Volume 12 Issue 3
Jun.  2022
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Ihatanderson A. Silva, Ana Luiza Lima, Tais Gratieri, Guilherme M. Gelfuso, Livia L. Sa-Barreto, Marcilio Cunha-Filho. Compatibility and stability studies involving polymers used in fused deposition modeling 3D printing of medicines[J]. Journal of Pharmaceutical Analysis, 2022, 12(3): 424-435. doi: 10.1016/j.jpha.2021.09.010
Citation: Ihatanderson A. Silva, Ana Luiza Lima, Tais Gratieri, Guilherme M. Gelfuso, Livia L. Sa-Barreto, Marcilio Cunha-Filho. Compatibility and stability studies involving polymers used in fused deposition modeling 3D printing of medicines[J]. Journal of Pharmaceutical Analysis, 2022, 12(3): 424-435. doi: 10.1016/j.jpha.2021.09.010

Compatibility and stability studies involving polymers used in fused deposition modeling 3D printing of medicines

doi: 10.1016/j.jpha.2021.09.010
Funds:

This research was financially supported by the Brazilian agencies DPI/UnB, FAP-DF (Grant No.: 193.001.741/2017), and CNPq (Grant No.: 408291/2018–4). The authors would like to thank the contribution of Ms. Daniela Galter and Ms. Karina Riccomini from Ashland Specialty Ingredients, Ms. Beatriz Pancica from Merck, Ms. Renata Colenci from Evonik, and Mr. Fabio Ito from BASF for kindly supplying the material used in this work. Additionally, the authors thank the laboratory LaProNat/UnB for allowing the use of its facilities.

  • Received Date: May 23, 2021
  • Accepted Date: Sep. 17, 2021
  • Rev Recd Date: Sep. 03, 2021
  • Publish Date: Sep. 20, 2021
  • One of the challenges in developing three-dimensional printed medicines is related to their stability due to the manufacturing conditions involving high temperatures. This work proposed a new protocol for preformulation studies simulating thermal processing and aging of the printed medicines, tested regarding their morphology and thermal, crystallographic, and spectroscopic profiles. Generally, despite the strong drug-polymer interactions observed, the chemical stability of the model drugs was preserved under such conditions. In fact, in the metoprolol and Soluplus® composition, the drug's solubilization in the polymer produced a delay in the drug decomposition, suggesting a protective effect of the matrix. Paracetamol and polyvinyl alcohol mixture, in turn, showed unmistakable signs of thermal instability and chemical decomposition, in addition to physical changes. In the presented context, establishing protocols that simulate processing and storage conditions may be decisive for obtaining stable pharmaceutical dosage forms using three-dimensional printing technology.
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  • I. Alves-Silva, L.C.L. Sa-Barreto, E.M. Lima, et al., Preformulation studies of itraconazole associated with benznidazole and pharmaceutical excipients, Thermochim. Acta. 575(2014)29-33
    M.K. Trivedi, N. Dixit, P. Panda, et al., In-depth investigation on physicochemical and thermal properties of magnesium (II) gluconate using spectroscopic and thermoanalytical techniques, J. Pharm. Anal. 7(2017)332-337
    A. Talvani, M.T. Bahia, L.C.L. de Sa-Barreto, et al., Carvedilol:decomposition kinetics and compatibility with pharmaceutical excipients, J. Therm. Anal. Calorim. 115(2014)2501-2506
    Food and Drug Administration, reportPharmaceutical Development Report Example QbD for IR Generic Drugs, Module 3 Quality 3.2.P.2 Pharmaceutical Development. https://www.fda.gov/files/drugs/published/quality-by-design-% 28QbD% 29-for-an-immediate-release.pdf, 2012(accessed 14 July 2021)
    R. Ferreira-Nunes, T. Gratieri, G.M. Gelfuso, et al., Mixture design applied in compatibility studies of catechin and lipid compounds, J. Pharm. Biomed. Anal. 149(2018)612-617
    B. Rojek, B. Suchacz, M. Wesolowski, Artificial neural networks as a supporting tool for compatibility study based on thermogravimetric data, Thermochim. Acta 659(2018)222-231
    F.Q. Pires, L.A. Pinho, D.O. Freire, et al., Thermal analysis used to guide the production of thymol and Lippia origanoides essential oil inclusion complexes with cyclodextrin, J. Therm. Anal. Calorim. 137(2019)543-553
    E.M. Materon, A. Wong, T.A. Freitas, et al., A sensitive electrochemical detection of metronidazole in synthetic serum and urine samples using low-cost screen-printed electrodes modified with reduced graphene oxide and C60, J. Pharm. Anal.(2021)
    A. Awad, F. Fina, A. Goyanes, et al., Advances in powder bed fusion 3D printing in drug delivery and healthcare, Adv. Drug Deliv. Rev. 174(2021)406-424
    M.D. Sarker, S. Naghieh, N.K. Sharma, et al., 3D biofabrication of vascular networks for tissue regeneration:a report on recent advances, J. Pharm. Anal. 8(2018)277-296
    S.J. Trenfield, A. Awad, C.M. Madla, et al., Shaping the future:recent advances of 3D printing in drug delivery and healthcare, Expert Opin. Drug Deliv. 16(2019)1081-1094
    F. Fina, A. Goyanes, M. Rowland, et al., 3D printing of tunable zero-order release printlets, Polymers (Basel)12(2020) E1769
    S. Ayyoubi, J.R. Cerda, R. Fernandez-Garcia, et al., 3D printed spherical mini-tablets:Geometry versus composition effects in controlling dissolution from personalised solid dosage forms, Int. J. Pharm. 597(2021)120336
    V.M. Vaz, L. Kumar, 3D printing as a promising tool in personalized medicine, AAPS PharmSciTech 22(2021)49
    M. Cunha-Filho, M.R. Araujo, G.M. Gelfuso, et al., FDM 3D printing of modified drug-delivery systems using hot melt extrusion:a new approach for individualized therapy, Ther. Deliv. 8(2017)957-966
    H. Oblom, J.X. Zhang, M. Pimparade, et al., 3D-printed isoniazid tablets for the treatment and prevention of tuberculosis-personalized dosing and drug release, AAPS PharmSciTech 20(2019)52
    F.Q. Pires, I. Alves-Silva, L.A.G. Pinho, et al., Predictive models of FDM 3D printing using experimental design based on pharmaceutical requirements for tablet production, Int. J. Pharm. 588(2020)119728
    A. Goyanes, A.B. Buanz, G.B. Hatton, et al., 3D printing of modified-release aminosalicylate (4-ASA and 5-ASA) tablets, Eur. J. Pharm. Biopharm. 89(2015)157-162
    K. Ilyes, N.K. Kovacs, A. Balogh, et al., The applicability of pharmaceutical polymeric blends for the fused deposition modelling (FDM)3D technique:Material considerations-printability-process modulation, with consecutive effects on in vitro release, stability and degradation, Eur. J. Pharm. Sci. 129(2019)110-123
    A. Goyanes, H. Chang, D. Sedough, et al., Fabrication of controlled-release budesonide tablets via desktop (FDM)3D printing, Int. J. Pharm. 496(2015)414-420
    W. Kempin, V. Domsta, I. Brecht, et al., Development of a dual extrusion printing technique for an acid-and thermo-labile drug, Eur. J. Pharm. Sci. 123(2018)191-198
    I. El Aita, J. Breitkreutz, J. Quodbach, On-demand manufacturing of immediate release levetiracetam tablets using pressure-assisted microsyringe printing, Eur. J. Pharm. Biopharm. 134(2019)29-36
    G. Matijasic, M. Gretic, J. Vincic, et al., Design and 3D printing of multi-compartmental PVA capsules for drug delivery, J. Drug Deliv. Sci. Technol. 52(2019)677-686
    A.Q. Low, J. Parmentier, Y.M. Khong, et al., Effect of type and ratio of solubilising polymer on characteristics of hot-melt extruded orodispersible films, Int. J. Pharm. 455(2013)138-147
    M. Sadia, B. Arafat, W. Ahmed, et al., Channelled tablets:an innovative approach to accelerating drug release from 3D printed tablets, J. Control. Release 269(2018)355-363
    F. Dores, M. Kuzminska, C. Soares, et al., Temperature and solvent facilitated extrusion based 3D printing for pharmaceuticals, Eur. J. Pharm. Sci. 152(2020)105430
    J.X. Zhang, X. Feng, H. Patil, et al., Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets, Int. J. Pharm. 519(2017)186-197.]
    T.C. Okwuosa, C. Soares, V. Gollwitzer, et al., On demand manufacturing of patient-specific liquid capsules via co-ordinated 3D printing and liquid dispensing, Eur. J. Pharm. Sci. 118(2018)134-143
    A. Melocchi, G. Loreti, M.D. Del Curto, et al., Evaluation of hot-melt extrusion and injection molding for continuous manufacturing of immediate-release tablets, J. Pharm. Sci. 104(2015)1971-1980
    D.M. Smith, Y. Kapoor, G.R. Klinzing, et al., Pharmaceutical 3D printing:Design and qualification of a single step print and fill capsule, Int. J. Pharm. 544(2018)21-30
    L.F.B. Malaquias, H.L. Schulte, J.A. Chaker, et al., Hot melt extrudates formulated using design space:one simple process for both palatability and dissolution rate improvement, J. Pharm. Sci. 107(2018)286-296
    G. Kollamaram, D.M. Croker, G.M. Walker, et al., Low temperature fused deposition modeling (FDM)3D printing of thermolabile drugs, Int. J. Pharm. 545(2018)144-152
    K. Klimova, J. Leitner, DSC study and phase diagrams calculation of binary systems of paracetamol, Thermochim. Acta 550(2012)59-64
    A.L. Lima, L.A.G. Pinho, J.A. Chaker, et al., Hot-melt extrusion as an advantageous technology to obtain effervescent drug products, Pharmaceutics 12(2020)779
    E. Villicana-Molina, E. Pacheco-Contreras, E.A. Aguilar-Reyes, et al., Pectin and chitosan microsphere preparation via a water/oil emulsion and solvent evaporation method for drug delivery, Int. J. Polym. Mater. Polym. Biomater. 69(2020)467-475
    M.D. Phale, P.D. Hamrapurkar, Optimization and establishment of a validated stability-indicating HPLC method for study of the stress degradation behavior of metoprolol succinate, J. AOAC Int. 93(2010)911-916
    B. Marciniec, M. Ogrodowczyk, B. Czajka, et al., The influence of radiation sterilisation on some β-blockers in the solid state, Thermochim. Acta 514(2011)10-15
    R.M. Borkar, B. Raju, R. Srinivas, et al., Identification and characterization of stressed degradation products of metoprolol using LC/Q-TOF-ESI-MS/MS and MSn experiments, Biomed. Chromatogr. 26(2012)720-736
    Y. Ikeuchi-Takahashi, S. Ito, A. Itokawa, et al., Preparation and evaluation of orally disintegrating tablets containing taste masked microparticles of acetaminophen, Pharmazie 75(2020)2-6
    M.A. Alhnan, A.W. Basit, In-process crystallization of acidic drugs in acrylic microparticle systems:influence of physical factors and drug-polymer interactions, J. Pharm. Sci. 100(2011)3284-3293
    R. Pezzoli, J.G. Lyons, N. Gately, et al., Stability studies of hot-melt extruded ternary solid dispersions of poorly-water soluble indomethacin with poly (vinyl pyrrolidone-co-vinyl acetate) and polyethylene oxide, J. Drug Deliv. Sci. Technol. 52(2019)248-254
    G.G.G. de Oliveira, A. Feitosa, K. Loureiro, et al., Compatibility study of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in physical mixtures, Saudi Pharm. J. 25(2017)99-103
    G. Verstraete, W. De Jaeghere, J. Vercruysse, et al., The use of partially hydrolysed polyvinyl alcohol for the production of high drug-loaded sustained release pellets via extrusion-spheronisation and coating:In vitro and in vivo evaluation, Int. J. Pharm. 517(2017)88-95
    K.L. O'Donnell, G.S. Oporto-Velasquez, N. Comolli, Evaluation of acetaminophen release from biodegradable poly (vinyl alcohol)(PVA) and nanocellulose films using a multiphase release mechanism, Nanomaterials (Basel)10(2020) E301
    M.K. Lai, R.C. Tsiang, Encapsulating acetaminophen into poly (L-lactide) microcapsules by solvent-evaporation technique in an O/W emulsion, J. Microencapsul. 21(2004)307-316
    Y.S. Yang, A. Gupta, A.S. Carlin, et al., Comparative stability of repackaged metoprolol tartrate tablets, Int. J. Pharm. 385(2010)92-97
    J. Varshosaz, H. Faghihian, K. Rastgoo, Preparation and characterization of metoprolol controlled-release solid dispersions, Drug Deliv. 13(2006)295-302
    K.P. Sawant, R. Fule, M. Maniruzzaman, et al., Extended release delivery system of metoprolol succinate using hot-melt extrusion:effect of release modifier on methacrylic acid copolymer, Drug Deliv. Transl. Res. 8(2018)1679-1693
    S.M. Alshahrani, W.L. Lu, J.B. Park, et al., Stability-enhanced hot-melt extruded amorphous solid dispersions via combinations of Soluplus® and HPMCAS-HF, AAPS PharmSciTech 16(2015)824-834
    A.B. Albadarin, C.B. Potter, M.T. Davis, et al., Development of stability-enhanced ternary solid dispersions via combinations of HPMCP and Soluplus® processed by hot melt extrusion, Int. J. Pharm. 532(2017)603-611
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