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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Stability of Diclofenac Sodium Oral Suspensions Packaged in Amber Polyvinyl Chloride Bottles
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Stability of Diclofenac Sodium Oral Suspensions Packaged in Amber Polyvinyl Chloride Bottles

机译：琥珀色聚氯乙烯瓶包装的双氯芬酸钠口服混悬液的稳定性

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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 die 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 (23degC or under refrigeration (5degC). 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 chromatog-raphy 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.
机译：背景：为儿童开具双氯芬酸的处方剂量通常不同于市售剂量。该药物仅以片剂形式提供，在获得的剂量变得不准确之前，它只能被分割多次。此外，儿童可能难以吞咽药片。出于这些原因，液体剂型的配方对于确保将药物有效地递送给儿科患者至关重要。目的：开发双氯芬酸钠的配方并确定该化合物在实验室中储存时扩展的物理和化学稳定性方法：从市售双氯芬酸钠片中制备双氯芬酸钠悬浮液（10 mg / mL），并以Ora-Blend作为悬浮剂和调味剂。将悬浮液包装在60 mL琥珀色PVC处方瓶中，并在室温（23℃或冷藏（5℃）下保存。在第0、7、14、21、27、56和93天收集样品。使用经验证的稳定性指示高效液相色谱法测定悬浮液的含量，在每个采样时间检查悬浮液的外观（例如颜色，分层，结块，易于重悬浮），气味和pH变化。双氯芬酸钠悬浮液非常稳定，无论储存温度如何，均可在长达93天的时间内保持至少99.5％的原始浓度，悬浮液的物理外观没有明显变化，气味或气味也没有任何实质性变化。 pH值的结论：双氯芬酸钠（10 mg / mL）的悬浮液在定量上是稳定的，但由于片剂的肠溶衣而难以制备，因此，建议使用双氯芬酸钠粉作为片剂。 e制备悬浮液。对于儿科使用，应考虑适口性，在给药前应添加掩蔽剂。建议的有效期最长为93天。

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