3D-PRINT OF ORALLY DISINTEGRATING TABLETS – HOW TO GET STARTED
European Statement
Production and Compounding
Author(s)
K. Koch, The Pharmacy of the capital region of Denmark, Quality, Herlev, Denmark
R. Højmark, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
L.R. Duckert, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
T. Schnor, The Pharmacy of the capital region of Denmark, production, Herlev, Denmark
Why was it done?
There is an interest in implementing more safe, affordable, and sustainable treatment methods for patients for whom a personalized approach is beneficial. These treatments can be expensive and associated with patient safety and compliance issues. For the pediatric population, many medications are not available in appropriate form or dose and therefore is being manipulated before administration. Extemporaneous oral solutions often have a limited shelf life and bad physical properties or undesirable excipients.
Patients with impaired renal function or need for accurate dose adjustments are also expected to benefit from 3D-printed orally disintegrating tablets (OTDs).
What was done?
The initial steps necessary before implementing 3D-printing for manufacturing personalized ODTs has been identified and completed. The clinical advantages and barriers of the personalized treatment has been discussed interdisciplinary and the new dosage form has been risk evaluated in dialogue with the competent authority. As a result, the best suited technology has been identified.
How was it done?
The European marked has been searched for technologies suitable for extemporaneous personalized production in hospital pharmacies. 3D-printed OTDs was identified as most easily implemented both concerning technology, GMP and patient acceptance.
A dialogue about risks and benefits regarding 3D-ptinted ODTs was initiated with the hospital staff. Risks identified concerned the number of drugs available for 3D-printing, the need for stability testing and resistance from authorities. Benefits like flexibility, just-in-time preparation and patient safety was identified.
A meeting was held with the competent authority, to establish the level of validation, documentation and analysis needed on the final product and starting materials.
What has been achieved?
The necessary steps to get started have been identified and completed. Risks and benefits were assessed, and the decision about implementing 3D-printed ODTs was made. An equipment that is reliable and automated has been sourced.
An API for the initial manufacture was selected, combining clinical relevance and adequate physical properties.
Ink/matrix for the 3D-printer was evaluated and found safe for medicines for children. The matrix is manufactured according to GMP.
A regulatory framework has been agreed upon with the competent authority.
What next?
Validation of the equipment and printing of the first ODTs to be used in the clinic.