09 Petrolatum and Lanolin Alcohols 512 Phenol 514 Phenoxyethanol 517 Phenylethyl Alcohol 519 Phenylmercuric Acetate 521 Phenylmercuric Borate 524 Phenylmercuric Nitrate 526 Phosphoric Acid 530 Polacrilin Potassium 532 Poloxamer 535 Polycarbophil 539 Polydextrose 542 Polyethylene Glycol 545 Polyethylene Oxide 551 Polymethacrylates 553 Poly(methyl vinyl ether/maleic anhydride) 561 Polyoxyethylene Alkyl Ethers 564 Polyoxyethylene Castor Oil Derivatives 572 Polyoxyethylene Sorbitan Fatty Acid Esters 580 Polyoxyethylene Stearates 585 Polyvinyl Acetate Phthalate 589 Polyvinyl Alcohol 592 Potassium Alginate 594 Potassium Benzoate 596 Potassium Bicarbonate 598 Potassium Chloride 600 Potassium Citrate 603 Potassium Hydroxide 605 Potassium Metabisulfite 607 Potassium Sorbate 609 Povidone 611 Propionic Acid 617 Propyl Gallate 619 Propylene Carbonate 622 Propylene Glycol 624 Propylene Glycol Alginate 627 Propylparaben 629 2-Pyrrolidone 633 Raffinose 635 Saccharin 638 Saccharin Sodium 641 Saponite 644 Sesame Oil 646 Shellac 649 Contents vii Simethicone 652 Sodium Acetate 654 Sodium Alginate 656 Sodium Ascorbate 659 Sodium Benzoate 662 Sodium Bicarbonate 665 Sodium Borate 669 Sodium Chloride 671 Sodium Citrate Dihydrate 675 Sodium Cyclamate 678 Sodium Hyaluronate 681 Sodium Hydroxide 683 Sodium Lactate 685 Sodium Lauryl Sulfate 687 Sodium Metabisulfite 690 Sodium Phosphate, Dibasic 693 Sodium Phosphate, Monobasic 696 Sodium Propionate 699 Sodium Starch Glycolate 701 Sodium Stearyl Fumarate 705 Sodium Sulfite 708 Sorbic Acid 710 Sorbitan Esters (Sorbitan Fatty Acid Esters) 713 Sorbitol 718 Soybean Oil 722 Starch 725 Starch, Pregelatinized 731 Starch, Sterilizable Maize 734 Stearic Acid 737 Stearyl Alcohol 740 Sucralose 742 Sucrose 744 Sugar, Compressible 748 Sugar, Confectioner’s 750 Sugar Spheres 752 Sulfobutylether b-Cyclodextrin 754 Sulfuric Acid 758 Sunflower Oil 760 Suppository Bases, Hard Fat 762 Talc 767 Tartaric Acid 770 Tetrafluoroethane (HFC) 772 Thaumatin 775 Thimerosal 777 Thymol 780 Titanium Dioxide 782 Tragacanth 785 Trehalose 788 Triacetin 790 Tributyl Citrate 792 Triethanolamine 794 Triethyl Citrate 796 Vanillin 798 Vegetable Oil, Hydrogenated 800 Water 802 Wax, Anionic Emulsifying 807 Wax, Carnauba 809 Wax, Cetyl Esters 811 Wax, Microcrystalline 813 Wax, Nonionic Emulsifying 815 Wax, White 817 Wax, Yellow 819 Xanthan Gum 821 Xylitol 824 Zein 828 Zinc Acetate 830 Zinc Stearate 832 Appendix I: Suppliers’ Directory 835 Appendix II: List of Excipient ‘E’ Numbers 882 Appendix III: List of Excipient ‘EINECS’ Numbers 884 Appendix IV: List of Excipient Molecular Weights 886 Index 889 viii Contents International Steering Committee Gregory E Amidon Pharmacia Corporation Kalamazoo, MI, USA Graham Buckton University of London London, UK Colin G Cable Western General Hospital Edinburgh, UK Brian A Carlin FMC Biopolymer Princeton, NJ, USA Walter Cook AstraZeneca Loughborough, UK Henk J de Jong Servier International Research Institute Courbevoie, France Stephen Edge DMV International Veghel, The Netherlands Roger T Guest GlaxoSmithKline Ware, Hertfordshire, UK Bruno Hancock Pfizer Inc Groton, CT, USA Stephen W Hoag University of Maryland at Baltimore Baltimore, MD, USA Arthur H Kibbe Wilkes University Wilkes-Barre, PA, USA William J Lambert Eisai Inc Research Triangle Park, NC, USA M Jayne Lawrence King’s College, University of London London, UK John MacLaine Boots Contract Manufacturing Nottingham, UK Colin P McCoy Queens University Belfast Belfast, UK R Christian Moreton Idenix Pharmaceuticals Cambridge, MA, USA Sandeep Nema Pfizer Inc Chesterfield, MO, USA Siaˆ n C Owen Royal Pharmaceutical Society of Great Britain London, UK Anthony Palmieri III University of Florida Gainesville, FL, USA Raymond C Rowe Intelligensys Ltd Billingham, UK Shirish A Shah Watson Pharmaceuticals Corona, CA, USA Bob Sherwood JRS Pharma Patterson, NY, USA Paul J Sheskey The Dow Chemical Co Midland, MI, USA Kamalinder K Singh SNDT Women’s University Mumbai, India Paul J Weller Royal Pharmaceutical Society of Great Britain London, UK Tim Wood GlaxoSmithKline Ware, Hertfordshire, UK Mukund Yelvigi Wyeth Research Pearl River, NY, USA Editorial Staff Editorial Staff of the Pharmaceutical Press: Laurent Y Galichet Louise ME McIndoe Siaˆn C Owen Paul J Weller Contributors O AbuBaker Pfizer Inc Ann Arbor, MI, USA KS Alexander University of Toledo Toledo, OH, USA LV Allen International Journal of Pharmaceutical Compounding Edmond, OK, USA GE Amidon Pharmacia Corporation Kalamazoo, Michigan, USA GP Andrews The Queen’s University of Belfast Belfast, UK NA Armstrong Harpenden, Hertfordshire, UK ME Aulton De Montford University Leicester, UK S Behn AstraZeneca Macclesfield, UK M Bond Danisco Sweeteners Ltd Redhill, Surrey, UK CG Cable Western General Hospital Edinburgh, UK E Cahill AstraZeneca Macclesfield, UK W Camarco ISP Corp Wayne, NJ, USA WG Chambliss University of Mississippi University, MS, USA RK Chang Shire Laboratory Rockville, MD, USA R Chen Pfizer Inc Groton, CT, USA JH Chu Pfizer Inc Groton, CT, USA JH Collett University of Manchester Manchester, UK JT Colvin Pfizer Inc Groton, CT, USA W Cook AstraZeneca Loughborough, UK DQM Craig The University of East Anglia Norwich, UK TC Dahl Gilead Sciences Foster City, CA, USA A Day AstraZeneca Loughborough, UK HJ de Jong Servier International Research Institute Courbevoie, France SP Denyer University of Cardiff Cardiff, UK X Duriez Roquette Fre`res Lestrem, France S Edge DMV International Veghel, The Netherlands K Fowler Schering-Plough Healthcare Products Memphis, TN, USA SO Freers Grain Processing Corporation Muscatine, IA, USA B Fritzsching Palatinit GmbH Mannheim, Germany G Frunzi Bristol-Myers Squibb New Brunswick, NJ, USA LY Galichet Royal Pharmaceutical Society of Great Britain London, UK SR Goskonda Sunnyvale, CA, USA JL Gray The Queen’s University of Belfast Belfast, UK RT Guest GlaxoSmithKline Ware, Hertfordshire, UK RR Gupta SNDT Women’s University Mumbai, India VK Gupta Tyco HealthCare Mallinckrodt St Louis, MO, USA G Haest Cargill Cerestar BVBA Mechelen, Belgium BC Hancock Pfizer Inc Groton, CT, USA RJ Harwood Bensalem, PA, USA S Hem Purdue University West Lafayette, IN, USA L Hendricks Rhodia Inc Cranbury, NJ, USA SE Hepburn Bristol Royal Infirmary Bristol, UK NA Hodges University of Brighton Brighton, UK JT Irwin Perrigo Corporation MI, USA BR Jasti University of the Pacific Stockton, CA, USA R Johnson AstraZeneca Loughborough, UK DS Jones The Queen’s University of Belfast Belfast, UK AS Kearney GlaxoSmithKline King-of-Prussia, PA, USA SW Kennedy Morflex Inc Greensboro, NC, USA VL Kett The Queen’s University of Belfast Belfast, UK AH Kibbe Wilkes University Wilkes-Barre, PA, USA V King Rhodia Inc Cranbury, NJ, USA PB Klepak Reheis Inc Berkley Heights, NJ, USA JJ Koleng University of Texas at Austin Austin, TX, USA K Kussendrager DMV International Veghel, The Netherlands WJ Lambert Eisai Inc Research Triangle Park, NC, USA BA Langdon Pfizer Inc Groton, CT, USA MJ Lawrence King’s College, University of London London, UK JC Lee Cellegy San Jose´, CA, USA MG Lee Medicines and Healthcare products Regulatory Agency London, UK X Li University of the Pacific Stockton, CA, USA EB Lindblad Brenntag Biosector Frederikssund, Denmark O Luhn Palatinit GmbH Mannheim, Germany PE Luner Pfizer Inc Groton, CT, USA HJ Mawhinney The Queen’s University of Belfast Belfast, UK CP McCoy The Queen’s University of Belfast Belfast, UK OS McGarvey The Queen’s University of Belfast Belfast, UK JW McGinity University of Texas at Austin Austin, TX, USA LME McIndoe Royal Pharmaceutical Society of Great Britain London, UK LA Miller Pfizer Inc Groton, CT, USA RW Miller Bristol-Myers Squibb New Brunswick, NJ, USA J-P Mittwollen BASF Aktiengesellschaft Ludwigshafen, Germany RC Moreton Idenix Pharmaceuticals Cambridge, MA, USA G Mosher CyDex Inc Lenexa, KS, USA C Mroz Colorcon Ltd Dartford, Kent, UK MP Mullarney Pfizer Inc Groton, CT, USA S Murdande Pfizer Inc Groton, CT, USA RA Nash St John’s University Jamaica, NY, USA S Nema Pfizer Inc Chesterfield, MO, USA SC Owen Royal Pharmaceutical Society of Great Britain London, UK A Palmieri University of Florida Gainesville, FL, USA D Parsons ConvaTec Ltd Clwyd, UK Y Peng University of Tennessee Memphis, TN, USA JD Pipkin CyDex Inc Lenexa, KS, USA D Pipkorn Pfizer Inc Ann Arbor, MI, USA JC Price University of Georgia Athens, GA, USA MA Repka University of Mississippi University, MS, USA B Sarsfield Bristol-Myers Squibb New Brunswick, NJ, USA T Schmeller BASF Aktiengesellschaft Ludwigshafen, Germany A Schoch Palatinit GmbH Mannheim, Germany CJ Sciarra Sciarra Laboratories Inc Hicksville, NY, USA Contributors xi JJ Sciarra Sciarra Laboratories Inc Hicksville, NY, USA SA Shah Watson Pharmaceuticals Corona, CA, USA RM Shanker Pfizer Inc Groton, CT, USA PJ Sheskey The Dow Chemical Co Midland, MI, USA AJ Shukla University of Tennessee Memphis, TN, USA KK Singh SNDT Women’s University Mumbai, India R Steer AstraZeneca Loughborough, UK JT Stewart University of Georgia Athens, GA, USA Y Sun University of Tennessee Memphis, TN, USA AK Taylor Baton Rouge, LA, USA MS Tesconi Wyeth Research Pearl River, NY, USA D Thassu UCB Pharma Inc Rochester, NY, USA BF Truitt Pfizer Inc Groton, CT, USA CK Tye Pfizer Inc Kalamazoo, MI, USA HM Unvala Bayer Corporation Myerstown, PA, USA KD Vaughan Boots Healthcare International Nottingham, UK H Wang Pfizer Inc Groton, CT, USA PJ Weller Royal Pharmaceutical Society of Great Britain London, UK AJ Winfield Aberdeen, UK AW Wood GlaxoSmithKline Research Triangle Park, NC, USA M Yelvigi Wyeth Research Pearl River, NY, USA PM Young University of Sydney Sydney, Australia About the Editors Raymond C Rowe BPharm, PhD, DSc, FRPharmS, CChem, FRSC, CPhys, MInstP Raymond Rowe has been involved in the Handbook of Pharmaceutical Excipients since the first edition was published in 1986, initially as an author then as a Steering Committee member. In addition to his position as Chief Scientist at Intelligensys, UK, he is also Professor of Industrial Pharmaceutics at the School of Pharmacy, University of Bradford, UK. He was formerly Senior Principal Scientist at AstraZeneca, UK. In 1998 he was awarded the Chiroscience Industrial Achievement Award, and in 1999 he was the British Pharmaceutical Conference Science Chairman. He has contributed to over 350 publications in the pharmaceutical sciences including a book and eight patents. Paul J Sheskey BSc, RPh Paul Sheskey has been involved in the Handbook of Pharmaceutical Excipients as an author and member of the Steering Committee since the third edition. He is a Technical Service Leader in the Water Soluble Polymers, Pharmaceutical R&D Group at The Dow Chemical Company in Midland, Michigan, USA. Paul received his BSc degree in pharmacy from Ferris State University. Previously, he has worked as a research pharmacist in the area of solid dosage form development at the Perrigo Company and the Upjohn (Pharmacia) Company. Paul has authored numerous journal articles in the area of pharmaceutical technology. He is a member of the AAPS, Controlled Release Society, and the Institute for Briquetting and Agglomeration. Siaˆn C Owen BSc, MA Siaˆn Owen has been involved with the Handbook of Pharmaceutical Excipients since the fourth edition, as a contributor and Steering Committee member. Siaˆn received her BSc degree in pharmacology from the University of Sunderland, and her MA in biotechnological law and ethics from the University of Sheffield. xii Contributors New Monographs The following new monographs have been added to the Handbook of Pharmaceutical Excipients, 5th edition