It has especially found ground for paediatric dosage forms due to its flexibility to fabricate precise dosage forms with complex geometries but also with acceptable palatability for children. Overall, the development of such pharmaceutical products with high quality, safety and clinical efficacy is extremely challenging and requires the implementation of novel manufacturing technologies which can address the aforementioned challenges but also to produce personalised dosage forms that fit the patient’s clinical needs (e.g., dose, pharmacokinetics, palatability).Ī disruptive technology that has attracted enormous interest in pharmaceutical research over the last few years is 3D printing or also known as additive manufacturing. Another consideration in the development of paediatric products is the selection of the excipients which should be approved for paediatric patients and thus the formulations should be carefully designed. Organoleptic properties such as appearance, taste, texture or smell are also important including and promote adherence in paediatric populations. The administration of oral dosage forms is the most acceptable for school children but also for infants (mini-tablets < 2 mm), especially those that can be easily swallowed and disintegrate in the oral cavity. Thus, the European Union recognises the need for paediatric-centric medicines and introduced the paediatric investigation plan and several guidelines for pharmaceutical development and clinical trials for paediatric products. In addition, most pharmaceutical products are not indicated for paediatric applications as clinical trials in the pre-development stage exclude children. Very often the lack of therapy adherence leads to deprived health consequences for paediatric patients. Paediatric patients are a special population that requires specific considerations when designing drug products due to the need for clinical safety and medication adherence.
The findings of the study can be used for the development of paediatric dosage forms with enhanced organoleptic properties, palatability and medication adherence. The evaluation showed complete taste masking of the bitter DPH and revealed a synergistic effect of the sweetener and the strawberry flavour with enhanced sweet strawberry, fruity and aftertaste perception.
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Trained panellists performed a full taste and sensory evaluation of the sweetener intensity and the strawberry aroma. DPH was released rapidly from the 3D printed fruit-chew designs with >85% within the first 30 min. Physicochemical characterisation confirmed the formation of glass solution where DPH was molecularly dispersed within the hydrophilic carriers. The thermoplastic filaments were used to print 3D fruit-chew designs by Fused Deposition Modelling (FDM) technology. In the current study extruded filaments of the highly bitter Diphenhydramine Hydrochloride (DPH) were fabricated by using suitable hydrophilic carries such as hydroxypropyl cellulose (Klucel ELF TM) and a non-ionic surfactant (Gelucire 48/16 TM) combined with sweetener (Sucralose) and strawberry flavour grades.
The development of personalised paediatric dosage forms using 3D printing technologies has gained significant interest over the last few years.
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