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Mannogem® Mannitol

 

 

 

More flexibility for formulators with lower total production costs!

Mannitol is a popular excipient used by drug manufacturers due to its unique, advantageous properties. It is inert, non-hygroscopic, and has high drug loading capabilities. Mannitol is also preferred for patients because it has a higher tolerance than alternatives such as lactose and fructose and mannitol has no impact on blood glucose levels, making it especially suitable for diabetic patients. SPI Pharma is the expert on mannitol and has recently increased their product offering with the addition of new Mannogem® grades to offer drug manufacturers even more options.

 

View Products

 

Types Available

  • Powder
  • Spray Dried
  • Granular
  • Co-processed

 

Formulation Benefits

  • Better binding and tabletability
  • Higher API loading capability
  • Improved throughput of difficult to manufacture tablets
  • Higher manufacturing productivity with wider design space

 

Monographs Available

  • U.S. Pharmacopeia (USP)
  • National Formulary (NF)
  • European Pharmacopeia (EP)
  • Japanese Pharmacopeia (JP)

 

Patient Benefits

  • Pleasant mouthfeel
  • Faster disintegration
  • Softer texture in chewable tablets
  • No impact on blood glucose levels

 

Mannogem® XL Technology improves compressibility and adds functionality

Mannogem® XL Technology combines SPI Pharma’s mannitol expertise with proprietary processing and advanced particle engineering. The result is compendial mannitol with a ground-breaking improvement in tableting. The superior functionality against standard grades of directly compressible (DC) mannitol (including increased tensile strength and improved friability) opens up new formulation possibilities – it works well with taste-masked APIs and enable advanced dosage forms like multiple unit particle systems (MUPS). XL Technology brings additional value to drug manufacturers by improving production with a broader design space, higher yields, and faster production speeds. Mannitol produced with XL Technology also enhances the patient experience with better organoleptics to increase patient adherence.

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Products

Mannitol Type

Mannogem® Grade

Avg. Particle Size

Approx. Relative Compressibility

Manufacturing Process

End Use Applications

Monographs

Package Size

 

 

Powder

Emerald**

25 µm

 

Wet granulation

Tablets (swallow), liquids

USP-NF, EP

25 kg drum

Onyx** 

50 µm

 

Wet granulation

Tablets (swallow), liquids

USP-NF, EP

25 kg drum

 

 

 

Spray Dried

EZ

140 µm

•••

Direct compression

Tablets (swallow, chewable, ODT, effervescent), hard capsules, lozenges, sachets/stick packs

USP-NF, EP

50 kg drum

XL*

140 µm

••••

Direct compression

Tablets

(swallow, chewable, ODT)

USP-NF, EP

25 kg drum

XL Opal**

160 µm

••••

Direct compression

Tablets

(swallow, chewable, ODT)

USP-NF, EP, JP

25 kg drum

 

 

 

Granular

XL Ruby**

300 µm

•••

Direct compression

Tablets (swallow, chewable, ODT, fast melt, TM, MUPS)

USP-NF, EP, JP

50 kg drum

2080

320 µm

••

Direct compression

Tablets (swallow, chewable, effervescent), sachets/stick packs

USP-NF, EP

100 kg drum

Granular

480 µm

••

Direct compression

Tablets (swallow, chewable, effervescent), sachets/stick packs

USP-NF, EP

100 kg drum

 

 

 

Co-processed

(includes Mannogem® mannitol)

Pharmaburst® 500

 

••••

Direct compression

Tablets (ODT)

All ingredients are USP-NF

50 kg drum

Pharmasperse® 416

 

 

Dry blend

Sachets/stick packs (ODP)

All ingredients are USP-NF

50 kg drum

Advantol® 300

 

•••

Direct compression

Tablets

(chewable, ODT, fast melt)

All ingredients are USP-NF

50 kg drum

*New in 2019!

**New in 2020!

 

Applications

Oral Solid Dosage Forms (OSDF)

Conventional swallow tablets, chewable tablets, orally disintegrating tablets (ODT), hard capsules, lozenges, effervescent tablets, sachets/stick packs (orally disintegrating powders/ODP), sublingual tablets, multiple unit pellet system (MUPS), liquid suspensions/syrups

 

 

Regulatory Information

  • Chemical name: D-mannitol
  • CAS number: 69-65-8
  • EC number: 200-711-8
  • REACH registration number: Not applicable
  • FDA Inactive Ingredient Database (IID) listed


Univar Solutions is the premier distributor of food ingredients in the USA

  • Vast network includes over 60 FDA-registered sites in the USA
  • Efficient private fleet with dedicated drivers servicing local regions
  • Partnership with world class food ingredient manufacturers
  • Experienced sales force with broad ingredient and food industry knowledge
  • Food scientists available to help customers through their new product development (NPD) cycles
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