Advertisement

Journal of Thermal Analysis and Calorimetry

, Volume 133, Issue 1, pp 603–617 | Cite as

Compatibility study of dry extract of Ximenia americana L. and pharmaceutical excipients used in solid state

  • Cleildo P. Santana
  • Felipe H. A. Fernandes
  • Deysiane O. Brandão
  • Paulo César D. Silva
  • Lidiane P. Correia
  • Fernanda P. Nóbrega
  • Francinalva D. de Medeiros
  • Paulo Henrique G. D. Diniz
  • Germano Véras
  • Ana Cláudia D. Medeiros
Article
  • 74 Downloads

Abstract

Ximenia americana L. is a plant of the Olacaceae family, used in the treatment of infectious diseases. Dry extracts are API’s of great interest for the pharmaceutical industry and have been used as final and intermediate products, resulting in different pharmaceutical forms. The aim of this study is to evaluate the compatibility of dry extract of X. americana with pharmaceutical excipients used in the solid forms. The extract was obtained by spray dryer, and binary mixtures of the dry extract and pharmaceutical excipients were analyzed. The studies were obtained using thermal analysis, X-ray powder diffraction and optical microscopy. With the data obtained from DSC curves, matrices for hierarchical cluster analysis (HCA) were made. The X-ray diffraction analysis showed changes in the mixtures’ profile with corn starch, lactose and magnesium stearate. Thermal behavior of the mixtures showed incompatibilities between the extract and lactose, corn starch and magnesium stearate. This study shows the importance of using instrumental analytical techniques in the early stages of development of herbal medicine to ensure the effectiveness, safety and quality of the final product.

Keywords

Ximenia americana L. Dry extract Herbal medicine Hierarchical cluster analysis 

Notes

Acknowledgements

The authors thank to PROPESQ/UEPB, FAPESQ, CNPq (Grant No. 484408/2010-0) for financial supporting this research and CERTBIO/UEPB for analysis, and the authors especially thank to the Professor Ivan Coelho Dantas (in memoriam) for indicating the plant to studied in this work.

References

  1. 1.
    Brasileiro MT, Egito AA, Lima JR, Randau KP, Pereira GC, Rolim Neto PJ. Ximenia americana L.: botany, chemistry and pharmacology in the pharmaceutical technology interest. Braz J Pharm. 2008;89:164–7.Google Scholar
  2. 2.
    Mevy J, Bessiere J, Greff S, Zombre G, Viano J. Composition of the volatile oil from the leaves of Ximenia americana L. Syst Ecol. 2006;34:549–53.CrossRefGoogle Scholar
  3. 3.
    Asres K, Bucar F, Karting T, Witvrouw M, Pannecouque C, Clerq E. Antiviral activity against human immunodeficiency virus type 1 (HIV-1) and HIV-2 of ethnobotanically selected Ethiopian medicinal plants. Phytother Res. 2001;15:62–9.CrossRefGoogle Scholar
  4. 4.
    Silva MSP, Brandão DO, Chaves TP, Formiga Filho ALN, Costa EMMB, Santos VL, Medeiros ACD. Study bioprospecting of medicinal plant extracts of the semiarid northeast: contribution to the control of oral microorganisms. Evidence Based Compl Alternat Med. 2012. doi: 10.1155/2012/681207.Google Scholar
  5. 5.
    Silva KM, Chaves TP, Santos RL, Brandão DO, Fernandes FHA, Ramos Júnior FJ, Santos VL, Felismino DC, Medeiros ACD. Modulation of the erythromycin resistance in Staphylococcus aureus by ethanolic extracts of Ximenia americana L and Schinopsis brasiliensis Engl. Bol Lat Am Caribe Plan Med Aromat. 2015;14:92–8.Google Scholar
  6. 6.
    Soro TY, Traore F, Sakande J. Analgesic activity of the aqueous extract from Ximenia americana. CR Biologies. 2009;332:371–7.CrossRefGoogle Scholar
  7. 7.
    James DB, Abu EA, Wurochekke AU, Orji GN. Phytochemical and antimicrobial investigation of the aqueous and methanolic extracts of Ximenia americana. J Med Sci. 2007;07:284.CrossRefGoogle Scholar
  8. 8.
    Costa EMMB, Barbosa AS, Arruda TA, Oliveira PT, Dametto FR, Carvalho RA, Melo MD. In vitro antimicrobial activity of plant extracts against Enterococcus faecalis. Braz J Med Lab Path. 2010;46:175.CrossRefGoogle Scholar
  9. 9.
    Omer MEFA, Elnima EI. Antimicrobial activity of Ximenia americana. Fitoter. 2003;74:122–6.Google Scholar
  10. 10.
    Ogunleye DS, Ibitoye SF. Studies of antimicrobial activity and chemical constituents of Ximenia americana. Trop J Pharm Res. 2003;02:239–41.Google Scholar
  11. 11.
    Silva GG, Souza PA, Morais PLD, Santos EC, Moura RD, Menezes JB. Wild plum fruit characterization (Ximenia americana L.). Braz J Frut. 2008;30:311–4.CrossRefGoogle Scholar
  12. 12.
    Le NHT, Malterud KE, Diallo D, Paulsen SB, Nergård CS, Wangensteen H. Bioactive polyphenols in Ximenia americana and the traditional use among Malian healers. J Ethnopharmacol. 2012;139:858–62.CrossRefGoogle Scholar
  13. 13.
    Brandão DO, Fernandes FHA, Ramos FJL, Silva PCD, Santana CP, Medeiros FD, Véras JG, Medeiros ACD. Validation of UPLC method for determination of gallic acid from Ximenia americana L. Planta Med. 2014. doi: 10.1055/s-0034-1395050.Google Scholar
  14. 14.
    Medeiros ACD, Medeiros IA, Macêdo RO. Thermal studies of Albizia inopinata crude extract in the presence of cyclodextrin and Aerosil® by TG and DSC coupled to the photovisual system. Therm Acta. 2002;392:93–8.CrossRefGoogle Scholar
  15. 15.
    Oliveira OW, Petrovick PR. Spray drying of plant extracts: basic remarks and application. Braz J Pharm. 2010;20:641.CrossRefGoogle Scholar
  16. 16.
    Borchardt RT. Value of pharmaceutical sciences. J Pharm Biomed Anal. 1998;16:1387–401.CrossRefGoogle Scholar
  17. 17.
    Chieng N, Rades T, Aaltonen J. An overview of recent studies on the analysis of pharmaceutical polymorphs. J Pharm Biomed Anal. 2011;55:618–44.CrossRefGoogle Scholar
  18. 18.
    Tita B, Fulias A, Bandur G, Marian E, Tita D. Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms. J Pharm Biomed Anal. 2011;56:221–7.CrossRefGoogle Scholar
  19. 19.
    Medeiros ACD, Cervantes NAB, Gomes APB, Macêdo RO. Thermal stability of prednisone drug and tablets. J Therm Anal Calorim. 2001;64:745.CrossRefGoogle Scholar
  20. 20.
    Medeiros ACD, Correia LP, Simões MOS, Macêdo RO. Technological quality determination of pharmaceutical disintegrant by DSC cooling and DSC photovisual. J Therm Anal Calorim. 2007;88:311–5.CrossRefGoogle Scholar
  21. 21.
    Santos AFO, Basílio Júnior ID, Souza FS, Medeiros AFD, Pinto MF, Santana DP, Macedo RO. Application of thermal analysis of binary mixtures with metformin. J Therm Anal Calorim. 2008;93:361–4.CrossRefGoogle Scholar
  22. 22.
    Procópio JVV, Souza VG, Costa RA, Correia LP, Souza FS, Macêdo RO. Applicatin of thermal analysis and pyrolysis coupled to CG/MS in the qualification of simvastatin pharmaceutical raw material. J Therm Anal Calorim. 2011;106:665.CrossRefGoogle Scholar
  23. 23.
    Oliveira AH, Moura EA, Pinto MF, Procópio JVV, Souza VG, Souza FS, Macêdo RO. Thermal characterization of raw material pentoxifylline using thermoanalytical techniques and Pyr-CG/MS. J Therm Anal Calorim. 2011;106:763–6.CrossRefGoogle Scholar
  24. 24.
    Fernandes FHA, Santana CP, Santos RL, Correia LP, Conceição MM, Macêdo RO, Medeiros ACD. Thermal characterization of dried extract of medicinal plant by DSC and analytical techniques. J Therm Anal Calorim. 2013;113:443–7.CrossRefGoogle Scholar
  25. 25.
    Aragão CFS, Souza FS, Barros ACS, Veras JWE, Barbosa Filho JM, Macêdo RO. Aplicação da termogravimetria (TG) no controle de qualidade da milona (Cissampelos sympodialis Eichl.) Menispermaceae. Braz J Pharmacog. 2002;12:60–1.CrossRefGoogle Scholar
  26. 26.
    Correia LP, Procópio JVV, Santana CP, Santos AFO, Cavalcante HMMO, Macêdo RO. Characterization of herbal medicine with different particle sizes using pyrolysis GC/MS, SEM and thermal techniques. J Therm Anal Calorim. 2011;123:993–1001.CrossRefGoogle Scholar
  27. 27.
    Rowe RC, Sheskey PJ, Quinn MC. Handbook of pharmaceutical excipients. 6th ed. Washington: Pharmaceutical Press; 2009.Google Scholar
  28. 28.
    Maximiano FP, Novack KM, Bahia MT, Sá-Barreto LL, Cunha-Filho MSS. Polymorphic screen and drug–excipient compatibility studies of the antichagasic benznidazole. J Therm Anal Calorim. 2011;106:819–24.CrossRefGoogle Scholar
  29. 29.
    Souza FS, Barreto APG, Macêdo RO. Characterization of starch pharmaceuticals by DSC coupled to a photovisual system. J Therm Anal Calorim. 2001;64:739–43.CrossRefGoogle Scholar
  30. 30.
    Desai SR, Shaikh MM, Dharwadkar SR. Preformulation compatibility studies of etamsylate and fluconazole drugs with lactose by DSC. J Therm Anal Calorim. 2003;71:651–8.CrossRefGoogle Scholar
  31. 31.
    Cides LCS, Araújo AAS, Santos-Filho M, Matos JR. Thermal behaviour, compatibility study and decomposition kinetics of glimepiride under isothermal and non-isothermal conditions. J Therm Anal Calorim. 2006;84:441–5.CrossRefGoogle Scholar
  32. 32.
    Verma RK, Garg S. Compatibility studies between Isosorbide Mononitrate and selected excipients used in the development of extended release formulations. J Pharm Biomed Anal. 2004;35:449–58.CrossRefGoogle Scholar
  33. 33.
    Oliveira GGG, Ferraz HG, Matos JSR. Thermoanalytical study of glibenclamide and excipients. J Therm Anal Calorim. 2005;79:267.CrossRefGoogle Scholar
  34. 34.
    Ibrahim HK, El-Setouhy DA. Valsartan orodispersible tablets: formulation, in vitro/in vivo characterization. AAPS Pharm Sci Tech. 2010;11:189–96.CrossRefGoogle Scholar
  35. 35.
    Bharate SS, Bharate SB, Bajaj AN. Incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. J Excip Food Chem. 2010;1:3–26.Google Scholar
  36. 36.
    Fernandes FHA, Almeida VE, Medeiros FD, Silva PCD, Simões MOS, Véras G, Medeiros ACD. Evaluation of compatibility between Schinopsis brasiliensis Engler extract and pharmaceutical excipients using analytical techniques associated with chemometric tools. J Therm Anal Calorim. 2016;123:2531–42.CrossRefGoogle Scholar
  37. 37.
    Skoog DA, Holler FJ, Nieman TA. Principles of Instrumental Analysis. 5th ed. Philadelphia: Harcourt Brace & Company; 1998.Google Scholar
  38. 38.
    Silverstein RM, Webster FX, Kiemle DJ. Identificação Espectrométrica de Compostos Orgânicos. 6th ed. Rio de Janeiro: Livros Técnicos e Científicos; 2006.Google Scholar
  39. 39.
    Júnior JOCS, Vieira JLF, Barbosa WLR, Pereira NL. Caracterização físico-química do extrato fluido e seco por nebulização de Symphytum officinale L. Braz J Farmacogn. 2006;16:671–7.CrossRefGoogle Scholar

Copyright information

© Akadémiai Kiadó, Budapest, Hungary 2017

Authors and Affiliations

  • Cleildo P. Santana
    • 1
  • Felipe H. A. Fernandes
    • 1
  • Deysiane O. Brandão
    • 1
  • Paulo César D. Silva
    • 2
  • Lidiane P. Correia
    • 2
  • Fernanda P. Nóbrega
    • 1
  • Francinalva D. de Medeiros
    • 1
  • Paulo Henrique G. D. Diniz
    • 3
  • Germano Véras
    • 3
  • Ana Cláudia D. Medeiros
    • 1
    • 2
  1. 1.Laboratório de Desenvolvimento e Ensaios de Medicamentos, Centro de Ciências Biológicas e da SaúdeUniversidade Estadual da ParaíbaCampina GrandeBrasil
  2. 2.Departamento de FarmáciaUniversidade Estadual da ParaíbaCampina GrandeBrasil
  3. 3.Laboratório de Química Analítica e QuimiometriaUniversidade Estadual da ParaíbaCampina GrandeBrasil

Personalised recommendations