Mannogem Mannitol

Pharmaceutical Excipient
Mannogem® Mannitols
Mannitol is becoming more popular as a filler/binder
in formulations because of its chemical stability, low
hygroscopicity, solubility and organoleptic properties.
It has favorable tabletting characteristics that produce
robust tablets with good disintegration.

Mannitol is a versatile excipient that is ideal for the

formulation development and manufacturing of a wide
range of patient friendly dosage forms:

¥¥Swallow Tablets
¥¥Chewable Tablets and Lozenges
¥¥Orally Disintegrating Tablets
¥¥Orally Dispersible Powders
¥¥Effervescent Tablets
¥¥Hard Gelatin Capsules

Chemical Stability Hygroscopicity of Mannogem EZ Compared to MCC

Mannitol contains only hydroxyl groups, which are less
15
reactive than aldehydes and ketones. Mannitol does Mannogem EZ at 25°C
not promote acid-base reactions, oxidation or undergo
MCC 102 at 25°C
Maillard reaction with primary amines. Mannitol is stable 12
Moisture Content (% dry mass)

to heat, melting without decomposition, and is capable

of forming stable crystalline polymorphs. In addition, 9
low levels of reducing sugar impurities make mannitol a
superior choice for formulating. 6

Solubility 3
Mannitol dissolves rapidly while retaining porosity
making it the excipient of choice in lyophilized and
directly compressible orodispersible formulations. This 0 10 20 30 40 50 60 70 80 90 100
easily wettable binder is excellent in solid dispersion for Relative Humidity (%)
improving the solubility of poorly soluble APIs.

Minimal Moisture Content

Low hygroscopicity adds protection against moisture
to safeguard the chemical and physical stability of
the API and excipients within a formulation. Without
hydrate formation or water retention, faster drying and
processing times are possible during wet granulation and
coprocessing applications.

Low Calorie and Non-Cariogenic

Mannitol has low calorie content and does not contribute
to tooth decay.

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 Product Sales Bulletin

Organoleptic Properties
Mannitol has a negative heat of solution which imparts a pleasant cooling sensation. Due to the fast dissolving property of
mannitol, it quickly delivers excellent palatability through a creamy texture and a mild sweetness. These characteristics make
it an ideal excipient for the formulation of convenient, patient friendly dosage forms that are easy to administer.

Relative Sweetness to Sucrose Relative Cooling Effect (cal/g)

Sucrose Sucrose

Maltitol Maltitol

Sorbitol Sorbitol

Xylitol Xylitol

Mannitol Mannitol

0% 20% 40% 60% 80% 100% 0 5 10 15 20 25 30 35

THE MANNOGEM ADVANTAGE

Our extensive experience in polyol chemistry enables SPI Pharma to offer a range of Mannogem Mannitol product options
for all oral dosage formulation applications. We focus solely on products for the pharmaceutical market that are engineered
to provide customized solutions to meet our customers' specific processing needs.

PRODUCT GRADE TARGET APPLICATION TARGET DOSAGE FORM

Dry Blending of Micronized and Swallow Tablets
Low Dose Actives Orally Disintegrating Tablets
Direct Compression Chewable Tablets and Lozenges
Mannogem EZ
Roller Compaction Effervescent Tablets
Hard Gelatin Capsules
Sachets and Stick Packs
Direct Compression Swallow Tablets
Dry Blending Chewable Tablets and Lozenges
Mannogem Granular
Roller Compaction Tablets with Taste Masked APIs
Mannogem 2080 Hard Gelatin Capsules
Sachets and Stick Packs
Wet Granulation Swallow Tablets
Hot Melt Extrusion Pellets (especially Proton Pump Inhibitors)
Wet Mass Extrusion and Liquid Suspensions/Syrups
Mannogem Powder
Spheronization
Lyophilization
Spray-Dry Coprocessing

3
Direct Compression Grades
Mannogem Mannitols are available in a number of functional grades to meet the specific application needs of the formulator.
To ensure consistent blend and tablet content uniformity results, select the grade that best meets the specific requirements
of individual formulations based on particle size and density properties of the API and other components in the formulation.

Mannogem EZ Spray Dried SEM Mannogem EZ (100x Magnification)

The proprietary process used to manufacture Mannogem
EZ yields a porous material with lower disintegration times,
a narrow particle size distribution, enhanced flow, and
compression properties. It is due to these properties that
Mannogem EZ is excellent in ODT formulations.

It produces tablets with higher hardness than other

excipients at comparable compression forces, and its higher
surface area allows Mannogem EZ to work well as a base SPI Spray-Dried Mannitol EZ 100x
for ordered mixing with micronized APIs and low dose
formulations.

Mannogem Granular Grades

Both Mannogem Granular and Mannogem 2080 are manufactured through a wet granulation process and have a larger
particle size than our Mannogem EZ spray dried material. They exhibit excellent flow, disintegration and compression
properties. These products are ideal for formulating tablets with taste masked APIs, which often have a larger particle size due
to the taste masking process.

Mannogem Granular Mannogem 2080

Mannogem Granular has a larger particle size that has
shown to contribute to a softer texture for chewable
tablets. The larger particle size allows it to match
specific particle size and density constraints to minimize
segregation during transport and manufacturing.
Mannogem 2080 has a smaller average particle size, and
a tighter overall particle size range. This lower particle
size produces a higher surface area relative to Mannogem
Granular, making it an effective API carrier system.

SEM Mannogem Granular (100x Magnification) SEM Mannogem 2080 (100x Magnification)

SPI Granular Mannitol 100x SPI Granular Mannitol 2080 100x

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 Product Sales Bulletin

Compactibility

200
Mannogem Granular 2080
Mannogem Granular
Mannogem EZ
High Compactibility
160
Mannogem direct compression grades are highly
Tablet Hardness (N)

compactible and gain hardness rapidly with increasing

120 compression force. The high binding capacity of Mannogem
makes it an excellent tablet binder, capable of producing
Globe Pharma 8
quality, robust tablets at lower compression forces.
80 Station Instrumented Press
25 RPM
0.5512" FFBE Punches
Tablet Weight: 700mg
mg stearate: 2.5%
40
10 15 20 25
Compression Force (kN)

Disintegration vs Hardness (no disintegrant added)

9.0
Mannogem Granular 2080
Mannogem Granular Excellent Disintegration
Mannogem EZ
7.5 Mannogem direct compression grades are readily soluble
Disintegration Time (min)

and typically exhibit shorter disintegration times, without the

aid of disintegrants, that are independent of tablet hardness.
6.0
These grades are easily wettable and dissolve rapidly, leading
to increased drug release. Shorter disintegration times may
4.5
Globe Pharma 8
Station Instrumented Press
help to enhance dissolution of poorly soluble drugs.
25 RPM
0.5512" FFBE Punches
Tablet Weight: 700mg
mg stearate: 2.5%
3.0
40 60 80 100 120 140 160
Tablet Hardness (N)

Friability

2.0%
Globe Pharma 8
Mannogem Granular 2080 Station Instrumented Press
Mannogem Granular 25 RPM
0.5512" FFBE Punches
Low Friability
1.5% Mannogem EZ Tablet Weight: 700mg
mg stearate: 2.5%
Mannogem products form durable, robust tablets with low
friability that can withstand the stresses associated with film
Friability (%)

coating, printing and packaging.

1.0%

0.5%

0.0%
10 15 20 25
Compression Force (kN)

5
 Deformation Mechanism Imparts Formulation Benefits
Mannitol is a brittle material that fractures under compression. Brittle fracture deformation results in the constant creation
of new surfaces during compression. This characteristic allows mannitol to be less sensitive to lubricant levels and blend
times. It also contributes to enhanced compactibility, producing robust tablets independent of dwell time.

Tablet Hardness vs. Dwell Time in Milliseconds (Mannogem EZ)

220
Allows High Speed Production 39 ms
20 ms
Mannogem has low sensitivity to press speed and can 180 13 ms
be tabletted over a wide range of dwell times. Higher 10 ms
production rates are possible with Mannogem direct

Tablet Hardness (N)

140
compression grades because tablet robustness is not
compromised with increased press speeds.
100

Manesty Beta Press

60 20, 40, 60, 80 RPM
0.625" FFBE Punches
Tablet Weight: 1000 mg
SSF 2.5%
20
5 10 15 20 25 30 35
Compression Force (kN)

Lubrication Sensitivity

200
Mannogem EZ at 2 min
Mannogem EZ at 30 min
Low Sensitivity to Lubricant Levels and Over Blending 160 Mannogem 2080 at 2 min
The increased surface area resulting from the brittle Mannogem 2080 at 30 min
fracture deformation exposes clean new surfaces for
Tablet Hardness (N)

120
bonding that reduce mannitol's sensitivity to lubricant
levels and extended blending times.
80

Globe Pharma 8
Station Instrumented Press
40
25 RPM
0.5512" FFBE Punches
Tablet Weight: 700mg
mg stearate: 2.5%
0
5 10 15 20 25
Compression (kN)

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 Product Sales Bulletin

Powder Grade
Mannogem Mannitol Powder is an excellent tablet diluent/ SEM Mannogem Powder (100x Magnification)
filler for use in wet granulation and lyophilization. It dries
rapidly, resulting in shorter processing time and increased
productivity.

Mannitol is also a good excipient for hot melt extrusion

applications. It melts without decomposition at
a temperature of approximately 165° C. Its rapid
recrystallization upon cooling make it an attractive carrier to
improve solubility of poorly soluble APIs.
SPI Mannitol POWDER

OUR PRODUCTS AND SERVICES CAN HELP YOU TO SOLVE THE MOST CHALLENGING FORMULATION
PROBLEMS– EFFICIENTLY, COST-EFFECTIVELY AND WITH A FOCUS ON SERVICE.

ANTACID ACTIVES FUNCTIONAL EXCIPIENTS

The global leader in immediate-relief antacid
actives, we specialize in aluminum, magnesium,
calcium products, and preformulated solutions for
the production of antacid suspensions and tablets.
DRUG DELIVERY SYSTEMS
A full spectrum of ODT products, services, and
technologies to support every stage of your
product life cycle.
TASTE-MASKED ACTIVES
Our Actimask® technology provides an excellent
taste barrier and mouthfeel without hindering API
release and onset of therapeutic relief.
Ingredients and formulation expertise to support a
wide range of patient friendly dosage forms.
VACCINE ADJUVANTS
Years of expertise in aluminum hydroxide chemistry
ensure our vaccine adjuvants exhibit a very regular
profile in terms of compliance, morphology, particle
size distribution, and protein adsorption capacity.
DRUG DEVELOPMENT SERVICES
Our complete drug development and testing service
can provide unique options to energize your drug
portfolio. No time? Limited resources?
We can deliver your project to you.

7
Mannogem® Mannitol
Typical Properties
Bulk Density Tapped Density Avg. Particle Size
Product Carr's Index
g/mL g/mL d(0.5)

Mannogem Powder 0.45 0.68 34 ≈60

Mannogem EZ 0.44 0.56 21 ≈140

Mannogem 2080 0.56 0.67 16 ≈300

Mannogem Granular 0.62 0.70 11 ≈400

*Typical properties not intended to be product specifications.

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503 Carr Rd., Suite 210 13240 Septemes-Les Vallons Hosur Road, Bangalore – 560100 Enfield NSW 2136
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© SPI Pharma 2016. All trademarks are the property of SPI Pharma. The information contained in this document is proprietary to SPI Pharma and Order No. SPI-EXC-MGM-0100-03201600
may not be used or disseminated inappropriately. The information and recommendations contained herein are to the best of SPI Pharma, Inc.’s 03-2016 | All rights reserved
knowledge reliable and accurate. Any recommendations are made without warranty, either implied or expressed, due to the variations in
equipment, conditions, and methods which may be used in commercially processing the products. No warranties of any kind are made, express or
implied, including those of merchantability and fitness for particular purpose, other than the products conform to current standard specifications.
SPI Pharma, Inc. makes no warranty that the use of the products or formulations provided by SPI Pharma, Inc. will not infringe any trademark, trade
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