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Nifedipin-Yüklü Partiküler İlaç Tașıyıcı Sistemlere Genel Bir Bakıș

Year 2014, Issue: 2, 73 - 95, 01.06.2014

Abstract

Dihidropridin grubuna ait bir kalsiyum kanal blokeri olan nifedipin NF başlıca antianjinal ve antihipertansif etkilere sahiptir. NF’nin sudaki çözünürlüğü oldukça düşüktür ve yüksek oranda fotooksidasyona uğrar. NF’nin hemen salım yapan dozaj şekillerinin çeşitli sakıncaları ilk-geçiş etkisinden dolayı düşük oral biyoyararlanım, çoklu dozlama, plazma NF konsantrasyonunda dalgalanmalar ve hipotansiyon, taşikardi gibi yan etkiler mevcuttur. Bu derlemede, NFnin fizikokimyasal ve farmakolojik özelliklerinden kısaca bahsedildikten sonra NF’nin stabilitesi ve farmakolojik etkileri açısından sakıncalarını gidermek/iyileştirmek üzere geliştirilen partiküler ilaç taşıyıcı sistemlerle ilgili çalışmalar ele alınarak sunulmuştur.

References

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  • h t t p s : / / w w w . r s c . o r g / M e r c k - I n d e x / m o n o g r a p h / m o n o 1 5 0 0 0 0 6 6 1 3 / nifedipine?q=unauthorize (28.08.2014)
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  • Friedrich, H., Nada, A., Bodmeier, R.: Solid State and Dissolution Rate Characterization of Co-ground Mixtures of Nifedipine and Hydrophilic Carriers, Drug Dev Ind Pharm, 31, 719–728 (2005)
  • http://www.who.int/medicines/publications/essentialmedicines/en/index.html (28.08.2014)
  • Conde-Agudelo, A., Romero, R., Kusanovic, J.P.: Nifedipine in the Management of Preterm Labor: A Systematic Review and Metaanalysis, Am J Obstet Gynecol. 204(2),134.e1-20 (2011)
  • Shen, J.B., Jiang, B., Pappano, A.J.: Comparison of L-type Calcium Channel Blockade By Nifedipine and/or Cadmium in Guinea Pig Ventricular Myocytes, J Pharmacol Exp Ther, 294(2),562-570 (2000)
  • Verhoeven, F.A., Moerings, E.P., Lamers, J.M., Hennemann, G., Visser, T.J., Everts, M.E.: Inhibitory Effects of Calcium Channel Blockers on Thyroid Hormone Uptake in Neonatal Rat Cardiomyocytes, Am J Physiol Heart Circ Physiol, 281(5),H1985-1991 (2001)
  • Lipscombe, D., Helton, T.D., Xu, W.: L-type Calcium Channels: The Low Down, J Neurophysiol. 92(5), 2633-2641 (2004)
  • Sousa, C.P., Navarro, C.M., Sposto, M.R.: Clinical Assessment of Nifedipine-Induced Gingival Overgrowth in A Group of Brazilian Patients, ISRN Dent, doi: 10.5402/2011/102047 (2011)
  • Lucas, R.M., Howell, L.P., Wall, B.A.: Nifedipine-induced Gingival Hyperplasia. A Histochemical and Ultrastructural Study, J Periodontol, 56(4),211-215 (1985)
  • Fami, M.J., Ho, N.T., Mason, C.M.: Another Report of Adverse Reactions to İmmediate- Release Nifedipine, Pharmacotherapy,18(5),1133-1135 (1998)
  • Mansoor, A.F., Keefer, L.A.H.: The Dangers of Immediate-Release Nifedipine for Hypertensive Crises, CME Credit (Jefferson Medical College), 27(7), 362-365 (2002)
  • Li, H., Yan, G., Wu, S., Wang, Z., Lam, K.Y.: Numerical Simulation of Controlled Nifedipine Release From Chitosan Microgels, J Appl Polym Sci, 93, 1928-1937 (2004)
  • Fu, E., Nieh, S., Hsiao, C.T., Hsieh, Y.D., Wikesjö, U.M., Shen, E.C.: Nifedipine-Induced Gingival Overgrowth in Rats: Brief Review and Experimental Study, J Periodontol, 69, 765- 71 (1998)
  • Snider, M.E., Nuzum, D.S., Veverka A.: Long-acting Nifedipine in the Management of the Hypertensive Patient, Vasc Health Risk Manag, 4, 1249-1257 (2008)
  • http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (29.08.2014)
  • Pawar, A.P., Shelake, M.R., Bothiraja C., Kamble R.N.: Development of Photostable Gastro Retentive Formulation for Nifedipine Using Low-Density Polypropylene Microporous Particles, J Microencapsul, 29, 409–416 (2012)
  • Emara, L.H., Badr, R.M., Elbary, A.A.: Improving the Dissolution and Bioavailability of Nifedipine Using Solid Dispersions and Solubilizers, Drug Dev Ind Pharm, 28, 795–807
  • Jagdale, S.C., Jadhav, V.N., Chabukswar, A.R., Kuchekar, B.S.: Solubility Enhancement, Physicochemical Characterization and Formulation of Fast-Dissolving Tablet of Nifedipine- Betacyclodextrin Complexes, BJPS, 48(1), 131-145 (2012)
  • Lalitha, Y., Lakshmi, P.K.: Enhancement Of Dissolution of Nifedipine by Surface Solid Dispersion Technique, Int J Pharm Pharm Sci, 3(3), 41-46 (2011)
  • Annapureddy, T., Preetha, J.P., Kumar, A.N., Reddy, M.S.: Enhancement of Solubility of Nifedipine by Liquisolid Compacts Technique, IAJPR, 3(4), 3433-3465 (2013)
  • Hecq, J., Deleers, M., Fanara, D., Vranckx, H., Amighi, K.: Preparation and Characterization of Nanocrystals for Solubility and Dissolution Rate Enhancement of Nifedipine, Int J Pharm, 299, 167-177 (2005)
  • Kim, Y.I., Fluckiger, L., Hoffman, M., Lartaud-Idjouadiene, I., Atkinson, J., Maincent, P.: The Antihypertensive Effect of Orally Administered Nifedipine-Loaded Nanoparticles in Spontaneously Hypertensive Rats, Br J Pharmacol, 120(3), 399-404 (1997)
  • Aydın, A.: Preterm Eylemin Durdurulmasında Ritodrin ve Nifedipinin Tedavi Etkinliklerinin Maternal ve Fetal Etkilerinin Karşılaştırılması, Uzmanlık Tezi, İstanbul (2005)
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  • http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2934261f-3606-439e-8418- 12438aae1b2a (29.08.2014)
  • Patel, N., Polak, S., Jamei, M., Rostami-Hodjegan, A., Turner, D.B.: Quantitative Prediction of Formulation-Specific Food Effects and Their Population Variability From In Vitro Data With The Physiologically-Based ADAM Model: A Case Study Using The BCS/BDDCS Class II Drug Nifedipine, Eur J Pharm Sci, 57,240-249 (2014)
  • Lin, X., Tang, D., Du, H.: Self-assembly and Controlled Release Behaviour of The Water- İnsoluble Drug Nifedipine From Electrospun PCL-Based Polyurethane Nanofibres, J Pharm Pharmacol, 65, 673-681 (2013)
  • Gürsoy, A.Z., “Giriş”, Gürsoy, A.Z. (Ed.), Kontrollü Salım Sistemleri, İstanbul, Kontrollü Salım Sistemleri Derneği, (2002), 3.
  • Chandana, N., Gopinath, H., Bhowmik, D., Williamkeri, Thirupathi, R.A.: Modified Release Dosage Forms, JCHPS, 6(1), 13-21 (2013)
  • Kaş, H.S., “İlaç taşıyıcı partiküler sistemler”, Gürsoy, A.Z. (Ed.), Kontrollü Salım Sistemleri, İstanbul, Kontrollü Salım Sistemleri Derneği, (2002), 65-102.
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  • http://eudragit.evonik.com/product/eudragit/en/products-services/eudragit-products/ enteric-formulations/Pages/default.aspx (16.02.2015)
  • Mallick, S., Gupta, B.K., Ghosal, S.K.: Assessment of Bioavailability of Experimental Controlled Release Microcapsules of Nifedipine, Acta Pol Pharm, 57(3), 175-180 (2000)
  • Varde, N.K., Pack, D.W.: Microspheres for Controlled Release Drug Delivery, Expert Opin Biol Ther, 4(1), 35-51 (2004)
  • Chuo,W.H., Tsai, T.R., Hsu, S.H., Cham, T.M.: Preparation and In-vitro Evaluation of Nifedipine Loaded Albumin Microspheres Cross-Linked by Different Glutaraldehyde Concentrations, Int J Pharm, 144, 241–245 (1996)
  • Dhawan, S., Singla, A.K.: Nifedipine Loaded Chitosan Microspheres Prepared by Emulsification Phase-Separation, Biotech Histochem, 78, 243-254 (2003)
  • Kumbar, S.G., Aminabhavi, T.M.: Synthesis and Characterization of Modified Chitosan Microspheres: Effect of the Grafting Ratio on the Controlled Release of Nifedipine through Microspheres, J Appl Polym Sci, 89, 2940–2949 (2003)
  • Dinarvand, R., Kouchakzadeh, Z., Moghadam, S.H., Atyabi, F.: Effect of Microencapsulation on Photo-Stability of Nifedipine, Iranian J Pharm Res, 5(4), 239-244 (2006)
  • Cilurzo, F., Selmin, F., Minghetti, P., Gennari, C.G., Demartin, F., Montanari, L.: Characterization and Physical Stability of Fast-Dissolving Microparticles Containing Nifedipine, Eur J Pharm Biopharm, 68, 579–588 (2008)
  • Guyot, M., Fawaz, F.: Nifedipine Loaded-Polymeric Microspheres: Preparation and Physical Characteristics, Int J Pharm, 175, 61–74 (1998)
  • Soppimath, K.S., Kulkarni, A.R., Aminabhavi, T.M.: Encapsulation of Antihypertensive Drugs in Cellulose-Based Matrix Microspheres: Characterization and Release Kinetics of Microspheres and Tableted Microspheres, J Microencapsul, 18(3), 397-409 ( 2001)
  • Sansdrap, P., Moës, A.J.: Influence of Additives on the Release Profile of Nifedipine from Poly(DL-lactide-co-glycolide) Microspheres, J Microencapsul, 5(5), 545-553 (1998)
  • Soppimath, K.S., Aminabhavi, T.M.: Ethyl Acetate as a Dispersing Solvent in the Production of Poly(DL-lactide-co-glycolide) Microspheres: Effect of Process Parameters and Polymer Type, J Microencapsul,19(3), 281-292 (2002)
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Overview on nifedipine loaded particulate drug delivery systems

Year 2014, Issue: 2, 73 - 95, 01.06.2014

Abstract

Nifedipine NF , a dihydropyridine calcium-channel blocker, has primarily antianginal and antihypertensive effects. It is a poorly water-soluble drug and highly sensitive to photo-oxidation. The immediate release NF dosage forms have several disadvantages such as low oral bioavailability due to first-pass effect, multiple dosing fluctuations in the plasma NF concentration and adverse effects such as hypotension, tachycardia . In this review, after briefly mentioned the physicochemical and pharmacological properties of NF, the studies with regard to the particulate drug delivery systems developed to eliminate/improve the drawbacks in terms of the stability and pharmacological effect of NF were presented.

References

  • Sweetman S. Martindale: The complete drug reference, Electronic version. London, Pharmaceutical Press, 2007
  • h t t p s : / / w w w . r s c . o r g / M e r c k - I n d e x / m o n o g r a p h / m o n o 1 5 0 0 0 0 6 6 1 3 / nifedipine?q=unauthorize (28.08.2014)
  • Hayashi, K., Homma, K., Wakino, S., Tokuyama, H., Sugano, N., Saruta, T., Itoh, H.: T-type Ca Channel Blockade as a Determinant of Kidney Protection, Keio J Med, 59 (3), 84–95 (2010)
  • Friedrich, H., Nada, A., Bodmeier, R.: Solid State and Dissolution Rate Characterization of Co-ground Mixtures of Nifedipine and Hydrophilic Carriers, Drug Dev Ind Pharm, 31, 719–728 (2005)
  • http://www.who.int/medicines/publications/essentialmedicines/en/index.html (28.08.2014)
  • Conde-Agudelo, A., Romero, R., Kusanovic, J.P.: Nifedipine in the Management of Preterm Labor: A Systematic Review and Metaanalysis, Am J Obstet Gynecol. 204(2),134.e1-20 (2011)
  • Shen, J.B., Jiang, B., Pappano, A.J.: Comparison of L-type Calcium Channel Blockade By Nifedipine and/or Cadmium in Guinea Pig Ventricular Myocytes, J Pharmacol Exp Ther, 294(2),562-570 (2000)
  • Verhoeven, F.A., Moerings, E.P., Lamers, J.M., Hennemann, G., Visser, T.J., Everts, M.E.: Inhibitory Effects of Calcium Channel Blockers on Thyroid Hormone Uptake in Neonatal Rat Cardiomyocytes, Am J Physiol Heart Circ Physiol, 281(5),H1985-1991 (2001)
  • Lipscombe, D., Helton, T.D., Xu, W.: L-type Calcium Channels: The Low Down, J Neurophysiol. 92(5), 2633-2641 (2004)
  • Sousa, C.P., Navarro, C.M., Sposto, M.R.: Clinical Assessment of Nifedipine-Induced Gingival Overgrowth in A Group of Brazilian Patients, ISRN Dent, doi: 10.5402/2011/102047 (2011)
  • Lucas, R.M., Howell, L.P., Wall, B.A.: Nifedipine-induced Gingival Hyperplasia. A Histochemical and Ultrastructural Study, J Periodontol, 56(4),211-215 (1985)
  • Fami, M.J., Ho, N.T., Mason, C.M.: Another Report of Adverse Reactions to İmmediate- Release Nifedipine, Pharmacotherapy,18(5),1133-1135 (1998)
  • Mansoor, A.F., Keefer, L.A.H.: The Dangers of Immediate-Release Nifedipine for Hypertensive Crises, CME Credit (Jefferson Medical College), 27(7), 362-365 (2002)
  • Li, H., Yan, G., Wu, S., Wang, Z., Lam, K.Y.: Numerical Simulation of Controlled Nifedipine Release From Chitosan Microgels, J Appl Polym Sci, 93, 1928-1937 (2004)
  • Fu, E., Nieh, S., Hsiao, C.T., Hsieh, Y.D., Wikesjö, U.M., Shen, E.C.: Nifedipine-Induced Gingival Overgrowth in Rats: Brief Review and Experimental Study, J Periodontol, 69, 765- 71 (1998)
  • Snider, M.E., Nuzum, D.S., Veverka A.: Long-acting Nifedipine in the Management of the Hypertensive Patient, Vasc Health Risk Manag, 4, 1249-1257 (2008)
  • http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (29.08.2014)
  • Pawar, A.P., Shelake, M.R., Bothiraja C., Kamble R.N.: Development of Photostable Gastro Retentive Formulation for Nifedipine Using Low-Density Polypropylene Microporous Particles, J Microencapsul, 29, 409–416 (2012)
  • Emara, L.H., Badr, R.M., Elbary, A.A.: Improving the Dissolution and Bioavailability of Nifedipine Using Solid Dispersions and Solubilizers, Drug Dev Ind Pharm, 28, 795–807
  • Jagdale, S.C., Jadhav, V.N., Chabukswar, A.R., Kuchekar, B.S.: Solubility Enhancement, Physicochemical Characterization and Formulation of Fast-Dissolving Tablet of Nifedipine- Betacyclodextrin Complexes, BJPS, 48(1), 131-145 (2012)
  • Lalitha, Y., Lakshmi, P.K.: Enhancement Of Dissolution of Nifedipine by Surface Solid Dispersion Technique, Int J Pharm Pharm Sci, 3(3), 41-46 (2011)
  • Annapureddy, T., Preetha, J.P., Kumar, A.N., Reddy, M.S.: Enhancement of Solubility of Nifedipine by Liquisolid Compacts Technique, IAJPR, 3(4), 3433-3465 (2013)
  • Hecq, J., Deleers, M., Fanara, D., Vranckx, H., Amighi, K.: Preparation and Characterization of Nanocrystals for Solubility and Dissolution Rate Enhancement of Nifedipine, Int J Pharm, 299, 167-177 (2005)
  • Kim, Y.I., Fluckiger, L., Hoffman, M., Lartaud-Idjouadiene, I., Atkinson, J., Maincent, P.: The Antihypertensive Effect of Orally Administered Nifedipine-Loaded Nanoparticles in Spontaneously Hypertensive Rats, Br J Pharmacol, 120(3), 399-404 (1997)
  • Aydın, A.: Preterm Eylemin Durdurulmasında Ritodrin ve Nifedipinin Tedavi Etkinliklerinin Maternal ve Fetal Etkilerinin Karşılaştırılması, Uzmanlık Tezi, İstanbul (2005)
  • http://dailymed.nlm.nih.gov/dailymed/drugınfo.cfm?setid=4617417a-08df-4417- a944-dfc30de183db&cfıd=871840&cftoken=1cb8b1d12050b1e5-01802f95-b47e-e996- d69a38ae78d4dbe4 (29.08.2014)
  • http://dailymed.nlm.nih.gov/dailymed/archives/fdadrugınfo.cfm?archiveid=9958 (29.08.2014)
  • http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8ebcb33c-f43b-4b36-9f94- 9774b2a59e06 (29.08.2014)
  • http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2934261f-3606-439e-8418- 12438aae1b2a (29.08.2014)
  • Patel, N., Polak, S., Jamei, M., Rostami-Hodjegan, A., Turner, D.B.: Quantitative Prediction of Formulation-Specific Food Effects and Their Population Variability From In Vitro Data With The Physiologically-Based ADAM Model: A Case Study Using The BCS/BDDCS Class II Drug Nifedipine, Eur J Pharm Sci, 57,240-249 (2014)
  • Lin, X., Tang, D., Du, H.: Self-assembly and Controlled Release Behaviour of The Water- İnsoluble Drug Nifedipine From Electrospun PCL-Based Polyurethane Nanofibres, J Pharm Pharmacol, 65, 673-681 (2013)
  • Gürsoy, A.Z., “Giriş”, Gürsoy, A.Z. (Ed.), Kontrollü Salım Sistemleri, İstanbul, Kontrollü Salım Sistemleri Derneği, (2002), 3.
  • Chandana, N., Gopinath, H., Bhowmik, D., Williamkeri, Thirupathi, R.A.: Modified Release Dosage Forms, JCHPS, 6(1), 13-21 (2013)
  • Kaş, H.S., “İlaç taşıyıcı partiküler sistemler”, Gürsoy, A.Z. (Ed.), Kontrollü Salım Sistemleri, İstanbul, Kontrollü Salım Sistemleri Derneği, (2002), 65-102.
  • Li, D.X., Kim, J.O., Oh, D.H., Lee, W.S., Hong, M.J., Kang, J.Y., Choi, J.S., Woo, J.S., Yong, C.S., Choi, H.G.: Development of Nifedipine-Loaded Coated Gelatin Microcapsule as a Long Acting Oral Delivery, Arch Pharm Res, 32(1), 127-132 ( 2009)
  • http://eudragit.evonik.com/product/eudragit/en/products-services/eudragit-products/ enteric-formulations/Pages/default.aspx (16.02.2015)
  • Mallick, S., Gupta, B.K., Ghosal, S.K.: Assessment of Bioavailability of Experimental Controlled Release Microcapsules of Nifedipine, Acta Pol Pharm, 57(3), 175-180 (2000)
  • Varde, N.K., Pack, D.W.: Microspheres for Controlled Release Drug Delivery, Expert Opin Biol Ther, 4(1), 35-51 (2004)
  • Chuo,W.H., Tsai, T.R., Hsu, S.H., Cham, T.M.: Preparation and In-vitro Evaluation of Nifedipine Loaded Albumin Microspheres Cross-Linked by Different Glutaraldehyde Concentrations, Int J Pharm, 144, 241–245 (1996)
  • Dhawan, S., Singla, A.K.: Nifedipine Loaded Chitosan Microspheres Prepared by Emulsification Phase-Separation, Biotech Histochem, 78, 243-254 (2003)
  • Kumbar, S.G., Aminabhavi, T.M.: Synthesis and Characterization of Modified Chitosan Microspheres: Effect of the Grafting Ratio on the Controlled Release of Nifedipine through Microspheres, J Appl Polym Sci, 89, 2940–2949 (2003)
  • Dinarvand, R., Kouchakzadeh, Z., Moghadam, S.H., Atyabi, F.: Effect of Microencapsulation on Photo-Stability of Nifedipine, Iranian J Pharm Res, 5(4), 239-244 (2006)
  • Cilurzo, F., Selmin, F., Minghetti, P., Gennari, C.G., Demartin, F., Montanari, L.: Characterization and Physical Stability of Fast-Dissolving Microparticles Containing Nifedipine, Eur J Pharm Biopharm, 68, 579–588 (2008)
  • Guyot, M., Fawaz, F.: Nifedipine Loaded-Polymeric Microspheres: Preparation and Physical Characteristics, Int J Pharm, 175, 61–74 (1998)
  • Soppimath, K.S., Kulkarni, A.R., Aminabhavi, T.M.: Encapsulation of Antihypertensive Drugs in Cellulose-Based Matrix Microspheres: Characterization and Release Kinetics of Microspheres and Tableted Microspheres, J Microencapsul, 18(3), 397-409 ( 2001)
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There are 63 citations in total.

Details

Primary Language Turkish
Journal Section Research Article
Authors

Emrah Özakar This is me

Evren Alğın Yapar This is me

Meltem Çetin This is me

Publication Date June 1, 2014
Published in Issue Year 2014 Issue: 2

Cite

Vancouver Özakar E, Yapar EA, Çetin M. Nifedipin-Yüklü Partiküler İlaç Tașıyıcı Sistemlere Genel Bir Bakıș. HUJPHARM. 2014(2):73-95.