International journal of pharmaceutical compounding
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The chemical stability of an intrathecally administered analgesic combination may influence the frequency of pump refills necessary to maintain safe and effective analgesia. Previous work has shown that the stability of ziconotide at body temperature is reduced substantially by the presence of morphine sulfate 35 mg/mL. The current study was performed to evaluate the chemical stability of admixtures combining ziconotide with lower concentrations of morphine sulfate during simulated intrathecal infusion under laboratory conditions at 37 deg C. ⋯ Morphine sulfate 10 mg/mL, the mean ziconotide concentration declined to 81.4% of the initial concentration in 60 days, and 90% and 80% stabilites were maintained for 34 days and 65 days, respctively. In the admixture containing morphine sulfate 20 mg/mL, the mean ziconotide concentration declined to 85.3% of the initial concentration in 28 days, and 90% and 80% stabilities were maintained for 19 days and 37 days, respectively. Decreasing the concentration of morphine in an admixture containing ziconotide improves the stablity of ziconotide.
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Atropine is one of the preferred antidotes for nerve gas exposure. Effective therapy requires large doses. Stockpiling of atropine in forms currently available commercially can be costly and can require a large storage area. ⋯ The solutions were physically compatible and chemically stable when stored for 28 days at 35 deg C and exposed to light, 364 days at 23 deg C and exposed to light, or 364 days at 5 deg C and protected from light. Concentrated solutions of atropine sulfate can be compounded quickly and easily by using commercially available pharmaceutical-grade powder as the active ingredient. The extended shelf-life allows the preparation to be readily available in the field as required.
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United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations pertains to all preadministration manipulations and procedures involved in the preparation of sterile compounds of application, implantations, infusion, inhalation, injection, insertion, instillation, or irrigation, including preparation, storage, and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patient. ⋯ Chapter 797 sets standards for all compounded sterile preparations, including those for immediate use. This article discusses the techniques and standards used when immediate-use compounded sterile preparations are needed.
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Although the U. S. Food and Drug Administration has not approved the combined use of intrathecal medications, practitioners frequently prescribe combination intrathecal therapy for patients who do not experience adequate analgesia with a single intrathecal agent; however, the chemical stability of an analgesic combination may influence the frequency of pump refills necessary to maintain safe and efective pain control. ⋯ Ziconotide was 90% stable for 26 days and 80% stable for 58 days (extrapolated) when combined with fentanyl; when combined with sufentanil, ziconotide was 90% stable for 33 days and 80% stable for 68 days (extrapolated). The opioids were stable throughout the study. At the concentrations used in this study, ziconotide/fentanyl and ziconotide/sufentanil admixtures were relatively stable.
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Beyond-use-dates for sterile preparations are divided into two categories. If a program of sterility testing is not in place, then the short beyond-use dates specified in United States Pharmacopeia Chapter 797 for the different risk levels are to be used. If a program of sterility testing is in place, then the beyond-use dates described in United States Pharmacopeia Chpater 795 for stability of various types of preparations/formulations can be used, which are somewhat longer than those in Chapter 797. ⋯ If a longer beyond-use date is needed, then appropriate and specific stability studies of the compounded preparation must be undertaken. A very generalized difference between Chapter 795 and Chapter 797 is the requirement for sterility. The majority of Chapter 797 is involved with the requirements necessary to achieve and/or maintain sterility in compounded preparations and includes standards for the facility, equipment materials, personnel, and training.