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Stability and Compatibility of Combinations of Hydromorphone

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Stability and Compatibility of Combinations of Hydromorphone The Canadian Journal of Hospital Pharmacy - Volume 46, No. 2, April 1993 61 Stability and Compatibility of Combinations oman of Hydromorphone and Dimenhydrinate, ations Lorazepam or Prochlorperazine Jnally >hoto- Scott E. Walker, John Iazzetta, Carlo De Angelis and Danny W.C. Lau laser :ii, in­ figure ABSTRACT RESUME .Each The stability and compatibility of combinations of hydro­ On a melange diverses solutions d'hydromorphone .rabic morphone (2, 10 and 40 mg/ml) admixed separately with (2, 10 et 40 mg/ml) avec, separemen( un volume egal :onse- dimenhydrinate (50 mg/ml), prochlorperazine (5 mg/ml), d'une solution soit de dimenhydrate (50 mglmL), de 1ld be or lorazepam (4 mg/ml) were tested over a seven-day prochlorperazine (5 mglmL) ou de lorazepam (4 mglmL), Jarate period at 4°C, 23°C and 37°C In addition to visual pour verifier la compatibilite de ces trois medicaments avec lished inspection and pH, the concentration of each component l'hydromorphone et determiner la stabilite du melange ie ac­ in the binary mixture was determined by a stability­ binaire pendant sept jours a 4°C, a 23°C et a 37°C ion to indi.cating lifjuid chromatographic method Each test was En plus d'effectuer wz examen visuel et de deter­ ipt. completed at time zero, one, four, six and seven days after miner le pH, on a dose !es composants des melanges par mixing equal volumes of each medication. une methode de chromatographie en phase lifjuide indi­ The hydromorphone-dimenhydrinate combination was quant la stabilite. On a analyse !es melanges au moment compatible and stable for 24 hours. By 48 hours, 8-chlo­ de leur preparation, puis apres un, quatre, six et septjours. es for rotheophylline had precipitated and the degree of precip­ L'hydromorphone et le dimenhydrate sont compatibles d key itate was enhanced by increasing hydromorphone concen­ et leur melange reste stable 24 heures. Cependan( apres ;cripts s. The. tration. Lorazepam was physically compatible with hydro­ 48 hew-es, la 8-chlorotheophylline precipite; la precipitation 1 brief morphone. However, lorazepam degraded such that 90% s'accroft avec la concentration d'hydromorphone. Le lora­ of the of the initial concentration was maintained for six days zepam et l'hydromorphone sont physifjuement compatibles. s. The at 4°C, four days at 23°C and only 24 hours at 37°C Neanmoins, le lorazepam se degrade, de sorte que le melange ssions Prochlorperazine and hydromorphone were physically ne contient plus que 90% de la concentration initiate de ·iption compatible for seven days, even though prochl01perazine Ce medicament apres sixjours a 4°C, quatrejours a 23°C :nces. stability was affected by the presence of hydromorphone. et seulement 24 heures, it 37°C La prochl01perazine et However, less than 10% of the prochlorperazine degraded l'hydromorphone sont physifjuement compatibles pendant over seven days, even at 37°C sept jours, mais l'hydrom01phone altere la stabilite de la es for Jtions: We recommend a seven-day expiration date for the com­ prochlorperazine. La decomposition de cette derniere est ed; the bination of hydromorphone and prochlorperazine based toutefois inferieure a 10% apres septjours, meme a 37°C imited on the observed physical and chemical stability of the On recommande de fixer a septjours la duree de stockage igures combination at temperatures up to 37°C However, we du melange d 'hydromorphone et de prochlorperazine, etant cannot recommend admixing hydromorphone and dimen­ donne sa stabilite physique et chimiquejusqu'a 37°C Par hydrinate due to the precipitation of 8-chlorotheophylline. contre, me/anger des solutions d'hydromorphone et de Admixtures ofhydromotphone and lorazepam were phys­ dimenhydrinate n 'est pas indi.que, en raison de la preci­ ically compatible but the mixture was limited by the stability pitation de la 8-chlorotheophylline. Les solutions d'hydro­ es for of lorazepam and so it is recommended that the expiry morphone et de lorazepam sont physiquement compatibles, :o the valua­ date not exceed 96 hours (four days) at 4°C This will mais la stabilite du lorazepam dans le melange etant limitee, in the allow the solution to be stored at room temperature for on deconseille de le stocker plus de 96 heures (quatre jours) issues up to an additional 24 hours prior to administration. c14°C Ceci pennettra de stocker la solution a temperature Key Words: compatibility, dimenhydrinate, diphenhy­ ambiante jusqu'a 24 heures additionnelles avant /'ad­ dramine, 8-chlorotheophylline, hydromorphone, loraze­ ministration. pam, prochlorperazine, stability Mots cles: compatibilite, dimenhydrinate, diphenhy­ dwith dramine, 8-chlorotheophylline, hydromorphone, loraze­ or for Can J Hosp Phann 1993;46:61-65 pam, prochlorperazine, stabilite Scott E. Walker, MSc. Phm. is Director, Biopharmaceutics, IWF Research, Scarborough Ontario and Associate Professor. Faculty of Pharmacy, University of Toronto. John Iazzetta, Pharm D. is Coordinator, Drug Information Centre, Department of Pharmacy and Division of Pharmacology, Sunnybrook Health Science Centre and Assistant Professor. Faculty of Pharmacy, University of Toronto. rmacy Carlo De Angelis, Pharm D. is Coordinator. Oncology, Department of Pharmacy, Toronto Bayview Clinic and Division of Pharmacology, Sunnybrook Health Science Centre and Lecturer, Faculty of Pharmacy, University of Toronto. Danny W.C. Lau, Dip. Pharm. Technol. is Senior Research Assistant, Department of Pharmacy, Sunnybrook Health Science Centre. Address Reprint Requests to: Carlo De Angelis, Department of Pharmacy, Sunnybrook Health Science Centre, 2075 Bayview Avenue, Toronto, Ontario · 1992 M4N 3M5. Acknowledgements: This study was funded by a grant from Knoll Laboratories Canada. 62 The Canadian Journal <l Hospital Phannacy - Volume 46, No. 2, April 1993 INTRODUCTION compatibility with other medica­ pumped at 2.0 mL/min through a Pharmacists are often asked ques­ tions.4-11 However, the compatibil­ 25 cm x 4.2 mm C 18, 5 µm column tions regarding the compatibility of ity and stability of hydromorphone (Beckman, Ultrasphere). Hydro­ medications. Our interest in the combined with prochlorperazine, morphone, prochlorperazine, lora­ compatibility of hydromorphone lorazepam, or dimenhydrinate has zepam, diphenhydramine and 8- with other medications stems from not been addressed. chlorotheophylline were detected recent advances in the manage­ Therefore, it was the intent of using ultraviolet light at 230 nm ment of chronic pain through the this study to test the compatibility (Schoeffel SF770) and chromato­ development of reliable portable and stability of the combination of grams were recorded on a chroma­ infusion devices. 1 The use of these hydromorphone with prochlor­ tographic integrator(Spectra Phys­ devices to deliver continuous in­ perazine, lorazepam or dimenhy­ ics, SP4200). Table I lists the travenous or subcutaneous infu­ drinate over a seven-day period. specific conditions of the chroma­ sions of narcotics to control For each combination the concen­ tographic system and methods for chronic pain in cancer patients has tration of both medications was intentional degradation. become an acceptable method of evaluated by a validated stability­ Following this first phase of eva­ treatment.2 In addition to improv­ indicating liquid chromatographic luation and validation, the accu­ ing the control of chronic pain, the method. racy and reproducibility of stand­ use of portable infusion pumps ard curves were tested over a five­ allows patients to be managed at METHODS day period and system suitability home2 with significant cost savings Assay Validation criteria (theoretical plates, tailing to the health care system. The ease The validated stability-indicating and retention time) were also es­ of managing a subcutaneous site liquid chromatographic method tablished for each compound of has promoted the use of this route previously reported for hydro­ interest to ensure consistency be­ for antibiotics, antineoplastic morphone in combination with tween study days. Each sample was agents, antiemetics and hormonal other medications10 was modified chromatographed in duplicate. agents. The success of the subcu­ for each mixture to ensure the Inter- and intra-day reproducibility taneous route with some of these separation of hydromorphone and were assessed using the coefficient agents has produced a desire for its degradation products from of variation of the peak area for simultaneous administration of either prochlorperazine, loraze­ samples determined in duplicate. agents and it is, therefore, not sur­ pam or dimenhydrinate and their prising that suggestions to simplify degradation products according to Compatibility Study therapy include mixing medica­ accepted stability-indicating pro­ For each study hydromorphone tions in the same infusion contain­ cedures.12-14 Briefly, this involved 2mg/mL injection (Dilaudid, Knoll er. Thus, questions concerning the intentional degradation of each Pharmaceuticals, lot #00500 I 09), compatibility between hydromor­ compound using acid or base and or IO mg/mL and 40 mg/mL solu­ phone and other medications with­ heat and inspection of chromato­ tions prepared from hydromor­ in an infusion container or at the grams for the appearance of addi­ phonepowder(Dilaudid,KnollPhar­ site of injection frequently arise. tional peaks, changes in retention maceuticals: lot #LS I 050269) We have often discouraged the time, peak shape and UV-VIS were used. Each solution also con­ practice of mixing medications in spectral purity of each eluted peak tained
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