In Vivo Immunomodulatory, Cumulative Skin Irritation, Sensitization and Effect of d-Limonene on Permeation of 6-Mercaptopurine through Transdermal Drug Delivery
Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz di...
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| Published in | Biological & Pharmaceutical Bulletin Vol. 31; no. 4; pp. 656 - 661 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
The Pharmaceutical Society of Japan
01.04.2008
Pharmaceutical Society of Japan Japan Science and Technology Agency |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0918-6158 1347-5215 |
| DOI | 10.1248/bpb.31.656 |
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| Abstract | Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43±12.2 μg/cm2h (control) to 162.8±32.2 μg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35±9.3 min compared to control of 90 ±15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 μmol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3×106 cells/femur and α-esterase positive cells of 1259±328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. |
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| AbstractList | Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mer-captopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43±12.2μg/cm2h (control) to 162.8±32.2μg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35±9.3 min compared to control of 90±15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100μmol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3×106 cells/femur and α-esterase positive cells of 1259±328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43±12.2 μg/cm2h (control) to 162.8±32.2 μg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35±9.3 min compared to control of 90 ±15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 μmol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3×106 cells/femur and α-esterase positive cells of 1259±328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6- mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43+/-12.2 mu g/cm super(2)h (control) to 162.8+/-32.2 mu g/cm super(2)h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35+/-9.3 min compared to control of 90 +/-15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 mu mol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3x10 super(6) cells/femur and alpha-esterase positive cells of 1259+/-328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d- Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43+/-12.2 microg/cm2h (control) to 162.8+/-32.2 microg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35+/-9.3 min compared to control of 90 +/-15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 mumol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3 x 10(6) cells/femur and alpha-esterase positive cells of 1259+/-328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery.Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43+/-12.2 microg/cm2h (control) to 162.8+/-32.2 microg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35+/-9.3 min compared to control of 90 +/-15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 mumol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3 x 10(6) cells/femur and alpha-esterase positive cells of 1259+/-328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. Using skin as a port for systemic drug administration, transdermal drug delivery has expanded greatly over the last two decades. Our aim was to formulate the single layer drug-in-adhesive transdermal patch for 6-mercaptopurine (6-MP). In vitro permeation study was carried out using modified Franz diffusion cell with and without of different concentration of d-limonene in human cadaver skin. In vivo immunomodulatory was carried out in mice, cumulative skin irritation, sensitization and patch adherence study was done in both mice and human subjects. 6-MP flux increased from 43+/-12.2 microg/cm2h (control) to 162.8+/-32.2 microg/cm2h (6% w/v d-limonene) data was significant (p<0.05), with decrease in the lag time to 35+/-9.3 min compared to control of 90 +/-15.3 min. In vivo immunomodulatory effect was shown in the Balb/c mice with 100 mumol/kg/body wt of animal for 5d (one dose/d) of d-limonene. WBC count of 13469 cells/mm peak was observed on 12th day, bone marrow cells of 26.3 x 10(6) cells/femur and alpha-esterase positive cells of 1259+/-328.4 cells/4000 bone marrow cells. Cumulative skin irritation, sensitisation and patch adherence in animals and human subjects showed no skin irritation and sensitization. Patch adhesion was greater than 90.0% respectively in both human subjects and mice. The percentage of human subjects with adhesive residue was significantly less with scores of zero. d-Limonene proved as good chemical enhancer by increasing in the skin permeability with shortened the lag time. It proved that therapeutic amount of 6-MP can be delivered through transdermal drug delivery. |
| Author | Chandrashekar, N. S. Hiremath, Shobha Rani Rajeev |
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| CitedBy_id | crossref_primary_10_1007_s10298_015_1014_3 crossref_primary_10_1111_j_1468_2494_2012_00725_x crossref_primary_10_1038_jes_2016_68 crossref_primary_10_1080_03639045_2023_2204374 crossref_primary_10_1016_j_ijpharm_2020_119073 |
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| References | 13) Timmer A., McDonald J. W., Macdonald J. K., Cochrane Database Syst. Rev., 24, 478 (2007). 21) Aqil M., Ali A., Sultana Y., Najmi A. K., Pharmazie, 59, 631—635 (2004). 11) Millard-Salin D. G., Becourt P., Couarraze G., Int. J. Pharm., 200, 121—126 (2000). 31) Raphael T. J., Kuttan G., J. Exp. Clin. Cancer Res., 22, 419—424 (2003). 6) Lim Chye P. F., Liu X. Y., Kang L., Paul Lui Ho P. C., Chan Y. W., Chan S. Y., Int. J. Pharm., 311, 157—164 (2006). 28) Krishnaiah Y. S. R., Satyanarayana V., Bhaskar P., Pharmazie, 57, 842—847 (2002). 24) Zhao K., Singh J., J. Controlled Release, 55, 253—260 (1988). 17) Cuffari C., Hunt S., Bayless T. M., Alim. Pharmacol. Therap., 14, 1009—1014 (2000). 23) Moghimi H. R., Williams A. C., Barry B. W., Int. J. Pharm., 146, 41—54 (1997). 18) Romagnuolo J., Sadowski D. C., Lalor E., Jewell L., Thomson A. B., Can. J. Gastroenterol., 12, 479—483 (1988). 12) Dimas D. A., Dallas P. P., Rekkas D. M., Choulis N. H., AAPS Pharm. Sci. Tech., 1, 1—8 (2000). 29) Barry B. W., J. Control. Release, 15, 237—248 (1991). 25) Cornwell P. A., Barry B. W., Stoddart C. P., Bouwstra J. A., J. Pharm. Pharmcol., 46, 938—950 (1944). 20) Kligman A. M., Christophers E., Arch. Dermatol., 88, 70—73 (1963). 9) Minghetti P., Cilurzo F., Tosi L., Asiraghi A., Montanari L., AAPS Pharm. Sci. Tech., 4, 1—8 (2003). 1) Prausnitz M. R., Mitragotri S., Langer R., Nat. Rev. Drug Discovery, 3, 115—124 (2004). 32) Crowell P. L., Gould M. N., Crit. Rev. Oncol., 5, 1—22 (1994). 30) Ohara N., Takayama K., Machida Y., Nagai T., Int. J. Pharm., 105, 31—38 (1994). 4) Gupta P., Garg S., Pharm. Technol., 26, 144—161 (2002). 16) Sparrow M. P., Hande S. A., Friedman S., Cao D., Hanauer S. B., Clin. Gastroenterol. Hepatol., 5, 209—214 (2007). 27) Hashida M., Yamashita F., “Percutaneous Penetration Enhancers,” ed. by Smith E. W., Maibach H. I., CRC Press, Florida, 1995, pp. 309—321. 22) Su M. H., Lee L. H., Addel G. H., Earl K. R., William H. I., Drug Dev. Ind. Pharm., 20, 685—718 (1994). 7) Barry B. W., Nat. Biotechnol., 22, 165—167 (2004). 14) Nguyen G. C., Harris M. L., Dassopoulos T., Curr. Gastroenterol. Rep., 8, 499—450 (2006). 26) Williams A. C., Barry B. W., Adv. Drug Deliv., 56, 603—618 (2004). 3) Henningfield J. E., N. Engl. J. Med., 333, 1196—1203 (1995). 10) Kim J. H., Lee C. H., Choi H. K., Drug Dev. Ind. Pham., 28, 833—839 (2002). 15) Shullenberger C. C., Cancer Chemother. Rep., 16, 251—252 (1962). 2) Finnin B. C., Morgan T. M., J. Pharm. Sci., 88, 955—958 (1999). 5) Prausnitz M. R., Nat. Biotech., 24, 416—417 (2006). 8) Vyas S. P., Roop K. K., “Controlled Drug Delivery Concepts and Advances,” Vallabh Prakashan, New Delhi, 2002. 19) Murthy S. N., Shobha Rani R. H., AAPS Pharm. Sci. Tech., 2, 1—5 (2001). 22 23 Lim Chye P. F., Liu X. Y., Kang L. (6) 2006; 311 Prausnitz M. R., Mitragotri S., Lan (1) 2004; 3 26 Crowell P. L., Gould M. N. (32) 1994; 5 Murthy S. N., Shobha Rani R. H. (19) 2001; 2 Gupta P., Garg S. (4) 2002; 26 29 Cuffari C., Hunt S., Bayless T. M. (17) 2000; 14 RAPHAEL T J (31) 2003; 22 Krishnaiah Y. S. R., Satyanarayana (28) 2002; 57 Dimas D. A., Dallas P. P., Rekkas D (12) 2000; 1 Kligman A. M., Christophers E. (20) 1963; 88 Aqil M., Ali A., Sultana Y., Najmi (21) 2004; 59 30 11 Barry B. W. (7) 2004; 22 Kim J. H., Lee C. H., Choi H. K. (10) 2002; 28 Cornwell P. A., Barry B. W., Stodda (25) 1944; 46 Minghetti P., Cilurzo F., Tosi L. (9) 2003; 4 Hashida M., Yamashita F. (27) 1995 2 3 Timmer A., McDonald J. W., Macdonal (13) 2007; 24 Prausnitz M. R. (5) 2006; 24 Romagnuolo J., Sadowski D. C., Lalo (18) 1988; 12 Shullenberger C. C. (15) 1962; 16 Zhao K., Singh J. (24) 1988; 55 8 Nguyen G. C., Harris M. L., Dassopo (14) 2006; 8 Sparrow M. P., Hande S. A., Friedma (16) 2007; 5 |
| References_xml | – reference: 12) Dimas D. A., Dallas P. P., Rekkas D. M., Choulis N. H., AAPS Pharm. Sci. Tech., 1, 1—8 (2000). – reference: 30) Ohara N., Takayama K., Machida Y., Nagai T., Int. J. Pharm., 105, 31—38 (1994). – reference: 19) Murthy S. N., Shobha Rani R. H., AAPS Pharm. Sci. Tech., 2, 1—5 (2001). – reference: 27) Hashida M., Yamashita F., “Percutaneous Penetration Enhancers,” ed. by Smith E. W., Maibach H. I., CRC Press, Florida, 1995, pp. 309—321. – reference: 10) Kim J. H., Lee C. H., Choi H. K., Drug Dev. Ind. Pham., 28, 833—839 (2002). – reference: 3) Henningfield J. E., N. Engl. J. Med., 333, 1196—1203 (1995). – reference: 25) Cornwell P. A., Barry B. W., Stoddart C. P., Bouwstra J. A., J. Pharm. Pharmcol., 46, 938—950 (1944). – reference: 29) Barry B. W., J. Control. Release, 15, 237—248 (1991). – reference: 13) Timmer A., McDonald J. W., Macdonald J. K., Cochrane Database Syst. Rev., 24, 478 (2007). – reference: 1) Prausnitz M. 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| SubjectTerms | 6-mercaptopurine Administration, Cutaneous Animals Blood Cell Count Bone Marrow Cells - drug effects Cell Membrane - drug effects Cell Membrane - metabolism Chemical Phenomena Chemistry, Physical Cyclohexenes - adverse effects Cyclohexenes - pharmacology d-limonene Diffusion Chambers, Culture Humans immunomodulatory Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - adverse effects Immunosuppressive Agents - pharmacology In Vitro Techniques Irritants - pharmacology Limonene Mercaptopurine - administration & dosage Mercaptopurine - adverse effects Mercaptopurine - pharmacology Mice Mice, Inbred BALB C Skin - pathology Skin Absorption - drug effects Terpenes - adverse effects Terpenes - pharmacology transdermal |
| Title | In Vivo Immunomodulatory, Cumulative Skin Irritation, Sensitization and Effect of d-Limonene on Permeation of 6-Mercaptopurine through Transdermal Drug Delivery |
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