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Suchschritt : FT=glucosamine AND FT=osteoarthritis
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ND: | ME16529337
PMID: | 16529337
LR: | 20061115
CED: | 20060313
DCO: | 20060407
Autoren: | Barnhill JG; Fye CL; Williams DW; Reda DJ; Harris CL; Clegg DO
Titel: | Chondroitin product selection for the glucosamine/chondroitin arthritis intervention trial.
Quelle: | Journal of the American Pharmacists Association : JAPhA; VOL: 46 (1); p. 14-24 /2006 Jan-Feb/
PM: | Print
SU: | IM
Sprache: | English
CY: | United States
JID: | 101176252
ISSN: | 1544-3191
Institution: | Biopharmaceutics/Pharmacokinetics Laboratory, VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, 2401 Centre Ave., SE, Albuquerque, NM 87106, USA. jamie.barnhill@csp.research.med.va.gov
DT: | Comparative Study; Historical Article; Journal Article; Research Support, N.I.H., Extramural
NG: | AR92236 AR NIAMS
Schlagwörter
CT: | CHONDROITIN/*analysis; CHONDROITIN/*standards; CHONDROITIN/therapeutic use; CLINICAL TRIALS, PHASE III; DIETARY SUPPLEMENTS; DRUG COMBINATIONS; GLUCOSAMINE/*analysis; GLUCOSAMINE/*standards; GLUCOSAMINE/therapeutic use; HISTORY, ANCIENT; HUMANS; HUMIDITY; HYDROGEN-ION CONCENTRATION; MOLECULAR WEIGHT; OPTICAL ROTATION; OSTEOARTHRITIS/*drug therapy; REFERENCE STANDARDS
CTG: | CHONDROITIN/*Analyse; CHONDROITIN/*Standard; CHONDROITIN/therapeutische Anwendung; KLINISCHE STUDIEN, PHASE-III; NAHRUNGSERGÄNZUNGSMITTEL; ARZNEIMITTELKOMBINATIONSPRÄPARATE; GLUCOSAMIN/*Analyse; GLUCOSAMIN/*Standard; GLUCOSAMIN/therapeutische Anwendung; GESCHICHTE, ALTERTUMS-; MENSCH; FEUCHTIGKEIT; WASSERSTOFFIONENKONZENTRATION; MOLEKULARGEWICHT; OPTISCHE DREHUNG; OSTEOARTHROSE/*Arzneimitteltherapie; REFERENZSTANDARDS
TE: | Drug Combinations; Glucosamine/3416-24-8; Chondroitin/9007-27-6
CR: | 3416-24-8; 9007-27-6
AB: | OBJECTIVE: To select a high-quality chondroitin dosage form and/or an appropriate source of sodium chondroitin for the National Institutes of Health's Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT). DESIGN: Controlled experimental trials. SETTING: Laboratory. PATIENTS OR PARTICIPANTS: Not applicable. INTERVENTIONS: Commercially available chondroitin products were reviewed, and purified sodium chondroitin from two suppliers was evaluated through tests (infrared and near-infrared identification, moisture content, pH, optical rotation, color and clarity of aqueous solutions prepared from the powders, protein contamination, total residue following ignition and nitrogen content, determination of sodium chondroitin molecular weight, disaccharide analysis, and measurement of chondroitin, sodium, and total glycosaminoglycan content) and an onsite supplier audit. MAIN OUTCOME MEASURES: Purity, potency, and quality of sodium chondroitin powders. RESULTS: No commercially available chondroitin product was deemed appropriate for use in GAIT. Samples of sodium chondroitin powder from two suppliers exhibited similar disaccharide and glycosaminoglycan content. Each contained approximately 2% hyaluronic acid and 8%-9% unsulfated disaccharide. Potency was inconsistent across groups, which might have resulted from different analytical methods and choice of reference standard. Mean potency obtained by five separate methods ranged from 82.2% to 95.5% for one supplier, 92.5% to 110.1% for another, and 95.1% to 112.5% for a commercially obtained reference standard. Critical issues raised by the results include choice of reference standard, selection of assay method, and the consistent appearance of an unidentifiable contaminant present in all three lots from one supplier. CONCLUSION: This blinded study determined methods to identify acceptable agents and provided results, which, in addition to regulatory compliance supplier audits, formed the basis for chondroitin product selection in GAIT.

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