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In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants

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Abstract

The determination of the in vitro release profile of water-insoluble drug products requires dissolution media different from those used for water-soluble drug products. Since the relevance of drug dissolution in organic solvents is questionable, we investigated the use of surfactants to determine the dissolution profiles of water-insoluble drug products. In most cases, the drug dissolution rate and extent increased as the surfactant concentration in the aqueous dissolution medium increased. Suitable dissolution profiles were obtained in the presence of sodium lauryl sulfate (SLS) for water-insoluble drug products, such as griseofulvin, carbamazepine, clofibrate, medroxyprogesterone, and cortisone acetate. These findings recommend the use of surfactants for determining the aqueous dissolution of water-insoluble drug products rather than adding organic solvents to the dissolution medium.

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Authors and Affiliations

  1. Division of Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, 20857

    Vinod P. Shah, A. Carol Noorizadeh & Jerome P. Skelly

  2. Philadelphia District Lab, FDA, Philadelphia, Pennsylvania, 19106

    John J. Konecny

  3. Baltimore District Lab, FDA, Baltimore, Maryland, 21201

    Richard L. Everett

  4. Chicago District Lab, FDA, Chicago, Illinois, 60616

    Brace McCullough

Authors
  1. Vinod P. Shah
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  2. John J. Konecny
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  3. Richard L. Everett
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  4. Brace McCullough
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  5. A. Carol Noorizadeh
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  6. Jerome P. Skelly
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Shah, V.P., Konecny, J.J., Everett, R.L. et al. In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants. Pharm Res 6, 612–618 (1989). https://doi.org/10.1023/A:1015909716312

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