Dissolution of USP prednisone calibrator tablets: effects of stirring conditions and particle size distribution. 2003

M Röst, and P-O Quist
AstraZeneca Tablet Production Sweden, Quality Assurance and Control, Process Analytical Chemistry, SE-151 85 Södertälje, Sweden.

We investigate the effect of stirring conditions on the dissolution of United States Pharmacopoeial Convention (USP) prednisone calibrator tablets. The experiments are performed in an automated USP-II dissolution test apparatus. For this study we use a special paddle-propeller, which can be changed from an ordinary paddle to either a pulling or pushing propeller by changing the angle of the paddle blades. According to the dissolution curves obtained we find that the fastest dissolution, and hence best stirring at a certain stirring frequency, is obtained when the blades of the paddle-propeller is about +30 degrees. This setting corresponds to a pushing, downward flow in the centre of the vessel. We show that the shape of the dissolution curves is similar to that expected from a mix of two different fractions of particles, provided that the stirring is sufficiently intense: one fraction, approximately 60 wt.%, with small particles, and one fraction with large particles. The weight of a large particle is about 100-250 times that of a small. We derive a mathematical expression, based on the cube root law, for the dissolution curves. The expression is fitted to the experimental dissolution curves to investigate the variation of key parameters with stirring and temperature.

UI MeSH Term Description Entries
D010316 Particle Size Relating to the size of solids. Particle Sizes,Size, Particle,Sizes, Particle
D011241 Prednisone A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver. Dehydrocortisone,delta-Cortisone,Apo-Prednisone,Cortan,Cortancyl,Cutason,Dacortin,Decortin,Decortisyl,Deltasone,Encorton,Encortone,Enkortolon,Kortancyl,Liquid Pred,Meticorten,Orasone,Panafcort,Panasol,Predni Tablinen,Prednidib,Predniment,Prednison Acsis,Prednison Galen,Prednison Hexal,Pronisone,Rectodelt,Sone,Sterapred,Ultracorten,Winpred,Acsis, Prednison
D002138 Calibration Determination, by measurement or comparison with a standard, of the correct value of each scale reading on a meter or other measuring instrument; or determination of the settings of a control device that correspond to particular values of voltage, current, frequency or other output. Calibrations
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
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

Related Publications

M Röst, and P-O Quist
May 1984, Journal of pharmaceutical sciences,
M Röst, and P-O Quist
February 2002, International journal of pharmaceutics,
M Röst, and P-O Quist
February 1999, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,
M Röst, and P-O Quist
May 2006, Journal of pharmaceutical sciences,
M Röst, and P-O Quist
January 2001, Pharmaceutical development and technology,
M Röst, and P-O Quist
January 1978, Journal of pharmaceutical sciences,
M Röst, and P-O Quist
July 1978, Journal of pharmaceutical sciences,
Copied contents to your clipboard!