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Kendiliğinden Emülsifiye Olabilen İlaç Taşıyıcı Sistemler ve Farmasötik Alanda Uygulamaları

Yıl 2011, Sayı: 2, 151 - 170, 01.06.2011

Öz

İçeriğinde yağ, sürfaktan ve yardımcı çözücü/yardımcı sürfaktan bulunan izotropik sistemler olan SEDDS’ler Self-Emulsifying Drug Delivery Systems, SEDDS ilaç taşınımı, suda az çözünen ilaçların biyoyararlanımlarının artırılması ve lenfatik hedeflendirme gibi amaçlarla kullanılmaktadır. SEDDS’ler üçgen faz diyagramları ve yüksek verimli görüntüleme sistemleri yardımı ile özgün bileşimlerde hazırlanmaktadırlar. Çeşitli farmakolojik aktivitelere sahip düşük çözünürlükte ilaçlar ve peptit/ protein yapılı maddeler SEDDS’ler içine hapsedilebilmektedir. Bu yolla oral yolla verilmesi sorunlu olan maddelerin oral kullanımı mümkün olabilmektedir. SEDDS’ler ile formüle edilen ve oral biyoyararlanımı artırılan ilaçlardan olan Sandimmune Neoral® Siklosporin A , Norvir® Ritonavir ve Fortovase® Saquinavir günümüzde piyasada bulunmaktadır. Sıvı SEDDS formülasyonlarının sert veya yumuşak jelatin kapsüllere doldurulması ve püskürterek kurutma ile katı SEDDS’lerin hazırlanması sonucu daha yüksek mikrobiyolojik dayanıklılığa sahip formülasyonlar hazırlanmaktadır. SEDDS’lere olan ilginin artması ile birçok ilacın piyasaya kazandırılması veya daha etkin bir şekilde düşük doz, oral kullanımın sağlanması vb. kullanılabilmesi mümkün olabilecektir.

Kaynakça

  • Bouchemal, K., Briançon, S., Perrier, E., Fessi, H.: Nano-emulsion formulation using spontaneous emulsification: solvent, oil and surfactant optimisation, Int J Pharm, 280, 241, (2004).
  • Solans, C., Izquierdo, P., Nolla, J., Azemar, N., Garcia-Celma, M.J.: Nano-emulsions, Curr Opın Colloıd In, 10, 102, (2005).
  • Tadros, T., Izquierdo, P., Esquena, J., Solans, C.: Formation and stability of nano- emulsions, Adv Colloıd Interfac, 108 –109, 303, (2004).
  • Gursoy, R.N., Benita, S.: Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs, Biomed Pharmacother, 58, 173, (2004).
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  • Gursoy, N., Garrigue, J.S., Razafindratsita, A., Lambert, G.,Benita, S.: Excipient effects on in vitro cytotoxicity of a novel paclitaxel self-emulsifying drug delivery system, J Pharm Sci, 92, 2411, (2003).
  • Zhang, N., Zhang, W., Jin, Y., Quan, D.Q.: Studies on preparation of carbamazepine (CBZ) supersaturatable self-microemulsifying (S-SMEDDS) formulation and relative bioavailability in beagle dogs, Pharm Dev Technol, 30, 1, (2010).
  • Pouton, C.W.: Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and ‘self-microemulsifying’ drug delivery systems, Eur J Pharm Sci, 11, 93, (2000).
  • Porter, C.J.H., Trevaskis, N.L.,Charman, W.N.: Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs, Nat Rev Drug Discov, 6, 231, (2007).
  • Barakat, N.S.: Enhanced oral bioavailability of etodolac by self-emulsifying systems: in-vitro and in-vivo evaluation, J Pharm Pharmacol, 62, 173, (2010).
  • Cheng, M.B., Wang, J.C., Li, Y.H., Liu, X.Y., Zhang, X., Chen, D.W., Zhou, S.F., Zhang, Q.: Characterization of water-in-oil microemulsion for oral delivery of earthworm fibri- nolytic enzyme, J Control Release, 129, 41, (2008).
  • Rao, S.P.V.R., Shao, J.: Self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of protein drugs I. Formulation development, Int J Pharm, 362, 2, (2008).
  • Kohli, K., Chopra, S., Dhar, D., Arora, S.,Khar, R.K.: Self-emulsifying drug delivery sys- tems: an approach to enhance oral bioavailability, Drug Discov Today, 15, 958, (2010).
  • http://www.aapsj.org/abstracts/AM_2010/W5282.pdf.
  • Porter, C.J.H., Charman, W.N.: Uptake of drugs into the intestinal lymphatics after oral administration, Adv Drug Deliver Rev, 25 , 71, (1997).
  • Kabalnov, A., Lindman, B., Olsson, U., Piculell, L., Thuresson, K., Wennerström, H.: Microemulsions in amphiphilic and polymer-surfactant systems, Colloid Polym Sci, 274, 297, (1996).
  • Sakai, K., Yoshimori, T., Obata, K., Maeda, H.: Design of self-microemulsifying drug delivery systems using a high-throughput formulation screening system, Drug Dev Ind Pharm, 36, 1245 (2010).
  • Basalious, E.B., Shawky, N., Badr-Eldin, S.M.: SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: development and opti- mization, Int J Pharm, 391, 203, (2010).
  • Cirri, M., Mura, P., Mora, P.C.: Liquid spray formulations of xibornol by using self- microemulsifying drug delivery systems, Int J Pharm, 340, 84, (2007).
  • Elnaggar, Y.S., El-Massik, M.A., Abdallah, O.Y.: Self-nanoemulsifying drug delivery systems of tamoxifen citrate: design and optimization, Int J Pharm, 380, 133, (2009).
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  • Chambin, O., Jannin, V.: Interest of multifunctional lipid excipients: case of Gelucire 44/14, Drug Dev Ind Pharm, 31, 527, (2005).
  • Atef, E., Belmonte, A.A.: Formulation and in vitro and in vivo characterization of a phenytoin self-emulsifying drug delivery system (SEDDS), Eur J Pharm Sci, 35, 257, (2008).
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  • Zvonar, A., Berginc, K., Kristl, A., Gasperlin, M.: Microencapsulation of self- micro- emulsifying system: Improving solubility and permeability of furosemide, Int J Pharm, 388, 151, (2010).
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  • Reiss, H.: Entropy-induced dispersion of bulk liquids, Journal of Colloid and Interface Science, 53, 61, (1975).
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Self - Emulsifying Drug Delivery Systems and their Pharmaceutical Applications

Yıl 2011, Sayı: 2, 151 - 170, 01.06.2011

Öz

Self emulsifying drug delivery systems SEDDS are isotropic mixtures which contain surfactant, oil and cosolvents and they are used for drug delivery, enhanced bioavailability of poorly soluble drugs and lymphatic drug targeting. SEDDS are prepared using ternary phase diagrams and high throughput screening systems with spesific ratios of excipients. Various poorly soluble drugs which have different pharmacological activities and peptide/protein drugs can be entrapped in SEDDS. By this way, drugs which have solubility or stability problems can be formulated with SEDDS and oral route could be possible for administration. Sandimmune Neoral® Cyclosporine A , Norvir® Ritonavir and Fortovase® Saquinavir are products on the pharmaceutical market which are formulated with SEDDS formulations and have improved oral bioavailability. Liquid SEDDS formulations can be filled into hard or soft gelatine capsules and solid SEDDS can be prepared by spray drying which have more microbiological stability. Because of increased interest in SEDDS, new drug compounds can be formulated and marketed or they can be used more efficiently like lower dose, enhanced stability or oral administration.

Kaynakça

  • Bouchemal, K., Briançon, S., Perrier, E., Fessi, H.: Nano-emulsion formulation using spontaneous emulsification: solvent, oil and surfactant optimisation, Int J Pharm, 280, 241, (2004).
  • Solans, C., Izquierdo, P., Nolla, J., Azemar, N., Garcia-Celma, M.J.: Nano-emulsions, Curr Opın Colloıd In, 10, 102, (2005).
  • Tadros, T., Izquierdo, P., Esquena, J., Solans, C.: Formation and stability of nano- emulsions, Adv Colloıd Interfac, 108 –109, 303, (2004).
  • Gursoy, R.N., Benita, S.: Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs, Biomed Pharmacother, 58, 173, (2004).
  • Dixit, A.R., Rajput, S.J., Patel, S.G.: Preparation and bioavailability assessment of SMEDDS containing valsartan, AAPS PharmSciTech, 11, 314, (2010).
  • Shen, Q., Li, X., Yuan, D., Jia, W.: Enhanced oral bioavailability of daidzein by self- microemulsifying drug delivery system, Chem Pharm Bull (Tokyo), 58, 639, (2010).
  • Gursoy, N., Garrigue, J.S., Razafindratsita, A., Lambert, G.,Benita, S.: Excipient effects on in vitro cytotoxicity of a novel paclitaxel self-emulsifying drug delivery system, J Pharm Sci, 92, 2411, (2003).
  • Zhang, N., Zhang, W., Jin, Y., Quan, D.Q.: Studies on preparation of carbamazepine (CBZ) supersaturatable self-microemulsifying (S-SMEDDS) formulation and relative bioavailability in beagle dogs, Pharm Dev Technol, 30, 1, (2010).
  • Pouton, C.W.: Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and ‘self-microemulsifying’ drug delivery systems, Eur J Pharm Sci, 11, 93, (2000).
  • Porter, C.J.H., Trevaskis, N.L.,Charman, W.N.: Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs, Nat Rev Drug Discov, 6, 231, (2007).
  • Barakat, N.S.: Enhanced oral bioavailability of etodolac by self-emulsifying systems: in-vitro and in-vivo evaluation, J Pharm Pharmacol, 62, 173, (2010).
  • Cheng, M.B., Wang, J.C., Li, Y.H., Liu, X.Y., Zhang, X., Chen, D.W., Zhou, S.F., Zhang, Q.: Characterization of water-in-oil microemulsion for oral delivery of earthworm fibri- nolytic enzyme, J Control Release, 129, 41, (2008).
  • Rao, S.P.V.R., Shao, J.: Self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of protein drugs I. Formulation development, Int J Pharm, 362, 2, (2008).
  • Kohli, K., Chopra, S., Dhar, D., Arora, S.,Khar, R.K.: Self-emulsifying drug delivery sys- tems: an approach to enhance oral bioavailability, Drug Discov Today, 15, 958, (2010).
  • http://www.aapsj.org/abstracts/AM_2010/W5282.pdf.
  • Porter, C.J.H., Charman, W.N.: Uptake of drugs into the intestinal lymphatics after oral administration, Adv Drug Deliver Rev, 25 , 71, (1997).
  • Kabalnov, A., Lindman, B., Olsson, U., Piculell, L., Thuresson, K., Wennerström, H.: Microemulsions in amphiphilic and polymer-surfactant systems, Colloid Polym Sci, 274, 297, (1996).
  • Sakai, K., Yoshimori, T., Obata, K., Maeda, H.: Design of self-microemulsifying drug delivery systems using a high-throughput formulation screening system, Drug Dev Ind Pharm, 36, 1245 (2010).
  • Basalious, E.B., Shawky, N., Badr-Eldin, S.M.: SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: development and opti- mization, Int J Pharm, 391, 203, (2010).
  • Cirri, M., Mura, P., Mora, P.C.: Liquid spray formulations of xibornol by using self- microemulsifying drug delivery systems, Int J Pharm, 340, 84, (2007).
  • Elnaggar, Y.S., El-Massik, M.A., Abdallah, O.Y.: Self-nanoemulsifying drug delivery systems of tamoxifen citrate: design and optimization, Int J Pharm, 380, 133, (2009).
  • Kommuru, T.R., Gurley, B., Khan, M.A., Reddy, I.K.: Self-emulsifying drug delivery systems (SEDDS) of coenzyme Q10: formulation development and bioavailability as- sessment, Int J Pharm, 212, 233, (2001).
  • Hauss, D.J., Fogal, S.E., Ficorilli, J.V., Price, C.A., Roy, T., Jayaraj, A.A. ve diğerleri.: Lipid-based delivery systems for improving the bioavailability and lymphatic transport of a poorly water-soluble LTB4 inhibitor, J Pharm Sci, 87, 164, (1998).
  • Chambin, O., Jannin, V.: Interest of multifunctional lipid excipients: case of Gelucire 44/14, Drug Dev Ind Pharm, 31, 527, (2005).
  • Atef, E., Belmonte, A.A.: Formulation and in vitro and in vivo characterization of a phenytoin self-emulsifying drug delivery system (SEDDS), Eur J Pharm Sci, 35, 257, (2008).
  • Sha, X., Yan, G., Wu, Y., Li, J., Fang, X.: Effect of self-microemulsifying drug delivery systems containing Labrasol on tight junctions in Caco-2 cells, Eur J Pharm Sci, 24, 477, (2005).
  • Jannin, V., Musakhanian, J., Marchaud, D.: Approaches for the development of solid and semi-solid lipid-based formulations, Advanced Drug Delivery Reviews, 60, 734, (2008).
  • Constantinides, PP.: Lipid microemulsions for improving drug dissolution and oral ab- sorption: physical and biopharmaceutical aspects, Pharm Res, 12, 1561, (1995).
  • Grevel, J., Nuesch, E., Abisch, K., Kutz, K.: Pharmacokinetics of oral cyclopsorinA (Sandimmun) in healthy subjects, Eur J Clin Pharmacol, 31, 211, (1986).
  • Rang, M.J., Miller, C.A.: Spontaneous emulsification of oils containing hydrocarbon, non-ionic surfactant, and oleyl alcohol, J Colloids Interface Sci, 209, 179, (1999).
  • Gershanik, T., Haltner, E., Lehr, C.M., Benita, S.: Charge-dependent interaction of self- emulsifying oil formulations with Caco-2 cell monolayers: binding, effects on barrier function and cytotoxicity, Int J Pharm, 211, 29, (2000).
  • Zvonar, A., Berginc, K., Kristl, A., Gasperlin, M.: Microencapsulation of self- micro- emulsifying system: Improving solubility and permeability of furosemide, Int J Pharm, 388, 151, (2010).
  • Anton, N., Benoit, J.P., Saulnier, P.: Design and production of nanoparticles formulated from nano-emulsion templates-a review, J Control Release, 128, 185, (2008).
  • Quincke, G.: Ueber Emulsionbildung und den einfluss der galle bei der verdauung, Pluger Arch Physiol, 19, 129 (1879).
  • Leal-Calderon, F., Bibette, J, “Emulsification”, Emulsion Science, Basic Principles, Sec- ond Edition, New York, Springer, (2007), sayfa 10.
  • Lawrence, M.J., Rees, G.D.: Microemulsion-based media as novel drug delivery sys- tems, Adv Drug Deliver Rev, 45, 89, (2000).
  • Reiss, H.: Entropy-induced dispersion of bulk liquids, Journal of Colloid and Interface Science, 53, 61, (1975).
  • Dabros, T., Yeung, A., Masliyah, J., Czarnecki, J.: Emulsification through area contrac- tion, J Colloid Interf Sci, 210, 222, (1999).
  • Henry, J.V., Fryer, P.J., Frith, W.J.,Norton, I.T.: Emulsification mechanism and storage instabilities of hydrocarbon-in-water sub-micron emulsions stabilised with Tweens (20 and 80), Brij 96v and sucrose monoesters, J Colloid Interface Sci, 338, 201, (2009).
  • Nekkanti, V., Karatgi, P., Prabhu, R., Pillai, R.: Solid self-microemulsifying formulation for candesartan cilexetil, AAPS PharmSciTech, 11, 9, (2010).
  • Yi, T., Wan, J.L., Xu, H.B.,Yang, X.L.: A new solid self-microemulsifying formulation prepared by spray-drying to improve the oral bioavailability of poorly water soluble drugs, Eur J Pharm Biopharm, 70, 439, (2008).
  • Wasan, E.K., Bartlett, K., Gershkovich, P., Sivak, O., Banno, B., Wong, Z., Gagnon, J., Gates, B., Leon, C. G., Wasan, K. M. : Development and characterization of oral lipid-based Amphotericin B formulations with enhanced drug solubility, stability and antifungal activity in rats infected with Aspergillus fumigatus or Candida albicans, Int J Pharm, 372, 76, (2009).
  • Gershanik, T., Benita, S.: Self-dispersing lipid formulations for improving oral absorp- tion of lipophilic drugs. Eur J Pharm Biopharm, 50, 179, (2000).
  • Goddereis, C., Goderis, B., Den Mooter, G.V.: Lyotropic liquid crystalline nanostructu- res of aqueous dilutions of SMEDDS revealed by small-angle X-ray scattering: Impact on solubility and drug release, Eur J Pharm Sci, 40, 110, (2010).
  • Guo, C., Wang, J., Cao, F., Lee, R. J., Zhai, G.: Lyotropic liquid crystal systems in drug delivery, Drug Discov Today, 15, 1032, (2010).
  • Bowtle, W. J., “Materials, Process, and Manufacturing Considerations for Lipid-Based Hard-Capsule Formats”, Hauss, D.J. (Ed.), Oral Lipid Based Formulations - Enhanc- ing the Bioavailability of Poorly Water Soluble Drugs, New York, Informa Healthcare, (2007), sayfa 79.
  • Muller, R.H., Runge, S., Ravelli, V., Mehnert, W., Thunemann, A.F.,Souto, E.B.: Oral bioavailability of cyclosporine: solid lipid nanoparticles (SLN) versus drug nanocrystals, Int J Pharm, 31, 82, (2006).
  • Hansen, T., Holm, P., Schultz, K.: Process characteristics and compaction of spray- dried emulsions containing a drug dissolved in lipid, Int J Pharm, 287, 55, (2004).
  • Patil, P., Joshi, P., Paradkar, A.: Effect of formulation variables on preparation and evaluation of gelled self-emulsifying drug delivery system (SEDDS) of ketoprofen, AAPS Pharm Sci Tech, 5, article 42, (2004).
  • Seo, A., Holm, P., Kristensen, H.G., Schaefer, T.: The preparation of agglomerates con- taining solid dispersions of diazepam by melt agglomeration in a high shear mixer, Int J Pharm, 259, 161, (2003).
  • Iosio, T., Voinovich, D., Grassi, M., Pinto, J.F., Perissutti, B., Zacchigna, M., Quinta- valle, U., Serdoz, F.: Bi-layered self-emulsifying pellets prepared by co-extrusion and spheronization: influence of formulation variables and preliminary study on the in vivo absorption, Eur J Pharm Biopharm, 69, 686, (2008).
  • Tang, B., Cheng, G., Gu, J.C., Xu, C.H.: Development of solid self-emulsifying drug de- livery systems: preparation techniques and dosage forms, Drug Discov Today, 13, 606, (2008).
  • Yi, T., Wan, J.L., Xu, H.B., Yang, X.L.: A new solid self-microemulsifying formulation prepared by spray-drying to improve the oral bioavailability of poorly water soluble drugs, Eur J Pharm Biopharm, 70, 439, (2008).
  • Ito, Y., Kusawake, T., Ishida, M., Tawa, R., Shibata, N.,Takada, K.: Oral solid gentami- cin preparation using emulsifier and adsorbent, J Control Release, 105, 23, (2005).
  • Agarwal, V., Siddiqui, A., Ali, H., Nazzal, S.: Dissolution and powder flow characteriza- tion of solid self-emulsified drug delivery system (SEDDS), Int J Pharm, 366, 44, (2009).
  • Fabio, C., Elisabetta, C.: Pharmaceutical composition comprising a water/oil/water double emulsion incorporated in a solid support, Patent No: EP 1 467 710, (2008).
  • Wang, Z.Y., Sun, J., Wang, Y.J., Liu, X.H., Liu, Y.H., Fu, Q., Meng, P., Zhonggui, H.: Solid self-emulsifying nitrendipine pellets: Preparation and in vitro/in vivo evaluation, Int J Pharm, 383, 1, (2010).
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  • You, J., Cui, F.D., Han, X., Wang, Y.S., Yang, L., Yu, Y.W., Li, Q. P.: Study of the preparation of sustained-release microspheres containing zedoary turmeric oil by the emulsion-solvent-diffusion method and evaluation of the self-emulsification and bioavailability of the oil, Colloid Surface B, 48, 35, (2006).
  • Attama, A.A., Nkemnele, M.O. : In vitro evaluation of drug release from self micro- emulsifying drug delivery systems using a biodegradable homolipid from Capra hircus, Int J Pharm, 304, 4, (2005).
  • Dash, A.K., Trickler, W.J., Nagvekar, A.A.: A novel nanoparticle formulation for sus- tained paclitaxel delivery, AAPS PharmSciTech, 9, 486, (2008).
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  • Chae, G.S., Lee, J.S., Kim, S.H., Seo, K.S., Kim, M.S., Lee, H.B., Khang, G..: Enhance- ment of the stability of BCNU using self-emulsifying drug deliver systems (SEDDS) and in vitro antitumor activity of self-emulsified BCNU-loaded PLGA water. Int J Pharm, 301, 6, (2005).
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  • Garcia-Fuentes, M., Prego, C., Torres, D., Alonso, M.J.: A comparative study of the po- tential of solid triglyceride nanostructures coated with chitosan or poly(ethylene glycol) as carriers for oral calcitonin delivery, Eur J Pharm Sci, 25, 133, (2005).
  • Muller, R.H., Runge, S., Ravelli, V., Mehnert, W., Thunemann, A.F., Souto, E.B.: Oral bioavailability of cyclosporine: solid lipid nanoparticles (SLN) versus drug nanocrystals, Int J Pharm, 31, 82, (2006).
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  • Holm, R., Porter, C.J., Edwards, G.A., Mullertz, A., Kristensen, H.G., Charman, W.N.: Examination of oral absorption and lymphatic transport of halofantrine in a triple-can- nulated canine model after administration in self-microemulsifying drug delivery sys- tems (SMEDDS) containing structured triglycerides, Eur J Pharm Sci, 20, 91, (2003).
  • Khoo, S.M., Shackleford, D.M., Porter, C.J., Edwards, G.A.,Charman, W.N.: Intestinal lymphatic transport of halofantrine occurs after oral administration of a unit-dose lipid-based formulation to fasted dogs, Pharm Res, 20, 1460, (2003).
  • Trevaskis, N.L., Charman, W.N.,Porter, C.J.: Lipid-based delivery systems and intes- tinal lymphatic drug transport: a mechanistic update, Adv Drug Deliv Rev, 60, 702, (2008).
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  • 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 dexibupro- fen by a novel solid Self-emulsifying drug delivery system (SEDDS), Eur J Pharm Biop- harm,72, 539, (2009).
  • Chen, Y., Li, G.,Wu, X., Chen, Z., Hang, J., Qin, B., Chen, S., Wang, R.: Self- Micro- emulsifying drug delivery system of vinpocetine: formulation Developement and in vivo assesment, Biol. Pharm. Bull, 31, 118, (2008).
Toplam 75 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Bölüm Research Article
Yazarlar

R. Neslihan Gürsoy

Özge Çevik Bu kişi benim

Yayımlanma Tarihi 1 Haziran 2011
Yayımlandığı Sayı Yıl 2011 Sayı: 2

Kaynak Göster

Vancouver Gürsoy RN, Çevik Ö. Kendiliğinden Emülsifiye Olabilen İlaç Taşıyıcı Sistemler ve Farmasötik Alanda Uygulamaları. HUJPHARM. 2011(2):151-70.