ABSTRACT
OBJECTIVE: Noninvasive assessment of the immediate and delayed cardiopulmonary response to a 2% aminophylline-based topical thigh reducing cream. DESIGN: Prospective, double-blind, randomized, counterbalanced study with application of: no cream (NC), placebo cream (PC) or 2% aminophylline cream (AC). SUBJECTS: Nine healthy women (aged: 23+/-3 y; weight: 58+/-3 kg; height: 165+/-7 cm; body fat: 19+/-6%; estimated maximal aerobic fitness VO2max): 40+/-4 ml/kg/min). MEASUREMENTS: Medical history, skin patch test, skinfolds, YMCA submaximal cycle ergometry test, psychological evaluations (POMS and Speilberger STAI-1). Pulmonary function and spectral analysis on heart rate variability, measured immediately post-and 4 h post-treatment, on three separate days within a three-week period. RESULTS: Pulmonary function did not change. The averaged R-R interval (ms) was significantly lower for the immediate post AC treatment, but returned to baseline in 4 h. CONCLUSION: Application of a 2% aminophylline-based thigh cream does not affect pulmonary function, however, it may cause a temporary, transient reduction in the averaged R-R interval.
Subject(s)
Aminophylline/pharmacology , Anti-Obesity Agents/pharmacology , Heart Rate/drug effects , Respiration/drug effects , Administration, Cutaneous , Adult , Aminophylline/administration & dosage , Anti-Obesity Agents/administration & dosage , Double-Blind Method , Female , Humans , Patch Tests , Prospective Studies , Reference Values , ThighABSTRACT
A set of computer programs has been developed for the automated transfer, storage, and processing of data related to chromatographic pharmaceutical assay method validations. These programs calculate and report statistical parameters relating to the resolution, linearity of response, and precision of an assay method based upon peak width, retention time, and integration data provided by a commercial chromatographic data system. Utilization of an interface between the data system and a microcomputer minimizes manual handling of all data. Techniques and equations used in the development of the software are described, and an application to the validation of a high performance liquid chromatographic assay method for a bulk drug substance is demonstrated.
Subject(s)
Chromatography, High Pressure Liquid/instrumentation , Electronic Data ProcessingABSTRACT
A generalized gas chromatographic method is described for the determination of a wide variety of residual solvents and other volatile impurities in bulk pharmaceuticals. The method employs a highly selective graphitized carbon-black stationary phase, which is demonstrated to retain compounds on the basis of a linear combination of their boiling points and molecular volumes (i.e., molecular weight divided by density). An autosampler is utilized to optimize injection precision and to provide for high sample throughput. Analytical data from replicate determinations of seven representative compounds are reported, and it is shown that calibration of the chromatographic systems against external standards produces comparable results to those obtained by standard addition techniques.