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A crescent-shaped spindle for improved dissolution testing.
Pharmeur Bio Sci Notes. 2009 Oct; 2009(1):55-65.PB

Abstract

Current practices of drug dissolution testing require that the experimental conditions, such as medium and its volume and apparatus and its associated stirrer rotation speed, be established for each test product to achieve certain 'expected' dissolution characteristics or results. In reality, however, the purpose of dissolution testing should be to determine potentially unknown dissolution results reflective of a test product based on its formulation and/or manufacturing attributes. For appropriate testing, in particular for comparative purposes, the experimental conditions must be the same or consistent from product to product i.e. product independent. This article describes a newly developed spindle, known as crescent-shaped, which can easily be installed in the vessel-based dissolution apparatuses (basket and paddle) to provide a product-independent dissolution testing approach for improved drug dissolution assessments. The new spindle provides an improved stirring and mixing environment, leading to better characterization of pharmaceutical products. The use of the crescent-shaped spindles offers additional significant advantages over the current practices, such as: (1) allows analyses using a single method, compared to hundreds as currently required, for both immediate and extended-released products having the same or different active ingredients; (2) provides improved dissolution characteristics of products by avoiding false slow release properties for fast release type products; (3) simplifies testing by avoiding the necessity of developing separate QC and bio-relevant dissolution methods; (4) provides a rugged testing environment free from common sensitivities, in particular to de-aeration and vibration effects. Considering that the new design provides significant advantages, the spindle may be considered for inclusion in the Ph. Eur., as an option, in the general chapter on dissolution testing.

Authors+Show Affiliations

Qureshi SA
Therapeutic Products Directorate, Health Canada, Banting Research Centre (A/L 2202C1), Ottawa, Canada, K1A 0L2. saeed_qureshi@hc-sc.gc.ca

MeSH

Chemistry, PharmaceuticalDelayed-Action PreparationsPharmaceutical PreparationsReference StandardsReproducibility of ResultsSolubilityTechnology, PharmaceuticalVibration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

20144452

Citation

Qureshi, S A.. "A Crescent-shaped Spindle for Improved Dissolution Testing." Pharmeuropa Bio & Scientific Notes, vol. 2009, no. 1, 2009, pp. 55-65.
Qureshi SA. A crescent-shaped spindle for improved dissolution testing. Pharmeur Bio Sci Notes. 2009;2009(1):55-65.
Qureshi, S. A. (2009). A crescent-shaped spindle for improved dissolution testing. Pharmeuropa Bio & Scientific Notes, 2009(1), 55-65.
Qureshi SA. A Crescent-shaped Spindle for Improved Dissolution Testing. Pharmeur Bio Sci Notes. 2009;2009(1):55-65. PubMed PMID: 20144452.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A crescent-shaped spindle for improved dissolution testing. A1 - Qureshi,S A, PY - 2010/2/11/entrez PY - 2010/2/11/pubmed PY - 2010/4/7/medline SP - 55 EP - 65 JF - Pharmeuropa bio & scientific notes JO - Pharmeur Bio Sci Notes VL - 2009 IS - 1 N2 - Current practices of drug dissolution testing require that the experimental conditions, such as medium and its volume and apparatus and its associated stirrer rotation speed, be established for each test product to achieve certain 'expected' dissolution characteristics or results. In reality, however, the purpose of dissolution testing should be to determine potentially unknown dissolution results reflective of a test product based on its formulation and/or manufacturing attributes. For appropriate testing, in particular for comparative purposes, the experimental conditions must be the same or consistent from product to product i.e. product independent. This article describes a newly developed spindle, known as crescent-shaped, which can easily be installed in the vessel-based dissolution apparatuses (basket and paddle) to provide a product-independent dissolution testing approach for improved drug dissolution assessments. The new spindle provides an improved stirring and mixing environment, leading to better characterization of pharmaceutical products. The use of the crescent-shaped spindles offers additional significant advantages over the current practices, such as: (1) allows analyses using a single method, compared to hundreds as currently required, for both immediate and extended-released products having the same or different active ingredients; (2) provides improved dissolution characteristics of products by avoiding false slow release properties for fast release type products; (3) simplifies testing by avoiding the necessity of developing separate QC and bio-relevant dissolution methods; (4) provides a rugged testing environment free from common sensitivities, in particular to de-aeration and vibration effects. Considering that the new design provides significant advantages, the spindle may be considered for inclusion in the Ph. Eur., as an option, in the general chapter on dissolution testing. SN - 2075-2164 UR - https://www.unboundmedicine.com/medline/citation/20144452/A_crescent_shaped_spindle_for_improved_dissolution_testing_ L2 - https://medlineplus.gov/medicines.html DB - PRIME DP - Unbound Medicine ER -