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Processing Considerations for an EC Latex Coating System: Influence of Curing Time and Temperature

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Abstract

The influence of curing time and curing temperature for a commercially available ethylcellulose latex coating dispersion (Aquacoat®) were evaluated using response surface methodology. Levels for the factor curing time ranged from 30 to 300 minutes while levels for curing temperature ranged from 45° to 75°C. Responses, A, κ, and γ, were derived from regression analysis of the dissolution profiles and correspond to the maximum amount of drug released over the 12 hour sampling period, the rate of release, and the inflection point of the dissolution profile, respectively. The nature of the response surface was dramatically influenced by the plasticizer incorporated into the coating formula. When dibutyl sebacate was employed as the plasticizer, faster release resulted (higher A and κ values, lower γ values) when samples were exposed to higher curing temperatures or were stored for longer periods of time. Paradoxically, when tributyl citrate was used as the plasticizer, slower release resulted when samples were exposed to more rigorous conditions. Overall, curing temperature had a more dramatic effect than curing time.

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Author notes

  1. Dawn Hutchings

    Present address: Janssen Research Technology Center, Ann Arbor, Michigan, 48108

Authors and Affiliations

  1. Department of Pharmaceutics and Drug Delivery Systems, College of Pharmacy, University of Cincinnati, Cincinnati, Ohio, 45267

    Dawn Hutchings & Adel Sakr

  2. Regulatory and Clinical Development, Sharon Woods Technical Center, The Procter & Gamble Company, Cincinnati, Ohio, 45241

    Barbara Kuzmak

Authors
  1. Dawn Hutchings
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  2. Barbara Kuzmak
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  3. Adel Sakr
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Hutchings, D., Kuzmak, B. & Sakr, A. Processing Considerations for an EC Latex Coating System: Influence of Curing Time and Temperature. Pharm Res 11, 1474–1478 (1994). https://doi.org/10.1023/A:1018960310144

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  • DOI: https://doi.org/10.1023/A:1018960310144

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