[e-drug] Usage of parabens in dexamethasone tablets

e-drug
1

E-DRUG: Usage of parabens in dexamethasone tablets
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Dear e-druggers,

During a recent research project our working group has discovered small
amounts of methyl- and propylparabens (approx. 0.2 and 0.1 mg per tablet) in
four different products labeled as dexamethasone 0.5mg tablets.

I am aware that these parabens are widely used preservatives in liquid
pharmaceutical dosage forms, but is there any rationale for their usage of
parabens in solid oral dosage forms such as tablets? I am especially
surprised as I have not (yet) seen the usage of parabens in tablets
containing different APIs.

I am curious to learn from your experience with the use of parabens (methyl-
and propylparabenes) in tablets and would be happy to hear your opinion.

Regards

Gesa Gnegel

Gesa Gnegel, Licensed Pharmacist
Pharmaceutical Institute, Tuebingen University
Tuebingen, Germany
<gesa.gnegel@uni-tuebingen.de>

2

E-DRUG: Usage of parabens in dexamethasone tablets (2)
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Dear Gesa,

These inactive (excipients) can also be found in bulk paracetamol tablet
formulations, alike to prevent mould during its approved shelf life
as well as in topical products (cosmetics). Its presence is part of the
stability study of the product but not a formal label requirement (as far
as I know).

Specific criteria may apply to label preservatives in labels for injectable
products.

best regards,
Pascal

Pascal Verhoeven, MSc.Pharm, MPH
Laos
Pascal Verhoeven <verhoeven.pascal@gmail.com>