Skip to main content

Analysis of phase transition and dehydration processes of nevirapine


Solid-state characterization of crystalline drugs is an important pre-formulation step for the development and design of solid dosage forms, such as pellets and tablets. In this study, phase transition and dehydration processes of nevirapine have been studied by differential scanning calorimetry and thermogravimetry differential thermal analysis to overcome the problems of drug formulation, namely poor solubility and poor content uniformity. Phase solubility studies elucidated the mechanism of enhanced nevirapine solubility.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5


  1. Ramana LN, Sethuraman S, Ranga U, Krishnan UM. Development of a liposomal nanodelivery system for nevirapine. J Biomed Sci. 2010. doi:10.1186/1423-0127-17-57.

  2. Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK et al. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008. doi:10.1111/j.1468-1293.2008.00553.x.

  3. Reguri BR, Chakka R. Crystalline forms of nevirapine. US Patent 0183738 A1. 2006. Accessed 17 Aug 2006.

  4. Reguri BR, Chakka R. Novel crystalline forms of 11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2′,3′-e][1,4]diazepin-6-one (Nevirapine). US Patent 0059653A1 2005. Accessed 17 Mar 2005.

  5. Chadha R, Arora P, Saini A, Jain DS. Solvated crystalline forms of nevirapine: thermoanalytical and spectroscopic studies. AAPS Pharm Sci Tech. 2010. doi:10.1208/s12249-010-9511-z.

  6. Willart JF, Descamps M. Solid state amorphization of pharmaceuticals. Mol Pharm. 2008. doi:10.1021/mp800092t.

  7. Giron D. Applications of thermal analysis in the pharmaceutical industry. J Pharm Biomed Anal. 1986. doi:0731-7085(86)80086-3.

  8. Xia D, Cui F, Piao H, Cun D, Jiang Y, Ouyang M et al. Effect of crystal size on the in vitro dissolution and oral absorption of nitrendipine in rats. Pharm Res. 2010. doi:10.1007/s11095-010-0200-0.

  9. Park YJ, Xuan JJ, Oh DH, Balakrishnan P, Yang HJ, Yeo WH et al. Development of novel itraconazole-loaded solid dispersion without crystalline change with improved bioavailability. Arch Pharm Res. 2010. doi:10.1007/s12272-010-0812-2.

  10. Soares-Sobrinho JL, de La Roca Soares MF, Lopes PQ, Correia LP, de Souza FS, Macedo RO et al. A preformulation study of a new medicine for Chagas disease treatment: physicochemical characterization, thermal stability, and compatibility of benznidazole. AAPS Pharm Sci Tech. 2010. doi:10.1208/s12249-010-9495-8.

  11. Park J, Park HJ, Cho W, Cha KH, Kang YS, Hwang SJ. Preparation and pharmaceutical characterization of amorphous cefdinir using spray-drying and SAS-process. Int J Pharm. 2010. doi:10.1016/j.ijpharm.2010.06.032.

  12. Passerini N, Calogera G, Albertini B, Rodriguez L. Melt granulation of pharmaceutical powders: a comparison of high-shear mixer and fluidised bed processes. Int J Pharm. 2010. doi:10.1016/j.ijpharm.2010.03.013.

  13. Paluch KJ, Tajber L, McCabe T, O’Brien JE, Corrigan OI, Healy AM. Preparation and solid state characterisation of chlorothiazide sodium intermolecular self-assembly suprastructure. Eur J Pharm Sci. 2010. doi:10.1016/j.ejps.2010.08.013.

  14. Kumar S, Chawla G, Sobhia ME, Bansal AK. Characterization of solid-state forms of mebendazole. Pharmazie. 2008. doi: 10.1691/ph.2008.7168.

  15. Murdande SB, Pikal MJ, Shanker RM, Bogner RH. Solubility advantage of amorphous pharmaceuticals: I. A thermodynamic analysis. J Pharm Sci. 2010. doi:10.1002/jps.21903.

  16. Ruscica R, Bianchi M, Quintero M, Martinez A, Vega DR. Solid-state forms of zoledronic acid: polymorphism in hydrates. J Pharm Sci. 2010. doi:10.1002/jps.22223.

  17. Yoshida MI, Gomes EC, Soares CD, Cunha AF, Oliveira MA. Thermal analysis applied to verapamil hydrochloride characterization in pharmaceutical formulations. Molecules. 2010. doi:10.3390/molecules15042439.

  18. Kobayashi K, Fukuhara H, Kawamoto I, Hata T, Sekine A, Uekusa H et al. Physicochemical analyses of phase transition and dehydration processes of a new oral 1beta-methylcarbapenem antibiotic agent, CS-834. Chem Pharm Bull (Tokyo). 2002. doi: 10.1248/cpb.50.1570.

  19. Araújo AAS, Bezerra MdS, Storpirtis S, Matos JdR. Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC. Brazilian J Pharm Sci. 2010. doi:10.1590/S1984-82502010000100005.

  20. Wojnarowska Z, Grzybowska K, Adrjanowicz K, Kaminski K, Paluch M, Hawelek L et al. Study of the amorphous glibenclamide drug: analysis of the molecular dynamics of quenched and cryomilled material. Mol Pharm. 2010. doi:10.1021/mp100077c.

  21. Grob PM, Wu JC, Cohen KA, Ingraham RH, Shih CK, Hargrave KD et al. Non nucleoside inhibitors of HIV-1 reverse transcriptase: nevirapine as a prototype drug. AIDS Res Hum Retroviruses. 1992. doi: 10.1089/aid.1992.8.145.

  22. Koup RA, Merluzzi VJ, Hargrave KD, Adams J, Grozinger K, Eckner RJ et al. Inhibition of human immunodeficiency virus type 1 (HIV-1) replication by the dipyridodiazepinone BI-RG-587. J Infect Dis. 1991. doi:10.1093/indis/163.5.966.

  23. Grangeiro A, Teixeira L, Bastos FI, Teixeira P. Sustainability of Brazilian policy for access to antiretroviral drugs. Rev Saude Publica. 2006. doi:S0034-89102006000700009.

  24. Grangeiro A, Ferraz D, Barbosa R, Barreira D, Veras MA, Villela W et al. UNGASS-HIV/AIDS: a review of the Brazilian response, 2001–2005. Rev Saude Publica. 2006. doi:S0034-89102006000700002.

  25. Grangeiro A, Strattmann RR, Alburquerque MM, Araújo AAS, Matos JR, Neto PJR. In vitro evaluation of dissolution profiles and thermal properties of some commercial formulations of nevirapine tablets. Acta Farm Bonaerense. 2006. Accessed 17 Dec 2010.

Download references


The authors wish to acknowledge the sponsorship of the FAPESP (Fundação de Amparo a Pesquisa) and CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior).

Author information

Authors and Affiliations


Corresponding author

Correspondence to Eliana B. Souto.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

de Oliveira, G.G.G., Ferraz, H.G., Severino, P. et al. Analysis of phase transition and dehydration processes of nevirapine. J Therm Anal Calorim 108, 53–57 (2012).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI:


  • Nevirapine
  • Differential scanning calorimetry (DSC)
  • Thermogravimetry differential thermal analysis (TG-DTA)
  • Solid dosage forms