Oral nanoparticulate atorvastatin calcium is more efficient and safe in comparison to lipicure® in treating hyperlipidemia

Lipids

Volumn 43, Issue 3, 2008, Pages 231-241

  Meena, A K ^a   Ratnam, D Venkat ^a   Chandraiah, G ^a   Ankola, D D ^a   Rao, P Rama ^a   Kumar, M N V Ravi ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

Bioavailability; Hyperlipidemia; Nanoparticles; Oral delivery; Rhabdomyolysis

Indexed keywords

ALPHA TOCOPHEROL; ATORVASTATIN; DIDODECYLDIMETHYLAMMONIUM BROMIDE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LIPICURE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NANOPARTICLE; POLYGLACTIN; STABILIZING AGENT; TOCOPHERYL POLYETHYLENE GLYCOL 1000 SUCCINATE; UNCLASSIFIED DRUG; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ANIMAL EXPERIMENT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; HYPERLIPIDEMIA; LIPID DIET; MALE; NONHUMAN; PH; RAT; TRIACYLGLYCEROL BLOOD LEVEL;

ADMINISTRATION, ORAL; ANIMALS; ANTICHOLESTEREMIC AGENTS; BLOOD GLUCOSE; CHOLESTEROL; DISEASE MODELS, ANIMAL; HEPTANOIC ACIDS; HYDROXYMETHYLGLUTARYL COA REDUCTASES; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPIDEMIAS; LACTIC ACID; LIPIDS; MALE; NANOPARTICLES; POLYGLYCOLIC ACID; PYRROLES; RATS; RATS, SPRAGUE-DAWLEY;

RATTUS;

EID: 41249101628     PISSN: 00244201     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11745-007-3142-5     Document Type: Article

References (35)

1. Shitara Y, Sugiyama Y (2006) Pharmacokinetic and pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol Ther 112:71-105
2. Lau YY, Okochi H, Huang Y, Benet LZ (2006) Multiple transporters affect the disposition of atorvastatin and its two active hydroxy metabolites: application of in vitro and ex situ systems. J Pharmacol Exp Ther 316:762-771
3. Black AE, Sinz MW, Hayes RN, Woolf TF (1998) Metabolism and excretion studies in mouse after single and multiple oral doses of the 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor atorvastatin. Drug Metab Dispos 26:755-763
4. Bottorff MB (2006) Statin safety and drug interactions: clinical implications. Am J Cardiol 97:S27
5. Cannon CP, Braunwald E, McCade CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM (2004) Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 350:1495-1504
6. Graham DJ, Staffa JA, Shatin D, Andrade SE, Schech SD, Grenade LL, Gurwitz JH, Chan KA, Goodman MJ, Platt R (2004) Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. J Am Med Assoc 292:2585-2590
7. Thompson PD, Clarkson P, Karas RH (2003) Statin associated myopathy. J Am Med Assoc 289:1681-1690
8. Sirtori CR (1993) Tissue selectivity of hydroxymethylglutaryl coenzyme A (HMG CoA) reductase inhibitors. Pharmacol Ther 60:431-459
9. Antons KA, Williams CD, Baker SK, Phillips PS (2006) Clinical perspectives of statin-induced rhabdomyolysis. Am J Med 119:400-409
10. Bala I, Bhardwaj V, Hariharan S, Sitterberg J, Bakowsky U, Kumar MNVR (2005) Design of biodegradable nanoparticles: a novel approach to encapsulating poorly soluble phytochemical ellagic acid. Nanotechnology 16:2819-2822
11. Shen HR, Li ZD, Zhong MK (2006) HPLC assay and pharmacokinetic study of atorvastatin in beagle dogs after oral administration of atorvastatin self-microemulsifying drug delivery system. Pharmazie 61:18-20
12. Srinivasan K, Viswanad B, Asrat L, Kaul CL, Ramarao P (2005) Combination of high-fat diet-fed and low-dose streptozotocin-treated rat: a model for type 2 diabetes and pharmacological screening. Pharmacol Res 52:313-320
13. Friedewald WT, Levy RI, Fredrickson DS (1972) Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 18:499-502
14. Hariharan S, Bhardwaj V, Bala I, Sitterberg J, Bakowsky U, Kumar MNVR (2006) Design of estradiol loaded PLGA nanoparticulate formulations: a potential oral delivery system for hormone therapy. Pharm Res 23:184-195
15. Ankola DD, Viswanad B, Bhardwaj V, Ramarao P, Kumar MNVR (2007) Development of potent oral nanoparticulate formulation of coenzyme Q10 for treatment of hypertension: can the simple nutritional supplements be used as first line therapeutic agents for prophylaxis/therapy? Eur J Pharm Biopharm 67:361-369
16. Mittal G, Sahana DK, Bhardwaj V, Kumar MNVR (2007) Estradiol loaded PLGA nanoparticles for oral administration: effect of polymer molecular weight and copolymer composition on release behavior in vitro and in vivo. J Control Release 119:77-85
17. Italia JL, Bhatt DK, Bhardwaj V, Tikoo K, Kumar MNVR (2007) PLGA nanoparticles for oral delivery of cyclosporine: nephrotoxicity and pharmacokinetic studies in comparison to Sandimmune Neoral. J Control Release 119-206:197-206
18. Zhang Z, Feng SS (2006) Self-assembled nanoparticles of poly(lactide)-Vitamin ETPGS copolymers for oral chemotherapy. Int J Pharm 324:191-198
19. Mu L, Feng SS (2003) PLGA/TPGS nanoparticles for controlled release of paclitaxel: effects of the emulsifier and drug loading ratio. J Control Release 86:33-48
20. Song KC, Lee HS, Choung IY, Cho KI, Ahn Y, Choi EJ (2006) The effect of type of organic phase solvents on the particle size of poly(D,L- lactide-co-glycolide) nanoparticles. Colloids Surf A Physicochem Eng Aspects 276:162-167
21. Sonaje K, Italia JL, Sharma G, Bhardwaj V, Tikoo K, Kumar MNVR (2007) Development of biodegradable nanoparticles for oral delivery of ellagic acid and evaluation of their antioxidant efficacy against cyclosporine A-induced nephrotoxicity in rats. Pharm Res 24:899-908
22. Mogi T, Ohtake N, Yoshida M, Chimura R, Kamaga Y, Ando S, Tsukamoto T, Nakajima T, Uenodan H, Otsuka M, Matsuda Y, Ohshima H, Makino K (2000) Sustained release of 17β-estradiol from poly (lactide-co-glycolide) microspheres in vitro and in vivo. Colloids Surf B Biointerfaces 17:153-165
23. Panyam J, Dali MM, Sahoo SK, Ma W, Chakravarthi SS, Amidon GL, Levy RJ, Labhasetwar V (2003) Polymer degradation and in vitro release of a model protein from poly(D,L-lactide-co-glycolide) nano-and microparticles. J Control Release 92:173-187
24. Lea AP, McTavish D (1997) Atorvastatin. A review of its pharmacology and therapeutic potential in the management of hyperlipidemias. Drugs 53:828-847
25. Rogers SL, Magliano DJ, Levison DB, Webb K, Clarke PJ, Grobler MP, Liew D (2007) A dose-specific meta-analysis of lipid changes in randomized controlled trials of atorvastatin and simvastatin. Clin Ther 29:242-252
26. Freeman DJ, Norrie J, Sattar N, Neely RDG, Cobbe SM, Ford I, Isles C, Lorimer AR, Macfarlane PW, McKillop JH, Packard CJ, Shepherd J, Gaw A (2001) Pravastatin and the development of diabetes mellitus. Circulation 103:357-362
27. Mangaloglu L, Iderstine SV, Chen B, Taghibiglou C, Cheung R, Adeli K (2000) Effect of atorvastatin (Lipitor™) on VLDL-apoB and VLDL-triglyceride overproduction in vivo in an insulin resistant hamster model. Atherosclerosis 151:45
28. Sakuma S, Suzuki N, Kikuchi H, Hiwatari K, Arikawa K, Kishida A, Akashi M (1997) Absorption enhancement of orally administered salmon calcitonin by polystyrene nanoparticles having poly (N-isopropylacrylamide) branches on their surfaces. Int J Pharm 158:69-78
29. Omar MA, Wilson J, Cox TS (2001) Rhabdomyolysis and HMG-CoA reductase inhibitors. Ann Pharmacother 35:1096-1107
30. Wolfe SM (2004) Dangers of rosuvastatin identified before and after FDA approval. Lancet 363:2189-2190
31. Cilla D, whitfield LR, Gibson DM, Sedman AJ, Posvar EL (1996) Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clin Pharmacol Ther 60:687-695
32. Pasternak RC, Smith SC, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C (2002) ACC/AHA/NHLBI Clinical advisory on the use and safety of statins. Stroke 33:2337-2341
33. Hodel C (2002) Myopathy and rhabdomyolysis with lipid-lowering drug. Toxicol Lett 128:159-168
34. Rimon D, Ludatscher R, Cohen L (1984) Clofibrate-induced muscular syndrome. Case report with ultrastructural findings and review of the literature. Isr J Med Sci 20:1082-1086
35. Ghirlanda G, Oradei A, Manto A, Lippa S, Uccioli L, Caputo S, Greco AV, Littarru GP (1993) Evidence of plasma CoQ10-lowering effect by HMG-CoA reductase inhibitors: a double-blind, placebo-controlled study. J Clin Pharmacol 33:226-229