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Formulation development and stability studies of norfloxacin extended-release matrix tablets
Paulo Renato Oliveira1, Cassiana Mendes, Lilian Klein
1Post Graduation Program in Pharmaceutical Sciences, Universidade Estadual do Centro Oeste (UNICENTRO), 85040-080 Guarapuava, PR, Brazil.
Biomed Research International
|October 2, 2013
Summary
This study developed stable, extended-release norfloxacin (NFX) tablets using hydrophilic polymers. Optimized formulations show potential for improved bioavailability through controlled drug release mechanisms.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Materials Science
Background:
- Extended-release formulations aim for once-daily dosing, improving patient compliance and therapeutic outcomes.
- Norfloxacin (NFX) is an antibiotic requiring optimized delivery for sustained therapeutic levels.
- Hydrophilic matrix systems offer a versatile approach for controlling drug release.
Purpose of the Study:
- To develop and characterize novel hydrophilic matrix systems for extended release of norfloxacin (NFX).
- To investigate the influence of polymer type, molecular weight (MW), and concentration on NFX release kinetics.
- To assess the stability and photodegradation potential of the developed NFX formulations.
Main Methods:
- Formulation of extended-release tablets using hydroxypropylmethylcellulose (HPMC) or poly(ethylene oxide) (PEO) at varying MWs and concentrations (20%, 30%).
- Stability testing under accelerated conditions (40°C ± 2°C / 75% ± 5% RH for 6 months).
- In vitro dissolution studies analyzed using the Korsmeyer-Peppas model to elucidate drug release mechanisms (diffusion, erosion).
Main Results:
- All developed formulations exhibited extended-release profiles for norfloxacin.
- Drug release mechanisms were identified as a combination of diffusion and polymer relaxation/erosion.
- Formulations with lower MW/concentration polymers showed more erosion-controlled release; higher MW/concentration polymers led to diffusion-controlled release.
- Optimal formulations (intermediate MW or high concentration of low MW polymers) achieved extended and complete in vitro release.
Conclusions:
- Stable extended-release norfloxacin tablets were successfully developed using hydrophilic matrix systems.
- Drug release kinetics are significantly influenced by polymer MW and concentration, allowing tuning of release profiles.
- Certain formulations demonstrated potential for enhanced in vivo bioavailability due to optimized in vitro release characteristics.
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