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Choice of rotation speed (rpm) for bio-relevant drug dissolution testing using a crescent-shaped spindle.
Eur J Pharm Sci. 2004 Nov; 23(3):271-5.EJ

Abstract

Recently a new crescent-shaped spindle has been proposed to address the issues related to poor hydrodynamics of the USP paddle apparatus and its associated artifacts of high variability and lack of bio-relevant results. For improved comparison of drug dissolution characterization, it is highly desirable to conduct testing using common experimental conditions such as spindle rotation speed. A study was conducted in which different products were tested using the crescent-shaped spindle to propose a common rpm speed for improved comparative drug dissolution testing. Conventional- (200 mg) and extended-release (200 and 400 mg) carbamazepine tablets of multiple brands and amoxicillin capsules (250 and 500 mg) were analysed using the crescent- shaped spindle at 25, 50 and/or 75 rpm. Drug release was evaluated for 1.5h for amoxicillin and for 3.0 and 24h for conventional- and extended-release carbamazepine tablets products respectively. The dissolution media used were 0.05 M phosphate buffer for amoxicillin capsules and water containing 0.5% sodium lauryl sulphate for carbamazepine tablet products. All products showed characteristic drug release profiles, reflecting the fast and slow drug release natures of the products tested with complete drug release within expected time durations. Based on an expected maximum drug release criterion of 85% in a reasonable time, at a relatively slow drug release rate and within a dosing interval, a spindle speed of 25 rpm was found to be the most appropriate. Thus, it is concluded that drug products can be analysed using a single spindle type (crescent) with a single rpm (25) which would, not only result in simpler dissolution procedures, but also provide enhanced efficiencies from economical and regulatory aspects.

Authors+Show Affiliations

Therapeutic Products Directorate, Health Products and Food Branch, Banting Research Centre, Tunney's Pasture (A/L 2202C1), Ottawa, Ontario K1A0L2, Canada. saeed_qureshi@hc-sc.gc.ca

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

15489128

Citation

Qureshi, Saeed A.. "Choice of Rotation Speed (rpm) for Bio-relevant Drug Dissolution Testing Using a Crescent-shaped Spindle." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 23, no. 3, 2004, pp. 271-5.
Qureshi SA. Choice of rotation speed (rpm) for bio-relevant drug dissolution testing using a crescent-shaped spindle. Eur J Pharm Sci. 2004;23(3):271-5.
Qureshi, S. A. (2004). Choice of rotation speed (rpm) for bio-relevant drug dissolution testing using a crescent-shaped spindle. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 23(3), 271-5.
Qureshi SA. Choice of Rotation Speed (rpm) for Bio-relevant Drug Dissolution Testing Using a Crescent-shaped Spindle. Eur J Pharm Sci. 2004;23(3):271-5. PubMed PMID: 15489128.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Choice of rotation speed (rpm) for bio-relevant drug dissolution testing using a crescent-shaped spindle. A1 - Qureshi,Saeed A, PY - 2004/03/05/received PY - 2004/07/28/revised PY - 2004/08/02/accepted PY - 2004/10/19/pubmed PY - 2005/5/25/medline PY - 2004/10/19/entrez SP - 271 EP - 5 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 23 IS - 3 N2 - Recently a new crescent-shaped spindle has been proposed to address the issues related to poor hydrodynamics of the USP paddle apparatus and its associated artifacts of high variability and lack of bio-relevant results. For improved comparison of drug dissolution characterization, it is highly desirable to conduct testing using common experimental conditions such as spindle rotation speed. A study was conducted in which different products were tested using the crescent-shaped spindle to propose a common rpm speed for improved comparative drug dissolution testing. Conventional- (200 mg) and extended-release (200 and 400 mg) carbamazepine tablets of multiple brands and amoxicillin capsules (250 and 500 mg) were analysed using the crescent- shaped spindle at 25, 50 and/or 75 rpm. Drug release was evaluated for 1.5h for amoxicillin and for 3.0 and 24h for conventional- and extended-release carbamazepine tablets products respectively. The dissolution media used were 0.05 M phosphate buffer for amoxicillin capsules and water containing 0.5% sodium lauryl sulphate for carbamazepine tablet products. All products showed characteristic drug release profiles, reflecting the fast and slow drug release natures of the products tested with complete drug release within expected time durations. Based on an expected maximum drug release criterion of 85% in a reasonable time, at a relatively slow drug release rate and within a dosing interval, a spindle speed of 25 rpm was found to be the most appropriate. Thus, it is concluded that drug products can be analysed using a single spindle type (crescent) with a single rpm (25) which would, not only result in simpler dissolution procedures, but also provide enhanced efficiencies from economical and regulatory aspects. SN - 0928-0987 UR - https://www.unboundmedicine.com/medline/citation/15489128/Choice_of_rotation_speed__rpm__for_bio_relevant_drug_dissolution_testing_using_a_crescent_shaped_spindle_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(04)00194-0 DB - PRIME DP - Unbound Medicine ER -