Elucidating raw material variability-importance of surface properties and functionality in pharmaceutical powders

AAPS PharmSciTech

Volumn 10, Issue 3, 2009, Pages 780-788

  Chamarthy, Sai P ^a,b   Pinal, Rodolfo ^a   Carvajal, M Teresa ^a  

^a PURDUE UNIVERSITY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Excipient variability; Functionality of excipients; Pharmaceutical sameness; Powder functionality; Raw material variability

Indexed keywords

DRUG; STARCH;

ARTICLE; CHEMICAL ANALYSIS; DRUG MANUFACTURE; DRUG PURIFICATION; PHARMACEUTICAL ENGINEERING; POWDER; SURFACE PROPERTY; TABLET COMPRESSION;

ALGORITHMS; CHROMATOGRAPHY, GAS; DRUG COMPOUNDING; EXCIPIENTS; HUMIDITY; PARTICLE SIZE; POWDERS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; STARCH; SURFACE PROPERTIES; TENSILE STRENGTH; THERMODYNAMICS; X-RAY DIFFRACTION;

EID: 70449523099     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-009-9267-5     Document Type: Article

References (48)

1. F Bochner JH Tyrer WD Hooper MJ Eadie 1972 Factors involved in an outbreak of phenytoin intoxication J Neurol Sci 16 4 481 487 5049106 10.1016/0022-510X(72)90053-6 1:STN:280:DyaE383ltVCjsQ%3D%3D
2. JH Tyrer MJ Eadie JM Sutherla WD Hooper 1970 Outbreak of anticonvulsant intoxication in an Australian city Br Med J 4 5730 271 273 5475846 10.1136/bmj.4.5730.271 1:STN:280:DyaE3M%2FisFejug%3D%3D
3. M Landin MP Gonzalez C Souto A Concheiro JL Gomezamoza R Martinezpacheco 1993 Comparison of 2 varieties of microcrystalline cellulose as filler-binders. 2. Hydrochlorothiazide tablets Drug Dev Ind Pharm 19 10 1211 1220 10.3109/03639049309063013 1:CAS:528:DyaK3sXis1Srur4%3D
4. M Landin R Martinezpacheco JL Gomezamoza C Souto A Concheiro RC Rowe 1993 Effect of country-of-origin on the properties of microcrystalline cellulose Int J Pharm 91 2-3 123 131 10.1016/0378-5173(93)90331-9 1:CAS:528: DyaK3sXkvVSjtLo%3D (Pubitemid 23159815)
5. M Landin R Martinezpacheco JL Gomezamoza C Souto A Concheiro RC Rowe 1993 Influence of microcrystalline cellulose source and batch variation on the tabletting behavior and stability of prednisone formulations Int J Pharm 91 2-3 143 149 10.1016/0378-5173(93)90333-B 1:CAS:528:DyaK3sXksFGqtbg%3D (Pubitemid 23159817)
6. M Landin R Martinezpacheco JL Gomezamoza C Souto A Concheiro RC Rowe 1993 Effect of batch variation and source of pulp on the properties of microcrystalline cellulose Int J Pharm 91 2-3 133 141 10.1016/0378-5173(93) 90332-A 1:CAS:528:DyaK3sXkvVSjtLs%3D (Pubitemid 23159816)
7. M Landin MJ Vazquez C Souto A Concheiro JL Gomezamoza R Martinezpacheco 1992 Comparison of 2 varieties of microcrystalline cellulose as filler-binders. 1. Prednisone tablets Drug Dev Ind Pharm 18 3 355 368 10.3109/03639049209043705 1:CAS:528:DyaK38XhsFyktbc%3D
8. CW Symecko CT Rhodes 1997 The effect of compaction force and type of pregelatinized starch on the dissolution of acetaminophen Drug Dev Ind Pharm 23 3 229 238 10.3109/03639049709149798 1:CAS:528:DyaK2sXhsFars7Y%3D
9. E Doelker 1993 Comparative compaction properties of various microcrystalline cellulose types and generic products Drug Dev Ind Pharm 19 17-18 2399 2471 10.3109/03639049309047196 1:CAS:528:DyaK2cXhsVKqtA%3D%3D
10. T Sam 2000 Regulatory implications of excipient changes in medicinal products Drug Inf J 34 3 875 894
11. P Maincent 1999 Potential problems when switching from one excipient to another in drug formulation Therapie 54 1 5 10 10216415 1:STN:280: DyaK1M3jt1Slsw%3D%3D
12. R. B. Casagrande, S. R. Georgetti, W. A. Verri, J. R. Jabor, A. C. Santos, and M. J. V. Fonseca. Evaluation of functional stability of quercetin as a raw material and in different topical formulations by its antilipoperoxidative activity. AAPS PharmSciTech 7(1), (2006).
13. P Timmins I Browning AM Delargy JW Forrester H Sen 1986 Effect of active raw-material variability on tablet production-physicochemical, physicomechanical and pilot-plant studies Drug Dev Ind Pharm 12 8-9 1293 1307 10.3109/03639048609065860 1:CAS:528:DyaL28XltVams7g%3D
14. J Barra R Somma 1996 Influence of the physicochemical variability of magnesium stearate on its lubricant properties: possible solutions Drug Dev Ind Pharm 22 11 1105 1120 10.3109/03639049609065947 1:CAS:528:DyaK28XmvVGmu7Y%3D
15. P Bracconi C Andres A Ndiaye 2003 Structural properties of magnesium stearate pseudopolymorphs: effect of temperature Int J Pharm 262 1-2 109 124 12927393 10.1016/S0378-5173(03)00339-9 1:CAS:528:DC%2BD3sXmtFaksro%3D (Pubitemid 36966699)
16. P Bracconi C Andres A N'Diaye Y Pourcelot 2005 Thermal analyses of commercial magnesium stearate pseudopolymorphs Thermochim Acta 429 1 43 51 10.1016/j.tca.2004.11.021 1:CAS:528:DC%2BD2MXjt1Srurg%3D (Pubitemid 40466932)
17. N Zhao LL Augsburger 2006 The influence of product brand-to-brand variability on superdisintegrant performance: a case study with croscarmellose sodium Pharm Dev Technol 11 2 179 185 16749528 10.1080/10837450600561281 1:CAS:528:DC%2BD28Xlt1SqtL8%3D (Pubitemid 43879941)
18. M Whiteman RJ Yarwood 1990 Variations in lactose NF from 2 different sources and their influence on tablet properties Drug Dev Ind Pharm 16 11 1815 1827 10.3109/03639049009025789 1:CAS:528:DyaK3cXlsFymtL8%3D
19. O'Neil MJ. The Merck index : an encyclopedia of chemicals, drugs, and biologicals. 13th ed. Whitehouse Station: Merck; 2001. p. 8878.
20. R Hoover 2000 Acid-treated starches Food Rev Int 16 3 369 392 10.1081/FRI-100100292 1:CAS:528:DC%2BD3cXlvFaitbo%3D
21. A Srichuwong N Isono T Mishima M Hisamatsu 2005 Structure of lintnerized starch is related to X-ray diffraction pattern and susceptibility to acid and enzyme hydrolysis of starch granules Int J Biol Macromol 37 3 115 121 16243388 10.1016/j.ijbiomac.2005.09.006 1:CAS:528:DC%2BD2MXht1SksLvI (Pubitemid 41607703)
22. G Wierik AC Eissens AC Besemer CF Lerk 1993 Preparation, characterization, and pharmaceutical application of linear dextrins. 1. Preparation and characterization of amylodextrin, metastable amylodextrins, and metastable amylose Pharm Res 10 9 1274 1279 10.1023/A:1018905426751 (Pubitemid 23261825)
23. ASTM E 104-02, Standard practice for maintaining constant relative humidity by means of aqueous solutions. 2002, ASTM International.
24. MCI Amin JT Fell 2002 Tensile strength and bonding in compacts: a comparison of diametral compression and three-point bending for plastically deforming materials Drug Dev Ind Pharm 28 7 809 813 12236066 10.1081/DDC-120005626 1:CAS:528:DC%2BD38XmvFOgt78%3D (Pubitemid 34977798)
25. P Stanley 2001 Mechanical strength testing of compacted powders Int J Pharm 227 1-2 27 38 11564538 10.1016/S0378-5173(01)00782-7 1:CAS:528: DC%2BD3MXmvVentL8%3D (Pubitemid 32868757)
26. CK Tye CC Sun GE Amidon 2005 Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction J Pharm Sci 94 3 465 472 15696587 10.1002/jps.20262 1:CAS:528:DC%2BD2MXisVWhs7o%3D (Pubitemid 40476512)
27. E Joiris P Di Martino C Berneron AM Guyot-Hermann JC Guyot 1998 Compression behavior of orthorhombic paracetamol Pharm Res 15 7 1122 1130 9688070 10.1023/A:1011954800246 1:CAS:528:DyaK1cXkvVWgu78%3D (Pubitemid 28356933)
28. CQ Sun DJW Grant 2001 Influence of crystal structure on the tableting properties of sulfamerazine polymorphs Pharm Res 18 3 274 280 11442264 10.1023/A:1011038526805 1:CAS:528:DC%2BD3MXltVSksLk%3D (Pubitemid 32595813)
29. RW Heckel 1961 An analysis of powder compaction phenomena Trans Metall Soc AIME 221 5 1001 1008
30. RW Heckel 1961 Density-pressure relationships in powder compaction Trans Metall Soc AIME 221 4 671 675 1:CAS:528:DyaF3MXht1ertb0%3D
31. E Ryshkewitch 1953 Compression strength of porous sintered alumina and zirconia, 9th Communication to Ceramography J Am Ceram Soc 36 2 65 68 10.1111/j.1151-2916.1953.tb12837.x
32. JM Newton AB Mashadi F Podczeck 1993 The mechanical-properties of an homologous series of benzoic-acid esters Eur J Pharm Biopharm 39 4 153 157 1:CAS:528:DyaK2cXmtlyhs74%3D
33. J Schultz L Lavielle C Martin 1987 The role of the interface in carbon-fiber epoxy composites J Adhes 23 1 45 60 10.1080/00218468708080469 1:CAS:528:DyaL2sXlvF2nsrY%3D
34. P Mukhopadhyay HP Schreiber 1995 Aspects of acid-base interactions and use of inverse gas-chromatography Colloid Surf A-Physicochem Eng Asp 100 47 71 10.1016/0927-7757(95)03137-3 1:CAS:528:DyaK2MXntFOgtLg%3D
35. NWH Cheetham LP Tao 1998 Variation in crystalline type with amylose content in maize starch granules: an X-ray powder diffraction study Carbohydr Polym 36 4 277 284 10.1016/S0144-8617(98)00007-1 1:CAS:528:DyaK1cXmtlCqu7w%3D
36. S Bates G Zografi D Engers K Morris K Crowley A Newman 2006 Analysis of amorphous and nanocrystalline solids from their X-ray diffraction patterns Pharm Res 23 10 2333 2349 17021963 10.1007/s11095-006-9086-2 1:CAS:528: DC%2BD28XhtVeqsbnM (Pubitemid 44515011)
37. RJ Roberts RC Rowe P York 1995 The relationship between the fracture properties, tensile-strength and critical stress intensity factor of organic-solids and their molecular-structure Int J Pharm 125 1 157 162 10.1016/0378-5173(95)00157-E 1:CAS:528:DyaK2MXot12js78%3D
38. CC Sun 2006 A material-sparing method for simultaneous determination of true density and powder compaction properties-aspartame as an example Int J Pharm 326 1-2 94 99 16926076 10.1016/j.ijpharm.2006.07.016 1:CAS:528: DC%2BD28XhtFKhsLnF (Pubitemid 44647748)
39. A Gupta GE Peck RW Miller KR Morris 2005 Influence of ambient moisture on the compaction behavior of microcrystalline cellulose powder undergoing uni-axial compression and roller-compaction: a comparative study using near-infrared spectroscopy J Pharm Sci 94 10 2301 2313 16136560 10.1002/jps.20430 1:CAS:528:DC%2BD2MXhtVOrurjI (Pubitemid 41665289)
40. CQ Sun 2004 A novel method for deriving true density of pharmaceutical solids including hydrates and water-containing powders J Pharm Sci 93 3 646 653 14762903 10.1002/jps.10595 1:CAS:528:DC%2BD2cXitV2lsLc%3D (Pubitemid 38332297)
41. A Nokhodchi MH Rubinstein 2001 An overview of the effects of material and process variables on the compaction and compression properties of hydroxypropyl methylcellulose and ethylcellulose STP Pharma Sci 11 3 195 202 1:CAS:528:DC%2BD3MXmtVOku7c%3D
42. T Suzuki H Nakagami 1999 Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets Eur J Pharm Biopharm 47 3 225 230 10382106 10.1016/S0939-6411(98)00102-7 1:CAS:528:DyaK1MXktVajuro%3D (Pubitemid 29257881)
43. V Nicolas O Chambin C Andres MH Rochat-Gonthier Y Pourcelot 1999 Preformulation: effect of moisture content on microcrystalline cellulose (Avicel PH-302) and its consequences on packing performances Drug Dev Ind Pharm 25 10 1137 1142 10529895 10.1081/DDC-100102280 1:CAS:528:DyaK1MXmslGlsLw%3D (Pubitemid 29477872)
44. F Khan N Pilpel S Ingham 1988 The effect of moisture on the density, compaction and tensile strength of microcrystalline cellulose Powder Technol 54 3 161 164 10.1016/0032-5910(88)80074-3 1:CAS:528:DyaL1cXhvVyltL8%3D (Pubitemid 18619857)
45. Petteri P, Jukka I. Porosity-pressure functions. In: Alderborn G, Nystrèom C, editors. Pharmaceutical powder compaction technology. New York: Marcel Dekker; 1996. p. 15. 610 p.
46. E Shotton BA Obiorah 1975 Effect of physical-properties on compression characteristics J Pharm Sci 64 7 1213 1216 1151686 10.1002/jps.2600640720 1:CAS:528:DyaE2MXlsFahtb8%3D
47. Wang CC. Mechanical properties and compaction properties of pharmaceutical pellets. Austin: The University of Texas at Austin; 1997. p. 254.
48. M Nardin E Papirer 1990 Relationship between vapor-pressure and surface-energy of liquids-application to inverse gas-chromatography J Colloid Interface Sci 137 2 534 545 10.1016/0021-9797(90)90426-O 1:CAS:528: DyaK3cXkt12kur0%3D (Pubitemid 20698325)