Biowaiver monograph for immediate release solid oral dosage forms: Ofloxacin

International Journal of Pharmacy and Pharmaceutical Sciences

Volumn 2, Issue SUPPL. 4, 2010, Pages 156-161

  Sakore, Somnath ^a   Choudhari, Sunil ^a   Chakraborty, Bhaswat ^a  

^a Cadila Pharmaceuticals Limited   (India)

Author keywords

Absorption; Biopharmaceutics classification system (BCS); Ofloxacin; Permeability; Solubility

Indexed keywords

ANTIBIOTIC AGENT; CIPROFLOXACIN; EXCIN; EXCIPIENT; FERROUS SULFATE; FLOXACIL; GATIFLOXACIN; GYROFLOX; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; LEVOFLOXACIN; MACROGOL; MAGNESIUM STEARATE; MOXIFLOXACIN; OFLO; OFLODURA; OFLOHEXAL; OFLOX; OFLOXACIN; OFLOXBETA; POLYSORBATE 80; QUINOLINE DERIVED ANTIINFECTIVE AGENT; STARCH; STARCH GLYCOLATE SODIUM; SUCRALFATE; TALC; TANVID; TITANIUM DIOXIDE; UNCLASSIFIED DRUG; URO TANVID;

ANTIBACTERIAL ACTIVITY; ARTICLE; ATYPICAL MYCOBACTERIOSIS; BACTERIAL INFECTION; BIOEQUIVALENCE; BIOWAIVER DECISION; BODY TEMPERATURE DISORDER; CHEMICAL COMPOSITION; CHLAMYDIA TRACHOMATIS; CHLAMYDIASIS; CHRONIC BRONCHITIS; CITROBACTER KOSERI; CLINICAL TRIAL; COLD FLUSH; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED DRUG RELEASE; CYSTITIS; DIARRHEA; DIZZINESS; DROWSINESS; DRUG ABSORPTION; DRUG ACTIVITY; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLASSIFICATION; DRUG CONTRAINDICATION; DRUG DISTRIBUTION; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG ELIMINATION; DRUG ERUPTION; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG MARKETING; DRUG PENETRATION; DRUG SOLUBILITY; DRUG URINE LEVEL; DRUG WITHDRAWAL; DYSGEUSIA; ESCHERICHIA COLI; FACE EDEMA; FOOD DRUG INTERACTION; GENITAL PRURITUS; HAEMOPHILUS INFLUENZAE; HOT FLUSH; HUMAN; IMMEDIATE DRUG RELEASE; INSOMNIA; KLEBSIELLA PNEUMONIAE; LEGIONELLA PNEUMOPHILA; LEPROSY; MEDICAL DECISION MAKING; MIXED INFECTION; MYCOPLASMA; NAUSEA; NEISSERIA GONORRHOEAE; NONSPECIFIC URETHRITIS; PARESTHESIA; PELVIC INFLAMMATORY DISEASE; PROSTATITIS; PROTEUS MIRABILIS; PRURITUS; PSEUDOMONAS AERUGINOSA; SINGLE DRUG DOSE; SKIN INFECTION; SLURRED SPEECH; SOLID; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; TABLET FORMULATION; URINARY TRACT INFECTION; UTERINE CERVICITIS; VAGINITIS; VOMITING;

EID: 78649727096     PISSN: 09751491     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. Amidon GL, Lennerna SH. Shah VP, Crison JR. A theoretical basis for a Biopharmaceutics Drug Classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995; 12: 413-420.
2. Committee for Proprietary Medicinal Products (CPMP) London. The European Agency for the evaluation of Medicinal products, Evaluation of medicines for human use. Note for guidance on the investigation of bioavailability and bioequivalence. Available from URL: 2001. http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf.
3. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. 2000.
4. United States Pharmacopoeias, United States Phamacopoeial Convention. INC. Twin Brook Parkway. Rockville. 2004; p1355.
5. Lamp KC, Bailey EM, Rybak MJ. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet 1992; 22(1):32-46.
6. U.S. Department of Health and Human services Food and Drug Administration, Center for Drug Evaluation and Research, 1998. Freedom of Information. Available from: http://www.fda.gov/cder/foi/label/2007/019735s058lbl.pdf
7. nded.
8. Henry AO, Ikhuoria MA. Analytical profile of the fluoroquinolone antibacterials I Ofloxacin. African J Biotech 2008; 7: 670-680.
9. Barbosa J, Berges R, Sanz-Nebot V. Retention behaviour of quinolone derivatives in high-performance liquid chromatography. Effect of pH and evaluation of ionization constants. J.Chromatogr A 1998;823: 411-422.
10. Fabre D, Bressolle F, Kinowski JM, Bouvet O, Paganin F, Galtier M. A reproducible, simple and sensitive HPLC assay for determination of ofloxacin in plasma and lung tissue. Application in pharmacokinetic studies. J Pharm Biomed Ana 1994;12: 1463-1469.
11. Volpe DA, Ciavarella AB, Asafu-Adjaye EB, Ellison CD, Faustino PJ, Yu LX. Method suitability of a Caco-2 cell model for drug permeability classification. AAPS Pharm Sci 2001;3: (S1).
12. Pickerill KE, Paladino JA, Schentag JJ. Comparison of the fluoroquinolones based on pharmacokinetic and pharmacodynamic parame-ters. Pharmacother 2000; 20: 417-428.
13. Bergan, T.; Pharmacokinetics of fluorinated quinolones. In: Andri-ole VT, ed. The Quinolones. London, UK: Academic Press. 1988. 119-152.
14. Castillo-garit J A, Marrero-ponce Y, Torrens F, Garcia-Domenech R. Predicting Caco-2 Cell Permeability Using Atom- Based Stochastic and Non-Stochastic Linear Indices. J Pharm Sci 2008; 97: 1946-1976.
15. Akerle JO, Okhamafe AO. Influence of oral co-administered metallic drugs on ofloxacin pharmacokinetics. J Antimicrob Chemother 1991; 28: 87-94.
16. Shimada J, Shiba K, Oguma T, Miwa H, Yoshimura Y, Nishikawa T, et al. Effect of antacid on absorption of the quinolone lomefloxacin. Antimicrob Agents Chemother 1992;36: 1219-1224.
17. Cabarga MM, Navarro AS, Gandarillas CL, Dominguez-Gil A. Effects of two cations on gastrointestinal absorption of ofloxacin. Antimicrob Agents Chemother. 1991; 35: 2102-2105.
18. Polk RE, Healy DP, Sahai J, Drwal L, Racht E. Effect of ferrous sulfate and multivitamins with zinc on absorption of 160 ciprofloxacin in normal volunteers. Antimicrob Agents Chemother 1989;33: 1841-1844.
19. Flor SD, Guay RP, Opsahl JA, Tack K, Matzke GR. Effects of magnesium-aluminum hydroxide and calcium carbonate antacids on bioavailability of ofloxacin. Antimicrob Agents Chemother 1990; 34: 2436-2438.
20. Verho, M., Malerczyk, V., Dagrosa, E., Korn, A. The effect' of food on the pharmacokinetics of ofloxacin. Curr Med Res Opin 1986; 10: 166-171.
21. Dudley MN, Marchbanks C R, Flor SC, Beals B. The effect of food or milk on the absorption kinetics of ofloxacin. Eur J Clinical Pharmacol 1991; 41: 569-571
22. Garrelts JC, Godley PJ, Peterie JD, Gerlach EH, Yakshe CC. Sucralfate significantly reduces ciprofloxacin concentrations in serum. Antimicrob Agents Chemother 1990;34: 9341-9343.
23. Van S, Nix DE, Wiltop JH, Love JH, Spivey JM, Goldstein HR. Combined use of ciprofloxacin and sucralfate. The Annals Of Pharmacotherapy 1991; 25: 578-582.
24. Bruce AM,. Effect of Enteral Feeding with Ensure on Oral Bioavailabilities of Ofloxacin and Ciprofloxacin. Antimicrob Agents Chemother 1994; 38: 2101-2105.
25. Flor SC. Bioequivalence of oral and intravenous ofloxacin after multiple -dose administration to healthy male volunteers. Antimicrob Agents Chemother 1993;37: 1468-1472.
26. Lamp KC. Ofloxacin clinical pharmacokinetics. Clin Pharmacokinet 1992;22: 32-46.
27. McMullin CM. The pharmacokinetics of once-daily oral 400 mg ofloxacin in patients with peritonitis complicating continuous ambulatory peritoneal dialysis. J Antimicrob Chemother 1997;39:29-31.
28. Furet YX, Deshusses J, Pechère JC. Transport of pefloxacin across the bacterial cytoplasmic membrane in quinolone- susceptible Staphylococcus aureus. Antimicrob Agents Chemother 1992;36: 2506-2511.
29. Hirai K, Aoyama H, Suzue S, Irikura T, Lyobe S, Mitsuhashi S. Isolation and characterization of norfloxacinresistant mutants of Escherichia coli K-12. Antimicrob Agents Chemother 1986;30: 248-253.
30. Gruber GU. Jaehde SF, Relationships between the chemical structure and the HPLC capacity factor of gyrase inhibitors and their metabolites in different methanol-water eluents. Fresenius Z Anal. Chem 1988;330: 388-389.
31. Croop JM, Raymond M, Haber D, Devault RJ, Arceci PG, Houseman DE. The three multidrug resistance genes are expressed in a tissue-specific manner in normal human tissues. Mol Cell Biol 1989;9: 1346-1350.
32. Thiebaut F, Tsuruo T, Hamada H, Gottesman MM, Pastan I, Willingham M C. Cellular localization of the multidrug- resistance gene product P-glycoprotein in normal human tissues. Proc Natl Acad Sci U. S. A. 1987; 84: 7735-7738.
33. Ince P, Elliott K, Appleton DR., Moorghen M, Finney KJ, Sunter JP, et al. Modulation by verapamil of vincristine pharmacokinetics and sensitivity to metaphase arrest of the normal rat colon in organ culture. Biochem Pharmacol 1991;41: 1217-1225.
34. Lyndia R. Intestinal elimination of ofloxacin enantiomers in the rat:evidence of a carrier-mediated process. Antimicrob Agent Chemother 1996; 40: 2126-2130.
35. Ashby J, Piddock LJV, Wise R. An investigation of the hydrophobicity of the quinolones. J Antimicrob Chemother 1985;16: 805-808.
36. Takacs NK, Jozan M, Hermecz I, Szasz G. Lipophilicity of antibacterial fluoroquinolones. Int J Pharm 1992;79: 89-96.
37. Nau R. Pharmacokinetics of ofloxacin and its metabolites in cerebrospinal fluid after a single intravenous infusion of 400 mgs of ofloxacin. Antimicrob Agents Chemother 1994;38: 1849-1853.
38. Hartmut I, Pharmacokinetics of ofloxacin after parenteral and oral administration. Antimicrob Agents Chemother 1987;31:1338-1342.
39. Donna A, Volpe E. Permeability Classification of Representative Fluoroquinolones by a Cell Culture Method. AAPS Pharm Sci 2004; 6(2): Article 13.
40. Awadallah B, Wahl MA. Transport of ofloxacin enantiomers in the Caco-2-TC7 cell line. AAPS Pharm Sci 2002; 4 (S1).