Abstract
3D printing technique has been utilised to develop novel and complex drug delivery systems that are almost impossible to produce by employing conventional formulation techniques. For example, this technique may be employed to produce tablets or Fast Dissolving oral Films (FDFs) with multilayers of active ingredients, which are personalised to patient's needs. In this article, we compared the production of FDFs by 3D printing to conventional methods such as solvent casting. Then, we evaluated the need for novel methods of producing fast dissolving oral films, and why 3D printing may be able to meet the shortfalls of FDF production. The challenges of producing 3D printed FDFs are identified at commercial scale by referring to the identification of suitable materials, hardware, qualitycontrol tests and Process Analytical Technology. In this paper, we discuss that the FDF market will grow to more than $1.3 billion per annum in the next few years and 3D printing of FDFs may share part of this market. Although companies are continuing to invest in technologies, which provide alternatives to standard drug delivery systems, the market for thin-film products is already well established. Market entry for a new technology such as 3D printing of FDFs will, therefore, be hard, unless, this technology proves to be a game changer. A few approaches are suggested in this paper.
Highlights
Three dimensional printing (3DP) has been employed for the development of novel pharmaceutical dosage forms. These include tablets,[1, 2] capsules,[3] nose patches,[4] filaments,[5] core-shell tablets,[6] gastero-floating tablets,[7] hollow cylinders,[8] dual compartmental dosage units,[9] multi-compartment capsular devices,[10] orodispersible films,[11] fast dissolving oral films,[12] and liquid capsules.[13] 3DP contributes to more end-stage personalisation of solid dosage forms.[14,15,16,17,18]
FDM 3DP and hot melt ram extrusion 3D printer have been applied to the formulation of Fast dissolving oral films (FDFs)
The disintegration time of 3DP FDFs is less than 3 minutes, which complies with pharmacopeia specifications, the disintegration time of films made by solvent casting method is much shorter
Summary
Three dimensional printing (3DP) has been employed for the development of novel pharmaceutical dosage forms These include tablets,[1, 2] capsules,[3] nose patches,[4] filaments,[5] core-shell tablets,[6] gastero-floating tablets,[7] hollow cylinders,[8] dual compartmental dosage units,[9] multi-compartment capsular devices,[10] orodispersible films,[11] fast dissolving oral films,[12] and liquid capsules.[13] 3DP contributes to more end-stage personalisation of solid dosage forms.[14,15,16,17,18] One aspect of personalised medicine is the move away from the concept of ‘onesize fits-all’ to treatment of patients meeting their particular needs.
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