Micronisation of simvastatin by the supercritical antisolvent technique: In vitro-in vivo evaluation

Journal of Microencapsulation

Volumn 32, Issue 2, 2015, Pages 193-200

  Patel, Jayvadan K ^a   Sutariya, Vijaykumar B ^b  

^a NOOTAN PHARMACY COLLEGE   (India)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

Bioavailability; Micronisation; Simvastatin; Supercritical antisolvent

Indexed keywords

SIMVASTATIN; TRIACYLGLYCEROL; ACETONE; ALCOHOL; CARBON DIOXIDE; DIMETHYL SULFOXIDE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHEMICAL PROCEDURES; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG RELEASE; DRUG SOLUBILITY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; IN VIVO STUDY; INFRARED SPECTROSCOPY; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; MORPHOLOGY; NONHUMAN; PARTICLE SIZE; RAT; SCANNING ELECTRON MICROSCOPY; SUPERCRITICAL ANTISOLVENT; TEMPERATURE; TIME TO MAXIMUM PLASMA CONCENTRATION; X RAY DIFFRACTION; ANIMAL; CHEMISTRY; WISTAR RAT;

ACETONE; ANIMALS; CARBON DIOXIDE; DIMETHYL SULFOXIDE; DRUG LIBERATION; ETHANOL; FEMALE; MALE; RATS; RATS, WISTAR; SIMVASTATIN;

EID: 84931037677     PISSN: 02652048     EISSN: 14645246     Source Type: Journal    
DOI: 10.3109/02652048.2014.995726     Document Type: Article

References (40)

1. Ambike AA, Mahadik KR, Paradkar A. Spray-dried amorphous solid dispersions of simvastatin, a low TG drug; in vitro and in vivo evaluations. Pharm Res, 2005;22:990-8.
2. Bristow S, Shekunov T, Shekunov BY, York P. Analysis of the supersaturation and precipitation process with supercritical CO2. J Supercrit Fluids, 2001;21:257-71.
3. Chavhan S, Joshi G, Petkar K, Sawant K. Enhanced bioavailability and hypolipidemic activity of simvastatin formulations by particle size engineering: Physicochemical aspects and in vivo investigations. Bio Eng J, 2013;79:221-9.
4. Chen YM, Tang M, Chen YP. Recrystallization and micronization of sulfathiazole by applying the supercritical antisolvent technology. Chem Eng J, 2010;165:358-64.
5. Cheng H, Sutton SC, Pipikin JD, Zentner GM, Rogers JD, Schwartz JI, Mitchel YB, Grasing K, Schwartz MS, Amin, RD, et al. Evaluation of sustained/controlled-release dosage forms of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in dogs and humans. Pharm Res, 1993;10:1683-7.
6. Day CY, Chang CJ, Chen CY. Phase equilibrium of ethanol +CO2 and acetone +CO2 at elevated pressures. J Chem Eng Data, 1996;41: 839-43.
7. Dixit RP, Nagarsenker MS. In vitro and in vivo advantage of celecoxib surface solid dispersion and dosage form development. Ind J Pharm Sci, 2007;69:370-7.
8. Elson CE. Tropical oils: Nutritional and scientific issues. Crit Rev Food Sci Nutr, 1992;31:79-102.
9. Godkar PB. 1996. Chemistry of lipids, in textbook of medical laboratory technology. Bombay, India: Bhilani Publishing House.
10. Jun SW, Kim MS, Kim JS, Park HJ, Lee S, Woo JS, Hwang SJ. Preparation and characterization of simvastatin/hydroxypropyl-bcyclodextrin inclusion complex using supercritical antisolvent (SAS) process. Eur J Pharm Sci, 2007;66:413-21.
11. Jung J, Perrut M. Particle design using supercritical fluids: Literature and patent survey. J Supercrit Fluids, 2001;20:179-219.
12. Kang BK, Lee JS, Chon SK, Jeong SY, Yuk SH, Khang G, Lee BH, Cho SH. Development of selfmicroemulsifying drug delivery systems (SMEDDS) for oral bioavailability enhancement of simvastatin in beagle dogs. Int J Pharm, 2004;274:65-73.
13. Kordikowski A, Schenk AP, van Nielen RM, Peters CJ. Volume expansions and vapor-liquid equilibria of binary mixtures of a variety of polar solvents and certain near-critical solvents. J Supercrit Fluids, 1995;8:205-16.
14. Kulhari H, Pooja D, Prajapati SK, Chauhan AS. Performance evaluation of PAMAM dendrimer based simvastatin formulations. Int J Pharm, 2011;405:203-9.
15. McClelland CA, Stubbs RJ, Fix JA, Pogany SA, Zentner GM. Enhancement of 3-hydroxy-3-methylglutaryl-coenzyme A (HMGCoA) reductase inhibitor efficacy through administration of a controlled-porosity osmotic pump dosage form. Pharm Res, 1991;8: 873-6.
16. Meng J, Zheng L. Application of mixture experimental design to simvastatin apparent solubility predictions in the microemulsifion formed by self-microemulsifying. Drug Dev Ind Pharm, 2007;33: 927-31.
17. Moshashaee S, Bisrat M, Forbes RT, Nyqvist H, York P. Supercritical fluid processing of proteins. I: Lysozyme precipitation from organic solution. Eur J Pharm Sci, 2000;11:239-45.
18. Muller RH, Jacobs C, Kayser O. Nanosuspensions as particulate drug formulations in therapy. Rationale for development and what we can expect for the future. Adv Drug Delivery Rev, 2001;47:3-19.
19. Oh DJ, Lee BC. Solubility of simvastation and lovastatin in mixtures of dichloromethane and supercritical carbon dioxide. J Chem Eng Data, 2007;52:1273-9.
20. Pandya P, Gattani S, Jain P, Khirwal L, Surana S. Co-solvent evaporation method for enhancement of solubility and dissolution rate of poorly aqueous soluble drug simvastatin: In vitro-in vivo evaluation. AAPS PharmSciTech, 2008;9:1247-52.
21. Patel J, Patil P. Preparation and characterization of amoxicillin mucoadhesive microparticles using solution-enhanced dispersion by supercritical CO2. J Microencapsulation, 2012;29:398-408.
22. Patel K, Padhye S, Nagarsenker M. Duloxetine HCl lipid nanoparticles: Preparation, characterization, and dosage form design. AAPS PharmSciTech, 2012;13:125-33.
23. Patil P, Patil V, Paradkar A. Formulation of a self-emulsifying system for oral delivery of simvastatin: In vitro and in vivo evaluation. Acta Pharm, 2007;57:111-22.
24. Rehman M, Shekunov BY, York P, Colthorpe P. Solubility and precipitation of nicotinic acid in supercritical carbon dioxide. J Pharm Sci, 2001;90:1570-82.
25. Reverchon E, Caputo G, DeMarco I. Role of phase behaviour and atomization in the supercritical antisolvent precipitation. Ind Eng Chem Res, 2003;42:6406-14.
26. Reverchon E, Della Porta G. Production of antibiotic micro-and nanoparticles by supercritical antisolvent precipitation. Powder Technol, 1999;106:23-9.
27. Reverchon E, Della Porta G, Falivene MG. Process parameters and morphology in amoxicillin micro and submicro particle generation by supercritical antisolvent precipitation. J Supercrit Fluids, 2000;17: 239-48.
28. Reverchon E. Supercritical antisolvent precipitation of micro-and nanoparticles. J Supercrit Fluids, 1999;15:1-21.
29. Shekunov BY, York P. Crystallization processes in pharmaceutical technology and drug delivery design. J Cryst Growth, 2000;211:122-6.
30. Suresh G, Manjunath K, Venkateswarlu V, Satyanarayana V. Preparation, characterization, and in vitro and in vivo evaluation of lovastatin solid lipid nanoparticles. AAPS PharmSciTech, 2007;8:162-70.
31. Tavares Cardoso MA, Monteiro GA, Cardoso JP, Prazeres TJV, Figueiredo JMF, Martinho JMG, Cabral JMS, Palavra AMF. Supercritical antisolvent micronization of minocycline hydrochloride. J Supercrit Fluids, 2008;44:238-44.
32. Tenorio A, Gordillo MD, Pereyra CM, Martínez de la Ossa EJ. Controlled submicro particle formation of ampicillin by supercritical antisolvent precipitation. J Supercrit Fluids, 2007;40:308-16.
33. Tu LS, Dehghani F, Foster NR. Micronization and microencapsulation of pharmaceuticals using a carbon dioxide antisolvent. Powder Technol, 2002;126:134-49.
34. Tubic-Grozdanis M, Hilfinger JM, Amidon GL, Kim JS, Kijek P, Staubach P, Langguth P. Pharmacokinetics of the CYP 3A substrate simvastatin following administration of delayed versus immediate release oral dosage forms. Pharm Res, 2008;25:1591-600.
35. Turk M, Hils P, Helfgen B, Schaber K, Martin HJ, Wahl MA. Micronization of pharmaceutical substances by the rapid expansion of supercritical solutions (RESS): A promising method to improve bioavailability of poorly soluble pharmaceutical agents. J Supercrit Fluids, 2002;22:75-84.
36. Ungaro F, Giovino C, Catanzano O, Miro A, Mele A, Quaglia F, Rotonda MIL. Use of cyclodextrins as solubilizing agents for simvastatin: Effect of hydroxypropyl-b-cyclodextrin on lactone/hydroxyacid aqueous equilibrium. Int J Pharm, 2011;404:49-56.
37. USP 24/NF 19. 2000. United States Pharmacopeial Convention. Rockville.
38. Vivek K, Reddy H, Murthy RS. Investigations of the effect of the lipid matrix on drug entrapment, in vitro release, and physical stability of olanzapine-loaded solid lipid nanoparticles. AAPS PharmSciTech, 2007;8:16-24.
39. Won DH, Kim MS, Lee S, Park JS, Hwang SJ. Improved physicochemical characteristics of felodipine solid dispersion particles by supercritical anti-solvent precipitation process. Int J Pharm, 2005; 301:199-203.
40. Zhang Z, Bu H, Gao Z, Huang Y, Gao F, Li Y. The characteristics and mechanism of simvastatin loaded lipid nanoparticles to increase oral bioavailability in rats. Int J Pharm, 2010;394:147-53.