Stability of caffeine oral formulations for neonatal use.

Stability of caffeine oral formulations for neonatal use. Research Abstract Details 

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Stability of caffeine oral formulations for neonatal use. Abstract Text:

The stability of an oral formulation of 10 mg/ml caffeine citrate (equivalent to 5.03 mg/ml caffeine free base), which was preserved with potassium sorbate, was assessed at a range of temperatures. There was no appreciable change in pH or caffeine content over 1 year, even at storage temperatures of 32 degrees C and 45 degrees C. A batch-to-batch difference in the stability of potassium sorbate was detected, with losses over 1 year of 2% and 11% for two batches at 25 degrees C and 10% and 30%, respectively, at 45 degrees C. The formulation complied with the Antimicrobial Preservative Efficacy test of the British Pharmacopoeia throughout a period of storage at 25 degrees C for 1 year. There was no detectable benefit to preservative efficacy by adding 20% w/v sorbitol as an osmotic agent. The formula with no sorbitol may be preferable due to the potential for sorbitol to cause gastrointestinal upset. A shelf-life of 1 year at room temperature is feasible. The additional precaution of limiting the in-use storage life to 1 month after opening is recommended to ensure acceptable microbiological quality.

Stability of caffeine oral formulations for neonatal use. Publishing Authors By Initials

For similar inorganic chemicals: potassium compounds research abstracts see: inorganic chemicals: potassium compounds research

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Stability of caffeine oral formulations for neonatal use. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Journal of clinical pharmacy and therapeutics

VOLUME: 19

Page Numbers: 391-6

Journal Abbreviation: J Clin Pharm Ther

ISSN: 0269-4727

DAY: 28

MONTH: Dec

YEAR: 1994

Stability of caffeine oral formulations for neonatal use. Information

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LANGUAGE: eng

NlmUniqueID: 8704308

Stability of caffeine oral formulations for neonatal use. Keywords Mesh Terms:

KEYWORDS: Potassium Compounds

MESH TERMS: chemistry

Chemical & Substance for Abstract: Stability of caffeine oral formulations for neonatal use. Information

Substance Name: Caffeine

Registry Number: 58-08-2

Grant and Affiliation Information for Stability of caffeine oral formulations for neonatal use.

AFFILIATION: Pharmaceutical Sciences Institute, Aston University, U.K.

Country: ENGLAND

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MEDLINETA: J Clin Pharm Ther

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