Abstract

A strategy based on sequential design of experiments (screening, optimization and confirmation) was used to develop a tablet formulation of ibuprofen (400 mg) that is manufactured by direct compression. This formulation has a high content of ibuprofen (76%), in spite of the poor flowability of the drug substance. Sequential design of experiments proved to be an effective and efficient strategy in formulation development.

Highlights

  • Ibuprofen, a Non-Steroidal Anti-Inflammatory Drug (NSAID), is widely used as an analgesic, antiinflammatory and anti-pyretic agent

  • The objective of this research was to address the challenge of developing tablets containing a high content of ibuprofen (400 mg) by a direct compression method

  • The selected formulation had a high content of ibuprofen (76%), in spite of the poor flowability of the drug substance

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Summary

Introduction

A Non-Steroidal Anti-Inflammatory Drug (NSAID), is widely used as an analgesic, antiinflammatory and anti-pyretic agent. It is supplied as tablets with strengths of 200 to 800 mg[1]. Ibuprofen has the disadvantage of showing poor flowability which implies tableting problems, such as its high tendency of sticking to the punches[2]. An important problem of this method is the use of more than 30% of the drug substance in the formulation, mainly for drug substances that present low flowability, such as ibuprofen[3]. The objective of this research was to address the challenge of developing tablets containing a high content of ibuprofen (400 mg) by a direct compression method

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