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Validation of the stability of paracetamol in extemporaneously compounded suppositories
Author(s) -
Yang Tianzhi,
Shin Hae Jung,
Nguyen Kayla,
Bai Shuhua
Publication year - 2019
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr.1486
Subject(s) - suppository , medicine , polyethylene glycol , peg ratio , high performance liquid chromatography , dosage form , chromatography , anesthesia , pharmacology , chemistry , organic chemistry , finance , economics
Background Although compounded pain suppositories have been widely used in medical practice to accommodate specific patients’ needs, few studies have systemically evaluated the stability of compounded pain relief suppositories in different bases. Aim The aim of this study was to conduct long‐term stability studies on two types of compounded paracetamol suppositories under different storage conditions. Methods Suppositories were compounded in cocoa butter substitute Fattibase ® and polyethylene glycol ( PEG ) bases using a double‐casting fusion method with a dose of 325 mg paracetamol. Suppositories were stored at 4°C and 25°C, and sampled at 0, 7, 14, 30, 90 and 180 days. Samples were first assessed by weight, colour and the morphology of the suppositories. The pH of the extracted solution was measured and the amount of paracetamol was analysed by HPLC . Results The mean weight of the paracetamol suppository in PEG and Fattibase ® was 2.21 ± 0.02 and 1.89 ± 0.00 g, respectively. Initial paracetamol levels in the PEG and Fattibase ® suppositories were 103.7 ± 5.2% and 102.5 ± 6.5%, respectively. After 6 months, no significant changes were observed in the weight and morphology of the suppositories. However, the drug amount in the suppositories was slightly decreased in Fattibase ® at 25°C (p < 0.05). The measured pH values of the extracted drug solutions were significantly increased at 6 months in both bases (p < 0.05). Conclusion Two compounded paracetamol suppositories remained stable for 3 months at 4°C and 25°C. Three months could be assigned as the expiry date of compounded products.