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Initial characterization of D-cycloserine for future formulation development for anxiety disorders
Drug Discoveries & Therapeutics
|April 3, 2012
Summary
D-cycloserine (DCS) physicochemical properties were characterized to aid in developing new anxiety disorder treatments. Reformulated DCS capsules are stable for one year and release the drug rapidly, showing promise for therapeutic applications.
Area of Science:
- Pharmaceutical Sciences
- Medicinal Chemistry
Background:
- D-cycloserine (DCS) is being investigated for anxiety disorders.
- Formulation development requires understanding DCS physicochemical properties.
Purpose of the Study:
- To characterize D-cycloserine (DCS) physicochemical properties.
- To facilitate future formulation development of DCS for anxiety disorders.
Main Methods:
- Developed a stability-indicating HPLC assay for DCS quantitation.
- Determined partition coefficient (log Kp = -2.89 ± 0.06).
- Assessed solution stability across pH 2.0-11.5 and ionic strengths at 37°C.
- Compounded and tested 50 mg DCS capsules for stability and in vitro dissolution.
Main Results:
- DCS exhibits maximum stability under alkaline conditions, with peak degradation at pH 4.7.
- Recovered 100.3 ± 1.4% of DCS from 50 mg capsules.
- Reformulated DCS capsules are stable for at least one year at room temperature.
- In vitro dissolution showed complete DCS release from capsules within 10 minutes.
Conclusions:
- The physicochemical characterization provides essential data for DCS reformulation.
- The stable, rapidly dissolving DCS capsules show potential for anxiety disorder treatment.
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