Stability of an extemporaneous alcohol-free melatonin suspension

Johnson, Cary E.; Cober, M. Petrea; Thome, Tennille; Rouse, Emily

doi:10.2146/ajhp100274

Cited by 7 publications

(7 citation statements)

References 9 publications

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“…Furthermore, they can be compounded using either bulk drug powder or tablets. The results of this study show equivalent stability to other oral suspending vehicles, demonstrating that this dye‐free vehicle can be substituted for compounding when supporting studies are available …”

Section: Discussionmentioning

confidence: 58%

“…The results of this study show equivalent stability to other oral suspending vehicles, demonstrating that this dye-free vehicle can be substituted for compounding when supporting studies are available. 7 The study has been successful in producing useful new information regarding the stability of melatonin in a dye-free Oral Mix SF base. Future studies could be conducted whereby dosage, environment and study duration are further varied to provide a larger range of data on the stability of compounded oral suspensions.…”

Section: Discussionmentioning

confidence: 99%

“…It is also available as intraoral sprays and oral liquids containing alcohol. Melatonin is commonly used as a sleep aid to modulate sleeping patterns . Additionally, it is sometimes used to slow the advancement of neurodegenerative diseases …”

Section: Introductionmentioning

confidence: 99%

“…7,8 Additionally, it is sometimes used to slow the advancement of neurodegenerative diseases. 6,7 This study is aimed at establishing the chemical stability of extemporaneously prepared melatonin formulations using proprietary Oral Mix SF (Medisca Pharmaceutique Inc, Montreal, QC, Canada). Oral Mix SF is a dye-free, cherry-flavoured oral suspending vehicle used for extemporaneous compounding.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of stability of melatonin in extemporaneously compounded oral suspensions

Friciu

Savji

Zaraa

et al. 2016

Pharmacy Practice and Res

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Background Melatonin is commonly used to treat insomnia, sleep disturbance or hyperactivity disorders. It can be administered in paediatric patients as oral formulations prepared using either bulk powder or commercial products. Few studies have evaluated the stability of these oral formulations, but some storage conditions information may be lacking and a need has been identified for additional stability studies. Aim The aim of this research was to study the stability of extemporaneously prepared oral suspensions of melatonin (2 mg/mL), prepared from pure drug powder or commercial tablets using a proprietary dye‐free oral vehicle: Oral Mix SF (Medisca Pharmaceutique Inc.). Method Two melatonin oral liquid preparations were formulated: (a) tablets in Oral Mix SF and (b) pure drug powder in Oral Mix SF. Preparations were stored at room temperature (23–27°C) as well as under refrigeration (3–5°C) in amber plastic syringes (PreciseDose Dispenser™, Medisca Pharmaceutique Inc.) and amber polyethylene terephthalate (PET) bottles with appropriate closures for a period of 90 days. Preparations were assessed using a validated stability‐indicating high‐performance liquid chromatography method. Beyond use dates were evaluated by statistical analysis of the overall degradation trend. Results All preparations were physically and chemically stable for at least 90 days in all storage conditions at room temperature and under refrigeration. Conclusion Results showed that compared to other vehicles, these suspensions had equivalent stability, indicating that Oral Mix SF is a viable dye‐free and sugar‐free alternative for extemporaneous compounding of melatonin.

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Section: Discussionmentioning

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of stability of melatonin in extemporaneously compounded oral suspensions

Friciu

Savji

Zaraa

et al. 2016

Pharmacy Practice and Res

View full text Add to dashboard Cite

show abstract

“…The risk of false negative results was estimated to be <0.01%. The present chromatographic method was fast (melatonin retention time <3 min), and needed a small sample injection volume, without buffering or acidification of mobile phase as compared to previous methods ( Tables S4 and S5 ) [23] , [24] , [25] , [26] , [27] . Moreover, the absence of a buffer in the mobile phase, as used in some methods, reduced the risk of crystallization (no salt deposition on the seals of the pump or the level of the injector), preserving the longevity of the column, and without requiring any guard column.…”

Section: Resultsmentioning

confidence: 97%

Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial

Filali

Bergamelli

Tall

et al. 2017

Journal of Pharmaceutical Analysis

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A new institutional clinical trial assessed the improvement of sleep disorders in 40 children with autism treated by immediate-release melatonin formulation in different regimens (0.5 mg, 2 mg, and 6 mg daily) for one month. The objectives of present study were to (i) prepare low-dose melatonin hard capsules for pediatric use controlled by two complementary methods and (ii) carry out a stability study in order to determine a use-by-date. Validation of preparation process was claimed as ascertained by mass uniformity of hard capsules. Multicomponent analysis by attenuated total reflectance Fourier transformed infrared (ATR-FTIR) of melatonin/microcrystalline cellulose mixture allowed to identify and quantify relative content of active pharmaceutical ingredients and excipients. Absolute melatonin content analysis by high performance liquid chromatography in 0.5 mg and 6 mg melatonin capsules was 93.6%±4.1% and 98.7%±6.9% of theoretical value, respectively. Forced degradation study showed a good separation of melatonin and its degradation products. The capability of the method was 15, confirming a risk of false negative <0.01%. Stability test and dissolution test were compliant over 18 months of storage with European Pharmacopoeia. Preparation of melatonin hard capsules was completed manually and melatonin in hard capsules was stable for 18 months, in spite of low doses of active ingredient. ATR-FTIR offers a real alternative to HPLC for quality control of high-dose melatonin hard capsules before the release of clinical batches.

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Physicochemical and microbiological stability studies of a melatonin oral suspension in a commercially available vehicle for paediatric use

2014

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Objectives Melatonin is commonly prescribed in paediatric population, but it is commercially only available in tablet form. Oral suspensions are useful pharmaceutical preparations faced with difficulties from the pharmaceutical industry to provide medicines to children. Ready-for-use suspending agents are used, although their compositions are unsuitable for children. A new liquid vehicle for oral suspensions, Inorpha, was commercialised with a formulation adapted in paediatrics. The stability of a melatonin oral suspension 2 mg/mL in Inorpha was studied. The physicochemical and microbiological stabilities were respectively evaluated during 6 and 4 months. Methods A validated high-performance liquid chromatography method was used to assess the melatonin concentration under room temperature and refrigerated conditions weekly. A validated microbiological method was employed on 10 mL vials, on the one hand, and one 200 mL bottle opened every day, on the other hand, in order to evaluate respectively the microbiological stability before opening and under conditions of use. Results After 18 weeks under room temperature and refrigerated conditions, samples held respectively a melatonin minimal concentration of 99.3% and 96.7% of initial concentration. After 6 months, melatonin concentration was 96.1% of initial concentration. Total aerobic microbial counts obtained during the 4-month microbiological study were <10 CFU/mL. None of the melatonin suspensions presented fungal growth. Conclusions Variation of the active ingredient concentration did not exceed 5% after 6 months. Microbial enumeration assays demonstrated microbiological stability of suspensions over a period of 4 months. The microbiological quality was not altered by repeated openings of the bottle allowing production of multidose vials.

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Stability of an extemporaneous alcohol-free melatonin suspension

Abstract: Extemporaneously prepared, alcohol-free, 1-mg/mL suspensions of melatonin and melatonin-pyridoxine hydrochloride in a 1:1 mixture of Ora-Plus and either Ora Sweet or Ora Sweet SF were stable for at least 90 days when stored in 2-oz amber plastic bottles at room temperature.

Cited by 7 publications

References 9 publications

Evaluation of stability of melatonin in extemporaneously compounded oral suspensions

Evaluation of stability of melatonin in extemporaneously compounded oral suspensions

Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial

Physicochemical and microbiological stability studies of a melatonin oral suspension in a commercially available vehicle for paediatric use

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