title: Preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules.
abstract: 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.
authors.affiliation: Professional Product Information, Roche Laboratories, Nutley, NJ 07110-1199, USA. aleksander.winiarski@roche.com
authors.forename: Aleksander P
authors.initials: AP
authors.lastname: Winiarski
authors.forename: Martin H
authors.initials: MH
authors.lastname: Infeld
authors.forename: Ronald
authors.initials: R
authors.lastname: Tscherne
authors.forename: Maria
authors.initials: M
authors.lastname: Bachynsky
authors.forename: Richard
authors.initials: R
authors.lastname: Rucki
authors.forename: Kathy
authors.initials: K
authors.lastname: Nagano-Mate
mesh_terms: 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
chemical_list: D000998:Antiviral Agents; D002214:Capsules; D014677:Pharmaceutical Vehicles; D012996:Solutions; D053139:Oseltamivir