medigraphic.com
ISSN 2395-8723 (Digital)
ISSN 1405-888X (Impreso)
TIP Revista Especializada en Ciencias Químico-Biológicas

2023, Número 1

<< Anterior Siguiente >>

TIP Rev Esp Cienc Quim Biol 2023; 26 (1)


Evaluación de mezclas binarias para la preselección de acarreadores poliméricos

Alcántara-Fierro ET, Ortiz-Reynoso M, Llera-Rojas VG

Idioma: Español
Referencias bibliográficas: 86
Paginas: 1-18
Archivo PDF: 485.85 Kb.


RESUMEN

La selección de un polímero para mejorar la velocidad de disolución de un fármaco dentro de una fórmula farmacéutica implica el uso de múltiples pruebas que encarecen el proceso de selección, por requerir técnicas de alta especialización; lo opuesto es el uso de un método reducido basado en estudios calorimétricos y de disolución, que ayude en la selección preliminar de los materiales, sin altas inversiones monetarias o de tiempo. En este trabajo se realizó la preselección de un polímero acarreador, con potencial para ser usado en el desarrollo de dispersiones sólidas de clorhidrato de terbinafina, con base en la evaluación de mezclas binarias fármaco-polímero. Se evaluaron tres polímeros con diferentes mecanismos de solubilización, PVP-VA, PCAP-PEG y POE-POP. Los copolímeros de PVP-VA y PCAP-PEG resultaron candidatos factibles para su evaluación en el desarrollo de dispersiones sólidas por los métodos de fusión. Ambos polímeros mejoraron los valores de velocidad de disolución y el porcentaje disuelto de terbinafina, abatieron la entalpía de fusión del fármaco y mostraron termoplasticidad. Con este estudio se muestra un enfoque sencillo y de bajo costo para la preselección de polímeros útiles en la fabricación de dispersiones sólidas.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. Alopaeus, J. F., Hagesæther, E. & Tho, I. (2019). Micellisationmechanism and behaviour of soluplus®–furosemidemicelles: Preformulation studies of an oral nanocarrierbasedsystem. Pharmaceuticals, 12(1), 1–23. https://doi.org/10.3390/ph12010015

  2. Alruwaili, N. K., Zafar, A., Imam, S. S., Alharbi, K. S., Alshehri,S., Elsaman, T., Alomar, F. A., Akhtar, S., Fahmy, U. A.,Alhakamy, N. A. & Alshammari, M. S. (2020). Formulationof amorphous ternary solid dispersions of dapagliflozin usingPEG 6000 and Poloxamer 188: solid-state characterization,ex vivo study, and molecular simulation assessment. DrugDevelopment and Industrial Pharmacy, 46(9), 1458-1467.https://doi.org/10.1080/03639045.2020.1802482

  3. Alshahrani, S. M., Lu, W., Park, J. B., Morott, J. T., Alsulays,B. B., Majumdar, S., Langley, N., Kolter, K., Gryczke,A. & Repka, M. A. (2015). Stability-enhanced Hot-meltExtruded Amorphous Solid Dispersions via Combinationsof Soluplus® and HPMCAS-HF. AAPS Pharm. SciTech,16(4). https://doi.org/10.1208/s12249-014-0269-6

  4. Andrews, G. P., AbuDiak, O. A. & Jones, D. S. (2010).Physicochemical Characterization of Hot Melt ExtrudedBicalutamide–Polyvinylpyrrolidone Solid Dispersions.Journal of Pharmaceutical Sciences, 99(3), 1322–1335.https://doi.org/10.1002/jps.21914

  5. Andrews, G. P. & Jones, D. S. (2014). Hot melt extrusion- Processing solid solutions? Journal of Pharmacy andPharmacology, 66(2), 145–147. https://doi.org/10.1111/jphp.12202

  6. Arunprasad, K., Narayanan, N. & Rajalakshmi, G. (2010).Preparation and Evaluation of Solid Dispersion ofTerbinafine Hydrochloride. International Journal ofPharmaceutical Sciences Review and Research, 3(1),130–134.

  7. Auch, C., Harms, M. & Mäder, K. (2018). Melt-based screeningmethod with improved predictability regarding polymerselection for amorphous solid dispersions. EuropeanJournal of Pharmaceutical Sciences, 124, 339–348. https://doi.org/10.1016/j.ejps.2018.08.035

  8. B, P. K., Rao, S., K.V, R. M., Ravi, K. S. & Dr., B. R.(2011). Solid dispersion technique: A tool for enhancingbioavailability of poorly soluble drugs. Journal of Chemicaland Pharmaceutical Sciences, 4(4), 170–179.

  9. Baghel, S., Cathcart, H. & O’Reilly, N. J. (2016). PolymericAmorphous Solid Dispersions: A Review of Amorphization,Crystallization, Stabilization, Solid-State Characterization,and Aqueous Solubilization of BiopharmaceuticalClassification System Class II Drugs. Journal ofPharmaceutical Sciences, 105(9), 2527–2544. https://doi.org/10.1016/j.xphs.2015.10.008

  10. Baheti, A., Srivastava, S., Sahoo, D., Lowalekar, R., PrasadPanda, B., Kumar Padhi, B. & Raghuvanshi, R. (2016).Development and Pharmacokinetic Evaluation ofIndustrially Viable Self-microemulsifying Drug DeliverySystems (SMEDDS) for Terbinafine. Current DrugDelivery, 13(1), 65–75. https://doi.org/10.2174/1567201812666150120153357

  11. BASF. (2010). Technical Information Soluplus. BASF, PharmaIngredients & Services.

  12. BASF. (2011). Solubility Enhancement with BASF PharmaPolymers. Solubilizer Compendium. (T. Reintjes, Ed.).Lampertheim, Germany.

  13. BASF. (2020). Technical information Kolliphor ® P 188.

  14. BASF. (2021). Technical information Kollidon VA 64.

  15. Chaudhary, A., Nagaich, U., Gulati, N., Sharma, V. K. &Khosa, R. L. (2012). Enhancement of solubilization andbioavailability of poorly soluble drugs by physical andchemical modifications: A recent review. J. Adv. Pharm.Educ. Res., 2(1), 32–67.

  16. Chavan, R. B., Lodagekar, A., Yadav, B. & Shastri, N. R. (2020).Amorphous solid dispersion of nisoldipine by solventevaporation technique: preparation, characterization, invitro, in vivo evaluation and scale up feasibility study. DrugDelivery and Translational Research, 10, 903-918. https://doi.org/10.1007/s13346-020-00775-8

  17. Crowley, M. M., Zhang, F., Repka, M. A., Thumma, S., Upadhye,S. B., Kumar Battu, S., McGinity, J. W. & Martin, C.(2007). Pharmaceutical applications of hot-melt extrusion:Part I. Drug Development and Industrial Pharmacy, 33(9),909–926. https://doi.org/10.1080/03639040701498759

  18. Dabhade, D., Wadher, K., Bute, S., Naidu, N., Umekar, M. &Anantwar, S. (2021). Preparation and Characterization ofArtemether Solid Dispersion by Spray Drying Technique.Journal of Drug Delivery and Therapeutics, 11(2), 1–5.https://doi.org/10.22270/jddt.v11i2.4557

  19. De Mohac, L. M., Raimi-Abraham, B., Caruana, R., Gaetano,G. & Licciardi, M. (2020). Multicomponent solid dispersiona new generation of solid dispersion produced by spraydrying.Journal of Drug Delivery Science and Technology,57, 101750. https://doi.org/10.1016/j.jddst.2020.101750

  20. Devi, D. R., Sandhya, P. & Hari, B. N. V. (2013). Poloxamer:A novel functional molecule for drug delivery and genetherapy. Journal of Pharmaceutical Sciences and Research,5(8), 159–165.

  21. Djuris, J., Nikolakakis, I., Ibric, S., Djuric, Z. & Kachrimanis,K. (2013). Preparation of carbamazepine-Soluplus® soliddispersions by hot-melt extrusion, and prediction of drugpolymermiscibility by thermodynamic model fitting.European Journal ofPharmaceutics and Biopharmaceutics,84(1), 228–237. https://doi.org/10.1016/j.ejpb.2012.12.018

  22. Eedara, B. B., Nyavanandi, D., Narala, S., Veerareddy, P.R. & Bandari, S. (2021). Improved dissolution rate andintestinal absorption of fexofenadine hydrochloride bythe preparation of solid dispersions: In vitro and in situevaluation. Pharmaceutics, 13(3), 1–15. https://doi.org/10.3390/pharmaceutics13030310

  23. Fan, N., Lu, T. & Li, J. (2020a). Surface Tracking of CurcuminAmorphous Solid Dispersions Formulated by BinaryPolymers. Journal of Pharmaceutical Sciences, 109(2),1068–1078. https://doi.org/10.1016/j.xphs.2019.10.030

  24. Fan, W., Zhang, X., Zhu, W. & Di, L. (2020b). The Preparation ofCurcumin Sustained-Release Solid Dispersion by Hot-MeltExtrusion—Ⅱ. Optimization of Preparation Process andEvaluation In Vitro and In Vivo. Journal of PharmaceuticalSciences, 109(3), 1253–1260. https://doi.org/10.1016/j.xphs.2019.11.020

  25. Faraji, E., Mohammadi, M. & Mahboobian, M. M. (2021).Development of the Binary and Ternary AtorvastatinSolid Dispersions: In Vitro and in Vivo Investigations.BioMed Research International, vol. 2021. https://doi.org/10.1155/2021/6644630

  26. Fule, R., Paithankar, V. & Amin, P. (2016). Hot melt extrusionbased solid solution approach: Exploring polymercomparison, physicochemical characterization and in-vivoevaluation. International Journal of Pharmaceutics, 499(1–2), 280–294. https://doi.org/10.1016/j.ijpharm.2015.12.062

  27. Gaba, B., Fazil, M., Khan, S., Ali, A., Baboota, S. & Ali, J.(2015). Nanostructured lipid carrier system for topicaldelivery of terbinafine hydrochloride. Bulletin of Facultyof Pharmacy, Cairo University, 53(2), 147–159. https://doi.org/10.1016/j.bfopcu.2015.10.001

  28. Ghareeb, M. M., Abdulrasool, A. A., Hussein, A. A. & Noordin,M. I. (2009). Kneading Technique for Preparation of BinarySolid Dispersion of Meloxicam with Poloxamer 188. AAPSPharmSciTech, 10(4), 1206–1215. https://doi.org/10.1208/s12249-009-9316-0

  29. Gowardhane, A. P., Kadam, N. V. & Dutta, S. (2014). Review onEnhancement of Solubilization Process. American Journalof Drug Discovery and Development, 4(2), 134–152. https://doi.org/10.3923/ajdd.2014.134.152

  30. Hamed, R. & Omran, H. (2020). Development of dual–release pellets of the non-steroidal anti–inflammatorydrug celecoxib. Journal of Drug Delivery Science andTechnology, 55(September 2019), 101419. https://doi.org/10.1016/j.jddst.2019.101419

  31. Jadav, N. B. & Paradkar, A. (2020). Solid dispersions. InNanopharmaceuticals (pp. 91–120). Elsevier. https://doi.org/10.1016/B978-0-12-817778-5.00005-1

  32. Janssens, S. & Mooter, G. Van Den. (2009). Review: physicalchemistry of solid dispersions. Journal of Pharmacy andPharmacology, 61, 1571–1586. https://doi.org/10.1211/jpp/61.12.0001

  33. Jaskirat, S., Manpreet, W. & Harikumar, S. L. (2013). SolubilityEnhancement by solid dispersion method: A review. Journalof Drug Delivery and Therapeutics, 3(5), 148–155.

  34. Jung, H. J., Han, S. D. & Kang, M. J. (2015). EnhancedDissolution Rate of Dronedarone Hydrochloride viaPreparation of Solid Dispersion using Vinylpyrrolidone-Vinyl Acetate Copolymer (Kollidone® VA 64). Bulletin ofthe Korean Chemical Society, 36(9), 2320–2324. https://doi.org/10.1002/bkcs.10455

  35. Kachrimanis, K. & Nikolakakis, I. (2015). Polymersas Formulation Excipients for Hot-Melt ExtrusionProcessing of Pharmaceuticals. Handbook of Polymers forPharmaceutical Technologies, (Vol. 2), 121-149. https://doi.org/10.1002/9781119041412.ch5

  36. Kallakunta, V. R., Sarabu, S., Bandari, S., Batra, A., Bi, V.,Durig, T. & Repka, M. A. (2020). Stable amorphoussolid dispersions of fenofibrate using hot melt extrusiontechnology: Effect of formulation and process parametersfor a low glass transition temperature drug. Journal of DrugDelivery Science and Technology, 58, 101395. https://doi.org/10.1016/j.jddst.2019.101395

  37. Karekar, P., Salunkhe, N., Yadav, A., Bangar, D. & Yadav,D. (2014). Modulation of physico-chemical propertiesof terbinafine HCL by using solid dispersion technique.Research Journal of Pharmacy and Technology, 7(4),450–453.

  38. Kawabata, Y., Wada, K., Nakatani, M., Yamada, S. & Onoue, S.(2011). Formulation design for poorly water-soluble drugsbased on biopharmaceutics classification system: Basicapproaches and practical applications. International Journalof Pharmaceutics, 420(1), 1–10. https://doi.org/10.1016/j.ijpharm.2011.08.032

  39. Kumar, N., Jain, A., Singh, C. & Kumar, R. (2008). Development,characterization and solubility study of solid dispersion ofterbinafine hydrochloride by solvent evaporation method.Asian Journal of Pharmaceutics, 2(3), 154. https://doi.org/10.4103/0973-8398.43301

  40. Kumari, R., Chandel, P. & Kapoor, A. (2013). Paramount Roleof Solid Dispersion in Enhancement of Solubility. IndoGlobal Journal of Pharmaceutical Sciences, 3(1), 78–89.

  41. Kuminek, G., Rauber, G. S., Riekes, M. K., de Campos, C. E. M.,Monti, G.A., Bortoluzzi, A. J., Cuffini, S. L. & Cardoso, S. G.(2013). Single crystal structure, solid state characterizationand dissolution rate of terbinafine hydrochloride. Journal ofPharmaceutical andBiomedical Analysis, 78–79, 105–111.https://doi.org/10.1016/j.jpba.2013.02.001

  42. Lavra, Z. M. M., Pereira de Santana, D. & Ré, M. I. (2017).Solubility and dissolution performances of spray-dried soliddispersion of Efavirenz in Soluplus. Drug Developmentand Industrial Pharmacy, 43(1), 42–54. https://doi.org/10.1080/03639045.2016.1205598

  43. Lee, J. H., Jeong, H. S., Jeong, J. W., Koo, T. S., Kim, D.K., Cho, Y. H. & Lee, G. W. (2021). The developmentand optimization of hot-melt extruded amorphous soliddispersions containing rivaroxaban in combinationwith polymers. Pharmaceutics, 13(3), 1–20. https://doi.org/10.3390/pharmaceutics13030344

  44. Lian, X., Dong, J., Zhang, J., Teng, Y., Lin, Q., Fu, Y. &Gong, T. (2014). Soluplus® based 9-nitrocamptothecinsolid dispersion for peroral administration: Preparation,characterization, in vitro and in vivo evaluation. InternationalJournal of Pharmaceutics, 477(1–2), 399–407. https://doi.org/10.1016/j.ijpharm.2014.10.055

  45. Luo, Y., Hong, Y., Shen, L., Wu, F. & Lin, X. (2021).Multifunctional Role of Polyvinylpyrrolidone inPharmaceutical Formulations. AAPS PharmSciTech, 22(1),1-16. https://doi.org/10.1208/s12249-020-01909-4

  46. Mahajan, A., Surti, N., Patel, P., Gheewala, N., Patel, A.& Shah, D. (2021). Optimization of formulation andprocess variables using central composite design for theproduction of nevirapine spray dried solid dispersion.Drying Technology, 0(0), 1–14. https://doi.org/10.1080/07373937.2021.1874408

  47. Maniruzzaman, M., Morgan, D. J., Mendham, A. P., Pang, J.,Snowden, M. J. & Douroumis, D. (2013). Drug–polymerintermolecular interactions in hot-melt extruded soliddispersions. International Journal of Pharmaceutics, 443(1–2), 199–208. https://doi.org/10.1016/j.ijpharm.2012.11.048

  48. Mathers, A., Hassouna, F., Malinová, L., Merna, J., Růžička,K. & Fulem, M. (2020). Impact of Hot-Melt ExtrusionProcessing Conditions on Physicochemical Propertiesof Amorphous Solid Dispersions Containing ThermallyLabile Acrylic Copolymer. Journal of PharmaceuticalSciences, 109(2), 1008–1019. https://doi.org/10.1016/j.xphs.2019.10.005

  49. Mishra, D. K., Dhote, V., Bhargava, A. & Jain, D. K. (2015).Amorphous solid dispersion technique for improved drugdelivery: basics to clinical applications. Drug Deliveryand Translational Research, 5, 552–565. https://doi.org/10.1007/s13346-015-0256-9

  50. Moneghini, M., Bellich, B., Baxa, P. & Princivalle, F. (2008).Microwave generated solid dispersions containingIbuprofen. International Journal of Pharmaceutics, 361(1–2), 125–130. https://doi.org/10.1016/j.ijpharm.2008.05.026

  51. Najir, T., Adhav, B. & Sa, P. (2016). Bargir, T. N., Aj, A. D. H.A. V., & Sa, P. A. Y. G. H. A. N. (2016). Composition ofterbinafine HCL polymeric gel for mucosal drug delivery.International Journal of Biology, Pharmacy and AlliedSciences, 5(9), 2146–2168.

  52. Nanaki, S., Eleftheriou, R. M., Barmpalexis, P., Kostoglou,M., Karavas, E. & Bikiaris, D. (2019). Evaluation ofDissolution Enhancement of Aprepitant Drug in TernaryPharmaceutical Solid Dispersions with Soluplus® andPoloxamer 188 Prepared by Melt Mixing. Sci, 1(1), 11.https://doi.org/10.3390/sci1010011.v1

  53. Nandi, U., Ajiboye, A. L., Patel, P., Douroumis, D. & Trivedi,V. (2021). Preparation of solid dispersions of simvastatinand soluplus® using a single-step organic solvent-freesupercritical fluid process for the drug solubility anddissolution rate enhancement. Pharmaceuticals, 14(9).https://doi.org/10.3390/ph14090846

  54. Ong, H. J. & Pinal, R. (2018). Drug Solubilization by Means ofa Surface-Modified Edible Biopolymer Enabled by Hot MeltExtrusion. Journal of Pharmaceutical Sciences, 107(1),402–411. https://doi.org/10.1016/j.xphs.2017.10.022

  55. Pardhi, V. P. & Jain, K. (2021). Impact of binary/ternary soliddispersion utilizing poloxamer 188 and TPGS to improvepharmaceutical attributes of bedaquiline fumarate. Journalof Drug Delivery Science and Technology, 62(January),102349. https://doi.org/10.1016/j.jddst.2021.102349

  56. Passerini, N., Albertini, B., González-Rodríguez, M. L.,Cavallari, C. & Rodriguez, L. (2002). Preparation andcharacterisation of ibuprofen-poloxamer 188 granulesobtained by melt granulation. European Journal ofPharmaceutical Sciences, 15(1), 71–78. https://doi.org/10.1016/S0928-0987(01)00210-X

  57. Patel, H. R., Patel, R. P. & Patel, M. M. (2009). Poloxamers:A pharmaceutical excipients with therapeutic behaviors.International Journal of PharmTech Research, 1(2),299–303.

  58. Payghan, S. A., Bargir, T. N. & Adhav, A. J. (2016). Compositionof Terbinafine HCl Polymeric Gel for Mucosal DrugDelivery. International Journal of Biology, Pharmacy &Allied Sciences, 5(9), 2146–2168.

  59. Pereira, G. G., Figueiredo, S., Fernandes, A. I. & Pinto,J. F. (2020). Polymer selection for hot-melt extrusioncoupled to fused deposition modelling in pharmaceutics.Pharmaceutics, 12(9), 1–63. https://doi.org/10.3390/pharmaceutics12090795

  60. Potter, C., Tian, Y., Walker, G., McCoy, C., Hornsby, P., Donnelly,C., Jones, D. S. & Andrews, G. P. (2015). Novel supercriticalcarbon dioxide impregnation technique for the production ofamorphous solid drug dispersions: A comparison to hot meltextrusion. Molecular Pharmaceutics, 12(5), 1377–1390.https://doi.org/10.1021/mp500644h

  61. Rani, S., Mishra, S., Sharma, M., Nandy, A. & Mozumdar, S.(2020). Solubility and stability enhancement of curcuminin Soluplus® polymeric micelles: a spectroscopic study.Journal of Dispersion Science and Technology, 41(4),523–536. https://doi.org/10.1080/01932691.2019.1592687

  62. Repka, M. A., Bandari, S., Kallakunta, V. R., Vo, A. Q., McFall,H., Pimparade, M. B. & Bhagurkar, A. M. (2018). Meltextrusion with poorly soluble drugs – An integrated review.International Journal of Pharmaceutics, 535(1–2), 68–85.https://doi.org/10.1016/j.ijpharm.2017.10.056

  63. Sarode, A. L., Sandhu, H., Shah, N., Malick, W. & Zia,H. (2013). Hot Melt Extrusion for Amorphous SolidDispersions: Temperature and Moisture ActivatedDrug–Polymer Interactions for Enhanced Stability.Molecular Pharmaceutics, 10(10), 3665–3675. https://doi.org/10.1021/mp400165b

  64. Schittny, A., Ogawa, H., Huwyler, J. & Puchkov, M. (2018).A combined mathematical model linking the formationof amorphous solid dispersions with hot-melt-extrusionprocess parameters. European Journal of Pharmaceuticsand Biopharmaceutics, 132, 127–145. https://doi.org/10.1016/j.ejpb.2018.09.011

  65. Sharma, A., Jain, C. P. & Tanwar, Y. S. (2013). Preparationand characterization of solid dispersions of carvedilolwith poloxamer 188. Journal of the Chilean ChemicalSociety, 58(1), 1553–1557. https://doi.org/10.4067/S0717-97072013000100012

  66. Shi, H. & Xie, Y. (2017). Solubility and thermodynamics ofterbinafine hydrochloride in different neat and binarysolvents: Measurement, correlation and molecularinteractions. Journal of Molecular Liquids, 243, 293–301.https://doi.org/10.1016/j.molliq.2017.08.052

  67. Simões, M. F., Pinto, R. M. A. & Simões, S. (2021). Hot-MeltExtrusion: a Roadmap for Product Development. AAPSPharmSciTech, 22(5), 184. https://doi.org/10.1208/s12249-021-02017-7

  68. Tayel, S. A., El-Nabarawi, M. A., Tadros, M. I. & Abd-Elsalam,W. H. (2013). Promising ion-sensitive in situ ocularnanoemulsion gels of terbinafine hydrochloride: Design, invitro characterization and in vivo estimation of the ocularirritation and drug pharmacokinetics in the aqueous humor ofrabbits. International Journal of Pharmaceutics, 443(1–2),293–305. https://doi.org/10.1016/j.ijpharm.2012.12.049

  69. Thakkar, R., Thakkar, R., Pillai, A., Ashour, E. A. & Repka,M. A. (2020). Systematic screening of pharmaceuticalpolymers for hot melt extrusion processing: a comprehensivereview. International Journal of Pharmaceutics,576(October 2019), 118989. https://doi.org/10.1016/j.ijpharm.2019.118989

  70. Thatai, P. & Sapra, B. (2017). Transungual Gel of TerbinafineHydrochloride for the Management of Onychomycosis:Formulation, Optimization, and Evaluation. AAPSPharmSciTech, 18(6), 2316–2328. https://doi.org/10.1208/s12249-017-0711-7

  71. Thommes, M., Ely, D. R., Carvajal, M. T. & Pinal, R.(2011). Improvement of the Dissolution Rate of PoorlySoluble Drugs by Solid Crystal Suspensions. MolecularPharmaceutics, 8(3), 727–735. https://doi.org/10.1021/mp1003493

  72. Tian, Y., Jacobs, E., Jones, D. S., McCoy, C. P., Wu, H. &Andrews, G. P. (2020). The design and developmentof high drug loading amorphous solid dispersion forhot-melt extrusion platform. International Journal ofPharmaceutics, 586, 119545. https://doi.org/10.1016/j.ijpharm.2020.119545

  73. Tran, P., Pyo, Y.-C., Kim, D.-H., Lee, S.-E., Kim, J.-K. & Park,J.-S. (2019). Overview of the Manufacturing Methods ofSolid Dispersion Technology for Improving the Solubility ofPoorly Water-Soluble Drugs and Application to AnticancerDrugs. Pharmaceutics, 11(3), 132. https://doi.org/10.3390/pharmaceutics11030132

  74. Turton, R. & Virginia, W. (2002). Cooling processes andcongealing. In Encyclopedia of Pharmaceutical Technology(pp. 627–640).

  75. Uzqueda, M., Martín, C., Zornoza, A., Sánchez, M. & Vélaz,I. (2010). Physicochemical characterization of terbinafinecyclodextrincomplexes in solution and in the solidstate. Journal of Inclusion Phenomena and MacrocyclicChemistry, 66(3), 393–402. https://doi.org/10.1007/s10847-009-9656-0

  76. Vaghasiya, H., Kumar, A. & Sawant, K. (2013). Developmentof solid lipid nanoparticles based controlled release systemfor topical delivery of terbinafine hydrochloride. EuropeanJournal of Pharmaceutical Sciences, 49(2), 311–322.https://doi.org/10.1016/j.ejps.2013.03.013

  77. Vasconcelos, T., Marques, S., das Neves, J. & Sarmento, B.(2016). Amorphous solid dispersions: Rational selection ofa manufacturing process. Advanced Drug DeliveryReviews,100, 85–101. https://doi.org/10.1016/j.addr.2016.01.012

  78. Vasconcelos, T., Prezotti, F., Araújo, F., Lopes, C., Loureiro, A.,Marques, S. & Sarmento, B. (2021). Third-generation soliddispersion combining Soluplus and poloxamer 407 enhancesthe oral bioavailability of resveratrol. International Journalof Pharmaceutics, 595(January), 120245. https://doi.org/10.1016/j.ijpharm.2021.120245

  79. Vemula, S. K. (2011). Development and characterization of fastdisintegrating tablets of Terbinafine hydrochloride. Journalof Pharmaceutical Sciences, 4(7), 2273–2275.

  80. Verreck, G., Decorte, A., Heymans, K., Adriaensen, J., Cleeren,D., Jacobs, A., Liu, D., Tomasko, D., Arien, A., Peeters,J. & Rombaut, P. (2005). The effect of pressurized carbondioxide as a temporary plasticizer and foaming agent onthe hot stage extrusion process and extrudate properties ofsolid dispersions of itraconazole with PVP-VA 64. EuropeanJournal of Pharmaceutical Sciences, 26(3–4), 349–358.https://doi.org/10.1016/j.ejps.2005.07.006

  81. Wei, M. Y., Lei, X. P., Fu, J. J., Chen, M .Y., Li, J. X., Yu, X. Y.,Lin, Y. L., Liu, J. P., Du, L. R., Li, X. & Zhang, Y. (2020).The use of amphiphilic copolymer in the solid dispersionformulation of nimodipine to inhibit drug crystallization inthe release media: Combining nano-drug delivery systemwith solid preparations. Materials Science and Engineering:C, 111(January), 110836. https://doi.org/10.1016/j.msec.2020.110836

  82. Wlodarski, K., Tajber, L. & Sawicki, W. (2016). Physicochemicalproperties of direct compression tablets with spray driedand ball milled solid dispersions of tadalafil in PVP-VA.European Journal of Pharmaceutics and Biopharmaceutics,109, 14–23. https://doi.org/10.1016/j.ejpb.2016.09.011

  83. Worku, Z. A., Aarts, J. & Van Den Mooter, G. (2014). Influenceof compression forces on the structural stability of naproxen/PVP-VA 64 solid dispersions. Molecular Pharmaceutics,11(4), 1102–1108. https://doi.org/10.1021/mp5001313

  84. Xiong, X., Zhang, M., Hou, Q., Tang, P., Suo, Z., Zhu, Y.& Li, H. (2019). Solid dispersions of telaprevir withimproved solubility prepared by co-milling: formulation,physicochemical characterization, and cytotoxicityevaluation. Materials Science and Engineering: C, 105,110012. https://doi.org/10.1016/j.msec.2019.110012

  85. Zadaliasghar, S., Jouyban, A., Martinez, F., Barzegar-Jalali,M. & Rahimpour, E. (2020). Solubility of ketoconazole inthe binary mixtures of 2-propanol and water at differenttemperatures. Journal of Molecular Liquids, 300, 112259.https://doi.org/10.1016/j.molliq.2019.112259

  86. Zhang, J., Han, R., Chen, W., Zhang, W., Li, Y., Ji, Y., Chen, L.,Pan, H., Yang, X., Pan, W. & Ouyang, D. (2018). Analysisof the Literature and Patents on Solid Dispersions from 1980to 2015. Molecules, 23(7), 1697. https://doi.org/10.3390/molecules23071697




2020     |     www.medigraphic.com