PEARLITOL® C

PEARLITOL® mannitol
Versatile stable excipients for pharmaceutical applications

Roquette‘s  wide PEARLITOL® mannitol range is dedicated to the formulation of medicines.

The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability, with great organoleptic, non-cariogenic, sugar-free properties. Together with its versatile powder properties, it is the key to a wide range of oral and injectable applications, and for use in different processes (wet or dry granulation, direct compression, compaction or freeze-drying).  

DESCRIPTION Mannitol crystalline powder White, odourless, slightly sweet tasting, crystalline powder.   COMPLIANCE European Pharmacopoeia USP / NF Japanese Pharmacopoeia REGULATORY DOCUMENTATION CEP: R1CEP2000-039 US DMF Type IV n° 18 143    PROPERTIES Physical and chemical Very low hygroscopicity Excellent chemical stability Water solubility at 20°C = 17g / 100ml Organoleptic Sweetening power about 40% that of sucrose Cooling effect in the mouth Dietetic* Sugarless (non-cariogenic) May be advised for diabetics Low-calorie

PARTICLE SIZE** PEARLITOL® 160 C Mean diameter: 160 µm PEARLITOL® 50 C Mean diameter: 50 µm PEARLITOL® 25 C Mean diameter: 25 µm     APPLICATIONS Diluent for tablets, capsules and sachets Excipient for chemically unstable or moisture sensitive actives Freeze-drying carrier Excipient of choice for flash release forms Sweetener for pharmaceutical chewing gum Diuretic-osmotic for injectable solutions : PEARLITOL® PF    * Refer to local legislation ** by laser diffraction method

TYPICAL FORMULATION

Roquette has developped a number of typical formulations to serve as basic guidelines for obtaining optimum performance from PEARLITOL® C products.

• PH107CG Sugarless Chewing-Gum Tablet Centers With - Neosorb^® P60 W, Xylisorb^® 90, - Pearlitol^® C160 And Lycasin^® 80/55 Hds(PDF - 353 Ko)
• PH154CS Sugarless Pharmaceutical Chewy Sweets - With Vitamin C(PDF - 347 Ko)
• PH124CT Vitamin C chewable tablets using PEARLITOL 160C mannitol (Wet granulation)(PDF - 345 Ko)

 

APPLICATIONS LABORATORY SERVICES & SUPPORT Furthermore Roquette has long offered an integrated customer service for FORMULATION ASSISTANCE (see here presentation of Applications Laboratory Services & Support).

FORMULATION ASSISTANCE For special formulations requests, please contact us through our FORMULATION_ASSISTANCE form.

 

CURRENT PACKAGING FOR THIS FAMILY OF PRODUCTS:

• 25 kg pinch bottom bag (286Ko)
• 50 kg fiber drum (325Ko)
• 500 kg big-bag (232Ko)
• 1 000 kg big-bag

To check the immediate availability of these packaging formats or other special packaging, please contact us or your local Roquette representative for  further information.

 

QUALITY-RELATED DOCUMENTATION

• Group quality policy
• Group safety policy
• Group environmental policy / S.M.E.
• ISO certificate
• GMO certificate

TECHNICAL BROCHURES

• PEARLITOL® 200 SD – The ultimate mannitol for DC tablets – 20 pages
• PEARLITOL® mannitol for pharmaceutical applications - 20 pages
• Personal Care Products - 16 pages

 

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

Sample request form