EVALUATION OF TRACK ETCH MEMBRANE AS A SURROGATE FOR EX-VIVO DRUG PERMEATION STUDIES
Abstract
The track etch membranes has attracted the attention of researchers, as a kind of novel material, for their various applications such as precise separation of biological cells, detection of biomolecules and controlled drug release, especially for pharmaceutical and biomedical applications. In the present study, the efficacy of track etch membrane over goat skin for the Ex-vivo permeation of silver sulfadiazine gel has been investigated with the objective to evaluate track etch membrane as a surrogate for biological membrane owing to ethical issues and scarce availability of biological skins. The percent cumulative drug release from silver sulfadiazine gel using track etch membrane and goat skin were obtained as 18.18 % and 20.99 % respectively. The results obtained from track etch membrane and goat skin was similar with only a slight difference in percent drug diffusion which might be because of the lipids present in animal skin. Track etch membrane has the potential to mimic the animal skin for such ex-vivo drug diffusion studies with certain additional advantages such as sufficient mechanical strength and ruggedness. It can be efficiently reused and also surpasses the ethical issues involved with the use of biological membrane.
Keywords:
Carbopol, Diffusion, Silver Sulfadiazine, Track-etch membraneDOI
https://doi.org/10.25004/IJPSDR.2014.060303References
1. Shiow-Fern NG, Jennifer JR, Francis DS, Gillian ME. The Relevance of Polymeric Synthetic Membranes in Topical Formulation Assessment and Drug Diffusion Study. Arch. Pharm. Res. 2012; 35(4): 579-593.
2. Martinez M, Rathbone M, Burgess D, Huynh M. In vitro and In vivo Considerations Associated with Parenteral Sustained Release Products: A Review Based upon Information Presented and Points Expressed At the 2007 Controlled Release Society Annual Meeting. J. Control. Release 2008; 129 (2): 79-87.
3. Rathbone MJ, Martinez MN, Huynh M, Burgess DJ. CPS/AAPS Joint Workshop on Critical Variables in the In vitro and In vivo Performance of Parenteral Sustained-Release Products. Dissolution Technol. 2009; 16 (2): 55-56.
4. Franz TJ. Percutaneous Absorption. On The Relevance of In vitro Data. J. Invest. Dermatol. 1975; 64: 190-195.
5. Franz TJ. The Finite Dose Technique as a Valid In vitro Model for the Study of Percutaneous Absorption. Curr. Probl. Dermatol. 1978; 7: 58-68.
6. Zorin S, Kuylenstierna F, Thulin H. In vitro Test of Nicotine's Permeability through Human Skin-Risk Evaluation and Safety Aspects. Am. Occup. Hyg. 1999; 43: 405-413.
7. Siewert M, Dressman J, Brown CK, Shah VP. FIP/AAPS Guidelines to Dissolution/in vitro Release Testing of Novel/Special Dosage Forms. AAPS Pharm Sci. Tech. 2003; 4: Article 7.
8. Shah V, Elkins J, Williams R. Evaluation of the Test System Used For In vitro Release of Drugs For Topical Dermatological Drug Products. Pharm. Dev. Technol. 1999; 4: 377-385.
9. Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibach H, Marques M, Rytting H, Shaw S, Thakker K, Yacobi A. Topical and Transdermal Drug Products. Pharmacopeial Forum 2009; 35(3): 750-764.
10. Farinha A, Toscano C, Campos R, Bica A, Hadgraft J. Permeation of Naproxen from Saturated Solutions and Commercial Formulations through Synthetic Membranes. Drug Dev Ind Pharm. 2003; 29: 489-94.
11. Shah V, Elkins J, Lam S, Skelly J. Determination of In Vitro Drug Release from Hydrocortisone Creams. Int J Pharm. 1989; 53: 53-59.
12. Twist JN, Zatz JL. Influence of Solvents on Paraben Permeation through Idealized Skin Model Membranes. J. Soc. Cosmet. Chem. 1986; 37: 429-444.
13. Twist J, Zatz J. Membrane - Solvent - Solute Interaction in a Model Permeation System. J. Pharm. Sci. 1988; 77: 538-540.
14. Corbo M, Schultz TW, Wong GK, Van Buskirk GA. Development and Validation of In Vitro Release Testing Methods for Semisolid Formulations. Pharm. Tech. 1993; 9: 112-128.
15. Shiow-Fern NG, Jennifer R, Sanderson D, Eccleston, A Comparative Study of Transmembrane Diffusion and Permeation of Ibuprofen across Synthetic Membranes Using Franz Diffusion Cells. Pharmaceutics 2010; 2: 209-223.
16. Ulbricht M. Advanced Functional Polymer Membranes. Polymer 2006; 47: 2217-2262.
17. FDA-SUPAC-SS. Guidance for Industry. SUPAC-SS Non-sterile Semisolid Dosage Forms. Scale-up and Post approval Changes: Chemistry, Manufacturing and Controls. In vitro Release Testing and In Vivo Bioequivalence Documentation 1997; 19-24.
18. Wu ST, Shiu GK, Simmons JE, Bronaugh RL, Skelly JP. In Vitro Release of Nitroglycerin from Topical Products by Use of Artificial Membranes. J. Pharm. Sci. 1992; 81: 1153-1156.
19. Gallagher SJ, Trottet L, Carter TP, Heard CM. Effects of Membrane Type and Liquid/Liquid Phase Boundary on In Vitro Release of Ketoprofen from Gel Formulations. J. Drug target. 2003; 11: 373-379.
20. Clement P, Laugel C, Marty JP. Influence of Three Synthetic Membranes on the Release of Caffeine from Concentrated W/O Emulsions. J. Control Release 2000; 66: 243-254.
21. Dias M, Raghavan SL, Hadgraft J. ATR-FTIR Spectroscopic Investigation on The Effect of Solvents on The Permeation of Benzoic Acid and Salicylic Acid Through Silicone Membranes. Int. J. Pharm. 2001; 216: 51-59.
22. Friend D, Catz P, Heller J, Okagaki M. Transdermal Delivery of Levonorgestrel IV: Evaluation of Membranes. J. Pharm. Sci. 1989; 78: 477-481.
23. Proniuk S, Dixon SE, Blanchard J. Investigation of the Utility of an In vitro Release Test for Optimizing Semisolid Dosage Forms. Pharm. Dev. Technol. 2001; 6: 469-476.
24. Santoyo S, Arrelano A, Ygartua P, Martin C. In vitro Percutaneous Absorption of Piroxicam through Synthetic Membranes and Abdominal Rat Skin. Pharm. Acta. Helv. 1996; 71: 141-146.
25. Schwarb FP, Imanidis G, Smith EW, Haigh JM, Surber C. Effect of Concentration and Degree of Saturation of Topical Fluocinonide Formulations on In vitro Membrane Transport and In Vivo Availability on Human Skin. Pharm. Res. 1999; 16: 909-915.
26. Smith EW, Haigh JM. In vitro Diffusion Cell Design and Validation II: Temperature, Agitation and Membrane Effects on Betamethasone 17-Valerate Permeation. Acta. Pharm. Nord. 1992; 4: 171-178.
27. Thakker KD, Chern H. Development and Validation of In Vitro Release Tests for Semisolid Dosage Forms - Case Study. Disso. Tech. 2003; 10: 10-15.
28. Welin-Berger K, Neelissen JAM, Bergenstahl B. The Effect of Rheological Behaviour of A Topical Anaesthetic Formulation on The Release and Permeation Rates of The Active Compound. Eur. J. Pharm. Sci. 2001; 13: 309-318.
29. Fleischer R, Price P, Walker R. Nuclear Tracks in Solids: Principles and Applications: University of California Press, Berkeley, 1975.
30. Ferain E, Legras R. Heavy Ion Tracks in Polycarbonate. Radiation Effects and Defects in Solids 1993; 126(1-4): 243-246.
31. Apel P. Track Etching Technique in Membrane Technology. Radiation Measurements 2001; 34(1-6): 559-566.
32. Trautmann C, Brueckle W, Sophr R, Vetter J, Angert N. Pore Geometry of Etched Ion Tracks In Polyimide. Nucl. Instr. and Meth. Phys. Res. B. 1996a; 111: 70-74.
33. Chakarvarti SK. Track-Etch Membranes As Templates Enabled Nano/Micro Technology: A Review. Indian J. Phys. 2009; 83(6): 737-749.
34. Ferain E, Legras R. Pore Shape Control in Nanoporous Particle Track Etched Membrane. Nucl. Instr. and Meth. Phys. Res B. 2001; 174: 116-122.
35. Karim S, Ensinger W, Mujahid SA, Maaz K, Khan EU. Effect of Etching Conditions on Pore Shape in Etched Ion-Track Polycarbonate Membranes. Radiation Measurements 2009; 44(9-10): 779-782.
36. Garg R, Kumar V, Kumar D, Chakarvarti SK. Electrical Transport Through Micro Porous Track Etch Membranes of Same Porosity. Mod. Phys. Lett. B. 2012; 26(31): 12502091-12502097.
37. Quinn JA, Anderson JL, Ho WS, Petzny WJ. Model Pores of Molecular Dimension- The Preparation and Characterization of Track- Etched Membranes. Biophys J. 1972; 12(8): 990-1007.
38. Bashford CL. Membrane Pores- from Biology to Track-Etched Membranes. Bioscience Reports. 1995; 15(6): 553-565.
39. Kumar S, Zagorski DL, Kumar S, Chakarvarti SK. Chemical Synthesis of Polypyrrole Nano/Microstructures using Track Etch Membranes. J. Mater Sci. 2004; 39: 6137 – 6139.
40. Sanjeev K, Chakarvarti SK. Chemical Synthesis of Agcl Microstructures Using Etched Ion Track Polycarbonate Membranes. Synthesis and Reactivity in Inorganic, Metal-Organic, And Nano-Metal Chemistry 2012; 42: 1242-1245.
41. Kumar S, Chakarvarti SK. Electrodeposition of Copper Nanowires in Ion-Crafted Membranes as Templates. Dig. J. of Nanomater Bios. 2006; 1(4): 139-143.
42. Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic Modeling on Drug Release from Controlled Drug Delivery Systems. Acta Poloniae Pharmaceutica- Drug Research 2010; 67: 217-223.
2. Martinez M, Rathbone M, Burgess D, Huynh M. In vitro and In vivo Considerations Associated with Parenteral Sustained Release Products: A Review Based upon Information Presented and Points Expressed At the 2007 Controlled Release Society Annual Meeting. J. Control. Release 2008; 129 (2): 79-87.
3. Rathbone MJ, Martinez MN, Huynh M, Burgess DJ. CPS/AAPS Joint Workshop on Critical Variables in the In vitro and In vivo Performance of Parenteral Sustained-Release Products. Dissolution Technol. 2009; 16 (2): 55-56.
4. Franz TJ. Percutaneous Absorption. On The Relevance of In vitro Data. J. Invest. Dermatol. 1975; 64: 190-195.
5. Franz TJ. The Finite Dose Technique as a Valid In vitro Model for the Study of Percutaneous Absorption. Curr. Probl. Dermatol. 1978; 7: 58-68.
6. Zorin S, Kuylenstierna F, Thulin H. In vitro Test of Nicotine's Permeability through Human Skin-Risk Evaluation and Safety Aspects. Am. Occup. Hyg. 1999; 43: 405-413.
7. Siewert M, Dressman J, Brown CK, Shah VP. FIP/AAPS Guidelines to Dissolution/in vitro Release Testing of Novel/Special Dosage Forms. AAPS Pharm Sci. Tech. 2003; 4: Article 7.
8. Shah V, Elkins J, Williams R. Evaluation of the Test System Used For In vitro Release of Drugs For Topical Dermatological Drug Products. Pharm. Dev. Technol. 1999; 4: 377-385.
9. Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibach H, Marques M, Rytting H, Shaw S, Thakker K, Yacobi A. Topical and Transdermal Drug Products. Pharmacopeial Forum 2009; 35(3): 750-764.
10. Farinha A, Toscano C, Campos R, Bica A, Hadgraft J. Permeation of Naproxen from Saturated Solutions and Commercial Formulations through Synthetic Membranes. Drug Dev Ind Pharm. 2003; 29: 489-94.
11. Shah V, Elkins J, Lam S, Skelly J. Determination of In Vitro Drug Release from Hydrocortisone Creams. Int J Pharm. 1989; 53: 53-59.
12. Twist JN, Zatz JL. Influence of Solvents on Paraben Permeation through Idealized Skin Model Membranes. J. Soc. Cosmet. Chem. 1986; 37: 429-444.
13. Twist J, Zatz J. Membrane - Solvent - Solute Interaction in a Model Permeation System. J. Pharm. Sci. 1988; 77: 538-540.
14. Corbo M, Schultz TW, Wong GK, Van Buskirk GA. Development and Validation of In Vitro Release Testing Methods for Semisolid Formulations. Pharm. Tech. 1993; 9: 112-128.
15. Shiow-Fern NG, Jennifer R, Sanderson D, Eccleston, A Comparative Study of Transmembrane Diffusion and Permeation of Ibuprofen across Synthetic Membranes Using Franz Diffusion Cells. Pharmaceutics 2010; 2: 209-223.
16. Ulbricht M. Advanced Functional Polymer Membranes. Polymer 2006; 47: 2217-2262.
17. FDA-SUPAC-SS. Guidance for Industry. SUPAC-SS Non-sterile Semisolid Dosage Forms. Scale-up and Post approval Changes: Chemistry, Manufacturing and Controls. In vitro Release Testing and In Vivo Bioequivalence Documentation 1997; 19-24.
18. Wu ST, Shiu GK, Simmons JE, Bronaugh RL, Skelly JP. In Vitro Release of Nitroglycerin from Topical Products by Use of Artificial Membranes. J. Pharm. Sci. 1992; 81: 1153-1156.
19. Gallagher SJ, Trottet L, Carter TP, Heard CM. Effects of Membrane Type and Liquid/Liquid Phase Boundary on In Vitro Release of Ketoprofen from Gel Formulations. J. Drug target. 2003; 11: 373-379.
20. Clement P, Laugel C, Marty JP. Influence of Three Synthetic Membranes on the Release of Caffeine from Concentrated W/O Emulsions. J. Control Release 2000; 66: 243-254.
21. Dias M, Raghavan SL, Hadgraft J. ATR-FTIR Spectroscopic Investigation on The Effect of Solvents on The Permeation of Benzoic Acid and Salicylic Acid Through Silicone Membranes. Int. J. Pharm. 2001; 216: 51-59.
22. Friend D, Catz P, Heller J, Okagaki M. Transdermal Delivery of Levonorgestrel IV: Evaluation of Membranes. J. Pharm. Sci. 1989; 78: 477-481.
23. Proniuk S, Dixon SE, Blanchard J. Investigation of the Utility of an In vitro Release Test for Optimizing Semisolid Dosage Forms. Pharm. Dev. Technol. 2001; 6: 469-476.
24. Santoyo S, Arrelano A, Ygartua P, Martin C. In vitro Percutaneous Absorption of Piroxicam through Synthetic Membranes and Abdominal Rat Skin. Pharm. Acta. Helv. 1996; 71: 141-146.
25. Schwarb FP, Imanidis G, Smith EW, Haigh JM, Surber C. Effect of Concentration and Degree of Saturation of Topical Fluocinonide Formulations on In vitro Membrane Transport and In Vivo Availability on Human Skin. Pharm. Res. 1999; 16: 909-915.
26. Smith EW, Haigh JM. In vitro Diffusion Cell Design and Validation II: Temperature, Agitation and Membrane Effects on Betamethasone 17-Valerate Permeation. Acta. Pharm. Nord. 1992; 4: 171-178.
27. Thakker KD, Chern H. Development and Validation of In Vitro Release Tests for Semisolid Dosage Forms - Case Study. Disso. Tech. 2003; 10: 10-15.
28. Welin-Berger K, Neelissen JAM, Bergenstahl B. The Effect of Rheological Behaviour of A Topical Anaesthetic Formulation on The Release and Permeation Rates of The Active Compound. Eur. J. Pharm. Sci. 2001; 13: 309-318.
29. Fleischer R, Price P, Walker R. Nuclear Tracks in Solids: Principles and Applications: University of California Press, Berkeley, 1975.
30. Ferain E, Legras R. Heavy Ion Tracks in Polycarbonate. Radiation Effects and Defects in Solids 1993; 126(1-4): 243-246.
31. Apel P. Track Etching Technique in Membrane Technology. Radiation Measurements 2001; 34(1-6): 559-566.
32. Trautmann C, Brueckle W, Sophr R, Vetter J, Angert N. Pore Geometry of Etched Ion Tracks In Polyimide. Nucl. Instr. and Meth. Phys. Res. B. 1996a; 111: 70-74.
33. Chakarvarti SK. Track-Etch Membranes As Templates Enabled Nano/Micro Technology: A Review. Indian J. Phys. 2009; 83(6): 737-749.
34. Ferain E, Legras R. Pore Shape Control in Nanoporous Particle Track Etched Membrane. Nucl. Instr. and Meth. Phys. Res B. 2001; 174: 116-122.
35. Karim S, Ensinger W, Mujahid SA, Maaz K, Khan EU. Effect of Etching Conditions on Pore Shape in Etched Ion-Track Polycarbonate Membranes. Radiation Measurements 2009; 44(9-10): 779-782.
36. Garg R, Kumar V, Kumar D, Chakarvarti SK. Electrical Transport Through Micro Porous Track Etch Membranes of Same Porosity. Mod. Phys. Lett. B. 2012; 26(31): 12502091-12502097.
37. Quinn JA, Anderson JL, Ho WS, Petzny WJ. Model Pores of Molecular Dimension- The Preparation and Characterization of Track- Etched Membranes. Biophys J. 1972; 12(8): 990-1007.
38. Bashford CL. Membrane Pores- from Biology to Track-Etched Membranes. Bioscience Reports. 1995; 15(6): 553-565.
39. Kumar S, Zagorski DL, Kumar S, Chakarvarti SK. Chemical Synthesis of Polypyrrole Nano/Microstructures using Track Etch Membranes. J. Mater Sci. 2004; 39: 6137 – 6139.
40. Sanjeev K, Chakarvarti SK. Chemical Synthesis of Agcl Microstructures Using Etched Ion Track Polycarbonate Membranes. Synthesis and Reactivity in Inorganic, Metal-Organic, And Nano-Metal Chemistry 2012; 42: 1242-1245.
41. Kumar S, Chakarvarti SK. Electrodeposition of Copper Nanowires in Ion-Crafted Membranes as Templates. Dig. J. of Nanomater Bios. 2006; 1(4): 139-143.
42. Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic Modeling on Drug Release from Controlled Drug Delivery Systems. Acta Poloniae Pharmaceutica- Drug Research 2010; 67: 217-223.
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01-07-2014
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“EVALUATION OF TRACK ETCH MEMBRANE AS A SURROGATE FOR EX-VIVO DRUG PERMEATION STUDIES”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 3, July 2014, pp. 189-92, https://doi.org/10.25004/IJPSDR.2014.060303.
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How to Cite
“EVALUATION OF TRACK ETCH MEMBRANE AS A SURROGATE FOR EX-VIVO DRUG PERMEATION STUDIES”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 6, no. 3, July 2014, pp. 189-92, https://doi.org/10.25004/IJPSDR.2014.060303.
