Biomaterial Database

[Improvement of dissolution test using microdialysis method]. 2009

Noriaki Nagai, and Takatoshi Murao, and Yoshimasa Ito

School of Pharmacy, Kinki University, Higashi-Osaka, Japan.

Dissolution testing is a core performance test in pharmaceutical development and quality control. Generally, the HPLC method uses the analysis of dissolution testing. In this study, we attempted to improve the dissolution test by using microdialysis methods. We also investigated the comparison of the conventional HPLC dissolution method (batch-sampling method) and the improved dissolution test (microdialysis method). Histamine H(2)-receptor antagonist cimetidine tablets (200 mg), which are used clinically and of which there are also some generic examples, were selected for this comparison, and the dissolution behavior of the tablets by the two methods were found to be similar. On the other hand, standard deviation in the microdialysis method was lower than that of the batch-sampling method. In addition, the microdialysis method can omit many steps such as the filtration, collection and replenishment of sample solutions, and is also able to accomplish continuous sampling of sample solutions. These findings provide significant information that can be used in the pharmaceutical development and quality control of original and generic products.

UI	MeSH Term	Description	Entries
D011786	Quality Control	A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed)	Control, Quality,Controls, Quality,Quality Controls
D002626	Chemistry, Pharmaceutical	Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.	Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D002927	Cimetidine	A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.	Altramet,Biomet,Biomet400,Cimetidine HCl,Cimetidine Hydrochloride,Eureceptor,Histodil,N-Cyano-N'-methyl-N''-(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine,SK&F-92334,SKF-92334,Tagamet,HCl, Cimetidine,Hydrochloride, Cimetidine,SK&F 92334,SK&F92334,SKF 92334,SKF92334
D006863	Hydrogen-Ion Concentration	The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH	pH,Concentration, Hydrogen-Ion,Concentrations, Hydrogen-Ion,Hydrogen Ion Concentration,Hydrogen-Ion Concentrations
D012995	Solubility	The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)	Solubilities
D013607	Tablets	Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)	Tablet
D013678	Technology, Pharmaceutical	The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients.	Technology, Pharmacy,Pharmaceutic Technology,Pharmaceutical Technology,Pharmacy Technology,Technology, Pharmaceutic
D016568	Drugs, Generic	Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies.	Drugs, Nonproprietary,Generic Drug,Generic Drugs,Drug, Generic,Nonproprietary Drugs
D017551	Microdialysis	A technique for measuring extracellular concentrations of substances in tissues, usually in vivo, by means of a small probe equipped with a semipermeable membrane. Substances may also be introduced into the extracellular space through the membrane.