Advertisement

CDI cross-linked β-cyclodextrin nanosponges of paliperidone: synthesis and physicochemical characterization

  • Atul P. SherjeEmail author
  • Anushree Surve
  • Pravin Shende
Biomaterials Synthesis and Characterization Original Research
  • 23 Downloads
Part of the following topical collections:
  1. Biomaterials Synthesis and Characterization

Abstract

Paliperidone (PLP) is an antipsychotic drug indicated for treatment and management of schizophrenia. The current study demonstrates potential of PLP-loaded β-cyclodextrin-based nanosponges (CDNS) for solubility enhancement and prolonged release of PLP. The inclusion complexes of PLP with carbonyldiimidazole (CDI) cross-linked nanosponges were synthesized. The drug-loaded CDNS were characterized for particle size, zeta potential, encapsulation efficiency, stability study, in vitro drug release studies. The interaction of PLP with CDNS was ascertained by FTIR, DSC and PXRD studies. The particle size and zeta potential values were sufficient to obtain stable formulations. Solubility was significantly increased and in vitro drug release studies revealed prolonged release of PLP from the CDNS for 6 h. PXRD study revealed that the crystallinity of PLP was decreased due to complexation with the CDNS. Thus, cyclodextrin-based nanosponges represent a novel approach for solubility enhancement and improved dissolution of selected model drug PLP.

Notes

Acknowledgements

We are thankful to Cadila Pharmaceuticals Ltd, India and Gangwal Chemicals Pvt. Ltd., Mumbai, India for gift sample of Paliperidone and β-CD, respectively.

Supplementary material

10856_2019_6268_MOESM1_ESM.docx (12 kb)
Supplementary Information

References

  1. 1.
    Arima H, Hayashi Y, Higashi T, Motoyama K. Recent advances in cyclodextrin delivery techniques. Expert Opin Drug Deliv. 2015;12:1425–41.CrossRefGoogle Scholar
  2. 2.
    de Miranda HGFJC, de Azevedo Martins TE, Veiga F. Cyclodextrins and ternary complexes: technology to improve solubility of poorly soluble drugs. Brazilian J Pharm Sci. 2011;47:665–61.CrossRefGoogle Scholar
  3. 3.
    Loftsson T, Magnúsdóttir A, Másson M, Sigurjonsdottir JF. Self-association and cyclodextrin solubilization of drugs. J Pharm Sci. 2002;91:2307–16.CrossRefGoogle Scholar
  4. 4.
    Caldera F, Tannous M, Cavalli R, Zanetti M, Trotta F. Evolution of cyclodextrin nanosponges. Int J Pharm. 2017;531:470–9.CrossRefGoogle Scholar
  5. 5.
    Cavalli R, Trotta F, Tumiatti W. Cyclodextrin-based nanosponges for drug delivery. J Incl Phenom Macrocycl Chem. 2006;56:209–13.CrossRefGoogle Scholar
  6. 6.
    Sherje AP, Dravyakar BR, Kadam D, Jadhav M. Cyclodextrin-based nanosponges: a critical review. Carbohydr Polym. 2017;173:37–49.CrossRefGoogle Scholar
  7. 7.
    F Trotta, W Tumiatti, Cross-linked polymers based on cyclodextrins for removing polluting agents, US20050154198A1, 2002.Google Scholar
  8. 8.
    Shende PK, Trotta F, Gaud RS, Deshmukh K, Cavalli R, Biasizzo M. Influence of different techniques on formulation and comparative characterization of inclusion complexes of ASA with β-cyclodextrin and inclusion complexes of ASA with PMDA cross-linked β-cyclodextrin nanosponges. J Incl Phenom Macrocycl Chem. 2012;74:447–54.CrossRefGoogle Scholar
  9. 9.
    F Trotta, V Tumiatti, R Cavalli, C Maria, R Barbara, M Giovanni, et al., Cyclodextrin-based nanosponges as a vehicle for antitumoral drugs, WO2009003656A1, 2007.Google Scholar
  10. 10.
    Lockhart JN, Stevens DM, Beezer DB, Kravitz A, Harth E. Dual drug delivery of tamoxifen and quercetin: Regulated metabolism for anticancer treatment with nanosponges. J Control Release. 2015;220(Pt B):751–7.CrossRefGoogle Scholar
  11. 11.
    Swaminathan S, Cavalli R, Trotta F, Ferruti P, Ranucci E, Gerges I, et al. In vitro release modulation and conformational stabilization of a model protein using swellable polyamidoamine nanosponges of β-cyclodextrin. J Incl Phenom Macrocycl Chem. 2010;68:183–91.CrossRefGoogle Scholar
  12. 12.
    Owen RT. Extended-release paliperidone: efficacy, safety and tolerability profile of a new atypical antipsychotic. Drugs Today. 2007;43:249–58.CrossRefGoogle Scholar
  13. 13.
    Janicak PG, Winans EA, Paliperidone ER. a review of the clinical trial data. Neuropsychiatr Dis Treat. 2007;3:869–97. http://www.ncbi.nlm.nih.gov/pubmed/19300622. CrossRefGoogle Scholar
  14. 14.
    Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, et al. Kreyenbuhl, American Psychiatric Association, Steering Committee on Practice Guidelines, Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;161:1–56. http://www.ncbi.nlm.nih.gov/pubmed/15000267. CrossRefGoogle Scholar
  15. 15.
    Kozielska M, Johnson M, Pilla Reddy V, Vermeulen A, Li C, Grimwood S, et al. Pharmacokinetic-pharmacodynamic modeling of the D2 and 5-HT (2A) receptor occupancy of risperidone and paliperidone in rats. Pharm Res. 2012;29:1932–48.CrossRefGoogle Scholar
  16. 16.
    Meltzer HY, Matsubara S, Lee JC. Classification of typical and atypical antipsychotic drugs on the basis of dopamine D-1, D-2 and serotonin2 pKi values. J Pharmacol Exp Ther. 1989;251:238–46.Google Scholar
  17. 17.
    Kapur S, Remington G. Serotonin-dopamine interaction and its relevance to schizophrenia. Am J Psychiatry. 1996;153:466–76.CrossRefGoogle Scholar
  18. 18.
    Sherje A, Londhe V. Inclusion complexes of hydroxy Propyl-β-cyclodextrin and paliperidone: preparation and characterization. Curr Drug Discov Technol. 2014;11:271–8.CrossRefGoogle Scholar
  19. 19.
    Sherje AP, Londhe V. Ternary inclusion complex of paliperidone with β-cyclodextrin and hydrophilic polymer for solubility and dissolution enhancement. J Pharm Innov. 2015;10:324–34.CrossRefGoogle Scholar
  20. 20.
    Shende P, Kulkarni YA, Gaud RS, Deshmukh K, Cavalli R, Trotta F. F. Caldera, Acute and repeated dose toxicity studies of different β-cyclodextrin-based nanosponge formulations. J Pharm Sci. 2015;104:1856–63.CrossRefGoogle Scholar
  21. 21.
    F Trotta, Pravin Shende, Method for preparing dextrin nanosponges, WO/2012/147069, 2012.Google Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Quality AssuranceSVKM’s Dr. Bhanuben Nanavati College of Pharmacy, Vile Parle (W)MumbaiIndia
  2. 2.Department of Pharmaceutics, Shobhaben Pratapbhai Patel School of Pharmacy & Technology ManagementSVKM’s NMIMS, Vile Parle (W)MumbaiIndia

Personalised recommendations