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Research Article

The Impact of Formulation and Process Changes on In Vitro Dissolution and the Bioequivalence of Piroxicam Capsules

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Pages 443-452 | Received 28 Jan 1997, Accepted 09 Jan 1998, Published online: 27 Sep 2008

References

  • Augsburger L. L., Shangraw R., Lesko L. J., Williams R. An approach toward establishing a scientific foundation for interpreting regulations and workshop reports on scale-up and post approval changes. Pharm Res. 1994; 11(10)S–143
  • Tillman L., Augsburger L., Lesko L. J., Williams R. Center for drug evaluation and research (CDER) formulation research: investigation of critical manufacturing variables (CMV) of extended-release (ER) solid, oral dosage forms. Pharm Res. 1995; 12(9)S–185
  • Policy and Procedure Guide #22–90: Interim Policy on Exceptions to the Batch-Size and Production Condition Requirements for Non-Antibiotic. Solid, Oral-Dosage Form Products Supporting Proposed ANDA's, U.S. Department of Health and Human Services. Center for Drug Evaluation and Research, Office of Generic Drugs, September 13, 1990
  • 21 CFR Section 314.70. Supplements and other changes to an approved application. Office of Generic Drugs, Food and Drug Administration
  • Skelly J. P. G. A., Van Buskirk Savello D. R. G. L., et al. Amidon Scaleup of immediate release oral solid dosage forms. Pharm. Res. 1993; 10(2)313–316
  • Skelly J. P. G. A., Van Buskirk Arbit H. M., Amidon G. L., Augsburger L., et al. Workshop II report: scale-up of oral extended release dosage forms. Pharm. Res. 1993; 10(12)1800–1805
  • Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls: In Vitro Dissolution Testing; In vivo Bioequivalence Documentation; Guidance. Fed. Reg. November 30, 1995; 60(230)61638–61643
  • Amidon G. L., Lennernas H., Shah V. P., Crison J. R., et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995; 12(3)413–420
  • Kozjek F., Golic L., Zupet P., et al. Physico-chemical properties and bioavailability of two crystal forms of piroxicam. Acta Pharm. Jugosl. 1985; 35: 275–281
  • Brogden R. N., Heel R. C., Speight T. M., Avery G. S. Piroxicam: a review of its pharmacological properties and therapeutic efficacy. Drugs 1981; 22: 165–187
  • Schiantarelli P., Acerbi D., Bovis G. Some pharma-cokinetic properties and bioavailability by oral and rectal route of piroxicam in rodents and man. Arzneim-Forsch. 1981; 31: 92–97
  • Physicians' Desk Reference15th ed. Medical Economics Data, Montvale, NJ 1994
  • Small L. E., Augsburger L. L. Instrumentation of an automatic capsule-filling machine. J. Pharm. Sci. 1977; 66: 504–509
  • United States Pharmacopeia. National Formulary 1723rd ed. The United States Pharmacopeial Convention, Inc., Rockville, MD 1995
  • Gibaldi M., Pemer D. Pharmacokinetics. Marcel Dekker, Inc., New York 1982; 142–198
  • Gibaldi M., Perrier D. Pharmacokinetics. Marcel Dekker, Inc., New York 1982; 409–417
  • Guentert T. W., Defoin R., Mosberg H. The influence of cholestyramine on the elimination of tenoxicam and piroxicam. Eur. J. Clin. Pharmacol. 1988; 34: 283–289
  • Benveniste C., Striberni R., Dayer P. Indirect assessment of the enterohepatic recirculation of piroxicam and tenoxicam. Eur. J. Clin. Pharmacol. 1990; 38: 547–549
  • Hicks T. A., Patel B., Augsburger L. L., Shangraw R., Lesko L., Shah V., Young D. The effect of relative magnitudes of absorption and elimination half-lives on the decision of cmax-based bioequivalence. Pharm. Res. 1993; 10(10)S305
  • Michotte Y., Van Klaveren H. P., Detaevernier M. R., et al. Bioequivalence of two formulations of piroxicam. Drug Res. 1991; 41(3)244–246

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