Beyond-use date of extemporaneous morphine hydrochloride oral solution

Lin, Chia Yu; Shen, Li‐Jiuan; Huang, Chun‐Chia; Yang, Hsiu Li; Chen, Ying Jung; Wu, Feitong

doi:10.1016/j.jfda.2013.05.002

Cited by 6 publications

(5 citation statements)

References 7 publications

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“…Morphine degrades in aqueous solutions with the formation of mainly pseudomorphine, to a lesser extent morphine-N-oxide and probably apomorphine and discolouration has been observed when degradation products are found in morphine solution (6,18,19). The results of the colour, clarity and odour of the morphine oral suspension remained fairly unchanged and no precipitation was observed in any of the samples throughout the 12 months at both storage conditions (Table 2).…”

Section: Physicochemical Stabilitymentioning

confidence: 92%

“…Immediate-release formulations (tablet or aqueous solution) are much more flexible than long-acting preparations, both in the dose titration period and when the pain is poorly controlled (3). When compared to immediateand modified-release morphine tablets, morphine oral solution has an earlier onset and is easier to take and more convenient for dose titration (6).…”

Section: Introductionmentioning

confidence: 99%

“…However, when the stability data and validated formulations are not available, further research should be carried out to validate the formulations used in practice whenever possible and then the formulations should be standardized among all the hospitals (9). Morphine oral liquid is preferred in cancer patients who require tube feeding or have difficulties in swallowing (6). Many hospital pharmacists have to prepare morphine oral liquid extemporaneously because it is not available commercially (9).…”

Section: Introductionmentioning

confidence: 99%

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formulation-and-stability-of-extemporaneously-prepared-morphine-oral-suspension

Chan¹,

Yeoh²

2014

Mal J Pharm

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Morphine taken by mouth is an effective analgesic for most people with moderate or severe cancer pain. Hospital pharmacists commonly prepare morphine oral liquid extemporaneously for cancer patients who require tube feeding or have difficulties in swallowing because it is not available commercially in Malaysia. This study aims to provide the physical, chemical and microbiological stability data to determine the shelf-life and storage condition for the extemporaneous preparation of morphine oral suspension (10mg/5ml) using X-Temp Oral Suspension System. The samples were divided into 2 groups and were stored at 4ºC (refrigeration) and 30ºC / 75%RH (room temperature) protected from light for 12 months. The physical, chemical and microbiological stability were examined at the interval of months 0, 1, 2, 3, 4, 5, 6, 9 and 12. The content of morphine was determined using HPLC-UV method. The content of morphine remained above 95% of the original concentration throughout the study period. The colour, clarity and odour remained fairly unchanged throughout the study period and the pH values were steady at around pH 4. The extemporaneous preparation was not susceptible to microbial contamination. The results from the stability studies confirmed that the new formulation of morphine oral suspension is stable for up to 12 months when packed in HDPE bottles with polypropylene caps and stored at both 4ºC and 30ºC / 75%RH.

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Section: Physicochemical Stabilitymentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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formulation-and-stability-of-extemporaneously-prepared-morphine-oral-suspension

Chan¹,

Yeoh²

2014

Mal J Pharm

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“…Dari 21 jurnal pada tabel 1 menunjukkan bahwa proses penyimpanan obat sangat berperan penting terhadap kestabilan sediaan. Banyak faktor yang mempengaruhi terjadinya ketidakstabilan sediaan diantaranya adalah karena suhu (18) (19) (9) (23) (26), dpengaruhi oleh pH (19) (23) (30) (13) (33), mikroba (18) (24). Pada sediaan cair oral, pH dan viskositas merupakan salah satu titik kritis yang dapat mepengaruhi kestabilan (42).…”

Section: Fotostabilitasunclassified

Review : Evaluasi Stabilitas dan Inkompatibilitas Sediaan Oral Liquid

Qomara

2023

Maj. Farmasetika

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Stabilitas suatu sediaan sangat penting dalam menentukan kualitas, efikasi dan keamanan suatu produk karena produk yang stabil dapat menentukan keberhasilan pengobatan. Banyak faktor yang mempengaruhi suatu produk menjadi tidak stabil. Salah satu bentuk sediaan farmasi yang paling disukai adalah sediaan cairan oral karena kemudahan dalam mengkonsumsinya. Untuk menentukan stabilitas dan kompatibilitas sediaan oral liquid dilakukan pencarian literature pada situs Google Scholar dan PUBMED menggunakan kata kunci dengan total jurnal yang didapatkan adalah 266 jurnal dan setelah diskrining terdapat 21 jurnal yang masuk kriteria inklusi dan totalnya digunakan 53 referensi dalam review ini. Dari hasil pencarian literatur tersebut didapatkan bahwa banyak faktor yang dapat mempengaruhi kestabilan sediaan cair oral seperti suhu, pH dan juga mikroba. Untuk itu dalam proses formulasi perlu dikaji keadaan yang paling cocok dengan karakteristik bahan yang digunakan baik zat aktif, eksipien maupun bahan kemas. Untuk menentukan kestabilan sediaan farmasi dilakukan dengan uji stabilitas dengan mengatur suhu dan kelembaban sesuai dengan zona klimatik serta pengujian dilakukan pada rentang waktu tertentu. Setelah melakukan uji stabilitas perlu dilakukan evaluasi sediaan seperti pemampilan baik dari warna, bau rasa, kemudian dari viskositas, pH, kejernihan, endapan dan juga pemisahan fase, serta kadar sediaan.

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“…The maximum analgesic effect of oral morphine solution occurs one-hour post administration, where administration every six hours is equivalent to 24 hours of exposure [4]. Oral morphine solution is the preferred route of administration for certain patients, such as patients with chronic cancer pain who require frequent administration of analgesics for breakthrough pain, paediatric patients requiring individualised doses based on body weight, and patients who require dose titration or dose tapering of analgesics [5].…”

Section: Introductionmentioning

confidence: 99%

cost-outcomes-of-conversion-from-simple-syrup-to-x-temp-suspension-in-production-of-extemporaneous-oral-morphine-solution-in-hospital-tengku-ampuan-afzan

Zainal Abidin,

Haji Zunaidi

2023

Mal J Pharm

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Introduction: Oral morphine solution is produced extemporaneously in Hospital Tengku Ampuan Afzan (HTAA). Currently, X-Temp® oral suspension system (OSS), a commercially produced drug vehicle, is used to substitute Simple Syrup in the production of oral morphine solution. Within general hospitals, particularly in HTAA, there are no published documents or official studies on the cost comparison of using Simple Syrup and X-Temp® OSS in the production of extemporaneous oral morphine solution. Materials and method: This is a retrospective study on the batches of oral morphine solution produced using Simple Syrup and X-Temp® OSS. Data were obtained from Psychotropics and Dangerous Drug Registers, Excel data and other relevant databases. All data were further analysed and presented in tables, graphs, and charts whenever applicable and necessary. Results: The median cost per batch of oral morphine with Simple Syrup is RM71.73 (IQR: RM 0.986), which is cheaper than oral morphine with X-Temp® OSS (RM547.68, IQR: RM273.84). There is a significant difference in terms of cost per batch of production between both groups (p=0.0001), where oral morphine with X-Temp® OSS has a higher median score compared to oral morphine with Simple Syrup. Oral morphine with X-Temp® OSS was produced less frequently than oral morphine with Simple Syrup. Thus, the total time spent for production per year is lesser with the use of X-Temp® OSS. The odds of disposing of oral morphine solution were significantly lower in oral morphine with X-Temp® OSS, compared to oral morphine with Simple Syrup. (OR = 43.52; 95% p=0.0001). Conclusion: The direct cost of X-Temp® OSS in the production of oral morphine solution is higher, but the indirect costs are lower, hence making it more beneficial in terms of reducing the use of human resources, saving time & minimizing wastage.

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Beyond-use date of extemporaneous morphine hydrochloride oral solution

Cited by 6 publications

References 7 publications

formulation-and-stability-of-extemporaneously-prepared-morphine-oral-suspension

formulation-and-stability-of-extemporaneously-prepared-morphine-oral-suspension

Review : Evaluasi Stabilitas dan Inkompatibilitas Sediaan Oral Liquid

cost-outcomes-of-conversion-from-simple-syrup-to-x-temp-suspension-in-production-of-extemporaneous-oral-morphine-solution-in-hospital-tengku-ampuan-afzan

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