Pharmacological Response Data for Comparative Bioavailability Studies of Chlorpromazine Oral Dosage Forms in Humans: I. Pupilometry

¹ Department of Industrial and Physical Pharmacy, Purdue University, West Lafayette, Indiana 47907.
² Division of Biopharmaceutics, Bureau of Drugs, United States Food and Drug Administration, Rockville, Maryland 20852.
³ Interdisciplinary Drug Engineering and Assessment Laboratory (IDEAL), School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Indiana 47907.

Owing to the insensitivity of even the presently best chemical or radiological assay procedures, it is not feasible to perform comparative bioavailability studies of chlorpromazine oral drug products using blood or urine sampling; this is particularly the case for oral doses below 100-150 mg/70 kg. In contrast, the use of temporal miotic response data, which correlates with blood levels of unchanged drug, permits dose-response vs time profiles to be recorded with oral dose levels as low as 5-10 mg/70 kg. The monitoring of pupilometric data in up to 16 human volunteers demonstrated a sensitivity to both extents and rates of chlorpromazine bioavailability and revealed differences to exist between liquid and solid oral dosage forms of chlorpromazine.

Note:

The excellent advice and technical assistance of Dr. John Harter (Food and Drug Administration), Ms. Anne McKenzie, Mr. Edward Bronson, Ms. Christi Knevel, and Ms. Judy Bowker is gratefully acknowledged.

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