메뉴 건너뛰기




Volumn 11, Issue 4, 2004, Pages 13-18

A new crescent-shaped spindle for drug dissolution testing—but why a new spindle?

Author keywords

[No Author keywords available]

Indexed keywords

DILTIAZEM; PREDNISONE;

EID: 55749101070     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT110404P13     Document Type: Article
Times cited : (22)

References (29)
  • 1
    • 33749359835 scopus 로고    scopus 로고
    • USP 27-The United States Pharmacopeial Convention, Inc. Rockville, MD
    • USP. " General Chapter <711> Dissolution," USP 27-The United States Pharmacopeial Convention, Inc. Rockville, MD., pp. 2303-4 (2004).
    • (2004) General Chapter <711> Dissolution , pp. 2303-2304
    • USP1
  • 2
    • 0005736590 scopus 로고    scopus 로고
    • Dissolution Calibration: Recommendations for Reduced Chemical Testing and Enhanced Mechanical Calibration
    • PHRMA. Dissolution Calibration: Recommendations for Reduced Chemical Testing and Enhanced Mechanical Calibration. Pharmacopeial Forum, 26, 1149-66 (2000).
    • (2000) Pharmacopeial Forum , vol.26 , pp. 1149-1166
    • PHRMA1
  • 3
    • 4444231694 scopus 로고    scopus 로고
    • General Chapters <1092> The Dissolution Procedure: Development and Validation
    • USP. General Chapters <1092> The Dissolution Procedure: Development and Validation. Pharmacopeial Forum. 30, 351-363 (2004).
    • (2004) Pharmacopeial Forum , vol.30 , pp. 351-363
    • USP1
  • 4
    • 4444300767 scopus 로고    scopus 로고
    • Merits of Dissolution System Suitability Testing: Response to PhRMA's Proposal on Mechanical Calibration
    • Mirza, T., Grady, L. T. and Foster, T. S. Merits of Dissolution System Suitability Testing: Response to PhRMA's Proposal on Mechanical Calibration, Pharmacopeial Forum, 25(4), 1167-9 (2000).
    • (2000) Pharmacopeial Forum , vol.25 , Issue.4 , pp. 1167-1169
    • Mirza, T.1    Grady, L.T.2    Foster, T.S.3
  • 5
    • 0000185070 scopus 로고
    • Calibration of Dissolution Apparatuses 1 and 2-What to Do When Your Equipment Fails
    • Gray, V. A., Hubert, B. B. and Krasowski, J. A. Calibration of Dissolution Apparatuses 1 and 2-What to Do When Your Equipment Fails. Pharmacopeial Forum, 20, 8571-2 (1994).
    • (1994) Pharmacopeial Forum , vol.20 , pp. 8571-8572
    • Gray, V.A.1    Hubert, B.B.2    Krasowski, J.A.3
  • 10
    • 84923690893 scopus 로고    scopus 로고
    • SUPAC-MR: Modified-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls
    • SUPAC-MR: Modified-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation, http: //www. fda. gov/cder/guidance/1214fnl. pdf
    • Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
  • 11
    • 0020085526 scopus 로고
    • Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature From That of a Sphere
    • Cox, D. C., Wells, C. E., Furman W. B., Savage, T. S. and King, A. C., Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature From That of a Sphere, J. Pharm. Sciences. 71: 395-399, (1982).
    • (1982) J. Pharm. Sciences , vol.71 , pp. 395-399
    • Cox, D.C.1    Wells, C.E.2    Furman, W.B.3    Savage, T.S.4    King, A.C.5
  • 12
    • 0006967910 scopus 로고
    • Industry Perspective on Dissolution Apparatus Calibration
    • McCormick, T. J., Industry Perspective on Dissolution Apparatus Calibration. Dissolution Technology. 2: 12-15 (1995).
    • (1995) Dissolution Technology , vol.2 , pp. 12-15
    • McCormick, T.J.1
  • 13
    • 4444347930 scopus 로고    scopus 로고
    • An Open Response to the USP Subcommittee on Dissolution and Bioavailability (DBA)
    • Moore, T. W. and Cox, D. C. An Open Response to the USP Subcommittee on Dissolution and Bioavailability (DBA). Pharmcopeial Forum. 23, 4581-2 (1997).
    • (1997) Pharmcopeial Forum , vol.23 , pp. 4581-4582
    • Moore, T.W.1    Cox, D.C.2
  • 14
    • 3242754188 scopus 로고    scopus 로고
    • Shear Distribution and Variability in the USP Apparatus 2 under Turbulent Conditions
    • Kukura, J., Baxter, J. L., Muzzio F. J. Shear Distribution and Variability in the USP Apparatus 2 under Turbulent Conditions. Int. J. Pharm. 26: 9-17 (2004).
    • (2004) Int. J. Pharm , vol.26 , pp. 9-17
    • Kukura, J.1    Baxter, J.L.2    Muzzio, F.J.3
  • 15
    • 0141652948 scopus 로고    scopus 로고
    • Simulating the Hydrodynamic Conditions in the United States Pharmacopeia Paddle Dissolution Apparatus
    • McCarthy, L. G., Kosiol, C., Healy, A. M., Bradley, G., Sexton, J. C., Corrigan, O. I. Simulating the Hydrodynamic Conditions in the United States Pharmacopeia Paddle Dissolution Apparatus. AAPS PharmSciTech; 4, 172-187 (2003).
    • (2003) AAPS PharmSciTech , vol.4 , pp. 172-187
    • McCarthy, L.G.1    Kosiol, C.2    Healy, A.M.3    Bradley, G.4    Sexton, J.C.5    Corrigan, O.I.6
  • 16
    • 0028898199 scopus 로고
    • A Critical Assessment of the USP Dissolution Apparatus Suitability Test Criteria
    • Qureshi, S. A. and McGilveray, I. J. A Critical Assessment of the USP Dissolution Apparatus Suitability Test Criteria. Drug Develop. Ind. Pharm. 21, 905-92 (1995).
    • (1995) Drug Develop. Ind. Pharm , vol.21 , pp. 905-992
    • Qureshi, S.A.1    McGilveray, I.J.2
  • 17
    • 0031704891 scopus 로고    scopus 로고
    • Assessment of Pharmaceutical Quality of Furosemide Tablets From Multinational Markets
    • Qureshi, S. A. and McGilveray, I. J. Assessment of Pharmaceutical Quality of Furosemide Tablets From Multinational Markets. Drug Develop. Ind. Pharm., 24, 995-1005 (1998).
    • (1998) Drug Develop. Ind. Pharm , vol.24 , pp. 995-1005
    • Qureshi, S.A.1    McGilveray, I.J.2
  • 18
    • 0032923660 scopus 로고    scopus 로고
    • Typical variability in drug dissolution testing: Study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product
    • Qureshi, S. A. and McGilveray, S. A. Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product. Eur. J. Pharm. Sci., 7: 249-258 (1999).
    • (1999) Eur. J. Pharm. Sci , vol.7 , pp. 249-258
    • Qureshi, S.A.1    McGilveray, S.A.2
  • 20
    • 4444381163 scopus 로고    scopus 로고
    • Dissolution specifications for drug products
    • Repta, A. J, Dissolution specifications for drug products. AAPS Pharmsci. (Suppl.), 2531 (1999).
    • (1999) AAPS Pharmsci , pp. 2531
    • Repta, A.J.1
  • 21
    • 0028907748 scopus 로고
    • Evaluation of the Performance of Prednisone and Salicylic Acid Calibrators
    • Achanta, A. S., Gray, V. A., Cecil, T. L. and Grady, L. T. Evaluation of the Performance of Prednisone and Salicylic Acid Calibrators. Drug Develop. Ind. Pharm. 21, 1171-1182 (1995).
    • (1995) Drug Develop. Ind. Pharm , vol.21 , pp. 1171-1182
    • Achanta, A.S.1    Gray, V.A.2    Cecil, T.L.3    Grady, L.T.4
  • 23
    • 0020085526 scopus 로고
    • Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature From That of a Sphere
    • Cox, D. C., Wells, C. E., Furman W. B., Savage, T. S. and King, A. C. Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature From That of a Sphere, J. Pharm. Sciences. 71, 395-399 (1982).
    • (1982) J. Pharm. Sciences , vol.71 , pp. 395-399
    • Cox, D.C.1    Wells, C.E.2    Furman, W.B.3    Savage, T.S.4    King, A.C.5
  • 24
    • 0033674245 scopus 로고    scopus 로고
    • Cause of high variability in drug dissolution testing and its impact on setting tolerance
    • Qureshi, S. A. and Shabnam, J., Cause of high variability in drug dissolution testing and its impact on setting tolerance. Eur. J. Pharm. Sci., 12, 271-276 (2001).
    • (2001) Eur. J. Pharm. Sci , vol.12 , pp. 271-276
    • Qureshi, S.A.1    Shabnam, J.2
  • 25
    • 0031771036 scopus 로고    scopus 로고
    • Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets
    • Eddington, N. D., Ashraf, M., Augsburger, L. L., Leslie, J. L., Fossler, M. J., Lesko, L. J., Shah, V. P., Rekhi, G. S. Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets. Pharm Dev Technol. 3, 535-47 (1998).
    • (1998) Pharm Dev Technol , vol.3 , pp. 535-547
    • Eddington, N.D.1    Ashraf, M.2    Augsburger, L.L.3    Leslie, J.L.4    Fossler, M.J.5    Lesko, L.J.6    Shah, V.P.7    Rekhi, G.S.8
  • 26
    • 0041667785 scopus 로고    scopus 로고
    • Application of a new device (spindle) for improved characterization of drug release (dissolution) of pharmaceutical products
    • Qureshi, S. A. and Shabnam, J. Application of a new device (spindle) for improved characterization of drug release (dissolution) of pharmaceutical products. Eur. J. Pharm. Sci., 19: 291-7 (2003).
    • (2003) Eur. J. Pharm. Sci , vol.19 , pp. 291-297
    • Qureshi, S.A.1    Shabnam, J.2
  • 27
    • 0006896685 scopus 로고    scopus 로고
    • Dissolution testing: Collaborative study of the in-house NCDA #2 dissolution calibrator tablets with USP apparatus 2
    • Moore, T. W. and Cox, D. C. Dissolution testing: collaborative study of the in-house NCDA #2 dissolution calibrator tablets with USP apparatus 2. Pharmacopeial Forum. 23, 4250-5, 1997.
    • (1997) Pharmacopeial Forum , vol.23 , pp. 4250-4255
    • Moore, T.W.1    Cox, D.C.2
  • 28
    • 84962041633 scopus 로고    scopus 로고
    • USP 27-The United States Pharmacopeial Convention, Inc. Rockville, MD
    • USP. "Diltiazem Hydrochloride Tablets-Monograph," USP 27-The United States Pharmacopeial Convention, Inc. Rockville, MD., p. 628, 2004.
    • (2004) Diltiazem Hydrochloride Tablets-Monograph
    • USP1
  • 29
    • 0035990532 scopus 로고    scopus 로고
    • Hydrodynamic Flows Around Tablets in Different Pharmacopeial Dissolution Tests
    • Morihara, M., Aoyagi, N. Kaniwa, N., Katori, N., and Kojim, S. Hydrodynamic Flows Around Tablets in Different Pharmacopeial Dissolution Tests. Drug Develop. Ind. Pharm., 28, 655-662 (2002).
    • (2002) Drug Develop. Ind. Pharm , vol.28 , pp. 655-662
    • Morihara, M.1    Aoyagi, N.2    Kaniwa, N.3    Katori, N.4    Kojim, S.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.