Data acquisition and processing system for drug release characterization by thin layer chromatography.

Samples of an antibiotic released from an ocular insert in an in vitro test are characterized by thin layer chromatography (TLC). Conventional characterization methods include cutting and weighing strip chart paper peak profiles obtained with a scanning densitometer for spotted TLC plates, and relating peaks for unknowns to peaks for standards on the basis of relative weights. A data collection and processing system is described in which the data collection and processing is highly automated utilizing a specially developed software program. A Kontes densitometer (Model 800) and a personal computer (IBM PC-AT or Zenith-248) are interfaced using a Keithley 570 data acquisition system. Two BASIC software programs were developed to provide quantitative evaluation of chromatograms of an antibiotic (tylosin tartrate); the first program generates chromatograms on the computer screen through initiating controlled operation of a scanning densitometer for TLC plate analysis, and the second program processes the data providing quantitative analysis of the spectral output through a peak detection and peak integration routine. The approach represents a new general, versatile, quick and effective method to characterize TLC samples for various numbers of peaks for unknowns and standards for different concentration levels.

Development of ocular inserts for cattle.

Ring shaped ocular inserts have been developed to administer a therapeutic level of tylosin tartrate throughout a five day period to treat pinkeye in cattle. The inserts are based on polyvinyl chloride rings which are dip coated with a copolymer containing the antibiotic (tylosin tartrate). Scanning electron microscope (SEM) characterization of surfaces has been of value to evaluate the presence and extent of surface flaws in the hydrogel coating, and to contribute to improvement in fabrication of the rings to insure the establishment of satisfactory seals at joints, uniformity of microporosity and cross sections, and the absence of significant cracking or flaking. In vitro release rates were determined using thin layer chromatography techniques, and rates were seen to be above a few micrograms of antibiotic per hour for experiments as long as nine days at simulated tear rates as high as 2 milliliters per hour.