Lee T. Grady

Dissolution Testing of Ibuprofen Tablets

AbstractDissolution testing (using three different methods, USP, FDA and a suggested method) was performed on eight different brands of commercially available ibuprofen tablets as purchased and also after storage at 37 C and 75% Relative humidity. Two dissolution values were determined at time 15 and 30 minutes.Statistical interpretation was performed using a Students t test and Duncan multiple range test with an ANOVA on a SAS program.Some batches tested, notably, sugar coated tablets appeared to be particularly sensitive to the storage conditions used in this study and concern may be felt about possible loss of clinical efficacy. Of the three dissolution testing methodologies, the present USP method was the least discriminating, the FDA method was intermediate and the new proposed method was the most discriminating.

Carbon13 NMR of Z- and E-Doxepin Hydrochloride

Carbon13 chemical shift assignments are reported for Z- and E-doxepin hydrochloride [Z- and E-N,N,-dimethyl-dibenz[b,e]oxepin-delta-11(6H)], gamma-propylamine hydrochloride, and related model compounds. Doxepin hydrochloride, a mixture of approximately 85% E- and 15% Z-isomer is of clinical importance as an antidepressant drug. Previous proton NMR studies indicated that the dibenz(b,e,)oxepin ring exists in two conformations. This study indicates that one conformation may be favored for each isomer with alkylamino olefinic substituent orientation above the most adjacent aromatic ring. Homoand heteronuclear shift-correlated 2D NMR, selective INEPT, selective and off-resonance decoupling, and inversion-recovery (T1) experiments as well as model compound comparisons were used in assignments.

Overview of compendial standards for solid oral dosage forms

AbstractCompendial standards define acceptable articles at the time of use, in contrast to process control and product release strategies. The establishment of drug names and the setting of requirements for identity, strength, quality, purity, packaging, storage, and labeling are addressed by compendial standards. Because the solid oral dosage forms of drugs are used most frequently in drug therapy, it is crucial to examine how the attributes of these forms affect the development of quality standards. Compendial selections of tests for identity, dose uniformity, dissolution/disintegration, and limits and of assays to confirm content are surveyed in this article. Also discussed are the packaging and storage standards established by the compendia and the relationships between drug names and labeling requirements.

Carbon13 NMR shift assignments for E- and Z-dothiepin hydrochloride and 6H-dibenzo[b,e]thiepin-11-one

Carbon13 chemical shift assignments are reported for Z- and E-dothiepin hydrochloride (N,N-dimethyldibenzo[b,e]thiepin-delta-11(6H)′, gamma-propylamine hydrochloride). The commercial product, a mixture of approximately 95% E-isomer, is of clinical importance as an antidepressant drug. The precursor and degradation product, 6H-dibenzo[b,e]thiepin-11-one, and related model compounds were also studied. Homo- and heteronuclear shift-correlated 2D NMR, selective INEPT, selective and off-resonance decoupling, and inversion-recovery (T1) experiments as well as model compound comparisons were used in assignments.