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Compounded drugs

16 April 2013, by GLOOR S. , DEPLAZES C. , MÖLL F. & PANIZZON R.G.



Although they have been the subject of much criticism in recent years, compounded drugs have seen a resurgence and their usage has become established. The majority of dermatologists in France support the use of compounded drugs, as was demonstrated in a survey [1]. In Switzerland, compounded dermatology medications count for 30% of compounded drugs and they are used only in second place to oral preparations. They are first if the different range of pharmaceutical forms is taken into account [4-7]. In Germany, 40% of prescriptions issued in dermatology call for a compounded drug, and this trend is increasing [8, 9]. Compounded drugs have also been officially accepted in the United Kingdom [10] and the United States [11].


Compounded drugs are medications prepared for a patient on a medical prescription. They are part of the modern medical concept of personalised treatment, which has gained significant scientific support in recent years.

Although there is a wide range of dermatological pharmaceutical products available on the market, there are still numerous reasons why a personalised preparation may be prescribed for some patients.

The choice of a compounded drug may be justified in the following circumstances:

The selected active ingredient is not available as a commercial preparation.

For example: dithranol, capsaicin, oestradiol benzoate, thiabendazole, menthol, polidocanol.

The active ingredient is not available in the selected vehicle and/or it is not found at the desired concentration, for example:

– salicylic acid 10 - 20%;

– various dyes: In solution 0.1 - 2%;

– dithranol: in a washable cream/oil base 0.01 - 2%;

– polidocanol: suspended in an aqueous solution at 5% ;

– urea: in an emulsion at 10 - 40%;

– vitamin A acid (tretinoin): Oral solution at 0.005 – 0.02%.

The active ingredient is not normally sufficiently stable (dithranol, dyes, silver nitrate, polidocanol). In an emergency, it is possible to give a compounded drug a minimum stability of one week. In standard commercially available drugs, a stability of less than 2 years would pose problems.

The commercially available drug is contraindicated because of allergy.

The excipients are known and can be described for a compounded drug. Some preservatives, perfumes or emulsifying agents can be specifically removed and/or replaced. Equally, other ingredients with a low potential to cause allergies can be added if needed.

The preparation can be adjusted to suit patient’s skin type and the treatment schedule adopted.

This means that it is possible to treat the patient with increasing (or decreasing) quantities of the active ingredient, or even with no active ingredient: this is especially useful for long term treatments when the treatment ends up being the vehicle alone.

It is possible to apply treatments based on only ingredients that have been proven to be effective in chronic conditions. These treatments, and the vehicles that are used, have been known for many years. They are well described, easy to mix, and can be adapted depending on the seriousness of the condition.

– Suspension of bentonite, zinc oxide, talc, propylene glycol and distilled water (Supsensio alba cutanea). 

– Hydrophilic ointment (Ungt. Hydrophilicum) = O/W emulsion.

– Cold cream (Ungt. Leniens) = W/O emulsion.

– Almond oil cream (Ungt. Amygdalae) = oily cream.

– Zinc paste (Pasta zinci) = paste.

Compounded drugs that are issued as named-patient preparations improve patient compliance.

It is possible to make adjustments to the specific quantity required for treatment.

The points above show that compounded drugs are not being put forward as competitors for commercially available drugs; instead they should be considered to be complementary to these drugs. However, we must assess them within a more critical framework than before if we wish them to continue to have a role in the future. It is more likely that they will have to be examined furthermore from a quality perspective.

A compounded drug cannot (and will not be able to) meet the criteria for registration that commercially available drugs have to meet. It is neither possible nor necessary because one of the reason for the existence of compounded drugs is so that formulations containing “orphan drugs” can be offered, and without these some rare conditions would not be managed because these active ingredients do not or no longer interest pharmaceutical companies.

Furthermore, if you use a simple formulation, it is possible to obtain a compounded drug required for research in an university clinic. There is also a value of compounded drugs in emergencies, especially in paediatric medicine when some medications can only be administered in a liquid form.

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