Investigation into physical-chemical variables affecting the manufacture and dissolution of wet-milled clarithromycin nanoparticles

Pharmaceutical Development and Technology

Volumn 19, Issue 8, 2014, Pages 911-921

  Shahbazi Niaz, Maliheh ^a   Traini, Daniela ^b,c   Young, Paul M ^b,c   Ghadiri, Maliheh ^d   Rohanizadeh, Ramin ^d  

^a SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b WOOLCOCK INSTITUTE OF MEDICAL RESEARCH   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Clarithromycin; Dissolution efficiency; Nanoparticles; Stabilizers; Wet milling

Indexed keywords

CLARITHROMYCIN; NANOPARTICLE; POLOXAMER; POLYMER; POLYVINYL ALCOHOL; SURFACTANT;

ANALYTIC METHOD; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG BIOAVAILABILITY; DRUG MANUFACTURE; DRUG SOLUBILITY; DYNAMIC LIGHT SCATTERING; FREEZE DRYING; IN VITRO STUDY; PARTICLE SIZE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; WETTABILITY; X RAY POWDER DIFFRACTION;

ANTI-BACTERIAL AGENTS; CLARITHROMYCIN; DRUG COMPOUNDING; DRUG STABILITY; EXCIPIENTS; NANOPARTICLES; PARTICLE SIZE; SOLUBILITY;

EID: 84890410228     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2013.840844     Document Type: Article

References (43)

1. Junghanns J-UAH, Mueller RH. Nanocrystal technology, drug delivery and clinical applications. Int J Nanomed 2008;3:295-309
2. Noyes A, Whitney WR. The rate of solution of solid substances in their own solutions. J Am Chem Soc 1897;19:930-934
3. Van Eerdenbrugh B, Van den Mooter G, Augustijns P. Top-down production of drug nanocrystals: Nanosuspension stabilization, miniaturization and transformation into solid products. Int J Pharm 2008;364:64-75
4. Liu P, Rong X, Laru J, et al. Nanosuspensions of poorly soluble drugs: Preparation and development by wet milling. Int J Pharm 2011;411:215-222
5. Peltonen L, Hirvonen J. Pharmaceutical nanocrystals by nanomilling: Critical process parameters, particle fracturing and stabilization methods. J Pharm Pharmacol 2010;62:1569-1579
6. de Waard H, Frijlink HW, Hinrichs WLJ. Bottom-up preparation techniques for nanocrystals of lipophilic drugs. Pharm Res 2011;28: 1220-1223
7. Grubel P, Cave DR. Factors affecting solubility and penetration of clarithromycin through gastric mucus. Aliment Pharmacol Ther 1998;12:569-576
8. Hardy DJ, Guay DRP, Jones RN. Clarithromycin, a unique macrolide - A pharmacokinetic, microbiological, and clinical review. Diagn Microbiol Infect Dis 1992;15:39-53
9. Piscitelli SC, Danziger LH, Rodvold KA. Clarithromycin and azithromycin - new macrolide antibiotics. Clin Pharm 1992;11: 137-152
10. LingHao Q, Wei L. Formulation and evaluation of less-painful clarithromycin lipid microspheres. Arch Pharm Res 2007;30: 1336-1343
11. Traini D, Young PM. Delivery of antibiotics to the respiratory tract: An update. Expert Opin Drug Del 2009;6:897-905
12. Turner S, Ravishankar J, Fassihi R, inventors. Method for improving the bioavailability of orally delivered therapeutics. United State Patent Application, US20060068010 A1, Mar 30, 2006
13. Salem, II, Duzgunes N. Efficacies of cyclodextrin-complexed and liposome-encapsulated clarithromycin against Mycobacterium avium complex infection in human macrophages. Int J Pharm 2003;250:403-414
14. Inoue Y, Yoshimura S, Tozuka Y, et al. Application of ascorbic acid 2-glucoside as a solubilizing agent for clarithromycin: Solubilization and nanoparticle formation. Int J Pharm 2007;331:38-45
15. Yonemochi E, Kitahara S, Maeda S, et al. Physicochemical properties of amorphous clarithromycin obtained by grinding and spray drying. Eur J Pharm Sci 1999;7:331-338
16. Torchilin VP. Nanoparticulates as drug carriers. London: Imperial College Press; 2006
17. Singh-Joy SD, McLain VC. Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics. Int J Toxicol 2008;27:93-128
18. Liang HJ, Yang QX, Deng L, et al. Phospholipid-Tween 80 mixed micelles as an intravenous delivery carrier for paclitaxel. Drug Dev Ind Pharm 2011;37:597-605
19. Kronberg B, Dahlman A, Carlfors J, et al. Preparation and evaluation of sterically stabilized liposomes - colloidal stability, serum stability, macrophage uptake, and toxicity. J Pharm Sci 1990;79:667-671
20. Chen Y, Yang HW. Hydroxypropyl cellulose (Hpc)-stabilized dispersion polymerization of styrene in polar-solvents - effect of reaction parameters. J Polym Sci Polym Chem 1992;30:2765-2772
21. Hong J, Hong CK, Shim SE. Synthesis of polystyrene microspheres by dispersion polymerization using poly(vinyl alcohol) as a steric stabilizer in aqueous alcohol media. Colloid Surf A 2007;302: 225-233
22. Liu Y, Tong Z, Prud'homme RK. Stabilized polymeric nanoparticles for controlled and efficient release of bifenthrin. Pest Manag Sci 2008;64:808-812
23. Vergnault G, Grenier P, Nhamias A, inventors. Spironolactone nanoparticles, compositions and methods related thereto. United State Patent Application, US20080069886 A1, Mar 20, 2008
24. Kumar MP, Rao YM, Apte S. Formulation of nanosuspensions of albendazole for oral administration. Curr Nanosci 2008;4: 53-58
25. Ecevit B, Afolawemi A. A combined microhydrodynamics-polymer adsorption analysis for elucidation of the roles of stabilizers in wet stirred media milling. Int J Pharm 2012;439:193-206
26. Cerdeira AM, Mazzotti M, Gander B. Miconazole nanosuspensions: Influence of formulation variables on particle size reduction and physical stability. Int J Pharm 2010;396:210-218
27. Lee J, Choi JY, Park CH. Characteristics of polymers enabling nanocomminution of water-insoluble drugs. Int J Pharm 2008;355: 328-336
28. Brodka-Pfeiffer K, Langguth P, Grass P, Hausler H. Influence of mechanical activation on the physical stability of salbutamol sulphate. Eur J Pharm Biopharm 2003;56:393-400
29. Sepassi S, Goodwin DJ, Drake AF, et al. Effect of polymer molecular weight on the production of drug nanoparticles. J Pharm Sci 2007;96:2655-2666
30. Kumar N, Salman M, Gangakhedkar KK, inventors. Novel amorphous form of clarithromycin. World Intellectual Property Organization Patent Application, WO2000077017 A1, Dec 21, 2000
31. Westedt U, Rosenberg J, Knobloch M, et al. inventors. Preparation of compositions with essentially noncrystalline embedded macrolide antibiotics. United State Patent, US8337733 B2, Dec 25, 2012
32. Deng Z, Xu S, Li S. Understanding a relaxation behavior in a nanoparticle suspension for drug delivery applications. Int J Pharm 2008;351:236-243
33. Tozuka Y, Ito A, Seki H, et al. Characterization and quantitation of clarithromycin polymorphs by powder X-ray diffractometry and solid-state NMR spectroscopy. Chem Pharm Bull 2002;50: 1128-1130
34. Chokshi RJ, Sandhu HK, Iyer RM, et al. Characterization of physico-mechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion processs as a means to manufacture solid dispersion/solution. J Pharm Sci 2005;94: 2463-2474
35. Hecq J, Deleers M, Fanara D, et al. Preparation and characterization of nanocrystals for solubility and dissolution rate enhancement of nifedipine. Int J Pharm 2005;299:167-177
36. Dolenc A, Kristl J, Baumgartner S, Planinsek O. Advantages of celecoxib nanosuspension formulation and transformation into tablets. Int J Pharm 2009;376:204-212
37. Mashru RC, Sutariya VB, Sankalia MG, Yagnakumar P. Characterization of solid dispersions of rofecoxib using differential scanning calorimeter. J Therm Anal Calorim 2005;82:167-170
38. Strawhecker KE, Manias E. Structure and properties of poly(vinyl alcohol)/Na montmorillonite nanocomposites. Chem Mater 2000; 12:2943-2949
39. Tita B, Fulias A, Bandur G, et al. Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms. J Pharma Biomed 2011;56:221-227
40. Thomas J, Lowman A, Marcolongo M. Novel associated hydrogels for nucleus pulposus replacement. J Biomed Mater Res A 2003;67A: 1329-1337
41. Chakraborty S, Shukla D, Jain A, et al. Assessment of solubilization characteristics of different surfactants for carvedilol phosphate as a function of pH. J Colloid Interf Sci 2009;335:242-249
42. Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975;27:48-49
43. Heng D, Cutler DJ, Chan H-K, et al. What is a suitable dissolution method for drug nanoparticles? Pharm Res 2008;25:1696-1701