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Published on: August 15, 2016
Compatibility studies between ibuprofen or ketoprofen with cellulose ether polymer mixtures using thermal analysis
M L Vueba1, F Veiga, J J Sousa
1Centro de Estudos Farmacêuticos, Laboratório de Galénica e Tecnologia Farmacêutica, Faculdade de Farmácia da Universidade de Coimbra, Rua do Norte, Coimbra, Portugal.
Drug Development and Industrial Pharmacy
|December 1, 2005
Summary
Differential scanning calorimetry (DSC) detected drug-excipient interactions between ibuprofen/ketoprofen and cellulose ethers in controlled-release dosage forms. These interactions did not impact drug bioavailability, confirming polymer compatibility for pharmaceutical applications.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Cellulose ether derivatives are widely used in controlled-release dosage forms.
- Assessing drug-excipient compatibility is crucial for pharmaceutical formulation development.
Purpose of the Study:
- To investigate potential incompatibilities between ibuprofen (IBU) or ketoprofen (KETO) and various cellulose ether derivatives.
- To evaluate the impact of drug-excipient interactions on drug bioavailability.
Main Methods:
- Differential Scanning Calorimetry (DSC) was employed to analyze binary mixtures.
- Mixtures included methylcellulose (MC25), hydroxypropylcellulose (HPC), and hydroxypropylmethylcellulose (HPMC) K15M or K100M with IBU or KETO.
- Analysis focused on thermal events (peak shifts/disappearance) and enthalpy changes (DeltaH).
Main Results:
- Binary mixtures of the polymers themselves showed good compatibility.
- Solid-solid interactions were observed between IBU/KETO and the cellulose ethers, particularly at a 1:1:1 (w/w) drug:excipient ratio.
- Detected drug-excipient interactions did not negatively affect drug bioavailability.
Conclusions:
- Differential Scanning Calorimetry (DSC) is a reliable method for evaluating drug-excipient compatibility in pharmaceutical formulations.
- The studied cellulose ethers are compatible with ibuprofen and ketoprofen for controlled-release applications, as interactions do not compromise bioavailability.
