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Research ArticleRESEARCH ARTICLE

Formulation of a Stable Parenteral Product; Clonidine Hydrochloride Injection

Dolores Kostecka, Michelle R. Duncan and Dietmar Wagenknecht
PDA Journal of Pharmaceutical Science and Technology November 1998, 52 (6) 320-325;
Dolores Kostecka
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Michelle R. Duncan
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Dietmar Wagenknecht
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Abstract

Clonidine Hydrochloride Injection (Duraclon™) is a clear, colorless, preservative-free, pyrogen free, aqueous solution of clonidine hydrochloride. The indication for this product is for use as an adjunct in pain management, administered epidurally, when opiates are insufficient. The drug formulation was evaluated under both normal and stress conditions in the preformulation/formulation studies. The list of studies conducted includes a light sensitivity study, an oxygen sensitivity study, a pH/stability study, a stopper compatibility evaluation, a freeze-thaw study, and a stability study. Samples from the light, oxygen, pH/stability, and stability studies were evaluated for color, visual clarity, pH, potency, and chromatographic purity. Samples from the freeze-thaw study were evaluated for all of the above except chromatographic purity. The results for these studies demonstrate the stability of the product as formulated. The pH of this unbuffered product was consistently within the acceptance criteria. The product remained clear and colorless for the duration of each study. The values obtained for the potency and chromatographic purity assays showed no evidence of degradation. The reasons for the lack of degradation can be found in the molecular structure of the drug substance and the formulation of the drug product. Since the molecular structure is that of a Schiff base, it is theoretically possible, although difficult, to cleave the molecule. A catalyst would be required, and none of the possible catalysts are present in the formulation. The molecule could also be cleaved upon exposure to light, and the evidence indicates that the molecule does interact with light. This interaction is not to the degree, however, that product stability is affected. The formulation contains only the active drug substance and sodium chloride in water for injection with a pH of approximately 6. Although the product is unbuffered, the influence of the stoppers and glass vials upon the formulation pH was minimal. In addition, the stopper compatibility of the product is enhanced by the absence of chelating agents, preservatives, acids, and bases. Since the dilute concentrations of both the active and excipient are well below their solubility limits, no solubility related issues would be expected upon freezing and subsequent thawing. Clonidine Hydrochloride Injection, as formulated, does not require protection from light, oxygen, or freezing. The product shows acceptable stability within the pH range, and the rubber closure is compatible with the product. Real time stability data combined with statistical projections support a 36-month expiration date.

Footnotes

    • Received December 3, 1996.
    • Accepted April 27, 1998.
  • Copyright © Parenteral Drug Association. All rights reserved.

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PDA Journal of Pharmaceutical Science and Technology
Vol. 52, Issue 6
November/December 1998
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Formulation of a Stable Parenteral Product; Clonidine Hydrochloride Injection
Dolores Kostecka, Michelle R. Duncan, Dietmar Wagenknecht
PDA Journal of Pharmaceutical Science and Technology Nov 1998, 52 (6) 320-325;
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Formulation of a Stable Parenteral Product; Clonidine Hydrochloride Injection
Dolores Kostecka, Michelle R. Duncan, Dietmar Wagenknecht
PDA Journal of Pharmaceutical Science and Technology Nov 1998, 52 (6) 320-325;

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