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Research Articles

Thermal energy and tableting effects in benznidazole product: the impacts of industrial processing

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Pages 416-428 | Received 14 Mar 2023, Accepted 01 Jun 2023, Published online: 15 Jun 2023

References

  • Scheme Pic O. Guide to good manufacturing practice for medicinal products part I - PE 009-14. Geneva. 2018.
  • Rantanen J, Khinast J. The future of pharmaceutical manufacturing sciences. J Pharm Sci. 2015;104(11):3612–3638. doi: 10.1002/jps.24594.
  • Badman C, Cooney CL, Florence A, et al. Why we need continuous pharmaceutical manufacturing and how to make it happen. J Pharm Sci. 2019;108(11):3521–3523. doi: 10.1016/j.xphs.2019.07.016.
  • Allison G, Cain YT, Cooney C, et al. Regulatory and quality considerations for continuous manufacturing. May 20–21, 2014, continuous manufacturing symposium. J Pharm Sci. 2015;104(3):803–812. doi: 10.1002/jps.24324.
  • Freitas-Marques MB, de Araujo BCR, de Oliveira Sebastião R de C, et al. Kinetics study and Hirshfeld surface analysis for atorvastatin calcium trihydrate and furosemide system. Thermochim Acta. 2019;682:178408. doi: 10.1016/j.tca.2019.178408.
  • Silva CRG, Fialho SL, Barbosa J, et al. Compatibility by a nonisothermal kinetic study of azathioprine associated with usual excipients in the product quality review process. J Braz Chem Soc. 2021;32:638–651.
  • Freitas-Marques MB, Yoshida MI, Fernandes C, et al. Lumefantrine comparative study: single crystal, powder X-ray diffraction, Hirshfeld surface and thermal analysis. J Struct Chem. 2020;1:1–20.
  • Martin A. Martin: físico-farmácia e ciências farmacêuticas. Artmed; 2008.
  • Rabitz H. The foundations for chemical kinetics (Yeremin, E. N.). J Chem Educ. 1982;59(3):A106. doi: 10.1021/ed059pA106.1.
  • Giron D. Applications of thermal analysis in the pharmaceutical industry. J Pharm Biomed Anal. 1986;4(6):755–770. doi: 10.1016/0731-7085(86)80086-3.
  • Svärd M, Valavi M, Khamar D, et al. Thermodynamic stability analysis of tolbutamide polymorphs and solubility in organic solvents. J Pharm Sci. 2016;105(6):1901–1906. doi: 10.1016/j.xphs.2016.03.021.
  • Sokal A, Pindelska E, Szeleszczuk L, et al. Pharmaceutical properties of two ethenzamide-gentisic acid cocrystal polymorphs: drug release profiles, spectroscopic studies and theoretical calculations. Int J Pharm. 2017;522(1-2):80–89. doi: 10.1016/j.ijpharm.2017.03.004.
  • Brito LG, Leite GQ, Duarte FÍC, et al. Thermal behavior of ferulic acid employing isoconversional models and artificial neural network. J Therm Anal Calorim. 2019;138(5):3715–3726. doi: 10.1007/s10973-019-08114-x.
  • Surov AO, Vasilev NA, Churakov AV, et al. Solid forms of ciprofloxacin salicylate: polymorphism, formation pathways, and thermodynamic stability. Cryst Growth Des. 2019;19(5):2979–2990. doi: 10.1021/acs.cgd.9b00185.
  • Descamps M. Disordered pharmaceutical materials. John Wiley & Sons; 2016.
  • Vachon MG, Grant DJW. Enthalpy—entropy compensation in pharmaceutical solids. Int J Pharm. 1987;40(1-2):1–14. doi: 10.1016/0378-5173(87)90042-1.
  • Gibson M. Pharmaceutical preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form. CRC Press; 2016.
  • Krok A, Wu C-Y. Evolutions of temperature and density during roll compaction of a pharmaceutical excipient. Int J Pharm. 2019;572:118822. doi: 10.1016/j.ijpharm.2019.118822.
  • Aucamp M, Milne M. The physical stability of drugs is linked to quality-by-design (QbD) and in-process technology (PAT) perspectives. Eur J Pharm Sci. 2019;139:105057. doi: 10.1016/j.ejps.2019.105057.
  • Fernandes RP, de Carvalho ACS, Ekawa B, et al. Synthesis and characterization of meloxicam eutectics with mandelic acid and saccharin for enhanced solubility. Drug Dev Ind Pharm. 2020;46(7):1092–1099. doi: 10.1080/03639045.2020.1775633.
  • Vyazovkin S, Chrissafis K, Di Lorenzo ML, et al. ICTAC kinetics committee recommendations for collecting experimental thermal analysis data for kinetic computations. Thermochim Acta. 2014;590:1–23. doi: 10.1016/j.tca.2014.05.036.
  • International Conference on Harmonization – ICH [Internet]. Guid. Ind. Q8 Pharm. Dev. 2009 [cited 2023 Jan 20]. p. 25. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
  • Sarge S, Hemminger W, Gmelin E, et al. Metrologically based procedures for the temperature, heat and heat flow rate calibration of DSC. J Therm Anal. 1997;49(2):1125–1134. doi: 10.1007/BF01996802.
  • American Society for Testing and Materials. Standard test method for determining specific heat capacity by differential scanning calorimetry. 2018. ASTM E1269-18:2018.
  • Ditmars DA, Ishihara S, Chang SS, et al. Enthalpy and heat-capacity standard reference material: synthetic sapphire (α-Al2O3) from 10 to 2250 K. J Res Natl Bur Stand. 1982;87:159.
  • Araujo NRS, Sebastião RCO, Freitas-Marques MB, et al. Multilayer perceptron neural network applied to TG dynamic data of biopolymer chitosan–a robust tool to study the kinetics of solid thermal decomposition. Therm Sci Eng Prog. 2022;36:101490. doi: 10.1016/j.tsep.2022.101490.
  • Rotaru A, Goşa M. Computational thermal and kinetic analysis. J Therm Anal Calorim. 2009;97(2):421–426. doi: 10.1007/s10973-008-9772-x.
  • Maximiano FP, Novack KM, Bahia MT, et al. Polymorphic screen and drug–excipient compatibility studies of the antichagasic benznidazole. J Therm Anal Calorim. 2011;106(3):819–824. doi: 10.1007/s10973-011-1371-6.
  • Vromans H, Bolhuis GK, Lerk CF, et al. Studies on tableting properties of lactose. VII. The effect of variations in primary particle size and percentage of amorphous lactose in spray-dried lactose products. Int J Pharm. 1987;35(1-2):29–37. doi: 10.1016/0378-5173(87)90071-8.
  • Ling Z, Wang T, Makarem M, et al. Effects of ball milling on the structure of cotton cellulose. Cellulose. 2019;26(1):305–328. doi: 10.1007/s10570-018-02230-x.
  • Antosik-Rogóż A, Szafraniec-Szczęsny J, Gawlak K, et al. Tabletting solid dispersions of bicalutamide prepared using ball-milling or supercritical carbon dioxide: the interrelationship between phase transition and in-vitro dissolution. Pharm Dev Technol. 2020;25(9):1109–1117. doi: 10.1080/10837450.2020.1797787.
  • Zhou D, Schmitt EA, Law D, et al. Assessing physical stability risk using the amorphous classification system (ACS) based on simple thermal analysis. Mol Pharm. 2019;16(6):2742–2754. doi: 10.1021/acs.molpharmaceut.9b00275.
  • Brasil. Ministério da saúde. Agência nacinal de vigilância sanitária. Farmacopeia Brasileira. vol. 1. 6th ed. Agência Nacional de Vigilância Sanitária , editor. Brasília; 2019.
  • Alves-Silva I, Sá-Barreto LCL, Lima EM, et al. Preformulation studies of itraconazole associated with benznidazole and pharmaceutical excipients. Thermochim Acta. 2014;575:29–33. Elsevier doi: 10.1016/j.tca.2013.10.007.
  • Wang M-H, Tan Z-C, Sun X-H, et al. Heat capacity and thermodynamic properties of crystalline ornidazole (C7H10ClN3O3). Thermochim Acta. 2004;414(1):25–30. doi: 10.1016/j.tca.2003.11.005.
  • Lelievre J. Starch gelatinization. J Appl Polym Sci. 1974;18(1):293–296. doi: 10.1002/app.1974.070180124.
  • Gombas A, Szabó-Révész P, Kata M, et al. Quantitative determination of crystallinity of α-lactose monohydrate by DSC. J Therm Anal Calorim. 2002;68(2):503–510. doi: 10.1023/A:1016039819247.
  • Patel S, Kou X, Hou HH, et al. Mechanical properties and tableting behavior of amorphous solid dispersions. J Pharm Sci. 2017;106(1):217–223. doi: 10.1016/j.xphs.2016.08.021.
  • Rasenack N, Müller BW. Crystal habit and tableting behavior. Int J Pharm. 2002;244(1-2):45–57. doi: 10.1016/s0378-5173(02)00296-x.
  • Paul S, Tajarobi P, Boissier C, et al. Tableting performance of various mannitol and lactose grades assessed by compaction simulation and chemometrical analysis. Int J Pharm. 2019;566:24–31. doi: 10.1016/j.ijpharm.2019.05.030.
  • Andres C, Ndiaye A, Thomas C, et al. Influence of the parameters molecular structure and granularity on the compatibility of a powder. Drug Dev Ind Pharm. 1995;21(16):1875–1885. doi: 10.3109/03639049509070863.
  • Chattoraj S, Sun CC. Crystal and particle engineering strategies for improving powder compression and flow properties to enable continuous tablet manufacturing by direct compression. J Pharm Sci. 2018;107(4):968–974. doi: 10.1016/j.xphs.2017.11.023.
  • Wöstheinrich K, Schmidt PC. Polymorphic changes of thiamine hydrochloride during granulation and tableting. Drug Dev Ind Pharm. 2001;27(6):481–489. doi: 10.1081/ddc-100105172.
  • Otsuka M, Nakanishi M, Matsuda Y. Effects of crystalline form on the tableting compression mechanism of phenobarbital polymorphs. Drug Dev Ind Pharm. 1999;25(2):205–215. doi: 10.1081/ddc-100102161.
  • Mazel V, Delplace C, Busignies V, et al. Polymorphic transformation of anhydrous caffeine under compression and grinding: a re-evaluation. Drug Dev Ind Pharm. 2011;37(7):832–840. doi: 10.3109/03639045.2010.545416.
  • Widyastuti I, Ainurofiq A, Soewandhi SN. Effects of thermal energy, mechanical energy, and solvent on ciprofloxacin hydrochloride monohydrate physicochemical properties. RJC. 2019;12(04):1973–1984. doi: 10.31788/RJC.2019.1245426.
  • Fayed MH, Aldawsari MF, Ali AS, et al. Design-of-experiment approach to quantify the effect of nano-sized silica on tableting properties of microcrystalline cellulose to facilitate direct compression tableting of binary blend containing a low-dose drug. J Drug Deliv Sci Technol. 2022;68:103127. doi: 10.1016/j.jddst.2022.103127.
  • Mohylyuk V. Effect of roll compaction pressure on the properties of high drug-loaded piracetam granules and tablets. Drug Dev Ind Pharm. 2022;48(9):425–437. doi: 10.1080/03639045.2022.2123499.
  • Prikeržnik M, Srčič S. Multivariate analysis for optimization and validation of the industrial tablet-manufacturing process. Drug Dev Ind Pharm. 2021;47(1):61–71. doi: 10.1080/03639045.2020.1851244.
  • Castillo Henríquez L, Vargas Zúñiga R, Carazo Berrocal G, et al. Development of immediate release rupatadine fumarate 10 mg tablets: a quality by design (QbD) approach. Drug Dev Ind Pharm. 2019;45(10):1674–1681. doi: 10.1080/03639045.2019.1652637.
  • Yoshida MI, Lima Gomes EC, Vianna Soares CD, et al. Thermal behavior study and decomposition kinetics of amiodarone hydrochloride under isothermal conditions. Drug Dev Ind Pharm. 2011;37(6):638–647. doi: 10.3109/03639045.2010.534099.
  • Pereira E, Agda M, Pereira V, et al. Compatibility study between atorvastatin and excipients using DSC and FTIR. J Therm Anal Calorim. 2016;123(2):933–939. doi: 10.1007/s10973-015-5077-z.
  • Gomes Ec de L, Mussel WN, Resende JM, et al. Chemical interactions study of antiretroviral drugs efavirenz and lamivudine concerning the development of stable fixed-dose combination formulations for AIDS treatment. J Braz Chem Soc. 2013;24:573–579.
  • Liu M, Svirskis D, Proft T, et al. Preformulation studies of thymopentin: analytical method development, physicochemical properties, kinetic degradation investigations and formulation perspective. Drug Dev Ind Pharm. 2021;47(10):1680–1692. doi: 10.1080/03639045.2022.2048666.
  • Stojanovska Pecova M, Geskovski N, Petrushevski G, et al. Solid-state interaction of ibuprofen with magnesium stearate and product characterization thereof. Drug Dev Ind Pharm. 2020;46(8):1308–1317. doi: 10.1080/03639045.2020.1788067.
  • Batool N, Mahmood A, Sarfraz RM, et al. Formulation and evaluation of interpenetrating polymeric network for controlled drug delivery. Drug Dev Ind Pharm. 2021;47(6):931–946. doi: 10.1080/03639045.2021.1954939.
  • Bărbatu A, Lungan M-A, Toulbe N, et al. Physico-chemical properties of two anhydrous azathioprine forms and their interaction with typical pharmaceutical excipients: highlighting new findings in drug formulation development. Drug Dev Ind Pharm. 2021;47(10):1598–1606. doi: 10.1080/03639045.2022.2032131.
  • Tuğcu-Demiröz F, Saar S, Tort S, et al. Electrospun metronidazole-loaded nanofibers for vaginal drug delivery. Drug Dev Ind Pharm. 2020;46(6):1015–1025. doi: 10.1080/03639045.2020.1767125.
  • Freitas-Marques MB, Araujo BCR, Fernandes C, et al. Kinetics of lumefantrine thermal decomposition employing isoconversional models and artificial neural network. J Braz Chem Soc. 2020;31:512–522.

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