FMC Alubra brochure8 comp:Layout 1 - FMC BioPolymer

Alubra provides greater tablet strength.Trials were run on Alubra to evaluate its compressionperformance versus magnesium stearate. The results indicatethat Alubra offers superior compression versus magnesiumstearate across the complete compression profile. Furthermore,Alubra shows no drop-off in hardness versus magnesiumstearate at higher compression forces.Hardness (N)500450400350300250200Comparative Tablet HardnessAvicel ® PH-102 neatAvicel ® PH-102 + 1% Alubra Avicel ® PH-102 + 1% MgStWhen compactability was measured on a rotary press, theblend using Alubra resulted in the hardest tablets, indicatingthat Alubra is a better choice than magnesium stearate whenit comes to high-speed tableting, and/or higher compressionforces.1501005005Source: FMC BioPolymer 201010 15 20 25 30 35Compression Force (kN)FORMULAIngredient%FormulaAvicel ® PH-102: 99Alubra or Magnesium Stearate: 1PROCEDURE• Materials: Avicel ® PH-102 + 1% lubricant(Alubra or MgSt) and Avicel ® PH-102 neat• Sieved through 710µm• Blending time 5 minutes• Rotary press: Manesty D4• One set of round, normal concave, D-type,12 mm diameter punches (position #1)• Tablet weight: 500 mg• Rotation speed: 34 RPM• Compression force: 5, 10, 15, 20, 25, 30 kN(for Avicel ® PH-102 neat: 2, 4, 8, 12, 16, 20 kN)tablet strength and quality.Alubra meets the highest quality standards.Alubra is manufactured under IPEC and cGMP conditions,which comply with recognized global quality standards. FMC’sown quality initiatives are designed to produce a lubricant thatis chemically, physically, and functionally consistent, as wellas compliant with the stringent requirements of all majorpharmacopoeias. FMC carries out systematic product evaluationto ensure that Alubra continues to meet or surpass thesehigh standards.Alubra sodium stearyl fumarate is included in the FDAInactive Ingredient Database for oral capsules and tablets,as well as in the Canadian List of Acceptable Non-MedicinalIngredients.Alubra Commercial InformationAlubra complies with all major pharmacopoeias:• NF • PH. Eur. • CP• JPE• BPCommercial packaging:• 1 KG (fiber)• 5 KG (fiber)• 20 KG (fiber)Available supporting documentation for Alubra :• Specification Sheet• MSDS• COAs• BSE/TSE Certificate• GMO Certificate (Generally Modified Organism)• Residual Solvent Certification (as per USP Chapter 467)• Not of Human/Animal Origin Certificate• Allergen-Free Certificate1. Chowhan, Z.T. and Chi, L.H. (1986); Drug Excipient Interactions Resulting fromPowder Mixing IV: Role of Lubricants and their Effect on In Vitro Dissolution;Journal of Pharmaceutical Sciences, 75: 542-545. doi: 10.1002/jps.26007506042. Gebert, K. Meyer-Bohm, A. Maschke and K. Kolter; Compression Characterizationand Lubricant Sensitivity of Orally Disintegrating Tablets Based on Lubiflash;Pharmaceutical Technology Europe, January 1, 2009, Volume 21, Issue 13. G.K. Bolhuis, C.F. Lerk, H.T. Zijlstra and A.H. de Boer; Pharm. Weekblad 110 317(1975)4. Tommasina Coviello, Antonio Palleschi, Mario Grassi, Pietro Matricardi, GianfrancoBocchinfuso and Franco Alhaique; Scleroglucan: A Versatile Polysaccharide forModified Drug Delivery; Molecules 31, January 2005, 10, 6-33