properties.
Mannitol is used within pharmaceutical products as a sweetening agent, tablet and capsule diluent, and as an excipient for chewable tablets. The formulation of Mannogem XL means it can be used in the production of orally dissolving, fast melt and chewable tablets.
A spokesperson for SPI Pharma explained that Mannogem XL will create tablets with 25% greater tablet hardness and 38% quicker disintegration per tablet hardness, compared to compendial mannitol.
The spokesperson further explained: “It is a multifunctional, compendial grade of direct compression, spray dried mannitol that provides better binding and quick disintegration. XL delivers superior compactibility, simplified formulations, and can speed development at lower costs because it goes beyond acting as a standard diluent (filler) and performs as a binder with excellent disintegration.”
Companies using the product should also see productivity improvements, through development to manufacture, due to its tight particle size range, which should see greater dosage form consistency, we were told.
According to the spokesperson, manufacturers could see “fewer failures and create higher yields and tabletting rates through advanced process control and design”.
In regards to its pipeline of products to come, the spokesperson informed us that the company is initiating a new innovation strategy, of which Mannogem XL is the first product.
Earlier this year, SPI Pharma signed an agreement with Noramco to provide “ready-to-implement” formulation packages for clients. The deal would see SPI Pharma provide the excipients and co-processed drug delivery platforms and Noramco provide the active pharmaceuticals ingredients (APIs).