
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.
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 |
25 µm |
|
Wet granulation |
Tablets (swallow), liquids |
USP-NF, EP |
25 kg drum |
|
50 µm |
|
Wet granulation |
Tablets (swallow), liquids |
USP-NF, EP |
25 kg drum |
||
Spray Dried |
140 µm |
••• |
Direct compression |
Tablets (swallow, chewable, ODT, effervescent), hard capsules, lozenges, sachets/stick packs |
USP-NF, EP |
50 kg drum |
|
140 µm |
•••• |
Direct compression |
Tablets (swallow, chewable, ODT) |
USP-NF, EP |
25 kg drum |
||
160 µm |
•••• |
Direct compression |
Tablets (swallow, chewable, ODT) |
USP-NF, EP, JP |
25 kg drum |
||
Granular |
300 µm |
••• |
Direct compression |
Tablets (swallow, chewable, ODT, fast melt, TM, MUPS) |
USP-NF, EP, JP |
50 kg drum |
|
320 µm |
•• |
Direct compression |
Tablets (swallow, chewable, effervescent), sachets/stick packs |
USP-NF, EP |
100 kg drum |
||
480 µm |
•• |
Direct compression |
Tablets (swallow, chewable, effervescent), sachets/stick packs |
USP-NF, EP |
100 kg drum |
||
Co-processed (includes Mannogem® mannitol) |
|
•••• |
Direct compression |
Tablets (ODT) |
All ingredients are USP-NF |
50 kg drum |
|
|
|
Dry blend |
Sachets/stick packs (ODP) |
All ingredients are USP-NF |
50 kg drum |
||
|
••• |
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
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