Preparation and, in vitro, preclinical and clinical studies of aceclofenac spherical agglomerates

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 70, Issue 2, 2008, Pages 674-683

  Usha, Achutha Nayak ^a   Mutalik, Srinivas ^a,c   Reddy, Meka Sreenivasa ^a   Ranjith, Averineni Kumar ^a   Kushtagi, Pralhad ^b   Udupa, Nayanabhirama ^a  

^a MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES   (India)

^b KASTURBA MEDICAL COLLEGE   (India)

^c UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Aceclofenac; Analgesic; Anti inflammatory; Direct compression; Pharmacokinetics; Spherical crystallization; Tablets; Toxicity

Indexed keywords

ACECLOFENAC; HYDROXYPROPYLMETHYLCELLULOSE; POLYMER; SOLVENT;

ADULT; ANALGESIC ACTIVITY; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIINFLAMMATORY ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL STUDY; CONTROLLED STUDY; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG HALF LIFE; DRUG RELEASE; DRUG SOLUBILITY; DRUG STRUCTURE; DRUG SYNTHESIS; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; INFRARED SPECTROSCOPY; LIQUID; LIQUID CHROMATOGRAPHY; MALE; MAXIMUM PLASMA CONCENTRATION; MICROMERITIC PROPERTY; NONHUMAN; NORMAL HUMAN; PARTICLE SIZE; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; POROSITY; RAT; SCANNING ELECTRON MICROSCOPE; SPHERICAL AGGLOMERATE; SPHERICAL CRYSTALLIZATION TECHNIQUE; STATISTICAL ANALYSIS; TABLET FORMULATION; TECHNIQUE; WISTAR RAT; X RAY DIFFRACTION;

ADULT; ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; DICLOFENAC; DRUG STABILITY; HUMANS; MALE; RATS; RATS, WISTAR; SOLUBILITY; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 52949121078     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2008.06.010     Document Type: Article

References (25)

1. Shangraw R.F. Compressed tablets by direct compression. In: Lieberman H.A., Lachman L., and Schwartz J.B. (Eds). Pharmaceutical Dosage Forms vol. 1 (1989), Marcel Dekker, New York 195-246
2. Szabo-Revesz P., Hodi K.P., Eros I., and Farkas B. Development of spherical crystal agglomerates of an aspartic acid salt for direct tablet making. Powder Technol. 114 (2001) 118-124
3. Sano A., Kuriki T., Handa T., Takeuchi H., and Kawashima Y. Particle design of tolbutamide in the presence of soluble polymer or surfactant by the spherical crystallization technique: Improvement of dissolution rate. J. Pharm. Sci. 76 (1987) 471-474
4. Kawashima Y., Takeuchi H., Niwa T., Hino T., Yamakoshi M., and Kihara K. The Development of an emulsion-solvent-diffusion preparation method of agglomerated crystals for direct tableting and evaluation of the compressibilities. Powder Technol. 26 (1989) 659-665
5. Paradkar A.R., Mahadik K.R., and Pawar A.P. Spherical crystallization a novel particle design technique. Indian Drugs 31 (1998) 283-299
6. Kawashima Y., Cui F., Takeuchi H., Niwa T., Hino T., and Kiuchi K. Improvement in flowability and compressibility of pharmaceutical crystals for direct tableting by spherical crystallization with a two solvent system. Powder Technol. 78 (1994) 151-157
7. Paradkar A.R., Pawar A.P., and Chordiya J.K. Spherical crystallization of celecoxib. Drug Dev. Ind. Pharm 28 (2002) 1213-1220
8. Bhadra S., Kumar M., Jain S., Agrawal S., and Agrawal G.P. Spherical crystallization of mefenamic acid. Pharm. Tech. Feb (2004) 66-76
9. Di Martino P., Barthelemy C., Piva F., Joiris E., Joiris E., Palmieri G.F., and Martelli S. Improved dissolution behavior of fenbufen by spherical crystallization. Drug Dev. Ind. Pharm. 25 (1999) 1073-1081
10. Alvarez-Larena A., Piniella J.F., and Carrasco E. Crystal structure and spectroscopic study of 2-[(2,6-dichlorophenyl)amino]phenylacetoxyacetic acid (Aceclofenac). J. Chem. Crystallography 22 (1992) 323-328
11. Muatlik S., Usha A.N., Reddy M.S., Ranjith A.K., and Pandey S. Improved bioavailability of aceclofenac from spherical agglomerates: development, in vitro and preclinical studies. Pak. J. Pharm. Sci. 3 (2007) 218-226
12. Gupta V.R., Mutalik S., Patel M.M., and Jani G.K. Spherical crystals of celecoxib to improve solubility, dissolution rate and micromeritic properties. Acta Pharm. 2 (2007) 173-184
13. Chourasia M.K., Nitin K., Jain N.K., Jain S.K., and Jain N. Preparation and characterization of agglomerates of flurbiprofen by spherical crystallization technique. Indian J. Pharm. Sci. (2003) 287-291 May-June
14. Chourasia M.K., Jain A., Jain N., Vaidya S., and Jain S.K. Utilization of spherical crystallization for preparation of directly compressible materials. Indian Drugs 41 (2004) 319-329
15. E.M. Aulton, Pharmaceutical Technology, Pharmaceutics. The Science of Dosage Form Design, English Language Book Society, Churchill/livingstone, 1990, pp. 610-612.
16. Liebermann H.A., Lachman L., and Schwartz J.B. Pharmaceutical Dosage Forms: Tablets vol. 2 (1990), Marcel Dekker, New York
17. Sinko P.J. Micromeritics. Martin's Physical Pharmacy and Pharmaceutical Sciences. 5th ed. (2006), Lippincott Williams & Wilkins 533-560 Indian edition
18. Giants T.W. Crystallinity and Dielectric Properties of PEEK, Poly(ether ether ketone). IEEE Transactions on Dielectrics and Electrical Insulation 1 (1994) 991-999
19. Rasenack N., and Muller B.W. Properties of ibuprofen crystallized under various conditions: a comparative study. Drug Dev. Ind. Pharm. 28 (2002) 1077-1089
20. Lachman L., Lieberman H.A., and Kanic J.L. The theory and practice of industrial pharmacy. 3rd ed. (1990), Varghese publishing house, India pp. 296-303
21. Kulkarni S.K. Handbook of experimental pharmacology, 2nd revised and enlarged edition (1997), Vallabh Prakashan, India pp. 52-56
22. Mutalik S., Paridhavi K., Mallikarjuna R.C., and Udupa N. Analgesic and antipyretic effect of Solanum melongena. Indian J. Pharmacol. 35 (2003) 312-315
23. Mutalik S., Sulochana B., Chetana M., Udupa N., and Uma Devi P. Preliminary studies on acute and subacute toxicity of an antidiabetic herbal preparation, Dianex. Indian J. Exptl. Biol. 41 (2003) 316-320
24. Mutalik S., Naha A., Usha N., Ranjith A.K., Musmade P., Manoj K., Anju P., and Prasanna S. Preparation, in vitro, preclinical and clinical evaluations of once daily sustained release tablets of aceclofenac. Arch. Pharm. Res. 30 (2007) 222-234
25. Femi-Oyewo M.N., and Spring M.S. Studies on paracetamol crystals produced by growth in aqueous solutions. Int. J. Pharm. 112 (1994) 17-28