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Stability of diclofenac sodium oral suspensions packaged in amber polyvinyl chloride bottles
Ronald F Donnelly1, Elena Pascuet, Carmen Ma
1, MSc(Chem), BSC(Pharm), is Product Development Pharmacist with the Department of Pharmaceutical Sciences, The Ottawa Hospital (Civic Campus), Ottawa, Ontario.
Insights
A stable diclofenac sodium suspension was developed for pediatric use, maintaining over 99.5% concentration for 93 days. Diclofenac powder is recommended for easier preparation of this liquid dosage form.
Area of Science:
- Pharmaceutical Compounding
- Pediatric Pharmacology
- Drug Stability
Background:
- Diclofenac dosing for children often requires non-standard strengths.
- Commercial diclofenac tablets present challenges for accurate pediatric dosing due to divisibility and swallowing difficulties.
- A compounded liquid formulation is crucial for effective pediatric diclofenac delivery.
Purpose of the Study:
- To create a compounding formula for diclofenac sodium liquid suspension.
- To assess the physical and chemical stability of the compounded diclofenac sodium suspension.
- To evaluate stability under refrigeration and room temperature storage conditions.
Main Methods:
- A 10 mg/mL diclofenac sodium suspension was prepared using Ora-Blend.
- The suspension was stored in amber polyvinyl chloride (PVC) bottles at 5°C and 23°C.
- Chemical stability was assessed via HPLC; physical attributes (appearance, odor, pH) were monitored over 93 days.
Main Results:
- Diclofenac sodium suspensions retained >99.5% of original concentration for 93 days at both storage temperatures.
- No significant changes in physical appearance, odor, or pH were observed.
- The suspensions demonstrated excellent quantitative stability.
Conclusions:
- Compounded diclofenac sodium suspensions exhibit excellent stability for up to 93 days.
- Preparation from tablets is challenging due to enteric coating; diclofenac powder is preferred.
- Palatability enhancement is recommended for pediatric patients, with a 93-day expiry suggested.
Background:
Prescribing of diclofenac for children usually involves a dose different from commercially available strengths. This drug is available only as tablets, which can be divided only so many times before the dose obtained becomes inaccurate. In addition, children may have difficulty swallowing tablets. For these reasons, a compounding formula for a liquid dosage form is essential to ensure effective delivery of the drug to pediatric patients.
Objectives:
To develop a compounding formula for diclofenac sodium and to determine the extended physical and chemical stability of this compound when stored in amber polyvinyl chloride (PVC) prescription bottles under refrigeration and at room temperature.
Methods:
A suspension of diclofenac sodium (10 mg/mL) was prepared from commercially available diclofenac sodium tablets, with Ora-Blend as the suspending and flavouring agent. The suspension was packaged in 60-mL amber PVC prescription bottles and stored at either room temperature (23°C) or under refrigeration (5°C). Samples were collected on days 0, 7, 14, 21, 27, 56, and 93. Chemical stability was determined using a validated stability-indicating high-performance liquid chromatography method. At each sampling time, the suspensions were checked for changes in appearance (i.e., colour, layering, caking, ease of resuspension), odour, and pH.
Results:
The diclofenac sodium suspensions were very stable, retaining at least 99.5% of the original concentration for up to 93 days, regardless of storage temperature. There were no apparent changes in the physical appearance of the suspensions, nor were there any substantial changes in odour or pH.
Conclusions:
Suspensions of diclofenac sodium (10 mg/mL) were quantitatively stable but difficult to prepare because of the enteric coating of the tablets. Therefore, it is recommended that diclofenac powder be used for the preparation of suspensions. For pediatric use, palatability is a consideration, and a masking agent should be added before administration. An expiry date of up to 93 days is suggested.
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