Preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules.
OBJECTIVE
To develop a simple, standardized method for the extemporaneous compounding of an oral liquid form of oseltamivir from commercially available Tamiflu 75 mg capsules (Roche Pharmaceuticals) and to determine the stability of oseltamivir in this preparation.


METHODS
Chemical and microbial stability study.


METHODS
Laboratory.


METHODS
None.


METHODS
Extemporaneous oral liquid formulations of oseltamivir (15 mg/mL) were prepared in Cherry Syrup (Humco) and Ora-Sweet SF (Paddock Laboratories) using methods consistent with current compounding practice in a pharmacy setting. Preparations were stored in amber glass and amber polyethyleneterephthalate bottles at 5 degrees C +/- 2 degrees C (41 degrees F +/- 4 degrees F) and 25 degrees C +/- 2 degrees C (77 degrees F +/- 4 degrees F) at 60% +/- 5% relative humidity (RH) for 35 days and 30 degrees C +/- 2 degrees C (86 degrees F +/- 4 degrees F) at 65% +/- 5% RH for 13 days.


METHODS
Samples were monitored for appearance, pH, assay, degradation products, and microbiologic stability.


RESULTS
The Cherry Syrup preparation, in either bottle type, was stable for up to 35 days under refrigeration (5 degrees C) and up to 5 days at room temperature (25 degrees C). It was not stable when stored at 30 degrees C for 5 days. The Ora-Sweet SF preparation was stable for up to 35 days at 5 degrees C or 25 degrees C and for up to 13 days at 30 degrees C in either bottle type. Both preparations maintained microbiologic stability for 35 days.


CONCLUSIONS
Both preparations are stable under the described conditions and may provide an option in situations where the marketed suspension is unavailable.
Winiarski
Aleksander P
AP
Professional Product Information, Roche Laboratories, Nutley, NJ 07110-1199, USA. aleksander.winiarski@roche.com
Infeld
Martin H
MH
Tscherne
Ronald
R
Bachynsky
Maria
M
Rucki
Richard
R
Nagano-Mate
Kathy
K
D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage*; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D015169:Colony Count, Microbial; D004339:Drug Compounding; D004340:Drug Contamination; D004355:Drug Stability; D053139:Oseltamivir / Q000008:administration & dosage* / Q000032:analysis / Q000737:chemistry; D014677:Pharmaceutical Vehicles; D012996:Solutions
D000998:Antiviral Agents; D002214:Capsules; D014677:Pharmaceutical Vehicles; D012996:Solutions; D053139:Oseltamivir