Novel sugar esters proniosomes for transdermal delivery of vinpocetine: Preclinical and clinical studies

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 77, Issue 1, 2011, Pages 43-55

  El Laithy, Hanan M ^a   Shoukry, Omar ^b   Mahran, Laila G ^b  

^a CAIRO UNIVERSITY   (Egypt)

^b German University in Cairo GUC   (Egypt)

Author keywords

Niosomes; Proniosomes; Skin irritation; Sugar esters; Transdermal delivery; Vinpocetine

Indexed keywords

NIOSOME; POLYSORBATE 80; SUGAR ESTER; SURFACTANT; UNCLASSIFIED DRUG; VINPOCETINE; VINPORAL;

ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG HALF LIFE; DRUG PENETRATION; DRUG RELEASE; DRUG STABILITY; ENCAPSULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HISTOPATHOLOGY; HUMAN; HYDRATION; IN VITRO STUDY; MALE; NEWBORN; NONHUMAN; NORMAL HUMAN; SKIN INFLAMMATION; SKIN IRRITATION; SKIN PERMEABILITY;

ADMINISTRATION, CUTANEOUS; ADULT; ANIMALS; BIOLOGICAL AVAILABILITY; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; DRUG COMPOUNDING; DRUG STABILITY; HALF-LIFE; HUMANS; LIPOSOMES; MALE; NEUROPROTECTIVE AGENTS; PERMEABILITY; PHYSICOCHEMICAL PHENOMENA; RABBITS; SKIN; SKIN ABSORPTION; SKIN IRRITANCY TESTS; SURFACE-ACTIVE AGENTS; VINCA ALKALOIDS;

EID: 78650713351     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.10.011     Document Type: Article

References (62)

1. G. Betageri, and M. Habib Liposomes as drug carriers Pharm. Eng. 14 1994 76 77
2. P. Couvreur, E. Fattal, and A. Andremont Liposomes and nanoparticles in the treatment of intracellular bacterial infections Pharm. Res. 8 9 1991 1079 1086
3. S.G. Antimisiaris, P. Jayasekera, and G. Gregoriadis Liposomes as vaccine carriers. Incorporation of soluble and particulate antigens in giant vesicles J. Immunol. Methods 166 2 1993 271 280
4. S. Kim Liposomes as carriers of cancer chemotherapy. Current status and future prospects Drugs 46 4 1993 618 638
5. D.J. Booser, and G.N. Hortobagyi Anthracycline antibiotics in cancer therapy. Focus on drug resistance Drugs 47 2 1994 223 258
6. R.J. Stenekes, A.E. Loebis, C.M. Fernandes, D.J. Crommelin, and W.E. Hennink Controlled release of liposomes from biodegradable dextran microspheres: a novel delivery concept Pharm. Res. 17 6 2000 690 695
7. G. Gregoriadis, and A.T. Florence Liposomes in drug delivery. Clinical, diagnostic and ophthalmic potential Drugs 45 1 1993 15 28
8. C. Hunt, and S. Tsang Alpha tocopherol retards auto-oxidation and prolongs the shelf-life of liposomes Int. J. Pharm. 8 1981 101 110
9. M. Wong, and T. Thompson Aggregation of dipalmitoylphosphotidylcholine vesicles Biochemistry 21 1982 4133 4139
10. N.I. Payne, P. Timmins, C.V. Ambrose, M.D. Ward, and F. Ridgway Proliposomes: a novel solution to an old problem J. Pharm. Sci. 75 4 1986 325 329
11. C. Hu, and D.G. Rhodes Proniosomes: a novel drug carrier preparation Int. J. Pharm. 185 1 1999 23 35
12. I.F. Uchegbu, and S.P. Vyas Non-ionic surfactant based vesicles (niosomes) in drug delivery Int. J. Pharm. 172 1998 33 70
13. J.Y. Fang, S.Y. Yu, P.C. Wu, Y.B. Huang, and Y.H. Tsai In vitro skin permeation of estradiol from various proniosome formulations Int. J. Pharm. 215 1-2 2001 91 99
14. B. Vora, A.J. Khopade, and N.K. Jain Proniosome based transdermal delivery of levonorgestrel for effective contraception J. Control. Release 54 2 1998 149 165
15. I.A. Alsarra, A.A. Bosela, S.M. Ahmed, and G.M. Mahrous Proniosomes as a drug carrier for transdermal delivery of ketorolac Eur. J. Pharm. Biopharm. 59 3 2005 485 490
16. M.M. Ibrahim, O.A. Sammour, M.A. Hammad, and N.A. Megrab In vitro evaluation of proniosomes as a drug carrier for flurbiprofen AAPS PharmSciTech 9 3 2008 782 790
17. G. Csoka, S. Marton, R. Zelko, N. Otomo, and I. Antal Application of sucrose fatty acid esters in transdermal therapeutic systems Eur. J. Pharm. Biopharm. 65 2 2007 233 237
18. B.B. Youan, A. Hussain, and N.T. Nguyen Evaluation of sucrose esters as alternative surfactants in microencapsulation of proteins by the solvent evaporation method AAPS PharmSci 5 2 2003 E22
19. V.L. Feigin, B.M. Doronin, T.F. Popova, E.V. Gribatcheva, and D.V. Tchervov Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trial Eur. J. Neurol. 8 1 2001 81 85
20. P. Miskolczi, K. Kozma, M. Polgar, and L. Vereczkey Pharmacokinetics of vinpocetine and its main metabolite apovincaminic acid before and after the chronic oral administration of vinpocetine to humans Eur. J. Drug Metab. Pharmacokinet. 15 1 1990 1 5
21. L. Hua, P. Weisan, L. Jiayu, and Z. Ying Preparation, evaluation, and NMR characterization of vinpocetine microemulsion for transdermal delivery Drug Devlop. Ind. Pharm. 30 6 2004 657 666 (Pubitemid 38924636)
22. A. Abd-Elbary, H.M. El-laithy, and M.I. Tadros Sucrose stearate-based proniosome-derived niosomes for the nebulisable delivery of cromolyn sodium Int. J. Pharm. 357 1-2 2008 189 198
23. M. Sentjurc, K. Vrhovnik, and J. Kristl Liposomes as a topical delivery system: the role of size on transport studied by the EPR imaging method J. Control. Release 59 1 1999 87 97
24. M. Siewert, J. Dressman, C.K. Brown, and V.P. Shah FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms AAPS PharmSciTech 4 1 2003
25. M. Mokhtar, O.A. Sammour, M.A. Hammad, and N.A. Megrab Effect of some formulation parameters on flurbiprofen encapsulation and release rates of niosomes prepared from proniosomes Int. J. Pharm. 361 1-2 2008 104 111
26. T. Higuchi Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices J. Pharm. Sci. 52 1963 1145 1149
27. B.Y. Hwang, B.H. Jung, S.J. Chung, M.H. Lee, and C.K. Shim In vitro skin permeation of nicotine from proliposomes J. Control. Release 49 1997 177 184
28. A.C. Williams, and B.W. Barry Penetration enhancers Adv. Drug Deliv. Rev. 56 5 2004 603 618
29. M. Higashiyama, K. Inada, A. Ohtori, and K. Tojo Improvement of the ocular bioavailability of timolol by sorbic acid Int. J. Pharm. 272 1-2 2004 91 98
30. H.M. El-Laithy Novel transdermal delivery of timolol maleate using sugar esters: preclinical and clinical studies Eur. J. Pharm. Biopharm. 72 1 2009 239 245
31. H. Tang, S. Mitragotri, D. Blankschtein, and R. Langer Theoretical description of transdermal transport of hydrophilic permeants: application to low-frequency sonophoresis J. Pharm. Sci. 90 5 2001 545 568
32. P.C. Lerk, and H. Sucker Application of sucrose laurate in topical preparations of cyclosporin A Int. J. Pharm. 92 1993 203 210
33. A. Sintov, A. Ze'evi, R. Uzan, and A. Nyska Influence of pharmaceutical gel vehicles containing oleic acid/sodium oleate combinations on hairless mouse skin, a histological evaluation Eur. J. Pharm. Biopharm. 47 3 1999 299 303
34. FDA, Guidance of Industry, Food Effect, Bioavailability and Bioequivalance Studieos, 2002.
35. A. Abd-Elbary, N. Foda, O. El-Gazayerly, and M. El-Khatib Reversed phase liquid chromatographic determination of vinpocetine in human plasma and its pharmacokinetic application Anal. Lett. 35 6 2002 1041 1054
36. W. Hammes, and R. Weyhenmeyer Quantitative determination of vinpocetine in human plasma by capillary gas chromatography-mass spectrometry J. Chromatogr. 413 1987 264 269
37. I.F. Uchegbu, and A.T. Florence Non-ionic surfactant vesicles (niosomes): physical and pharmaceutical chemistry Adv. Colloid Interface Sci. 58 1995 1 55
38. A.S. Guinedi, N.D. Mortada, S. Mansour, and R.M. Hathout Preparation and evaluation of reverse-phase evaporation and multilamellar niosomes as ophthalmic carriers of acetazolamide Int. J. Pharm. 306 1-2 2005 71 82
39. A.R. Mohammed, N. Weston, A.G.A. Coombes, M. Fitzgerald, and Y. Perrie Liposome formulation of poorly water soluble drugs: optimisation of drug loading and ESEM analysis of stability Int. J. Pharm. 285 2004 23 34
40. D. van Hal, E. Jeremiasse, T. de Vringer, H.E. Junginger, and J.A. Bouwstra Encapsulation of lidocaine base and hydrochloride into non-ionic surfactant vesicles (NSVs) and diffusion through human stratum comeum in vitro Eur. J. Pharm. Sci. 4 1996 147 157
41. Y. Hao, L. Zhao, N. Li, Y. Yang, and K. Li Studies on a high encapsulation of colchicine by a niosome system Int. J. Pharm. 244 2002 73 80
42. R. Agarwal, O.P. Katare, and S.P. Vyas Preparation and in vitro evaluation of liposomal/niosomal delivery systems for antipsoriatic drug dithranol Int. J. Pharm. 228 1-2 2001 43 52
43. J. Varshosaz, A. Pardakhty, and S.M. Baharanchi Sorbitan monopalmitate-based proniosomes for transdermal delivery of chlorpheniramine maleate Drug Deliv. 12 2 2005 75 82
44. L. Coderch, J. Fonollosa, M. De Pera, J. Estelrich, A. De La Maza, and J.L. Parra Influence of cholesterol on liposome fluidity by EPR. Relationship with percutaneous absorption J. Control. Release 68 1 2000 85 95 (Pubitemid 30407064)
45. W.K. Subczynski, and A. Wisniewska Physical properties of lipid bilayer membranes: relevance to membrane biological functions Acta Biochim. Pol. 47 3 2000 613 625
46. D.D. Verma, S. Verma, G. Blumeb, and A. Fahr Particle size of liposomes influences dermal delivery of substances into skin Int. J. Pharm. 258 2003 141 151
47. P. Balakrishnan, S. Shanmugam, W.S. Lee, W.M. Lee, J.O. Kim, D.H. Oh, D.D. Kim, J.S. Kim, B.K. Yoo, H.G. Choi, J.S. Woo, and C.S. Yong Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery Int. J. Pharm. 2009 10.1016/j.ijpharm.2009.1004.1020
48. J.N. Israelachvili Intermolecular and Surface Forces 1985 Academic Press Sydney
49. R.M. Hathout, S. Mansour, N.D. Mortada, and A.S. Guinedi Liposomes as an ocular delivery system for acetazolamide: in vitro and in vivo studies AAPS PharmSciTech 8 1 2007 1
50. A. Szuts, E. Pallagi, G. Regdon Jr., Z. Aigner, and P. Szabo-Revesz Study of thermal behaviour of sugar esters Int. J. Pharm. 336 2 2007 199 207
51. C. Cable, An Examination of the Effects of Surface Modifications on the Physicochemical and Biological Properties of Non-ionic Surfactant Vesicles, Ph.D. Thesis, University of Strathclyde, Glasgow, UK, 1989.
52. A. Pardakhty, J. Varshosaz, and A. Rouholamini In vitro study of polyoxyethylene alkyl ether niosomes for delivery of insulin Int. J. Pharm. 328 2 2007 130 141
53. A. Szuts, Z. Makai, R. Rajko, and P. Szabo-Revesz Study of the effects of drugs on the structures of sucrose esters and the effects of solid-state interactions on drug release J. Pharm. Biomed. Anal. 48 2008 1136 1142
54. K.R. Brain, and K.A. Walters K.A. Walters, J. Hadgraft, Pharmaceutical Skin Penetration Enhancement 1993 Marcel Dekker New York 389 416
55. J. Cazares-Delgadillo, A. Naik, Y.N. Kalia, D. Quintanar-Guerrero, and A. Ganem-Quintanar Skin permeation enhancement by sucrose esters: a pH-dependent phenomenon Int. J. Pharm. 297 1-2 2005 204 212
56. H. Ayala-Bravo, D. Quintanar-Guerrero, Y.N. Kalia, A. Naik, J. Cornejo-Bravo, and A. Ganem-Quintanar Effects of sucrose oleate and sucrose laureate on in vivo human stratum corneum permeability J. Pharm. Res. 20 2003 1267 1273
57. J.Y. Fang, C.T. Hong, W.T. Chiu, and Y.Y. Wang Effect of liposomes and niosomes on skin permeation of enoxacin Int. J. Pharm. 219 1-2 2001 61 72
58. H.M. Tiemessen, H.E. Bodde, H. Mollee, and H.E. Junginger A human stratum corneum-silicone membrane sandwich to simulate drug transport under occlusion Int. J. Pharm. 53 1989 119 127
59. J.Y. Fang, T.L. Hwang, C.L. Fang, and H.C. Chiu In vitro and in vivo evaluations of the efficacy and safety of skin permeation enhancers using flurbiprofen as a model drug Int. J. Pharm. 255 2003 153 166
60. M.A. Thevenin, J.L. Grossiord, and M.C. Poelman Sucrose esters/cosurfactant microemulsion systems for transdermal delivery: assessment of bicontinuous structures Int. J. Pharm. 137 1996 177 186
61. D. Kobayashi, T. Matsuzawa, and K. Sugibayashi Feasibility of use of several cardiovascular agents in transdermal therapeutic systems with 1-menthol-ethanol system on hairless rat and human skin Biol. Pharm. Bull. 16 1993 254 258
62. L. Hua, P. Weisan, L. Jiayu, and L. Hongfei Preparation and evaluation of microemulsion of vinpocetine for transdermal delivery Pharmazie 59 4 2004 274 278 (Pubitemid 38480715)