LP3 Network Free Webinar - Veterinary Compounding, A Customized Approach

Download in electronic PDF format for $25



Search the Complete Journal Archives

Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes

Author(s):  Xu Quanyun A, Trissel Lawrence A, Pham Lien

Issue:  Jan/Feb 2002 - Compounding for Pain Management and Dental Medicine
View All Articles in Issue

Abstract:  The objective of this study was to evaluate the physical and chemical stability of morphine sulfate 5 mg/mL with clonidine hydrochloride 0.25 mg/mL in 0.9% sodium chloride injection and morphine sulfate 50 mg/mL with clonidine hydrochloride 4 mg/mL in sterile water for injection when packaged in plastic syringes.

Test samples of morphine sulfate 5-mg/mL with clonidine hydrochloride 0.25-mg/mL and morphine sulfate 50-mg/mL with clonidine hydrochloride 4-mg/mL solutions were packaged as 20 mL of drug solution in 30-mL plastic syringes, sealed with plastic tip caps, and stored at 4°C and 23°C for 60 days. Test samples were also stored at -20°C and 37°C (temperature extremes that might be encountered during shipping) for 2 days. Evaluations for physical and chemical stability were performed initially and throughout the storage periods. Physical stability was assessed by means of visual observation in normal room light and with a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drug was evaluated by means of a stability-indicating high-performance liquid chromatographic (HPLC) analytical technique.

All samples of morphine sulfate 5-mg/mL with clonidine hydrochloride 0.25-mg/mL solutions stored at 4°C, 23°C, and 37°C and the morphine sulfate 50-mg/mL with clonidine HCl 4-mg/mL solutions stored at 23°C and 37°C remained free of precipitation throughout the study. Little or no change in measured particulate burden and haze level were found in those solutions. However, morphine sulfate 50 mg/mL with clonidine HCl 4 mg/mL stored at 4°C exhibited an obvious precipitate within 2 to 4 days. Warming the solution to redissolve the precipitate left a substantial microparticulate content that was measured to be more than 33,000 microparticulates/mL. Upon freezing, both high- and low-concentration samples precipitated and yielded substantial measured microparticulate quantities up to 35,000 microparticulates/mL in the low-concentration combination and 50,000 microparticulates/mL in the high-concentration combination. In addition, as with morphine sulfate 50 mg/mL alone, the high-concentration combination exhibited a slight yellow discoloration after 30 days of storage at 23°C.

Little or no loss of morphine sulfate and clonidine hydrochloride occurred in any of the samples at any storage temperature throughout the study. Morphine concentrations were found to be about 98% or greater, and clonidine hydrochloride concentrations were about 97% or greater throughout the study period under each storage condition. Morphine sulfate solutions at concentrations ranging from 5 to 50 mg/mL combined with clonidine hydrochloride ranging from 0.25 to 4 mg/mL can be packaged in plastic syringes, Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes stored, and shipped with little or no loss of drug. However, freezing should be avoided.

Related Keywords: Clonidine hydrochloride and morphine sulfate, chemical stability of, Clonidine hydrochloride and morphine sulfate, physical stability of, Morphine sulfate and clonidine hydrochloride, chemical stability of, Morphine sulfate and clonidine hydrochloride, physical stability of

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes Xu Quanyun A, Trissel Lawrence A, Pham Lien Jan/Feb 2002 66-69 Buy
Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Bupivacaine Hydrochloride Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 70-73 Buy
Physical and Chemical Stability of Morphine Sulfate 5-mg/mL and 50-mg/mL Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 62-65 Buy
In Vitro Studies on the Release of Morphine Sulfate from Compounded Slow-Release Morphine-Sulfate Capsules Webster Kathy D, Al-Achi Antoine, Greenwood Robert Sep/Oct 1999 409-411 Buy
In Vitro Evaluation of Extemporaneously Compounded Slow-Release Capsules Containing Morphine Sulfate or Oxycodone Hydrochloride Glowiak Dana L, Green Julie L, Bowman Bill J Mar/Apr 2005 157-164 Buy
Ketamine Hydrochloride 5%, Gabapentin 10%, Clonidine Hydrochloride 0.2%, and Baclofen 2% in Lipoderm Allen Loyd V Jr May/Jun 2016 231 Buy
Morphine Sulfate 20-mg/mL and Clonidine HCl 10-mcg/mL Epidural Injection Allen Loyd V Jr Jul/Aug 2000 303 Buy
Physical and Chemical Stability of Hydromorphone Hydrochloride 1.5- and 80-mg/mL Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 74-76 Buy
Stability of Gentamicin Sulfate and Tobramycin Sulfate in AutoDose Infusion System Bags Xu Quanyun A, Trissel Lawrence A, Saenz Christopher A, Ingram Delshalonda S Mar/Apr 2002 152-154 Buy
Calculations Prince Shelly J Mar/Apr 2004 132 Buy