You are herePAEDIATRIC FORMULATIONS OR EXTEMPORANEOUS DOSAGE FORM FOR ORAL LIQUIDS

PAEDIATRIC FORMULATIONS OR EXTEMPORANEOUS DOSAGE FORM FOR ORAL LIQUIDS


Preparation of a Extemporaneous preparation-A Guide
• Consider an alternative drug.
• Consider an alternative method, for example, tablet dispersion or oral administration of the injection.
• Consult the latest information data-bases and publications. Prepare a formulation according to a published study and follow the conditions of this study as closely as possible. Modifications to published formulations are only appropriate if there are no detrimental effects on stability. A   maximum expiry date of one month from preparation is recommended and liquids without antimicrobial preservative should be given a shorter expiry date. If there are no data from a published study consult pharmaceutical manufacturers, other paediatric hospitals and research centers. It may be possible to adapt existing information from drug stability texts (e.g. solubility, stability profile) or from the formulation details of the injection or oral liquid available elsewhere. Monitor use of the product and observe for any signs of physical instability such as colour change or difficulty in re-suspension. Provide information to carrears to ensure correct use of the product (e.g. storage conditions, use of an oral syringe, shaking before administration). Ensure that formulations details are available to all practitioners involved in the patients care to ensure that the product is consistent in appearance and quality. Prescriptions could contain full details of the formula and hospital pharmacists could provide details to their community colleagues. [44]

CONCLUSION
The present article was described a many complex issues that have been described and to highlight some of the factors for pharmacists and paediatricians to consider in order to optimise drug therapy. Information sources such as specialised formularies, drug stability texts and the advice of pharmaceutical companies are invaluable. Most pharmaceutical companies will attempt to provide stability information and can sometimes recommend a specific formulation. Practitioners must continue to lobby for the development and availability of more paediatric oral liquids and paediatric strength tablets some of which may be obtainable in other countries. In order to make information more accessible investigators of clinical drug use should describe the formulation details of the preparation used in their research. This information is often omitted from the publication and can be extremely difficult to source especially when required rapidly. Investigators engaged in stability studies should aim to make the results of their research universally acceptable by designing simple formulations and avoiding the use of unnecessary or difficult to use ingredients. Valid protocol design for the stability study is essential and ideally the study should be carried out on formulations prepared from pure drug as well as tablets and the pure drug formulation used in practice whenever possible.  Finally, sharing information on extemporaneous preparation and research collaboration should be further encouraged especially between major paediatric hospitals and research centres to ensure that our patients receive the highest quality drug therapy.

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http://www.pharminfotech.co.nz/manual/Formulation/extemprep.pdf accesed on2011, 12 February

Reference ID: PHARMATUTOR-ART-1046

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