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Achieving a robust drug release from extended release tablets using an integrated continuous mixing and direct
Satu Lakio1, Pirjo Tajarobi1, Håkan Wikström1
1AstraZeneca Gothenburg, Pepparedsleden 1, SE-43183 Mölndal, Sweden.
International Journal of Pharmaceutics
|July 30, 2016
Summary
Continuous manufacturing enables robust extended release (ER) matrix tablets, even with challenging ibuprofen formulations and hydroxypropyl methylcellulose (HPMC) grades. This process overcomes limitations of traditional batch manufacturing for poorly flowing materials.
Area of Science:
- Pharmaceutical Technology
- Process Engineering
- Materials Science
Background:
- Manufacturing extended release (ER) matrix tablets presents challenges, particularly with poorly soluble and poorly flowing active pharmaceutical ingredients (APIs) like ibuprofen.
- Traditional batch processing methods can be limited when dealing with variable powder characteristics and specific excipient grades, such as hydroxypropyl methylcellulose (HPMC).
Purpose of the Study:
- To investigate the viability of integrated continuous mixing and compression for manufacturing ER matrix tablets.
- To evaluate the dissolution behavior and release robustness of tablets produced via continuous processing.
- To assess the combined effects of processing and compositional variables on release performance, especially with challenging formulations.
Main Methods:
- Utilized an integrated continuous mixing and compression process.
- Employed challenging formulations including variable ibuprofen (poorly soluble, poorly flowing) content and low amounts of two HPMC grades (CR and DC2).
- Analyzed dissolution behavior and release profiles to determine robustness.
Main Results:
- Robust ibuprofen release was achieved faster with hydroxypropyl methylcellulose (HPMC) CR grade.
- Robust release was also obtained with HPMC DC2 at high ibuprofen content, albeit with a longer steady-state achievement time.
- Continuous processing facilitated the manufacture of robust ER tablets from formulations unsuitable for traditional direct compression due to poor flowability.
Conclusions:
- Integrated continuous manufacturing is a viable approach for producing robust extended-release matrix tablets.
- This method overcomes limitations associated with traditional batch processing, particularly for challenging formulations with poor powder flow.
- Continuous processing offers a pathway to successfully formulate and manufacture complex ER tablets that might otherwise be unfeasible.
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