Dissolution criticality in developing solid oral formulations: from inception to perception

Crit Rev Ther Drug Carrier Syst. 2013;30(6):495-534. doi: 10.1615/critrevtherdrugcarriersyst.2013007795.

Abstract

Currently, dissolution testing has become a vital tool for accessing product performance, especially in the hierarchy of solid oral dosage forms. With advances in complicated, expensive, and sophisticated analytical instruments, characterization of formulations has become easier, but simple dissolution assembly is gradually gaining momentum from industrial environs as well as regulatory agencies. As such, simple dissolution testing involves many complexities which must be properly understood to reach correct conclusions. The appropriate selection of multiple parameters (e.g., apparatus, medium, agitation, etc.) involved in dissolution testing and understanding their impact on analysis require thorough subject knowledge. In the words of regulatory provisions, in vitro dissolution testing can become a surrogate for expensive and tedious bioequivalence studies in special cases (i.e., when a biowaiver is recommended). As a consequence, reduced human testing as well as lower product development cost ultimately benefit patients and society. Therefore, the dissolution science has recently become one of the keys for success for formulation scientists, especially generic manufacturers. While designing dissolution methodologies, generic manufacturers need to follow the respective regulatory guidelines at the product development stage; concomitant data are required for the approval process. This comprehensive review is an earnest attempt to acquaint readers with the history, contemporary practices, and relevant issues regarding dissolution which may become a guiding tool for overcoming challenges and opening better prospects in product development.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Oral
  • Animals
  • Drug Compounding* / instrumentation
  • Drug Compounding* / standards
  • Drug Compounding* / trends
  • Drug-Related Side Effects and Adverse Reactions / prevention & control
  • Guidelines as Topic
  • Humans
  • Legislation, Drug
  • Pharmaceutical Preparations / administration & dosage*
  • Pharmaceutical Preparations / chemistry
  • Pharmaceutical Preparations / standards
  • Quality Control
  • Solubility
  • United States
  • United States Food and Drug Administration

Substances

  • Pharmaceutical Preparations