Handbook of Pharmaceutical Granulation Technology, Third Edition, Volume 198 (Drugs and the Pharmaceutical Sciences) PDF
Preview Handbook of Pharmaceutical Granulation Technology, Third Edition, Volume 198 (Drugs and the Pharmaceutical Sciences)
Handbook of Pharmaceutical Granulation Technology DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs Executive Editor James Swarbrick PharmaceuTech,Inc. Pinehurst,NorthCarolina Advisory Board Larry L. Augsburger Harry G. Brittain Universityof Maryland Centerfor PharmaceuticalPhysicsMilford, Baltimore, Maryland NewJersey Jennifer B. Dressman Robert Gurny University ofFrankfurt Institute Universite deGeneve of PharmaceuticalTechnology Geneve,Switzerland Frankfurt,Germany Jeffrey A. Hughes Anthony J. Hickey University ofFloridaCollege University ofNorthCarolina ofPharmacy Schoolof Pharmacy Gainesville,Florida ChapelHill,NorthCarolina Vincent H. L. Lee Ajaz Hussain USFDA Centerfor Drug Sandoz EvaluationandResearch Princeton,NewJersey LosAngeles,California Joseph W. Polli Kinam Park GlaxoSmithKline PurdueUniversity ResearchTrianglePark WestLafayette,Indiana NorthCarolina Jerome P. Skelly Stephen G. Schulman Alexandria,Virginia University of Florida Gainesville, Florida Elizabeth M. Topp University ofKansas Yuichi Sugiyama Lawrence,Kansas University ofTokyo, Tokyo,Japan Peter York Geoffrey T. Tucker University ofBradford University ofSheffield SchoolofPharmacy Royal HallamshireHospital Bradford,United Kingdom Sheffield, United Kingdom For information on volumes 1–151 in the Drugs and Pharmaceutical Science Series, please visit www.informahealthcare.com 152. Preclinical Drug Development, edited by Mark C. Rogge and David R. Taft 153. Pharmaceutical Stress Testing: Predicting Drug Degradation, edited by Steven W. Baertschi 154. Handbook of Pharmaceutical Granulation Technology: Second Edition, edited by Dilip M. Parikh 155. Percutaneous Absorption: Drugs–Cosmetics–Mechanisms–Methodology, Fourth Edition, edited by Robert L. Bronaugh and Howard I. Maibach 156. Pharmacogenomics: Second Edition, edited by Werner Kalow, Urs A. Meyer and Rachel F. Tyndale 157. Pharmaceutical Process Scale-Up, Second Edition, edited by Michael Levin 158. Microencapsulation: Methods and Industrial Applications, Second Edition, edited by Simon Benita 159. Nanoparticle Technology for Drug Delivery, edited by Ram B. Gupta and Uday B. Kompella 160. Spectroscopy of Pharmaceutical Solids, edited by Harry G. Brittain 161. Dose Optimization in Drug Development, edited by Rajesh Krishna 162. Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives, edited by Y. W. Francis Lam, Shiew-Mei Huang, and Stephen D. Hall 163. Pharmaceutical Photostability and Stabilization Technology, edited by Joseph T. Piechocki and Karl Thoma 164. Environmental Monitoring for Cleanrooms and Controlled Environments, edited by Anne Marie Dixon 165. Pharmaceutical Product Development: In Vitro-In Vivo Correlation, edited by Dakshina Murthy Chilukuri, Gangadhar Sunkara, and David Young 166. Nanoparticulate Drug Delivery Systems, edited by Deepak Thassu, Michel Deleers, and Yashwant Pathak 167. Endotoxins: Pyrogens, LAL Testing and Depyrogenation, Third Edition, edited by Kevin L. Williams 168. Good Laboratory Practice Regulations, Fourth Edition, edited by Anne Sandy Weinberg 169. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition, edited by Joseph D. Nally 170. Oral-Lipid Based Formulations: Enhancing the Bioavailability of Poorly Water-soluble Drugs, edited by David J. Hauss 171. Handbook of Bioequivalence Testing, edited by Sarfaraz K. Niazi 172. Advanced Drug Formulation Design to Optimize Therapeutic Outcomes, edited by Robert O. Williams III, David R. Taft, and Jason T. McConville 173. Clean-in-Place for Biopharmaceutical Processes, edited by Dale A. Seiberling 174. Filtration and Purification in the Biopharmaceutical Industry, Second Edition, edited by Maik W. Jornitz and Theodore H. Meltzer 175. Protein Formulation and Delivery, Second Edition, edited by Eugene J. McNally and Jayne E. Hastedt 176. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition, edited by James McGinity and Linda A. Felton 177. Dermal Absorption and Toxicity Assessment, Second Edition, edited by Michael S. Roberts and Kenneth A. Walters 178. Preformulation Solid Dosage Form Development, edited by Moji C. Adeyeye and Harry G. Brittain 179. Drug-Drug Interactions, Second Edition, edited by A. David Rodrigues 180. Generic Drug Product Development: Bioequivalence Issues, edited by Isadore Kanfer and Leon Shargel 181. Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition, edited by Martin D. Hynes III 182. Pharmaceutical Project Management, Second Edition, edited by Anthony Kennedy 183. Modified Release Drug Delivery Technology, Second Edition, Volume 1, edited by Michael J. Rathbone, Jonathan Hadgraft, Michael S. Roberts, and Majella E. Lane 184. Modified-Release Drug Delivery Technology, Second Edition, Volume 2, edited by Michael J. Rathbone, Jonathan Hadgraft, Michael S. Roberts, and Majella E. Lane 185. The Pharmaceutical Regulatory Process, Second Edition, edited by Ira R. Berry and Robert P. Martin 186. Handbook of Drug Metabolism, Second Edition, edited by Paul G. Pearson and Larry C. Wienkers 187. Preclinical Drug Development, Second Edition, edited by Mark Rogge and David R. Taft 188. Modern Pharmaceutics, Fifth Edition, Volume 1: Basic Principles and Systems, edited by Alexander T. Florence and Ju¨rgen Siepmann 189. Modern Pharmaceutics, Fifth Edition, Volume 2: Applications and Advances, edited by Alexander T. Florence and Ju¨rgen Siepmann 190. New Drug Approval Process, Fifth Edition, edited by Richard A.Guarino 191. Drug Delivery Nanoparticulate Formulation and Characterization, edited by Yashwant Pathak and Deepak Thassu 192. PolymorphismofPharmaceuticalSolids,Second Edition, edited byHarryG.Brittain 193. Oral Drug Absorption: Prediction and Assessment, Second Edition, edited by Jennifer J. Dressman, Hans Lennernas, and Christos Reppas 194. Biodrug Delivery Systems: Fundamentals, Applications, and Clinical Development, edited by Mariko Morishita and Kinam Park 195. Pharmaceutical Process Engineering, Second Edition, edited by Anthony J. Hickey and David Ganderton 196. HandbookofDrugScreening,SecondEdition,editedbyRamakrishnaSeethalaand Litao Zhang 197. Pharmaceutical Powder Compaction Technology, Second Edition, edited by Metin Celik 198. Handbook of Pharmaceutical Granulation Technology, Third Edition, edited by Dilip M. Parikh T H I R D E D I T I O N Handbook of Pharmaceutical Granulation Technology edited by Dilip M. Parikh DPharma Group Inc. Ellicott City, Maryland, USA InformaHealthcareUSA,Inc. 52VanderbiltAvenue NewYork,NY10017 #2010byInformaHealthcareUSA,Inc. InformaHealthcareisanInformabusiness NoclaimtooriginalU.S.Governmentworks PrintedintheUnitedStatesofAmericaonacid-freepaper 10 9 8 7 6 5 4 3 2 1 InternationalStandardBookNumber-10:1-4398-0789-2(Hardcover) InternationalStandardBookNumber-13:978-1-4398-0789-7(Hardcover) Thisbookcontainsinformationobtainedfrom authenticandhighlyregarded sources.Reprinted materialis quotedwith permission,andsourcesareindicated.Awidevarietyofreferencesarelisted.Reasonableeffortshavebeenmadetopublish reliabledataandinformation,buttheauthorandthepublishercannotassumeresponsibilityforthevalidityofallmaterials orfortheconsequenceoftheiruse. Nopartofthisbookmaybereprinted,reproduced,transmitted,orutilizedinanyformbyanyelectronic,mechanical,or othermeans,nowknownorhereafterinvented,includingphotocopying,microfilming,andrecording,orinanyinformation storageorretrievalsystem,withoutwrittenpermissionfromthepublishers. 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Series:Drugsandthepharmaceuticalsciences;v.198. [DNLM:1. Technology,Pharmaceutical—Handbooks.2. Powders—Handbooks. W1 DR893Bv.1982009/QV735H23612009] RS199.G73H362009 6150.19—dc22 2009038625 ForCorporateSalesandReprintPermissionscall212-520-2700orwriteto:SalesDepartment,52VanderbiltAvenue, 7thfloor,NewYork,NY10017. VisittheInformaWebsiteat www.informa.com andtheInformaHealthcareWebsiteat www.informahealthcare.com To my wife Leena, son Neehar, and my friends, who never left my side during the good times and tough times. Their love, dedication, and support will remain with me always. Preface Since the Handbook of Pharmaceutical Granulation Technology, first and second editions, were published, there have been rapid developments in the science of granulation, particle engineering,andprocesscontrols,requiringthepublicationofthisthirdedition.Theconcepts of design space, process optimization, and harmonization of regulations by the global health authorities are being implemented in the industry. The U.S. and International regulatory bodies are restructuring their oversight of pharmaceutical quality regulation by developing a product qualityregulatorysystem, whichprovidesaframeworkforimplementing qualityby design, continuous improvement, and risk management. This edition addresses topics generated by these technological as well as regulatory changes in unit operation of particle generation and granulation. Current advances in the field have led us to include new chapters on subjects such as supercritical fluids, nanoparticulate technology, nutraceuticals, biotechnology, controlled- releasegranulation,processcontrol,andexpertsystemstobringthereaderuptodatewiththe keynewdriversinthefield.Allclassicandstandardbearerchapterssuchasfluidbed,roller compaction, continuous granulation, process modeling, spray-drying, and effervescent and rapid-release granulation have been thoroughly revised to meet the current state of the art. Within particle generation technologies, research and application of supercritical fluids and nanotechnology-based processes for particle production have proved suitable for controlling solid-state morphology and particle size of pharmaceuticals. Supercritical fluids have emerged as the basis of a system that optimizes the physicochemical properties of pharmaceuticalpowders.Supercriticalfluidsshouldbeconsideredinaprominentpositionin thedevelopmentprocessesofdrugproductsforthe21stcentury.Nanoparticulatetechnology offers a potential path to rapid preclinical assessment of poorly soluble drugs. It offers increased bioavailability, improved absorption, reduced toxicity, and the potential for drug targeting. Nanoparticulate technology may thus allow for the successful development of poorlywater-solublediscoverycompounds,aswellastherevitalizationofmarketedproducts through improvements in dosing. These particle generation technologies have been included in new chapters titled “Supercritical Fluid Technology” and “Pharmaceutical Applications of Nanoengineering.” Asthenutraceuticalsindustryisgrowingworldwide,anewchapterfor“Granulationof Plant Products and Nutraceuticals” is included in this edition. These herbal and mineral products pose unique challenges when preparing a solid dose. These products are normally formulatedwithnumerousingredientswithvaryingparticlesizes,morphology,hydrophobic or hydrophilic attributes, along with unique granulating and compressing challenges. Approaches to overcome these difficulties using various granulation techniques described in this chapter will be helpful to the professionals in dietary supplement industry. Regulatory approachestakenbydifferentworldregulatoryauthoritiesarehighlightedinthischapter,and impact of recent implementation of U.S. FDA Good Manufacturing Practices regulation for nutraceutical industry is discussed in this chapter as well. As the biotechnology industry grows worldwide, formulation efforts to formulate large molecules for oral dosage forms have accelerated. Research and application of classical granulation technologies have been investigated and presented in the chapter titled “Granulation Approaches in Biotech Industry,” which will provide much needed knowledge of the current status and challenges inherent in this effort. Controlled-release technology to produce matrix granulation is widely practiced. To prolong the life cycle of a product or to offer better patient compliance, controlled-release
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