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Formulation of controlled-release products.

J R Robinson, L J Gauger

    The Journal of Allergy and Clinical Immunology
    |October 1, 1986
    PubMed
    Summary
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    This paper reviews controlled drug delivery systems, focusing on prolonged-release theophylline products. It highlights the empirical nature of product development and the need for better clinical validation for sustained-release medications.

    Area of Science:

    • Pharmacology
    • Drug Delivery Systems

    Background:

    • Numerous prolonged-release theophylline products exist, each with unique claims.
    • The field of controlled drug delivery has a long history but is still developing a strong theoretical and clinical foundation.

    Purpose of the Study:

    • To provide an overview of controlled drug delivery.
    • To discuss the characteristics of available sustained- or controlled-release theophylline products.

    Main Methods:

    • Review of theoretical principles in controlled drug delivery.
    • Analysis of biologic constraints for oral administration.
    • Overview of current sustained- and controlled-release product types.

    Main Results:

    • Many sustained-release products are developed empirically.

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  • Clinical testing in healthy volunteers may not reflect real-world performance.
  • Controlled drug delivery is an emerging discipline with a growing theoretical and clinical base.
  • Conclusions:

    • The development of sustained-release theophylline products often relies on empirical methods.
    • There is a need for improved clinical relevance in the testing of these drug delivery systems.
    • Controlled drug delivery is advancing as a scientifically-grounded field.