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A new vancomycin formulation for oral use

European Statement

Production and Compounding

Author(s)

Mette Lethan, Tove Hansen, Trine Schnor, Louise Rasmussen Duckert

Why was it done?

Oral vancomycin 125 mg four times a day for 10 days, is the common treatment for antibiotic-associated clostridium difficile colitis. As solid oral formulations are unsuitable due to strong diarrhea, an i.v. formulation in a diluted form (10 mg/ml) is used. However, several issues with that use, required the need for creating a new formulation.
The product is used for treatment of kids and adults, often with nausea. The low strength requires large volumes of solution and with no flavoring the liquid is very bitter.
Furthermore, the current solution has a limited stability causing difficulties as it is often desired to treat the patients at home. Therefore, a wish arose for a new formulation with a higher concentration, better stability and improved organoleptic qualities.

What was done?

A new oral formulation of Vancomycin was developed to improve the treatment of antibiotic-associated clostridium difficile colitis. The new formulation consists of the active ingredient (API) Vancomycin as a powder with a solvency for dissolving prior to use.

How was it done?

To obtain the best stability it was selected to make a new formulation consisting of a premeasured API, with a solvency ready to mix before use, to obtain a final strength of 50 mg/ml and a volume equivalent to 48 hours of doses.
Vancomycin in pharmacopeia quality was acquired and analyzed. A solvency was formulated mostly consisting of water, conservation and orange flavoring. A test was conducted with a weighed-out API to ensure that it was dissolvable with the solvency in the selected packaging.

What has been achieved?

A product achieving the wanted changes was tested and made. Making a formulation consisting of a premeasured powder creates the possibility of a higher durability. When mixed with the flavored solvency, the wanted strength is achieved.
The new formulation can be stored at room temperature before dissolving. It can be dissolved by the patient before use and kept refrigerated until the full volume is used. The product is easy for the patient to handle and therefore enables treatment in the patients own home.

What next?

A new product was made. Final use by patients will be tested for ease of use and potential home treatment.

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