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Development and Evaluation of a Novel Dissolution Apparatus for Medicated Chewing Gum Products

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Abstract

A novel dissolution apparatus was developed for medicated chewing gum products. A prototype gum product containing phenylpropa-nolamine hydrochloride (PPA) was used to evaluate the apparatus. The apparatus consists of a conical Teflon base and a rotating, ribbed Teflon plunger suspended in a dissolution vessel. Parameters evaluated were rotation speed, plunger frequency, medium volume, medium type, medium sampling location, number of plunger ribs, and number of gum pieces. Samples were taken over a 20-min period and samples were analyzed by HPLC. Cumulative percentage re-leased-versus-time profiles were obtained for each parameter evaluated. Statistical analysis of the gum product indicated that the only significant differences occurred at the lowest rotation speed and lowest plunger frequencies. A Level A correlation was found between the in vitro release profile for the 20-rpm and 30-cycles/min plunger frequency and the in vivo chew-out study.

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Authors and Affiliations

  1. Department of Pharmaceutics, University of Mississippi, University, Mississippi, 38677

    James N. Rider, Robert W. Cleary, Ahmed H. Hikal, Peggy H. Rider, Christy M. Wyandt & Alan B. Jones

  2. Pharmaceutical Research and Development, Schering-Plough Health Care Products, Memphis, Tennessee, 38151

    Ed L. Brunson & Walter G. Chambliss

  3. Research Institute of Pharmaceutical Sciences, University of Mississippi, University, Mississippi, 38677

    Robert W. Cleary, Ahmed H. Hikal, Larry A. Walker, Christy M. Wyandt & Alan B. Jones

Authors
  1. James N. Rider
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  2. Ed L. Brunson
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  3. Walter G. Chambliss
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  4. Robert W. Cleary
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  5. Ahmed H. Hikal
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  6. Peggy H. Rider
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  7. Larry A. Walker
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  8. Christy M. Wyandt
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  9. Alan B. Jones
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Rider, J.N., Brunson, E.L., Chambliss, W.G. et al. Development and Evaluation of a Novel Dissolution Apparatus for Medicated Chewing Gum Products. Pharm Res 9, 255–259 (1992). https://doi.org/10.1023/A:1018901826635

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  • DOI: https://doi.org/10.1023/A:1018901826635

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