Formulation of avanafil in a solid self-nanoemulsifying drug delivery system for enhanced oral delivery

European Journal of Pharmaceutical Sciences

Volumn 93, Issue , 2016, Pages 447-455

  Soliman, Kareem AbuBakr ^a   Ibrahim, Howida Kamal ^a   Ghorab, Mahmoud Mohammed ^a  

^a CAIRO UNIVERSITY   (Egypt)

Author keywords

Aeroperl; Amorphous; Bioavailability; Dissolution; Nanoemulsion; Stability

Indexed keywords

AVANAFIL; CREMOPHOR; DIETHYLENE GLYCOL MONOETHYL ETHER; MIGLYOL; OIL; POLYSORBATE 80; EMULSION; LIPID; NANOPARTICLE; PHOSPHODIESTERASE V INHIBITOR; PYRIMIDINE DERIVATIVE; SURFACTANT;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DILUTION; DRUG ADSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG SOLUBILITY; DRUG SOLUTION; DRUG STORAGE; NANOEMULSION; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; TABLET FORMULATION; X RAY DIFFRACTION; ANIMAL; BIOAVAILABILITY; BLOOD; CHEMISTRY; EMULSION; ORAL DRUG ADMINISTRATION; POWDER DIFFRACTION; RABBIT; SOLUBILITY; ULTRASTRUCTURE;

ADMINISTRATION, ORAL; ANIMALS; BIOLOGICAL AVAILABILITY; CALORIMETRY, DIFFERENTIAL SCANNING; DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; EMULSIONS; LIPIDS; MICROSCOPY, ELECTRON, SCANNING; NANOPARTICLES; PARTICLE SIZE; PHOSPHODIESTERASE 5 INHIBITORS; POWDER DIFFRACTION; PYRIMIDINES; RABBITS; SOLUBILITY; SURFACE-ACTIVE AGENTS; X-RAY DIFFRACTION;

EID: 84985010349     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2016.08.050     Document Type: Article

References (48)

1. Alwaal, A., Al-Mannie, R., Carrier, S., Future prospects in the treatment of erectile dysfunction: focus on avanafil. Drug Des. Devel. Ther. 5 (2011), 435–443.
2. Ammar, H.O., Salama, H.A., Ghorab, M., Mahmoud, A.A., Formulation and biological evaluation of glimepiride-cyclodextrin-polymer systems. Int. J. Pharm. 309 (2006), 129–138.
3. Anderson, N.H., Bauer, M., Boussac, N., Khan-Malek, R., Munden, P., Sardaro, M., An evaluation of fit factors and dissolution efficiency for the comparison of in vitro dissolution profiles. J. Pharm. Biomed. Anal. 17 (1998), 811–822.
4. Balakrishnan, P., Lee, B.J., Oh, D.H., Kim, J.O., Hong, M.J., Jee, J.P., Kim, J.A., Yoo, B.K., Woo, J.S., Yong, C.S., Choi, H.G., Enhanced oral bioavailability of dexibuprofen by a novel solid self-emulsifying drug delivery system (SEDDS). Eur. J. Pharm. Biopharm. 72 (2009), 539–545.
5. Bari, A., Chella, N., Sanka, K., Shastri, N.R., Diwan, P.V., Improved anti-diabetic activity of glibenclamide using oral self nano emulsifying powder. J. Microencapsul. 32 (2015), 54–60.
6. Burke, R.M., Evans, J.D., Avanafil for treatment of erectile dysfunction: review of its potential. Vasc. Health Risk Manag. 8 (2012), 517–523.
7. Chen, C., Wang, L., Cao, F., Miao, X., Chen, T., Chang, Q., Zheng, Y., Formulation of 20(S)-protopanaxadiol nanocrystals to improve oral bioavailability and brain delivery. Int. J. Pharm. 497 (2016), 239–247.
8. Date, A.A., Nagarsenker, M.S., Design and evaluation of self-nanoemulsifying drug delivery systems (SNEDDS) for cefpodoxime proxetil. Int. J. Pharm. 329 (2007), 166–172.
9. Date, A.A., Desai, N., Dixit, R., Nagarsenker, M., Self-nanoemulsifying drug delivery systems: formulation insights, applications and advances. Nanomedicine (Lond.) 5 (2010), 1595–1616.
10. Dondapati, D., Srimathkandala, M.H., Sanka, K., Bakshi, V., Improved solubility and dissolution release profile of lurasidone by solid self-nanoemulsifying drug delivery system. Anal. Chem. Lett. 6 (2016), 86–97.
11. El-Laithy, H.M., Self-nanoemulsifying drug delivery system for enhanced bioavailability and improved hepatoprotective activity of biphenyl dimethyl dicarboxylate. Curr. Drug Deliv. 5 (2008), 170–176.
12. Emmadi, S.K., Sanka, K., Potu, A.R., Jukanti, R., Bandari, S., Veerareddy, P.R., Formulation and pharmacodynamics evaluation of meloxicam liquisolid compacts. Lat. Am. J. Pharm. 29 (2011), 1303–1310.
13. max for absorption rates in investigations of bioequivalence. Int. J. Clin. Pharmacol. Ther. Toxicol. 29 (1991), 394–399.
14. European Medicines Agency, Spedra (avanafil), European public assessment report (EPAR) - summary for the public (EMA/58674/2015). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002581/WC500145208.pdf/, 2013 accessed 15.04.15.
15. Fahmy, U.A., Ahmed, O.A., Hosny, K.M., Development and evaluation of avanafil self-nanoemulsifying drug delivery system with rapid onset of action and enhanced bioavailability. AAPS PharmSciTech 16 (2015), 53–58.
16. US Food and Drug Administration, Guidance for industry, dissolution testing of immediate release solid oral dosage forms. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf/, 1997 accessed 15.07.14.
17. US Food and Drug Administration, Guidance for industry, estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM078932.pdf/, 2005 accessed 15.07.18.
18. US Food and Drug Administration, FDA approves Stendra for erectile dysfunction. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302140.htm/, 2012 accessed 15.07.14.
19. US Food and Drug Administration, FDA-recommended dissolution methods. http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_getallData.cfm/, 2015 accessed 15.04.10.
20. Ghosh, P.K., Majithiya, R.J., Umrethia, M.L., Murthy, R.S., Design and development of microemulsion drug delivery system of acyclovir for improvement of oral bioavailability. AAPS PharmSciTech, 7, 2006, 77.
21. Gupta, S., Chavhan, S., Sawant, K.K., Self-nanoemulsifying drug delivery system for adefovir dipivoxil: design, characterization, in vitro and ex vivo evaluation. Colloids Surf. A Physicochem. Eng. Asp. 392 (2011), 145–155.
22. Kang, J.H., Oh, D.H., Oh, Y.K., Yong, C.S., Choi, H.G., Effects of solid carriers on the crystalline properties, dissolution and bioavailability of flurbiprofen in solid self-nanoemulsifying drug delivery system (solid SNEDDS). Eur. J. Pharm. Biopharm. 80 (2012), 289–297.
23. Lacey, L.F., Keene, O.N., Duquesnoy, C., Bye, A., Evaluation of different indirect measures of rate of drug absorption in comparative pharmacokinetic studies. J. Pharm. Sci. 83 (1994), 212–215.
24. European Union Law, Legislation for the protection of animals used for scientific purposes (directive 2010/6/EU). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0063&from=EN/, 2010 accessed 15.08.18.
25. Mahmoud, E.A., Bendas, E.R., Mohamed, M.I., Preparation and evaluation of self-nanoemulsifying tablets of carvedilol. AAPS PharmSciTech 10 (2009), 183–192.
26. Mohammed, K.A., Ibrahim, H.K., Ghorab, M.M., Effervescent tablet formulation for enhanced patient compliance and the therapeutic effect of risperidone. Drug Deliv. 23 (2016), 297–306.
27. Mohd, A.B., Sanka, K., Bandi, S., Diwan, P.V., Shastri, N., Solid self-nanoemulsifying drug delivery system (S-SNEDDS) for oral delivery of glimepiride: development and antidiabetic activity in albino rabbits. Drug Deliv. 22 (2015), 499–508.
28. Parmar, N., Singla, N., Amin, S., Kohli, K., Study of cosurfactant effect on nanoemulsifying area and development of lercanidipine loaded (SNEDDS) self nanoemulsifying drug delivery system. Colloids Surf. B: Biointerfaces 86 (2011), 327–338.
29. Rao, S.V., Shao, J., Self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of protein drugs: I. Formulation development. Int. J. Pharm. 362 (2008), 2–9.
30. Sanka, K., Munjulury, V.S., Mohd, A.B., Diwan, P.V., Enhancement of solubility, dissolution release profile and reduction in ulcerogenicity of piroxicam by inclusion complex with skimmed milk. Drug Deliv. 21 (2014), 560–570.
31. Sanka, K., Poienti, S., Mohd, A.B., Diwan, P.V., Improved oral delivery of clonazepam through liquisolid powder compact formulations: in-vitro and ex-vivo characterization. Powder Technol. 256 (2014), 336–344.
32. Sanka, K., Suda, D., Bakshi, V., Optimization of solid-self nanoemulsifying drug delivery system for solubility and release profile of clonazepam using simplex lattice design. J. Drug Deliv. Sci. Tech. 33 (2016), 114–124.
33. Sedgwick, G.W., Fenton, T.W., Thompson, J.R., Effect of protein precipitating agents on the recovery of plasma free amino acids. Can. J. Anim. Sci. 71 (1991), 953–957.
34. Shakeel, F., Haq, N., El-Badry, M., Alanazi, F.K., Alsarra, I.A., Ultra fine super self-nanoemulsifying drug delivery system (SNEDDS) enhanced solubility and dissolution of indomethacin. J. Mol. Liq. 180 (2013), 89–94.
35. Shanmugam, S., Baskaran, R., Balakrishnan, P., Thapa, P., Yong, C.S., Yoo, B.K., Solid self-nanoemulsifying drug delivery system (S-SNEDDS) containing phosphatidylcholine for enhanced bioavailability of highly lipophilic bioactive carotenoid lutein. Eur. J. Pharm. Biopharm. 79 (2011), 250–257.
36. Shehata, E.M.M., Elnaggar, Y.S.R., Galal, S., Abdallah, O.Y., Self-emulsifying phospholipid pre-concentrates (SEPPs) for improved oral delivery of the anti-cancer genistein: development, appraisal and ex-vivo intestinal permeation. Int. J. Pharm. 511 (2016), 745–756.
37. Shrivastava, A.R., Ursekar, B., Kapadia, C.J., Design, optimization, preparation and evaluation of dispersion granules of valsartan and formulation into tablets. Curr. Drug Deliv. 6 (2009), 28–37.
38. Singh, S.K., Verma, P.R., Razdan, B., Glibenclamide-loaded self-nanoemulsifying drug delivery system: development and characterization. Drug Dev. Ind. Pharm. 36 (2010), 933–945.
39. Soliman, K.A., Ibrahim, H.K., Ghorab, M.M., Formulation of risperidone as self-nanoemulsifying drug delivery system in form of effervescent tablets. J. Dispers. Sci. Technol. 33 (2012), 1127–1133.
40. Stevens, R.E., Gray, V., Dorantes, A., Gold, L., Pham, L., Scientific and regulatory standards for assessing product performance using the similarity factor, f2. AAPS J. 17 (2015), 301–306.
41. Taha, E.I., Al-Saidan, S., Samy, A.M., Khan, M.A., Preparation and in vitro characterization of self-nanoemulsified drug delivery system (SNEDDS) of all-trans-retinol acetate. Int. J. Pharm. 285 (2004), 109–119.
42. Tang, B., Cheng, G., Development of solid self-emulsifying drug delivery systems: preparation techniques and dosage forms. Drug Discov. Today 13 (2008), 606–612.
43. Villar, A.M., Naveros, B.C., Campmany, A.C., Trenchs, M.A., Rocabert, C.B., Bellowa, L.H., Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil. Int. J. Pharm. 431 (2012), 161–175.
44. Wang, L., Dong, J., Chen, J., Eastoe, J., Li, X., Design and optimization of a new self-nanoemulsifying drug delivery system. J. Colloid Interface Sci. 330 (2009), 443–448.
45. World Health Organization, Annex 2, stability testing of active pharmaceutical ingredients and finished pharmaceutical products., 2011 WHO Technical Report Series, No 953, 2009 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO.pdf/ accessed 15.02.12.
46. Xiong, J., Guo, J., Huang, L., Meng, B., Ping, Q., The use of lipid-based formulations to increase the oral bioavailability of Panax notoginseng saponins following a single oral gavage to rats. Drug Dev. Ind. Pharm. 34 (2008), 65–72.
47. Yoo, J.H., Shanmugam, S., Thapa, P., Lee, E.S., Balakrishnan, P., Baskaran, R., Yoon, S.K., Choi, H.G., Yong, C.S., Yoo, B.K., Han, K., Novel self-nanoemulsifying drug delivery system for enhanced solubility and dissolution of lutein. Arch. Pharm. Res. 33 (2010), 417–426.
48. Zhao, Y., Wang, C., Chow, A.H., Ren, K., Gong, T., Zhang, Z., Zheng, Y., Self-nanoemulsifying drug delivery system (SNEDDS) for oral delivery of zedoary essential oil: formulation and bioavailability studies. Int. J. Pharm. 383 (2010), 170–177.