Preparation of lipid aspirin sustained-release pellets by solvent-free extrusion/spheronization and an investigation of their stability

References

• Jannin V, Musakhanian J, Marchaud D. (2008). Approaches for the development of solid and semi-solid lipid-based formulations. Adv Drug Deliv Rev, 60:734–746.
   PubMed Web of Science ®Google Scholar
• Voinovich D, Moneghini M, Perissutti B, Filipovic-Grcic J, Grabnar I. (2000). Preparation in high-shear mixer of sustained-release pellets by melt pelletisation. Int J Pharm, 203:235–244.
   PubMed Web of Science ®Google Scholar
• Prabhu S, Ortega M, Ma C. (2005). Novel lipid-based formulations enhancing the in vivo dissolution and permeability characteristics of a poorly water-soluble model drug, piroxicam. Int J Pharm, 301:209–216.
   PubMedGoogle Scholar
• Kumar MK, Shah MH, Ketkar A, Mahadik KR, Paradkar A. (2004). Effect of drug solubility and different excipients on floating behaviour and release from glyceryl mono-oleate matrices. Int J Pharm, 272:151–160.
   PubMed Web of Science ®Google Scholar
• Pouton CW. (1985). Self-emulsifying drug delivery systems: assessment of the efficiency of emulsification. Int J Pharm, 27:335–348.
   Web of Science ®Google Scholar
• Breitkreutza J, Bornhoftb M, Wollb F, Kleinebudde P. (2003). Pediatric drug formulations of sodium benzoate: I. Coated granules with a hydrophilic binder. Eur J Pharm Biopharm, 56:247–253.
   PubMed Web of Science ®Google Scholar
• Podczeck F, Knight PE, Newton JM. (2008). The evaluation of modified microcrystalline cellulose for the preparation of pellets with high drug loading by extrusion/spheronization. Int J Pharm, 350:145–154.
   PubMed Web of Science ®Google Scholar
• Cusimano AG, Becker CH. (1968). Spray-congealed fomulations of sulfaethylthiadiazole (SETD) and waxes for prolonged-release medication. Effect of wax. J Pharm Sci, 57:1104–1112.
   PubMed Web of Science ®Google Scholar
• Thies R, Kleinebudde P. (1999). Melt pelletisation of a hygroscopic drug in a high shear mixer. Part 1. Influence of process variables. Int J Pharm, 188:131–143.
   PubMed Web of Science ®Google Scholar
• Sinchaipanid N, Junyaprasert V, Mitrevej A. (2004). Application of hot-melt coating for controlled release of propranolol hydrochloride pellets. Powder Tech, 141:203–209.
   Web of Science ®Google Scholar
• Reitz C, Kleinebudde P. (2007). Solid lipid extrusion of sustained release dosage form. Eur J Pharm Biopharm, 67:440–448.
   PubMed Web of Science ®Google Scholar
• Reitz C, Kleinebudde P. (2009). Spheronization of solid lipid extrudates. Powder Tech, 189:238–244.
   Web of Science ®Google Scholar
• Reitz C, Strachan C, Kleinebudde P. (2008). Solid lipid extrudates as sustained-release matrices: the effect of surface structure on drug release properties. Eur J Pharm Sci, 35:335–343.
   PubMed Web of Science ®Google Scholar
• Gures S, Kleinebudde P. (2011). Dissolution from Solid lipid extrudates containing release modifiers. Int J Pharm, 412:77–84.
   PubMed Web of Science ®Google Scholar
• Windbergs M, Strachan CJ, Kleinebudde P. (2009). Tailor-made dissolution profiles by extruded matrices based on lipid polyethylene glycol mixtures. J Controlled Release, 137:211–216.
   PubMed Web of Science ®Google Scholar
• Windbergs M, Strachan CJ, Kleinebudde P. (2009). Influence of structural variations on drug release from lipid/polyethylene glycol matrices. Eur J Pharm Sci, 35:555–562.
   Google Scholar
• Witzleb R, Kanikanti V.-R, Hamann H.-J, Kleinebudde P. (2011). Solid lipid extrusion with small die diameters-Electrostatic charging, taste masking and continuous production. Eur J Pharm Biopharm, 77:170–177.
   PubMed Web of Science ®Google Scholar
• Michalk A, Kanikanti V.-R, Hamann H.-J, Kleinebudde P. (2008). Controlled release of active as a consequence of the die diameter in solid lipid extrusion. J Controlled Release, 132:35–41.
   PubMed Web of Science ®Google Scholar
• Witzleb R, Kanikanti V.-R, Hamann H.-J, Kleinebudde P. (2011). Influence of needle-shaped drug particles on the solid lipid extrusion process. Powder Tech, 207:407–413.
   Web of Science ®Google Scholar
• Gures S, Siepmann F, Siepmann J, Kleinebudde P. (2011). Drug release from extruded solid lipid matrices: Theoretical predictions and independent experiments. Eur J Pharm Biopharm. DOI: 10.1016/j.ejpb.2011.10.002.
   PubMed Web of Science ®Google Scholar
• Krause J, Thommes M, Breitkreutz J. (2009). Immediate release pellets with lipid binders obtained by solvent-free cold extrusion. Eur J Pharm Biopharm, 71:138–144.
   PubMed Web of Science ®Google Scholar
• Windbergs M, Strachan CJ, Kleinebudde P. (2009). Understanding the solid-state behaviour of triglyceride solid lipid extrudates and its influence on dissolution. Eur J Pharm Biopharm, 71:80–87.
   PubMed Web of Science ®Google Scholar
• Fahmy R, Marmane W, Bensley DJ, Hollenbeck RG. (2001). Dissolution testing of aspirin boluses. Dissolution Tech, 8:1–4.
   Google Scholar
• Siepmann J, Peppas NA. (2001). Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv Drug Deliv Rev, 48:139–157.
   PubMed Web of Science ®Google Scholar
• Ozyazici M, Gokce EH, Ertan G. (2006). Release and diffusional modeling of metronidazole lipid matrices. Eur J Pharm Biopharm, 63:331–339.
   PubMed Web of Science ®Google Scholar
• Jaminet F, Evrard G. (1966). [Studies on the stabilizing influence of precirol on aspirin preparations]. Pharm Acta Helv, 41:601–606.
   PubMedGoogle Scholar
• Sutananta W, Craig DQM, Newton JM. (1994). The effects of ageing on the thermal behaviour and mechanical properties of pharmaceutical glycerides. Int J Pharm, 111:51–62.
   Web of Science ®Google Scholar
• Hamdani J, Moes AJ, Amighi K. (2003). Physical and thermal characterization of Precirol® and Compritol® as lipophilic glycerides used for the preparation of controlled-release matrix pellets. Int J Pharm, 260: 47–57.
   PubMed Web of Science ®Google Scholar
• Brubach JB, Jannin V, Mahler B, Bourgaux C, Lessieur P, Roy P et al. (2007). Structural and thermal characterization of glyceryl behenate by X-ray diffraction coupled to differential calorimetry and infrared spectroscopy. Int J Pharm, 336:248–256.
   PubMed Web of Science ®Google Scholar
• Windbergs M, Strachan CJ, Kleinebudde P. (2009). Influence of the composition of glycerides on the solid-state behaviour and the dissolution profiles of solid lipid extrudates. Int J Pharm, 381:184–191.
   PubMed Web of Science ®Google Scholar
• Dennis AB, Farr SJ, Kellaway IW, Taylor G, Davidson R. (1990). In vivo evaluation of rapid release and sustained release Gelucire capsule formulations. Int J Pharm, 65:85–100.
   Web of Science ®Google Scholar
• Cheboyina S, Wyandt CM. (2008). Wax-based sustained release matrix pellets prepared by a novel freeze pelletization technique I. Formulation and process variables affecting pellet characteristics. Int J Pharm, 359:158–166.
   PubMed Web of Science ®Google Scholar