Handbook of Pharmaceutical Excipients

Pharmaceutical dosage forms contain both pharmacologically active compounds and excipients added to aid the formulation and manufacture of the subsequent dosage form for administration to patients. Indeed, the properties of the final dosage form (i.e. its bioavailability and stability) are, for the most part, highly dependent on the excipients chosen, their concentration and interaction with both the active compound and each other. No longer can excipients be regarded simply as inert or inactive ingredients, and a detailed knowledge not only of the physical and chemical properties but also of the safety, handling and regulatory status of these materials is essential for formulators throughout the world. In addition, the growth of novel forms of delivery has resulted in an increase in the number of the excipients being used and suppliers of excipients have developed novel coprocessed excipient mixtures and new physical forms to improve their properties. The Handbook of Pharmaceutical Excipients has been conceived as a systematic, comprehensive resource of information ​ on all of these topics. URI http://repositorio.ub.edu.ar/handle/123456789/5143 Collections Libros Farmacia www.ub.edu.ar | biblioteca.ub.edu.ar Contact Us | Send Feedback Handbook of pharmaceutical excipients 

[1]  A. Walker Drinking water--doubts about quality. , 1992, BMJ.

[2]  H. Ohtani,et al.  Effect of Humidity on Solid‐state Isomerization of Various Kinds of Lactose During Grinding , 1993, The Journal of pharmacy and pharmacology.

[3]  R. Johnson,et al.  Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine. , 1998, Journal of pharmaceutical sciences.

[4]  D. Ganderton The effect of distribution of magnesium stearate on the penetration of a tablet by water , 1969, The Journal of pharmacy and pharmacology.

[5]  K. Goto,et al.  Pharmaceutical evaluation of multipurpose excipients for direct compressed tablet manufacture: comparisons of the capabilities of multipurpose excipients with those in general use. , 1999, Drug Development and Industrial Pharmacy.

[6]  J. J. Díaz Esquivel,et al.  Lubricant susceptibility of Cellactose and Avicel PH-200: a quantitative relationship. , 2000, Drug development and industrial pharmacy.

[7]  Jérôme Barra,et al.  Influence of the Physicochemical Variability of Magnesium Stearate on Its Lubricant Properties: Possible Solutions , 1996 .

[8]  D. Peters,et al.  Raw materials , 2007, Advances in biochemical engineering/biotechnology.

[9]  L. Augsburger,et al.  Multiple Sources of Sodium Starch Glycolate, NF: Evaluation of Functional Equivalence and Development of Standard Performance Tests , 2002, Pharmaceutical development and technology.

[10]  G. Ragnarsson,et al.  The influence of mixing time and colloidal silica on the lubricating properties of magnesium stearate , 1979 .

[11]  G. Bolhuis,et al.  On the Similarity of Sodium Starch Glycolate from Different Sources , 1986 .

[12]  W. Jung,et al.  In vitro dissolution from several experimental capsule formulations. , 1970, Journal of pharmaceutical sciences.

[13]  K. A. Khan,et al.  Disintegration properties of calcium phosphate dibasic dihydrate tablets. , 1975, Journal of pharmaceutical sciences.

[14]  V. Lehto,et al.  Effect of temperature and humidity on vegetable grade magnesium stearate , 2004 .

[15]  G. Peck,et al.  Development of agglomerated talc. II: Optimization of the processing parameters for the preparation of granulated talc , 1995 .

[16]  J. S. Bubik Preparation of sterile talc for treatment of pleural effusion. , 1992, American journal of hospital pharmacy.

[17]  C. Rhodes,et al.  Effect of storage at specified temperature and humidity on properties of three directly compressible tablet formulations. , 1976, Journal of pharmaceutical sciences.

[18]  H. Steckel,et al.  Alternative sugars as potential carriers for dry powder inhalations. , 2004, International journal of pharmaceutics.

[19]  Mats E. Johansson Granular magnesium stearate as a lubricant in tablet formulations , 1984 .

[20]  Hui Xu,et al.  Evaluation of hydroperoxides in common pharmaceutical excipients. , 2007, Journal of pharmaceutical sciences.

[21]  M. Durrani,et al.  Acrylic polymers: A review of pharmaceutical applications , 1997 .

[22]  P. Mura,et al.  Influence of formulation and process variables on in vitro release of theophylline from directly-compressed Eudragit matrix tablets. , 2005, Farmaco.

[23]  M. Gohel,et al.  A review of co-processed directly compressible excipients. , 2005, Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques.

[24]  M. Christensen,et al.  Storage of polyvinylpyrrolidone (PVP) in tissues following long-term treatment with a PVP-containing vasopressin preparation. , 2009, Acta Medica Scandinavica.

[25]  Y. Qiu,et al.  Design of pH-independent controlled release matrix tablets for acidic drugs. , 2003, International journal of pharmaceutics.

[26]  K. P. Prasad,et al.  Uptake of water by excipients in tablets , 1989 .

[27]  A. Barkley,et al.  The Use of Acrylic Resins for Improved Aqueous Enteric Coating , 2004 .

[28]  I. Saracovan,et al.  Measurement of the surface energy of lubricated pharmaceutical powders by inverse gas chromatography. , 2006, International journal of pharmaceutics.

[29]  J. Mcginity,et al.  Properties of Tablets Containing Granulations of Ibuprofen and an Acrylic Copolymer Prepared by Thermal Processes , 2001, Pharmaceutical development and technology.

[30]  M. Johansson Influence of the granulation technique and starting material properties on the lubricating effect of granular magnesium stearate , 1985, The Journal of pharmacy and pharmacology.

[31]  G. Bolhuis,et al.  Excipients for Direct Compaction—an Update , 2006, Pharmaceutical development and technology.

[32]  K. Yuen,et al.  Drug-Polymer Mixed Coating: A New Approach for Controlling Drug Release Rates in Pellets , 2006, Pharmaceutical development and technology.

[33]  J. Bossert,et al.  Effect of Mixing on the Lubrication of Crystalline Lactose by Magnesium Stearate , 1980 .

[34]  C. Rhodes,et al.  PHARMACEUTICAL AND COSMETIC USES OF TALC , 1990 .

[35]  C. Rhodes,et al.  Optimization of Tablet Formulations Containing Talc , 1991 .

[36]  S. M. Blaug,et al.  Interaction of dextroamphetamine sulfate with spray-dried lactose. , 1972, Journal of pharmaceutical sciences.

[37]  I. Colombo,et al.  A combination of vapor sorption and dynamic laser light scattering methods for the determination of the Flory parameter χ and the crosslink density of a powdered polymeric gel , 2000 .

[38]  D. F. Steele,et al.  Chemical characterisation of sodium starch glycolate particles. , 2002, International journal of pharmaceutics.

[39]  R. Bodmeier,et al.  Dry Powder Coating of Pellets with Micronized Eudragit® RS for Extended Drug Release , 2003, Pharmaceutical Research.

[40]  G. Bolhuis,et al.  Improvement of dissolution of poorly soluble drugs by solid deposition on a super disintegrant. II. The choice of super disintegrants and effect of granulation , 1997 .

[41]  P. Parab,et al.  Sustained Release from Precirol® (Glycerol Palmito-Stearate) Matrix. Effect of Mannitol and Hydroxypropyl Methylcellulose on the Release of Theophylline , 1986 .

[42]  M. Córdoba-Díaz,et al.  Validation of a high-performance liquid chromatographic method for the determination of norfloxacin and its application to stability studies (photo-stability study of norfloxacin). , 1999, Journal of pharmaceutical and biomedical analysis.

[43]  P. Vihervaara,et al.  Physical and lubrication properties of magnesium stearate. , 1992, Journal of pharmaceutical sciences.

[44]  M. H. Rubinstein,et al.  Structure-lubricity evaluation of magnesium stearate , 1988 .

[45]  Jaedeok Yoo,et al.  Evaluation of Critical Formulation Factors in the Development of a Rapidly Dispersing Captopril Oral Dosage Form , 2003, Drug development and industrial pharmacy.

[46]  E. Yonemochi,et al.  Application and mechanism of inhalation profile improvement of DPI formulations by mechanofusion with magnesium stearate. , 2008, Chemical & pharmaceutical bulletin.

[47]  J. Richards,et al.  Batch Variation of Magnesium Stearate and its Effect on the Dissolution Rate of Salicylic Acid from Solid Dosage Forms , 1982 .

[48]  M. P. Danckwerts,et al.  Pharmaceutical formulation of a fixed-dose anti-tuberculosis combination. , 2003, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[49]  Stanley E. Charm,et al.  Freeze Drying , 1964 .

[50]  The effect of glidant addition on the flowability of bulk particulate solids , 1970 .

[51]  M. Schoog,et al.  Polyvinylpyrrolidone (PVP), its diagnostic, therapeutic and technical application and consequences thereof. , 1971, Arzneimittel-Forschung.

[52]  P. Bracconi,et al.  Structural properties of magnesium stearate pseudopolymorphs: effect of temperature. , 2003, International journal of pharmaceutics.

[53]  R. Suryanarayanan,et al.  Influence of Processing Conditions on the Physical State of Mannitol—Implications in Freeze-Drying , 2007, Pharmaceutical Research.

[54]  D. F. Steele,et al.  Interaction of Moisture with Sodium Starch Glycolate , 2007, Pharmaceutical development and technology.

[55]  Matteo Cerea,et al.  A novel powder coating process for attaining taste masking and moisture protective films applied to tablets. , 2004, International journal of pharmaceutics.

[56]  Raquel López Arellano,et al.  Study of Load Capacity of Avicel PH-200 and Cellactose, Two Direct Compression Excipients, Using Experimental Design , 2000, Drug development and industrial pharmacy.

[57]  E. Mendell An evaluation of carboxymethyl starch as a tablet disintegrant. , 1974, Pharmaceutica acta Helvetiae.

[58]  K. A. Khan,et al.  Effect of disintegrant type upon the relationship between compressional pressure and dissolution efficiency , 1976, The Journal of pharmacy and pharmacology.

[59]  D. O. Kildsig,et al.  An examination of the moisture sorption characteristics of commercial magnesium stearate , 2008, AAPS PharmSciTech.

[60]  M. Blake,et al.  Fluorescent probe study of sulfonamide binding to povidone. , 1977, Journal of pharmaceutical sciences.

[61]  Soo-il Kim,et al.  Comparative Study of Disintegrating Agents in Tiaramide Hydrochloride Tablets , 1989 .

[62]  A. Molokhia,et al.  Aging of Tablets Prepared by Direct Compression of Bases with Different Moisture Content , 1987 .

[63]  H. Ueda,et al.  Dissolution Properties of Glibenclamide in Combinations with Polyvinylpyrrolidone , 1996 .

[64]  Ming Yang,et al.  Formulation Development of Oral Controlled-Release Pellets of Diclofenac Sodium , 1997 .

[65]  Joint Fao,et al.  Evaluation of certain food additives and contaminants. Thirtieth Report of the Joint FAO/WHO Expert Committee on Food Additives. , 1987, World Health Organization technical report series.

[66]  Claus J. W. Rubensdörfer,et al.  Evaluation of Ludipress as a “Multipurpose Excipient” for Direct Compression: Part II: Interactive Blending and Tableting with Micronized Glibenclamide , 1994 .

[67]  T. Uchida,et al.  Preparation and evaluation of Eudragit gels. VI: In vivo evaluation of Eudispert rectal hydrogel and xerogel containing salicylamide. , 1993, Journal of pharmaceutical sciences.

[68]  C. E. Bos,et al.  Lubricant sensitivity in relation to bulk density for granulations based on starch or cellulose , 1991 .

[69]  Xianggui Qu,et al.  Evaluation of the vibratory feeder method for assessment of powder flow properties. , 2004, International journal of pharmaceutics.

[70]  M. Saravanan,et al.  Eudragit NE30D based metformin/gliclazide extended release tablets: formulation, characterisation and in vitro release studies. , 2002, Chemical & pharmaceutical bulletin.

[71]  B. Wedzicha,et al.  Role of glucose in the maillard browning of maltose and glycine: a radiochemical approach. , 2005, Journal of agricultural and food chemistry.

[72]  F. Sadeghi,et al.  Combination of time-dependent and pH-dependent polymethacrylates as a single coating formulation for colonic delivery of indomethacin pellets. , 2006, International journal of pharmaceutics.

[73]  P. Schmidt,et al.  An evaluation of the disintegration efficiency of a sodium starch glycolate prepared from enset starch in compressed tablets , 1996 .

[74]  K. Wagner,et al.  A corn starch/α-lactose monohydrate compound as a new directly compressible excipient , 2002 .

[75]  D. Opota,et al.  Stress relaxation studies of granules as a function of different lubricants. , 2001, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[76]  H C Caldwell,et al.  Dissolution of lithium and magnesium from lithium carbonate capsules containing magnesium stearate. , 1974, Journal of pharmaceutical sciences.

[77]  The Effect of Binary Mixture Composition and Magnesium Stearate Concentration on the Hiestand Tableting Indices and Other Related Mechanical Properties , 2007, Pharmaceutical development and technology.

[78]  R. Fassihi,et al.  Application of response surface methodology to design optimization in formulation of a typical controlled release system , 1995 .

[79]  K. Riepma,et al.  THE EFFECT OF MOISTURE SORPTION ON THE STRENGTH AND INTERNAL SURFACE-AREA OF LACTOSE TABLETS , 1992 .

[80]  Joint Fao,et al.  Evaluation of certain food additives and contaminants. Twenty-seventh Report of the Joint FAO/WHO Expert Committee on Food Additives. , 1983, World Health Organization technical report series.

[81]  A. Bauer-Brandl,et al.  Effectiveness of binders in wet granulation: a comparison using model formulations of different tabletability. , 1997, Drug development and industrial pharmacy.

[82]  J. Mcginity,et al.  Influence of Thermal Processing on the Properties of Chlorpheniramine Maleate Tablets Containing an Acrylic Polymer , 2002, Pharmaceutical development and technology.

[83]  M. Volpe,et al.  Angiotensin II-receptor antagonist in the treatment of hypertension , 2005, Current hypertension reports.

[84]  J. Carstensen,et al.  An examination of the physical properties of pure magnesium stearate , 1988 .

[85]  Jin Sun,et al.  Time- and pH-dependent colon-specific drug delivery for orally administered diclofenac sodium and 5-aminosalicylic acid. , 2004, World journal of gastroenterology.

[86]  M. Kaufman,et al.  Characterization of a Solid State Reaction Product from a Lyophilized Formulation of a Cyclic Heptapeptide. A Novel Example of an Excipient-Induced Oxidation , 1996, Pharmaceutical Research.

[87]  S. Neau,et al.  The solution stability of vancomycin in the presence and absence of sodium carboxymethyl starch , 1998 .

[88]  G. Bolhuis,et al.  New Developments in Spray-Dried Lactose , 2004 .

[89]  M. Alonso,et al.  Development of a microencapsulated form of cefuroxime axetil using pH-sensitive acrylic polymers. , 1997, Journal of microencapsulation.

[90]  G. Alderborn,et al.  Compression behaviour and tablet-forming ability of spray-dried amorphous composite particles. , 2004, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[91]  D. Horn,et al.  Chromatographic study of interactions between polyvinylpyrrolidone and drugs. , 1982, Journal of pharmaceutical sciences.

[92]  Hirofumi Takeuchi,et al.  Spray-Dried Lactose Composite Particles Containing an Ion Complex of Alginate-Chitosan for Designing a Dry-Coated Tablet Having a Time-Controlled Releasing Function , 2001, Pharmaceutical Research.

[93]  Divyakant Desai,et al.  Physical interactions of magnesium stearate with starch-derived disintegrants and their effects on capsule and tablet dissolution , 1993 .

[94]  P. York,et al.  Physical and chemical characteristics of some high purity magnesium stearate and palmitate powders , 1985 .

[95]  G. Bolhuis,et al.  Effect of variation of degree of substitution, crosslinking and purity on the desintegration efficiency of sodium starch glycolate , 1984 .

[96]  P. Davidson,et al.  Antimicrobials in foods. , 1993 .

[97]  Sr. Richard J. Lewis,et al.  Sax's Dangerous Properties of Industrial Materials Eleventh Edition CD-ROM Networkable Version 11+ Users , 2005 .

[98]  P. Schmidt,et al.  Investigations on polymorphism of mannitol/ sorbitol mixtures after spray-drying using Differential scanning calorimetry, X-ray diffraction and Near-Infrared spectroscopy , 2000 .

[99]  K. Picker,et al.  Evaluation of a new coprocessed compound based on lactose and maize starch for tablet formulation , 2004, AAPS PharmSci.

[100]  J. Schwartz,et al.  Selecting Key Pharmaceutical Formulation Factors by Regression Analysis , 1979 .

[101]  J. Plaizier-Vercammen,et al.  Interaction of povidone with aromatic compounds III: Thermodynamics of the binding equilibria and interaction forces in buffer solutions at varying pH values and varying dielectric constant. , 1982, Journal of pharmaceutical sciences.

[102]  R. Young,et al.  COSMETIC TALC AND OVARIAN CANCER , 1979, The Lancet.

[103]  G. Bolhuis,et al.  Materials for Direct Compaction , 1995 .

[104]  L. Augsburger,et al.  Disintegrating Agents in Hard Gelatin Capsules. Part I: Mechanism of Action , 1988 .

[105]  E. L. Parrott,et al.  Effect of Tablet Lubricants on Axial and Radial Work of Failure , 1982 .

[106]  J. Mužíková,et al.  A study of the properties of tablets from coprocessed dry binders composed of alpha-lactose monohydrate and different types of cellulose. , 2007, Ceska a Slovenska farmacie : casopis Ceske farmaceuticke spolecnosti a Slovenske farmaceuticke spolecnosti.

[107]  E. Shefter,et al.  Drug-polyvinylpyrrolidone (PVP) dispersions. A differential scanning calorimetric study , 1980 .

[108]  C. Graffner,et al.  Water-solid interactions. III. Effect of glass transition temperature, Tg, and processing on tensile strength of compacts of lactose and lactose/polyvinyl pyrrolidone. , 1996, Pharmaceutical development and technology.

[109]  J. Gaddum,et al.  United States Pharmacopeia , 1955, Nature.

[110]  Marc S. Gordon,et al.  THE EFFECT OF AGING ON DISINTEGRANT EFFICIENCY IN DIRECT COMPRESSION TABLETS WITH VARIED SOLUBILITY AND HYGROSCOPICITY, IN TERMS OF DISSOLUTION , 1990 .

[111]  I. McNeill Hypersensitivity Reaction to Mannitol , 1985, Drug intelligence & clinical pharmacy.

[112]  M. H. Rubinstein,et al.  The effect of mixing time of magnesium stearate on the tableting properties of dried microcrystalline cellulose. , 1983, Pharmaceutica acta Helvetiae.

[113]  P. Paronen,et al.  Effects of Ethanol to Water Ratio in Feed Solution on the Crystallinity of Spray-Dried Lactose , 2002, Drug development and industrial pharmacy.

[114]  M. Córdoba-Díaz,et al.  Influence of Pharmacotechnical Design on the Interaction and Availability of Norfloxacin in Directly Compressed Tablets with Certain Antacids , 2000, Drug development and industrial pharmacy.

[115]  J. Campbell,et al.  EFFECTS OF SELECTED U.S.P. TALCS ON ACETYLSALICYLIC ACID STABILITY IN TABLETS. , 1964, Journal of pharmaceutical sciences.

[116]  L. Simioni,et al.  Should Magnesium Stearate be Assessed in the Formulation of Solid Dosage Forms by Weight or by Surface Area , 1984 .

[117]  P. Palevsky,et al.  Maltose-Induced Hyponatremia , 1993, Annals of Internal Medicine.

[118]  C. Lerk,et al.  Alterations of α-Lactose During DifferentialScanning Calorimetry , 1984 .

[119]  R. Walker,et al.  Toxicology of sorbic acid and sorbates. , 1990, Food additives and contaminants.

[120]  D. Norris,et al.  EVALUATION OF BATCH-TO-BATCH AND MANUFACTURER-TO- MANUFACTURER VARIABILITY IN THE PHYSICAL PROPERTIES OF TALC AND STEARIC ACID , 1994 .

[121]  U. Elofsson,et al.  Droplet and particle size relationship and shell thickness of inhalable lactose particles during spray drying. , 2003, Journal of pharmaceutical sciences.

[122]  S. Smolinske CRC Handbook of Food, Drug, and Cosmetic Excipients , 1992 .

[123]  P. Kleinebudde,et al.  A new multiparticulate delayed release system.: Part II: Coating formulation and properties of free films , 1997 .

[124]  K. Yuen,et al.  Eudragit NE40–Drug Mixed Coating System for Controlling Drug Release of Core Pellets , 2005, Drug Development and Industrial Pharmacy.

[125]  E. Gumand-Hoyer,et al.  [Individual sensitivity to lactose in lactose malabsorption]. , 1977, Ugeskrift for laeger.

[126]  H. Brittain,et al.  Physical characterization of the polymorphic variations of magnesium stearate and magnesium palmitate hydrate species , 1997 .

[127]  Kalakonda Sri Nataraj,et al.  The effect of tablet formulation and hardness on in vitro release of cephalexin from Eudragit L100 based extended release tablets. , 2002, Biological & pharmaceutical bulletin.

[128]  R. Guchardi,et al.  Influence of fine lactose and magnesium stearate on low dose dry powder inhaler formulations. , 2008, International journal of pharmaceutics.

[129]  K. Kolter,et al.  Formulation and Development of Tablets Based on Ludipress and Scale-Up from Laboratory to Production Scale , 2000, Drug development and industrial pharmacy.

[130]  O. Meyer,et al.  Magnesium stearate given perorally to rats. A short term study. , 1980, Toxicology.

[131]  G. Finet,et al.  Influence of the morphogranulometry and hydrophobicity of talc on its antisticking power in the production of tablets. , 2005, International journal of pharmaceutics.

[132]  P. York,et al.  Effect of commercial and high purity magnesium stearates on in-vitro dissolution of paracetamol DC tablets , 1992 .

[133]  G. Levy,et al.  EFFECT OF CERTAIN TABLET FORMULATION FACTORS ON DISSOLUTION RATE OF THE ACTIVE INGREDIENT. III. TABLET LUBRICANTS. , 1963, Journal of pharmaceutical sciences.

[134]  Deepak S. Phadke,et al.  Effect of Degassing Temperature on the Specific Surface Area and Other Physical Properties of Magnesium Stearate , 1994 .

[135]  G. Buckton,et al.  The use of thermal techniques to assess the impact of feed concentration on the amorphous content and polymorphic forms present in spray dried lactose , 1997 .

[136]  S. K. Tee,et al.  The use of different sugars as fine and coarse carriers for aerosolised salbutamol sulphate. , 2000, International journal of pharmaceutics.

[137]  D. Sekulović,et al.  The investigation of the influence of Explotab on the disintegrations of tablets. , 1986, Die Pharmazie.

[138]  C. Dukes,et al.  Further Experiments on Implantation of Materials into the Urinary Bladder of Mice , 1964, British Journal of Cancer.

[139]  M S Gordon,et al.  Effect of tablet solubility and hygroscopicity on disintegrant efficiency in direct compression tablets in terms of dissolution. , 1987, Journal of Pharmacy and Science.

[140]  I. Schwartz,et al.  Pulmonary vascular talc granulomatosis. , 1986, JAMA.

[141]  P. Young,et al.  Novel Temperature Controlled Surface Dissolution of Excipient Particles for Carrier Based Dry Powder Inhaler Formulations , 2006, Drug development and industrial pharmacy.

[142]  F. Cui,et al.  Preparation of roxithromycin-polymeric microspheres by the emulsion solvent diffusion method for taste masking. , 2006, International journal of pharmaceutics.

[143]  D. Craig,et al.  Characterisation of spray-dried lactose using modulated differential scanning calorimetry , 1998 .

[144]  Gerad Klaas Bolhuis,et al.  THE RELATIONSHIP BETWEEN BULK-DENSITY AND COMPACTIBILITY OF LACTOSE GRANULATIONS , 1994 .

[145]  A. Starr,et al.  Mannitol hemodilution-perfusion: the kinetics of mannitol distribution and excretion during cardiopulmonary bypass. , 1967, The Journal of surgical research.

[146]  G. Bolhuis,et al.  Studies on tableting properties of lactose. VII. The effect of variations in primary particle size and percentage of amorphous lactose in spray dried lactose products , 1987 .

[147]  Arvind K. Bansal,et al.  Coprocessed excipients for solid dosage forms , 2004 .

[148]  P. Paronen,et al.  Lactose modifications enhance its drug performance in the novel multiple dose Taifun DPI. , 2002, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[149]  Final Report of the Safety Assessment of Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate , 1982 .

[150]  C. Lefebvre,et al.  Study of Different Crystalline forms of Mannitol: Comparative Behaviour under Compression , 1987 .

[151]  J. Bouffard,et al.  Influence of Process Variable and Physicochemical Properties on the Granulation Mechanism of Mannitol in a Fluid Bed Top Spray Granulator , 2005, Drug development and industrial pharmacy.

[152]  J. Mcginity,et al.  Influence of hydroxyethylcellulose on the drug release properties of theophylline pellets coated with Eudragit RS 30 D. , 2005, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[153]  T. Matsubara,et al.  Pseudo-polymorphism and crystalline transition of magnesium stearate , 1992 .

[154]  C. Lerk,et al.  Interaction of tablet disintegrants and magnesium stearate during mixing. II. Effect on dissolution rate. , 1982, Pharmaceutica acta Helvetiae.

[155]  Z. Chowhan,et al.  Drug-excipient interactions resulting from powder mixing. V. Role of sodium lauryl sulfate , 1990 .

[156]  The production and properties of spray dried lactose. 1. The construction of an experimental spray drier and the production of spray dried lactose under various conditions of operation. , 1971, Pharmaceutica acta Helvetiae.

[157]  M. H. Rubinstein,et al.  An Investigation into Some Pharmaceutical Interactions by Differential Scanning Calorimetry , 1981 .

[158]  D. Grant,et al.  The release of a model low‐dose drug (riboflavine) from hard gelatin capsule formulations , 1979, The Journal of pharmacy and pharmacology.

[159]  M S Gordon,et al.  Effect of the mode of super disintegrant incorporation on dissolution in wet granulated tablets. , 1993, Journal of pharmaceutical sciences.

[160]  M. Al-Tabakha,et al.  Cellactose a co-processed excipient: a comparison study. , 2008, Pharmaceutical development and technology.

[161]  M. H. Rubinstein,et al.  IN VIVO EVALUATION OF THE EFFECT OF FIVE DISINTEGRANTS ON THE BIOAVAILABILITY OF FRUSEMIDE FROM 40MG TABLETS , 1977, The Journal of pharmacy and pharmacology.

[162]  Fernando Muzzio,et al.  A Homogeneity Study Using NIR Spectroscopy: Tracking Magnesium Stearate in Bohle Bin-Blender , 2003, Drug development and industrial pharmacy.

[163]  Influence of Magnesium Stearate on the Homogeneity of a Prednisone-Granule Ordered Mix , 1981 .

[164]  S. Dann,et al.  Lactose: a definitive guide to polymorph determination. , 2007, International journal of pharmaceutics.

[165]  J. L. Gómez-Amoza,et al.  A comparison of drug loading capacity of cellactose with two ad hoc processed lactose-cellulose direct compression excipients. , 2004, Chemical & pharmaceutical bulletin.

[166]  K. A. Khan,et al.  Further studies of the effect of compaction pressure on the dissolution efficiency of direct compression systems. , 1974, Pharmaceutica acta Helvetiae.

[167]  Yasmin Sultana,et al.  Taste Masking Technologies in Oral Pharmaceuticals: Recent Developments and Approaches , 2004, Drug development and industrial pharmacy.

[168]  K. A. Khan,et al.  Water-sorption properties of tablet disintegrants. , 1975, Journal of pharmaceutical sciences.

[169]  M. Levitt,et al.  A comparison of symptoms after the consumption of milk or lactose-hydrolyzed milk by people with self-reported severe lactose intolerance. , 1995, The New England journal of medicine.

[170]  J. B. Mielck,et al.  The tabletting behaviour of Cellactose® compared with mixtures of celluloses with lactoses , 1996 .

[171]  K. Murthy,et al.  Effect of shear mixing on in vitro drug release of capsule formulations containing lubricants. , 1977, Journal of pharmaceutical sciences.

[172]  M. Johansson Investigations of the mixing time dependence of the lubricating properties of granular and powdered magnesium stearate. , 1985, Acta pharmaceutica Suecica.

[173]  D. F. Steele,et al.  Effect of Moisture on the Compressibility and Compactibility of Sodium Starch Glycolate , 2007, Pharmaceutical development and technology.

[174]  A. Bansal,et al.  Impact of Solid-State Properties on Lubrication Efficacy of Magnesium Stearate , 2005, Pharmaceutical development and technology.

[175]  H. Jun,et al.  Microencapsulation of a Hydrophilic Drug into a Hydrophobic Matrix Using a Salting‐Out Procedure. II. Effects of Adsorbents on Microsphere Properties , 2004, Drug development and industrial pharmacy.

[176]  G. Peck,et al.  The Effect of the Variability in the Physical and Chemical Properties of Magnesium Stearate on the Properties of Compressed Tablets , 1987 .

[177]  Raj Suryanarayanan,et al.  Crystallization of Mannitol below Tg′ during Freeze-Drying in Binary and Ternary Aqueous Systems , 2004, Pharmaceutical Research.

[178]  Xiaorong He,et al.  Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength. , 2007, Journal of pharmaceutical sciences.

[179]  T. Baykara,et al.  COMPARING THE COMPRESSIBILITY OF LUDIPRESS WITH THE OTHER DIRECT TABLETING AGENTS BY USING ACETAMINOPHEN AS AN ACTIVE INGREDIENT , 1991 .

[180]  D. Phadke,et al.  EVALUATION OF PARTICLE SIZE DISTRIBUTION AND SPECIFIC SURFACE AREA OF MAGNESIUM STEARATE , 1991 .

[181]  Z T Chowhan,et al.  Drug-excipient interactions resulting from powder mixing. IV: Role of lubricants and their effect on in vitro dissolution. , 1986, Journal of pharmaceutical sciences.

[182]  M. Stowell,et al.  Handbook of Chemistry and Physics 50th Edn , 1970 .

[183]  C. Rhodes,et al.  Effect of molecular structure variation on the disintegrant action of sodium starch glycolate. , 1985, Journal of pharmaceutical sciences.

[184]  J. Sanderson,et al.  Review article: lactose intolerance in clinical practice – myths and realities , 2007, Alimentary pharmacology & therapeutics.

[185]  The Influence of Magnesium Stearate on time Dependent Strength Changes in Tablets , 1981 .

[186]  D. F. Steele,et al.  Powder Compaction Properties of Sodium Starch Glycolate Disintegrants , 2002, Drug development and industrial pharmacy.

[187]  A. Basit,et al.  A comparative in vitro assessment of the drug release performance of pH-responsive polymers for ileo-colonic delivery. , 2006, International journal of pharmaceutics.

[188]  L. Augsburger,et al.  Adhesion of Tablets in a Rotary Tablet Press II. Effects of Blending Time, Running Time, and Lubricant Concentration , 1982 .

[189]  Z. Chowhan,et al.  Drug-excipient interactions resulting from powder mixing. III: Solid state properties and their effect on drug dissolution. , 1986, Journal of pharmaceutical sciences.

[190]  D. F. Steele,et al.  Characterization of a surface modified dry powder inhalation carrier prepared by “particle smoothing” , 2002, The Journal of pharmacy and pharmacology.

[191]  Y. Lu Humectancies of d‐tagatose and d‐sorbitol , 2001, International journal of cosmetic science.

[192]  Amit Mehrotra,et al.  Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials. , 2007, International journal of pharmaceutics.

[193]  J. Carstensen,et al.  Chemical, physical, and lubricant properties of magnesium stearate. , 1988, Journal of pharmaceutical sciences.

[194]  G. V. Levin Tagatose, the new GRAS sweetener and health product. , 2002, Journal of medicinal food.

[195]  Peter York,et al.  The improved compaction properties of mannitol after a moisture-induced polymorphic transition. , 2003, International journal of pharmaceutics.

[196]  I. Wilding,et al.  Enteric coated HPMC capsules designed to achieve intestinal targeting. , 2002, International journal of pharmaceutics.

[197]  G. Peck,et al.  Development of agglomerated talc. I: Evaluation of fluidized bed granulation parameters on the physical properties of agglomerated talc , 1995 .

[198]  Armand Michoel,et al.  Comparative Evaluation of Co-processed Lactose and Microcrystalline Cellulose with Their Physical Mixtures in the Formulation of Folic Acid Tablets , 2002, Pharmaceutical development and technology.