FMC Alubra brochure8 comp:Layout 1 - FMC BioPolymer

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Alubra offers improved API dissolution.Lubricants are a vital part of the tableting manufactureprocess. Formulators have typically selected magnesiumstearate to meet these needs as a familiar, well-establishedlubricant.Given today’s challenges in formulating tablets, it is importantto ensure that the lubricant choice does not have a negativeimpact on disintegration and dissolution. Scientific evidencedemonstrates that magnesium stearate can negatively impactdisintegration and dissolution 1 . Formulators need to considerthese variables before selecting the appropriate lubricant fortheir formulation.Alubra has important solubility benefits that can be usedto advantage in developing poorly soluble drugs, orallydisintegrating tablets (ODTs) 2 , and effervescent dosage forms,which all require more water-soluble type lubricants thanmagnesium stearate.Product Benefits:Compared with the widely used lubricantmagnesium stearate, Alubra offers:Enhanced dissolutionCompatibility with a range of APIsFlexibility in blendingImproved compactabilitySimilar lubrication performanceBetter tablet qualityAlubra delivers betterThe chemistry of Alubra provides importantadvantages.In addition to offering improved water dispersability of themolecule, the fumarate moiety of Alubra increases themelting temperature, which allows greater functionality at highpress speeds when compared to magnesium stearate. Thestearate chain of Alubra maintains the lubricity of the compound,supporting low ejection forces.Chemical structure of Alubra sodium stearyl fumarateHOOTypical Alubra PropertiesMolecular Formula: C 22 H 39 NaO 4Formula Weight: 390.53Melting Point:220-240° CRecommended Use level: 0.5-2.0% of FormulationChemical name:2-Butenedioicacidiconoctadecyl ester,sodium saltAcidity:pH 8.3 (5% water solutionat 90° C)Solubility:acetone practically insolubleParticle morphology of Alubra ethanol practically insolublemethanol slightly solubleWater 1:5 90° CWater 1:20,000 25° CDensity (bulk):0.3 to 0.5 g/ccOO-Na +Density (tapped):0.4 to 0.6 g/ccEINECS #: 223-781-1CID #: 23665634CAS No. 4070-80-8
Alubra enhances dissolution of poorlysoluble APIs.Many of the new generation APIs are poorly soluble, creatingnew challenges for tablet manufacturers.While it is today’s most widely used lubricant, magnesiumstearate is very hydrophobic and has detrimental effects onthe dissolution profile of APIs 1 , especially poorly soluble APIs 3 .As a highly soluble lubricant, Alubra sodium stearyl fumaratehas shown improved disintegration times in hydrophilic matrixformations 4 and ODTs 2 when compared to magnesium stearate.Magnesium stearate tends to form ‘envelopes’ around APIparticles, slowing tablet disintegration and API dissolution, asopposed to the more hydrophilic Alubra , which promotesfaster API dissolution of poorly soluble APIs.% API released12010080604020Comparative Dissolution Propertiesof 500mg Acetaminophen Tablets98% acetaminophen + 2% Alubra(Hardness 108N; relative density 85.35%)98% acetaminophen + 2% MgSt(Hardness 119N; relative density 87.85%)0 5 10 15 20 25 30 35 40 45 50 55 60 65Time (min)Source: FMC BioPolymer 2010dissolution and much more.Alubra offers the lubrication performanceyou want.During manufacture, an extensive amount of friction is generatedbetween the tablet and the surfaces of the die and punch asthe tablet is ejected. This can impart considerable amounts ofstrain and shear to a tablet, resulting in defects such as sticking,capping, and lamination.Lubricants like magnesium stearate and sodium stearyl fumaratehave a notable effect in reducing ejection forces. The higherthe ejection force, the greater the possibility that costly tabletdefects will occur.Ejection Force (N)300250200150100Comparative Ejection ForcesAvicel ® PH-102 neatAvicel ® PH-102 + 1% Alubra Avicel ® PH-102 + 1% MgStThe chemistry of Alubra sodium stearyl fumarate is uniquein promoting improved wettability of the tablet while still allowingfor high formulation lubricity, especially at higher tabletingspeeds. Under the high melting temperatures that result,Alubra allows prolonged compression times at highercompression forces. Test results indicate that Alubra is equalto magnesium stearate when it comes to ejection forces.500 5 10 15 20 25 30 35Source: FMC BioPolymer 2010Compression Force (kN)
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FMC Alubra brochure8 comp:Layout 1 - FMC BioPolymer

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