Published June 1, 2024 | Version v1
Journal article Open

DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS: MORE THAN JUST A TEST, AN ART

Creators

  • 1. DI-Solution Consulting Inc., Canada.
  • 2. Faculty of Pharmacy, University of Montreal, Canada.

Description

Solid dosage forms, such as tablets and hard gelatine capsules have been on the market for a very long time. Despite the growth of biological molecules that are mainly given though parenteral routes (implying in a lot of cases, the need for a professional in health sciences) solid oral dosage form will remain very successful for several reasons: Their low cost of goods (compared to injectables) and the patient’s compliance. Furthermore, it can be said that the oral route is and will remain the Royal route.

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Additional details

References

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  • Patrick J. M. History and Evolution of the Dissolution Test. Diss. Tech, 2014, August 11-15.
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  • SUPAC-MR: Modified Release Solid Oral Dosage Forms, Scale-Up and Post approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation; Guidance for Industry; Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), U.S. Government Printing Office: Washington, DC, 1997.
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