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Formulation of a stable parenteral product; Clonidine Hydrochloride Injection
D Kostecka1, M R Duncan, D Wagenknecht
1Fujisawa USA, Incorporated, Melrose Park, IL 60160, USA.
PDA Journal of Pharmaceutical Science and Technology
|March 2, 1999
Summary
Clonidine Hydrochloride Injection demonstrates excellent stability for pain management. Preformulation and formulation studies confirm its integrity under various conditions, supporting a 36-month expiration date.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Stability Studies
Background:
- Clonidine Hydrochloride Injection (Duraclon) is indicated for epidural pain management as an adjunct when opiates are insufficient.
- The drug is a clear, colorless, preservative-free, pyrogen-free aqueous solution of clonidine hydrochloride.
Purpose of the Study:
- To evaluate the stability of Clonidine Hydrochloride Injection under normal and stress conditions.
- To assess the impact of formulation components and environmental factors on drug product integrity.
Main Methods:
- Conducted light sensitivity, oxygen sensitivity, pH/stability, stopper compatibility, freeze-thaw, and stability studies.
- Evaluated samples for color, visual clarity, pH, potency, and chromatographic purity.
Main Results:
- The formulation remained clear, colorless, and stable throughout all studies.
- Potency and chromatographic purity assays showed no evidence of degradation.
- The unbuffered pH remained within acceptance criteria, with minimal influence from stoppers and vials.
Conclusions:
- Clonidine Hydrochloride Injection formulation is stable and does not require protection from light, oxygen, or freezing.
- The product exhibits acceptable stability within its pH range and is compatible with rubber closures.
- Stability data support a 36-month expiration date for the drug product.