3D printed orodispersible films with Aripiprazole.

Three dimensional printing technology is gaining in importance because of its increasing availability and wide applications. One of the three dimensional printing techniques is Fused Deposition Modelling (FDM) which works on the basis of hot melt extrusion-well known in the pharmaceutical technology. Combination of fused deposition modelling with preparation of the orodispersible film with poorly water soluble substance such as aripiprazole seems to be extra advantageous in terms of dissolution rate. 3D printed as well as casted films were compared in terms of physicochemical and mechanical properties. Moreover, drug-free films were prepared to evaluate the impact of the extrusion process and aripiprazole presence on the film properties. X-ray diffractometry and thermal analyses confirmed transition of aripiprazole into amorphous state during film preparation using 3D printing technique. Amorphization of the aripiprazole and porous structure of printed film led to increased dissolution rate in comparison to casted films, which, however have slightly better mechanical properties due to their continuous structure. It can be concluded that fused deposition modelling is suitable technique and polyvinyl alcohol is applicable polymer for orodispersible films preparation.

[1]  R. Tessadri,et al.  Conformational polymorphism in aripiprazole: Preparation, stability and structure of five modifications. , 2009, Journal of pharmaceutical sciences.

[2]  M. Wahl,et al.  Characterization of laminar extrudates manufactured at room temperature in the absence of solvents for the delivery of drugs. , 2013, International journal of pharmaceutics.

[3]  Federico Parietti,et al.  Hot-melt extruded filaments based on pharmaceutical grade polymers for 3D printing by fused deposition modeling. , 2016, International journal of pharmaceutics.

[4]  A. Basit,et al.  Effect of geometry on drug release from 3D printed tablets. , 2015, International journal of pharmaceutics.

[5]  Shaimaa M. Badr-Eldin,et al.  Aripiprazole-Cyclodextrin Binary Systems for Dissolution Enhancement: Effect of Preparation Technique, Cyclodextrin Type and Molar Ratio , 2013, Iranian journal of basic medical sciences.

[6]  Herman J. Woerdenbag,et al.  Orodispersible films in individualized pharmacotherapy: The development of a formulation for pharmacy preparations. , 2015, International journal of pharmaceutics.

[7]  Pharmacokinetics of a New Orally Disintegrating Tablet Formulation of Aripiprazole 15 mg Administered Without Water in Healthy Middle-aged Korean Subjects. , 2015, Clinical therapeutics.

[8]  Maren Preis,et al.  Printed Drug-Delivery Systems for Improved Patient Treatment. , 2016, Trends in pharmacological sciences.

[9]  N. Sandler,et al.  Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[10]  J Breitkreutz,et al.  Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy. , 2012, International journal of pharmaceutics.

[11]  S. Ibrić,et al.  Improvement of Aripiprazole Solubility by Complexation with (2-Hydroxy)propyl-β-cyclodextrin Using Spray Drying Technique , 2012, AAPS PharmSciTech.

[12]  Rebecca Voelker Adverse Events Linked With LVADs , 2015 .

[13]  J. Lewis,et al.  3D Printing of Interdigitated Li‐Ion Microbattery Architectures , 2013, Advanced materials.

[14]  R. Voelker The Printed Pill , 2015 .

[15]  Pezhman Kazemi,et al.  Empirical search for factors affecting mean particle size of PLGA microspheres containing macromolecular drugs , 2016, Comput. Methods Programs Biomed..

[16]  Jonathan Goole,et al.  3D printing in pharmaceutics: A new tool for designing customized drug delivery systems. , 2016, International journal of pharmaceutics.

[17]  Sheng Qi,et al.  Recent developments in micro- and nanofabrication techniques for the preparation of amorphous pharmaceutical dosage forms. , 2016, Advanced drug delivery reviews.

[18]  J. Breitkreutz,et al.  Comparative study on novel test systems to determine disintegration time of orodispersible films , 2014, The Journal of pharmacy and pharmacology.

[19]  R. Jachowicz,et al.  Orodispersible films and tablets with prednisolone microparticles. , 2015, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[20]  Mohammad Hassan Khalid,et al.  Transparent computational intelligence models for pharmaceutical tableting process , 2016, Complex Adapt. Syst. Model..

[21]  Francesca Selmin,et al.  Fast dissolving films made of maltodextrins. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[22]  A. Witkowska,et al.  Studies of phase transitions in the aripiprazole solid dosage form. , 2016, Journal of pharmaceutical and biomedical analysis.

[23]  Anthony Atala,et al.  3D bioprinting of tissues and organs , 2014, Nature Biotechnology.

[24]  Wei Wu,et al.  Enhanced dissolution and oral bioavailability of aripiprazole nanosuspensions prepared by nanoprecipitation/homogenization based on acid-base neutralization. , 2012, International journal of pharmaceutics.

[25]  Jörg Breitkreutz,et al.  Orodispersible drug formulations for children and elderly. , 2015, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[26]  P. Kleinebudde,et al.  Simplified formulations with high drug loads for continuous twin-screw granulation. , 2015, International journal of pharmaceutics.