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Stability of Extemporaneously Compounded Clonidine in Glass and Plastic Bottles and Plastic Syringes

2014; Canadian Society of Hospital Pharmacists; Volume: 67; Issue: 4 Linguagem: Inglês

10.4212/cjhp.v67i4.1377

1920-2903

Mary H. H. Ensom, Diane Décarie,

Safe Handling of Antineoplastic Drugs

Stability of Extemporaneously Compounded Clonidine in Glass and Plastic Bottles and Plastic SyringesClonidine suspensions to attenuate opioid withdrawal symptoms in children require low doses and dilute concentrations. 1 To the authors' knowledge, only one study on the stability of clonidine 0.01 mg/L suspensions (in OraBlend vehicle) has been published. 2he purpose of the current study was to evaluate whether extemporaneously prepared clonidine suspensions (0.010 mg/mL) are physically and chemically stable in other commercially available vehicles, specifically Oral Mix and Oral Mix SF, at 25°C and 4°C for up to 91 days.Stock clonidine suspensions (0.010 mg/mL) were prepared by crushing commercially available clonidine 0.1-mg tablets (Novopharm, Toronto, Ontario; lot 35204900A, expiry October 2015) in Oral Mix and Oral Mix SF (Medisca Inc, Plattsburgh, New York; lot 1074/A, expiry February 2015; lot 1071/A, expiry January 2015, respectively).Each suspension was divided among 6 amber glass bottles (Richards Distribution, Richmond, British Columbia), 6 amber polyethylene terephthalate bottles (Richards Distribution) and twenty-five 5-mL amber oral plastic syringes (PreciseDose Dispenser System, Medisca Inc; lot 46959/C).For each suspension, 3 glass and 3 plastic bottles were kept at 25°C and 3 glass and 3 plastic bottles at 4°C.All syringes were kept at 25°C.All samples were visually examined for colour, taste, odour, and ease of resuspension at time of preparation, every week up to 21 days, and then every 2 weeks up to 91 days.On each study day, one aliquot (3 mL) from each bottle and the contents of 3 syringes from each group were collected to determine pH.Immediately thereafter, 1.5-mL sample aliquots from each bottle or syringe were transferred to airtight polypropylene freezer vials (VWR International, Mississauga, Ontario) and stored at -85°C until analysis by a validated, stability-indicating high-performance liquid chromatography (HPLC) -ultraviolet detection method.Stock solutions (0.010 mg/mL) were prepared in HPLCgrade water (Fisher Scientific, Whitby, Ontario; lot 131258) from clonidine hydrochloride powder (Sigma-Aldrich, Oakville, Ontario; lot 110M1256V).Lidocaine (Alveda Pharmaceuticals Inc, Toronto, Ontario; lot 30399,