E-DRUG: Splitting of fixed dose combination tablets?
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Dear e-druggers
I have come across instances where fixed dose combination ARV tablets have
been split in half, particularly for children.
Is this rational? Is there any pharmacokinetic data that supports this practice and ensures that adequate amounts of the drug are being administered?
What are others' experiences with this practice?
Best regards,
Chengetanai T. Mangoro
Antiretrovirals/Essential Drugs Officer
UNICEF, 6 Fairbridge Ave, Belgravia,
P.O. Box 1250, Harare, Zimbabwe
Tel: 263-4-703941/2 Fax: 263-4-731849
[FDC tablets can theoretically be split if the substances are homogenously distributed in the tablet. However, some FDCs use the "pellet" technique, in which there is a "sub"-tablet inside the tablet. This would be tricky, as all of one ingredient could end up in half of the tablets only.
The real question might be: is the pharmaceutical industry prepared to make FDCs suitable for children? Some paediatric FDC ARVs have been developed by generic manufacturers, but they might not (yet) be widely available. UNITAID and Clinton Foundation have taken it upon them to make these better available. WB]
E-DRUG: Splitting of fixed dose combination tablets? (3)
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Dear e-druggers,
When it comes to FDCs and Children, we are stuck between a rock and a hard place. As a pharmacist in a pediatric hospital in a developing country, medicines supply for ARVs and anti-TBs is often donor funded and from generic manufacturer, there have been questions about the pharmacokinetic profile of these FDCs and whether they are bio-equivalent to the Innovator products, add that to splitting of tablets (which we have to do for children) then you have yourself to many variables.
It is technically irrational to split FDCs, but that seems to be a viable option in resource poor settings to assure access to these essential medicines to our children. Another option would be to resort to extemporaneous compounding, but even this has its challenges since most establishments lack the technical skills required and quality assurance structures,
The way forward is two pronged,
- lobby for Multinationals to explore research in pediatric formulations and donor organizations fund such research.
- promote rational and quality assured compounding for essential medicines
regards,
Dr Barasa W. Edwine
Drug Information Pharmacist
Gertrudes Gardens Childrens Hospital
Nairobi
Kenya
edwine.halton@gmail.com