Spray drying of drug-swellable dispersant suspensions for preparation of fast-dissolving, high drug-loaded, surfactant-free nanocomposites

Drug Development and Industrial Pharmacy

Volumn 41, Issue 10, 2015, Pages 1617-1631

  Azad, Mohammad ^a   Arteaga, Colby ^a   Abdelmalek, Beshoy ^a   Davé, Rajesh ^a   Bilgili, Ecevit ^a  

^a NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

Author keywords

Dispersants; Drug nanoparticles; Poorly water soluble; Spray drying; Wet stirred media milling

Indexed keywords

CROSCARMELLOSE SODIUM; DISPERSANT; DODECYL SULFATE SODIUM; GRISEOFULVIN; HYDROXYPROPYLCELLULOSE; MANNITOL; NANOCOMPOSITE; NANOCOMPOSITE MICROPARTICLE; NANOPARTICLE; POLYMER; STABILIZING AGENT; STARCH GLYCOLATE SODIUM; SURFACTANT; UNCLASSIFIED DRUG; CARBOXYMETHYLCELLULOSE; CELLULOSE; STARCH; SUSPENSION;

ARTICLE; CONTROLLED STUDY; CROSS LINKING; DISPERSION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; FEASIBILITY STUDY; LASER DIFFRACTION; PARTICLE SIZE; SCANNING ELECTRON MICROSCOPY; SPRAY DRYING; SUSPENSION; ULTRAVIOLET SPECTROSCOPY; X RAY POWDER DIFFRACTION; ANALOGS AND DERIVATIVES; CHEMISTRY; PHARMACEUTICS; POWDER DIFFRACTION; PROCEDURES;

CARBOXYMETHYLCELLULOSE SODIUM; CELLULOSE; DRUG DELIVERY SYSTEMS; DRUG LIBERATION; MANNITOL; MICROSCOPY, ELECTRON, SCANNING; NANOCOMPOSITES; PARTICLE SIZE; POWDER DIFFRACTION; SODIUM DODECYL SULFATE; STARCH; SUSPENSIONS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84928575619     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2014.976574     Document Type: Article

References (49)

1. Lindenberg M, Kopp S, Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of essential medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm 2004;58:265-78.
2. Noyes A, Whitney W. The rate of solution of solid substances in their own solutions. J Am Chem Soc 1897;19:930-4.
3. Bruno JA, Doty BD, Gustow E, et al. Method of grinding pharmaceutical substances. 1996; US Patent 5518187.
4. 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.
5. Gupta RB, Kompella U. Nanoparticle technology for drug delivery. New York: Taylor and Francis; 2006.
6. Kim CJ. Surface chemistry and colloids, advanced pharmaceutics: physicochemical principles. CRC Press; 2004.
7. Bilgili E, Afolabi 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.
8. Ryde N, Ruddy S. Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate. 2002; US Patent 6375986.
9. Lee J. Drug nano and microparticles processed into solid dosage forms: physical properties. J Pharm Sci 2003;92:2057-68.
10. Tewa-Tagne P, Briançon S, Fessi H. Preparation of redispersible dry nanocapsules by means of spray-drying: development and characterisation. Eur J Pharm Sci 2007;30:124-35.
11. Basa S, Muniyappan T, Karatgi P, et al. Production and in vitro characterization of solid dosage form incorporating drug nanoparticles. Drug Dev Ind Pharm 2008;34:1209-18.
12. Chaubal C, Popescu C. Conversion of nanosuspensions into dry powders by spray drying: a case study. Pharm Res 2008;25: 2302-8.
13. Kim S, Lee J. Effective polymeric dispersants for vacuum, convection and freeze drying of drug nanosuspensions. Int J Pharm 2010;397:218-24.
14. Bhakay A, Bilgili E, Dave R. Recovery of BCS Class II drugs during aqueous redispersion of core-shell type nanocomposite particles produced via fluidized bed coating. Powder Technol 2013;236: 221-34.
15. Bhakay A, Azad M, Vizzotti E, et al. Enhanced recovery and dissolution of griseofulvin nanoparticles from surfactant-free nanocomposite microparticles incorporating wet-milled swellable dispersants. Drug Dev Ind Pharm 2014;40:1509-22.
16. Bhakay A, Azad M, Bilgili E, Dave R. Redispersible fast dissolving nanocomposite microparticles of poorly water-soluble drugs. Int J Pharm Sci 2014;461:367-79.
17. Kesisoglou F, Panmai S, Wu Y. Nanosizing-oral formulation development and biopharmaceutical evaluation. Adv Drug Delivery Rev 2007;59:631-44.
18. Bilgili E, Bhakay A, Azad M, Dave R. Systems and methods for superdisintegrant-based composite particles for dispersion and dissolution of agents. 2013; US Patent Application, US 2013/0295190 A1.
19. Kho K, Hadinoto K. Effects of excipient formulation on the morphology and aqueous re-dispersibility of dry-powder silica nanoaggregates. Colloid Surf A 2010;359:71-81.
20. Hu J, Ng WK, Dong Y, et al. Continuous and scalable process for water-redispersible nanoformulation of poorly aqueous soluble APIs by antisolvent precipitation and spray-drying. Int J Pharm 2011;404: 198-204.
21. Mou D, Chen H, Wan J, et al. Potent dried drug nanosuspensions for oral bioavailability enhancement of poorly soluble drugs with pHdependent solubility. Int J Pharm 2011;413:237-44.
22. Niwa T, Miura S, Danjo K. Design of dry nanosuspension with highly spontaneous dispersible characteristics to develop solubilized formulation for poorly water-soluble drugs. Pharm Res 2011;28: 2339-49.
23. Cerdeira AM, Mazzotti M, Gander B. Miconazole nanosuspensions: influence of formulation variables on particle size reduction and physical stability. Int J Pharm 2010;396:210-8.
24. Knieke C, Azad M, Dave R, Bilgili E. A study of the physical stability of wet media-milled fenofibrate suspensions using dynamic equilibrium curves. Chem Eng Res Des 2013;91: 1245-58.
25. Florence, AT. Drug solubilization in surfactant systems. In: Yalkowsky SH, ed. Techniques of solubilization of drugs. New York: Marcel Dekker; 1981.
26. Verma S, Kumar S, Gokhale R, Burgess DJ. Physical stability of nanosuspensions: investigation of the role of stabilizers on Ostwald ripening. Int J Pharm 2011;406:145-52.
27. Ghosh I, Bose S, Vippagunta R, Harmon F. Nanosuspension for improving the bioavailability of a poorly soluble drug and screening of stabilizing agents to inhibit crystal growth. Int J Pharm 2011;409: 260-8.
28. Gupta S, Kesarla R, Omri A. Formulation strategies to improve the bioavailability of poorly absorbed drugs with special emphasis on self-emulsifying systems. ISRN Pharm 2013. doi:10.1155/2013/848043. Article ID 848043.
29. Liversidge GG, Cundy KC. Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: I. Absolute oral bioavailability of nanocrystalline danazol in beagle dogs. Int J Pharm 1995;125:91-7.
30. Suzuki M, Machida M, Adachi K, et al. Histopathological study of the effects of a single intratracheal instillation of surface active agents on lung in rats. J Toxicol Sci 2000;25: 49-55.
31. Wong J, Brugger A, Khare A, et al. Suspensions for intravenous (IV) injection: a review of development, preclinical and clinical aspects. Adv Drug Delivery Rev 2008;60:939-54.
32. Lebhardt T, Roesler S, Uusitalo H, Kissel T. Surfactant-free redispersible nanoparticles in fast-dissolving composite microcarriers for dry-powder inhalation. Eur J Pharm Biopharm 2011;78: 90-6.
33. Augsburger L, Brzeczko A, Shah U, Hahm H. Superdisintegrants: characterization and function. In: Swarbrick J, ed. Encyclopedia of pharmaceutical technology. New York: Informa Healthcare USA Inc.; 2007:3553-67.
34. Omidian H, Park K. Swelling agents and devices in oral drug delivery. J Drug Delivery Sci Technol 2008;18:83-93.
35. Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996;20:64-74.
36. Azad M, Afolabi A, Patel N, et al. Production of colloidal suspensions of superdisintegrants via wet stirred media milling. Particuology 2014;14:76-82.
37. US FDA. Guidance for industry: dissolution testing of immediaterelease solid oral dosage forms. US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Aug 1997. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm070237.pdf. [last accessed 1 Aug 2014].
38. Qureshi S, Shabnam J. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Eur J Pharm Sci 2001; 12:271-6.
39. Rasenack N, Hartenhauer H, Muller B. Microcrystals for dissolution rate enhancement of poorly water-soluble drugs. Int J Pharm 2003; 254:137-45.
40. Van Eerdenbrugh B, Vermant J, Martens J, et al. A screening study of surface stabilization during the production of drug nanocrystals. J Pharm Sci 2009;98:2091-103.
41. Winnik FM, Winnik MA. The interaction of sodium dodecylsulfate with (hydroxypropyl) cellulose. Polym J 1990;22: 482-8.
42. Petrović LB, Sovilj VJ, Katona, JM, Milanovic JL. Influence of polymer-surfactant interactions on o/w emulsion properties and microcapsule formation. J Colloid Interface Sci 2010;342: 333-9.
43. Quadir A, Kolter K. A comparative study of current superdisintegrants. Pharm Technol 2006;30:s38-42.
44. Brazel CS, Rosen SL. Fundamental principles of polymeric materials. New York: Wiley-Interscience; 1993.
45. Sombatsompop N, Christodoulo K. Penetration of aromatic hydrocar-bons into natural rubber. Polym Polym Compos 1997;5: 377-86.
46. Vehring R, Foss W, Lechuga-Ballesteros D. Particle formation in spray drying. J Aerosol Sci 2007;38:728-46.
47. Maa Y, Nguyen P, Andya J, et al. Effect of spray drying and subsequent processing conditions on residual moisture content and physical/biochemical stability of protein inhalation powders. Pharm Res 1998;15:768-75.
48. Monteiro A, Afolabi A, Bilgili E. Continuous production of drug nanoparticle suspensions via wet stirred media milling: a fresh look at the Rehbinder effect. Drug Dev Ind Pharm 2013;39: 266-83.
49. Van Eerdenbrugh B, Froyen L, Humbeeck J, et al. Alternative matrix formers for nanosuspension solidification: dissolution performance and X-ray microanalysis as an evaluation tool for powder dispersion. Eur J Pharm Sci 2008;35: 344-53.