Dissolution Testing

Dissolution Testing

An Example of Method Transfer and Controls: The USP Dissolution Test #2 Using the 10 mg Prednisone “NCDA Tablet #2” As a Process Control Sample. 1980. Related documents:

“Collaborative Study of the USP Dissolution Test for Prednisone Tablets with Appara tus 2,” Don C. Cox and William B. Furman, National Center for Drug Analysis, Food and Drug Administration, St. Louis, MO.
Tansmittal Cover Letter
Notes abstracted from: "Reproducibility of Dissolution Test Results," J.F. Hamilton, T.W. Moore, and C.M. Kerner, Pharm. Forum, 21, 1995, pp 1383-1386.

Guidelines for Dissolution Testing, Don D. Cox, Carol C. Douglas, William B. Furman, Ross D. Kirchoefer, James W. Myrick, and Clyde E. Wells, Pharmaceutical Technology, April 1978, 40-52.

Guidelines for Dissolution Testing, January 1980.

Studies in the Development of USP Dissolution Test Method Number 2, Thomas Layloff, Pharmacopeial Forum, Nov-Dec 1983, 3752-1357.

Guidelines for Dissolution Testing,: an addendum, Don C. Cox, William B. Firman, Terry W. Moore, and Clyde E. Wells, Pharmaceutical Technology, February 1984.

Historical Perspectives on Dissolution Technology, L. T. Grady, retired Director of the USP Drug Standards Division.

Drug Dissolution Testing Highlights Through the 1980’s, L. T. Grady, retired Director of the USP Drug Standards Division.

Division Dissolution Papers Published 1976-1997:

Kirchhoefer, R. Use of Round-bottom Resin Kettle for In Vitro Dissolution Testing, submitted to and appeared in J Assoc Off Anal Chem 1976; 59:367.
Myrick J, Wells C. Automated Sampling/Readout Devices for Analysis of Dissolution Media: Continuous-Cycling System and Application to Dissolution Profiling of Phenytoin Products, submitted to and appeared in J Assoc Off Anal Chem 1979; 62 (1) :56-66.
Wells C. Effect of Sampling Probe Size on Dissolution of Tableted Drug Samples, submitted to and appeared in J Pharm Sci 1981; 70(2):232.
Savage R, Wells C. Automated Sampling of In Vitro Dissolution Medium: Effect of Sampling Probes on Dissolution Rate of Prednisone Tablets, submitted to and appeared in J Pharm Sci 1982; 71(6):670-673.
Cox D, Furman W. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test I: Effects of Physical Alignment of the Dissolution Apparatus, submitted to and appeared in J Pharm Sci 1982; 71(4):451-452.
Cox D, Wells C, Furman W, Savage T, King A. Systematic error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature from that of a Sphere, submitted to and appeared in J Pharm Sci 1982; 71(4):395-399.
Cox D, Furman W, Thornton L, Moore T, Jefferson E. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test III: Limitations of Calibrators and the USP Suitability Test, submitted to and appeared in J_ Pharm Sci 1983; 72(8):910-913.
Cox D, Furman W, Page D. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test IV: Effect of Air Dissolved in the Dissolution Medium, submitted to and appeared in J Pharm Sci 1983; 72(9):1061-1064.
Cox D, Furman W. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test V: Interaction of Two Tableted Prednisone Formulations with Glass and Plastic Vessels, submitted to and appeared in J Pharm Sci 1983; 73 (8) :1125-1127.
Layloff T. Studies in the Development of USP Dissolution Test Method Number 2. Pharm Forum 1983; 9(6):3752-3757.
Knapp G, Page D. Effect on Dissolution of Tablet Storage in Counting Machines, submitted to and appeared in Am J Hosp Pharm 1983; 40:623-625.
Cox D, Furman W. Collaborative Study of the USP Dissolution Test for Prednisone Tablets with Apparatus 2, submitted to and appeared in J Pharm Sci 1984; 73(5):670.
Cox D, Furman W, Moore T, Wells C. Guidelines for Dissolution Testing: An Addendum, submitted to and appeared in Pharm. Technol. 1984; 8(2):42.
Kirchhoefer R, Hipp S. Niacin I: Dissolution Profiles of Sustained-Release Niacin Products by Automated and Manual Procedures, submitted to and appeared in J Assoc Off Anal Chem Int'l 1992; 76(2):394-398.
Hamilton J, Moore T, Kerner C. Reproducibility of Dissolution Test Results. Pharm Forum 1995; 21(5):1383-1386.
Moore T, Hamilton J, Kerner C. Dissolution testing: Limitations of the USP Prednisone and Salicylic Acid Calibrator Tablets. Pharm Forum 1995;21(5):1387-1396.
Kirchhoefer R, Hamilton J. Effect of USP Apparatus 1 and 2 at Different Rotational Speeds on Dissolution of Niacin Formulations, submitted to and appeared in J Assoc Off Anal Chem Int'l 1996; 79(4):1005-1008.
Moore T. Dissolution Testing: A Fast Efficient Procedure for Degassing Dissolution Medium. Dissolution Technologies, , submitted to and appeared in 1996; 3(2):3-5.
Moore T, Shangraw R, Habib Y. Dissolution Calibrator Tablets: A Recommendation for New Calibrator Tablets to Replace Both Current USP Calibrator Tablets. Pharm Forum 1996; 22(3):2423-2428.
Moore T, Cox D. An Open Response to the USP Subcommittee on Dissolution and Bioavailability (DBA). Pharm Forum 1997; 23 (4) :4581-4582.
Moore T, Cox D. Dissolution Testing: Collaborative Study of the In-house NCDA #2 Calibrator Tablets with Apparatus 2. Pharm Forum 1997; 23(3):4250-4255.
Moore T, Cox D, Demarest D. Dissolution Calibrator Tablets: A Scaled-up Lot of a New Calibrator Tablet Recommended to Replace Both Current USP Calibrator Tablets. Pharm Forum 1997; 23(6):5352-5359.

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