Modified Release Solid Oral Dosage Forms

  • Ashlee D. Brunaugh
  • Hugh D. C. Smyth
  • Robert O. Williams III
Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)


This chapter presents an extensive overview of the concepts of delayed-release, sustained-release, and pulsatile-release for drug delivery. Formulation approaches and delivery technologies are discussed in detail, along with the required performance testing for modified-release dosage forms. Abuse-deterrent technologies are also introduced.


Controlled release Delayed release dosage form Extended release dosage form Modified release dosage form Pulsatile release system pH-dependent drug release Enteric coating Dissolution testing Dose dumping Abuse deterrent 

Further Reading

  1. Suggested readings for the student include the following texts:Google Scholar
  2. 1.
    Food and Drug Administration Center for Drugs Evaluation Research. Abuse-deterrent opioids-evaluation and labeling. Maryland: FDA; 2015.Google Scholar
  3. 2.
    Conte U, Maggi L, Torre ML, Giunchedi P, La Manna A. Press-coated tablets for time-programmed release of drugs. Biomaterials. 1993;14(13):1017–23.CrossRefGoogle Scholar
  4. 3.
    Maincent J, Zhang F. Recent advances in abuse-deterrent technologies for the delivery of opioids. Int J Pharm. 2016;510(1):57–72.CrossRefGoogle Scholar
  5. 4.
    Miller DA, DiNunzio JC, Williams RO III. Advanced formulation design: improving drug therapies for the management of severe and chronic pain. Drug Dev Ind Pharm. 2008;34:117–33.CrossRefGoogle Scholar
  6. 5.
    Miller DA, Gamba M, Sauer D, Purvis TP, Clemens NT, Williams RO III. Evaluation of the USP dissolution test method a for enteric-coated articles by planar laser-induced fluorescence. Int J Pharm. 2007;330:61072.CrossRefGoogle Scholar
  7. 6.
    Perucca E. Extended-release formulations of antiepileptic drugs: rationale and comparative value. Epilep Curr. 2009;9(6):153–7.CrossRefGoogle Scholar
  8. 7.
    Rhodes CT, Porter SC. Coatings for controlled-release drug delivery systems. Drug Dev Ind Pharm. 1998;24(12):1139–54.CrossRefGoogle Scholar
  9. 8.
    Roy P, Shahiwala A. Multiparticulate formulation approach to pulsatile drug delivery: current perspectives. J Control Release. 2009;134(2):74–80.CrossRefGoogle Scholar
  10. 9.
    Verma RK, Krishna DM, Garg S. Formulation aspects in the development of osmotically controlled oral drug delivery systems. J Control Release. 2002;79(1–3):7–27.CrossRefGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Ashlee D. Brunaugh
    • 1
  • Hugh D. C. Smyth
    • 1
  • Robert O. Williams III
    • 1
  1. 1.College of PharmacyThe University of Texas at AustinAustinUSA

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