Biodegradable microspheres for protein delivery

Journal of Controlled Release

Volumn 90, Issue 3, 2003, Pages 261-280

  Sinha, V R ^a   Trehan, Aman ^a  

^a PANJAB UNIVERSITY   (India)

Author keywords

Delivery systems; Microspheres; Protein stability

Indexed keywords

BIODEGRADATION; BLOOD; CONTROLLED DRUG DELIVERY; TISSUE;

BIODEGRADABLE MICROSPHERES;

PROTEINS;

ASPARAGINASE MACROGOL; BETA LACTOGLOBULIN; CALCITONIN; CHOLERA VACCINE; DIPHTHERIA VACCINE; DRUG CARRIER; ENKEPHALIN; EYE OINTMENT; GLUCAGON; GONADORELIN; GOSERELIN; GROWTH HORMONE; HUMAN GROWTH HORMONE; INSULIN; JAPANESE ENCEPHALITIS VACCINE; LEUPRORELIN; MICROSPHERE; OCTREOTIDE; PEGADEMASE; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; POSILAC; PROLINE DIPEPTIDASE; PROTEIN; PROTIRELIN; RECOMBINANT ALPHA2 INTERFERON; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; STREPTOCOCCUS VACCINE; TETANUS TOXOID; TRIPTORELIN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VACCINE;

BIODEGRADABILITY; DERIVATIZATION; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUSTRY; DRUG MARKETING; DRUG STABILITY; EXCIPIENT COMPATIBILITY; GEL; OINTMENT; PRIORITY JOURNAL; PROTEIN DEGRADATION; PROTEIN STABILITY; PULSATILE DRUG RELEASE; REVIEW; SLOW DRUG RELEASE; SLOW RELEASE FORMULATION;

EID: 0038445582     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-3659(03)00194-9     Document Type: Review

References (111)

1. Cohen S., Yoshioka T., Lucarelli M., Hwang L.H., Langer R. Controlled delivery systems for proteins based on poly(lactic/glycolic acid) microspheres. Pharm. Res. 8:1991;713-720.
2. Banga A.K., Chien Y.W. Systemic delivery of therapeutic peptides and proteins. Int. J. Pharm. 48:1988;15-50.
3. Lee V.H.L. Ophthalmic delivery of peptides and proteins. Pharm. Technol. 11:1987;26-38.
4. Shire S.J. Formulation design of protein pharmaceuticals. Pharm. Technol. 11:1987;34-40.
5. Lee V.H.L. Peptide and protein drug delivery: opportunities and challenges. Pharm. Int. 7:1986;208-212.
6. Tice T.R., Mason D.W., Gilley R.M. Prescott L.F., Nimmo W.W. Novel Drug Delivery Systems and its Therapeutic Applications. 1989;223-224 Wiley, New York.
7. Hermann J., Bodmeier R. The effect of particle micro structure on the somatostatin release from poly(lactide) microspheres prepared by a w/o/w solvent evaporation method. J. Control. Release. 36:1995;63-71.
8. Takada S., Uda Y., Toguchi H., Ogawa Y. Application of a spray drying technique in production of TRH-containing injectable sustained release microparticles of biodegradable polymers. J. Pharm. Sci. Technol. 49:(4):1995;180-184.
9. Jalil R., Nixon J.R. Biodegradable poly(lactic acid) and poly(lactide-co-glycolide) microcapsules: problems associated with preparative techniques and release properties. J. Microencapsul. 7:1990;297-325.
10. Yolles S., Eldridge J.E., Woodland J.H.R. Sustained delivery of drugs from polymer drug mixtures. Polym. News. 1:1971;9-12.
11. Sanders L.M., McRae G.I., Vitale K.M., Kell B.A. Controlled delivery of LHRH analogues from biodegradable injectable microspheres. J. Control. Release. 2:1985;187-195.
12. Rogers J.A., Ownsu-Ababio G. Formulations of antibiotics in polymeric microcapsules: ciprofloxacin. The 20th International Meeting of the Controlled Release Society, Washington DC, July:1993;24-30.
13. Brannon-Peppas L., Grosvenor A.L., Smith B.S. Drug delivery of penicillin and β-estradiol from biodegradable microparticles within degradable and nondegradable films. The 21st International Meeting of the Controlled Release Society, Nice, France, June:1994;27-30.
14. Fujita S.M., Sherman J.M., Godowski K.C., Tipton A.J. Delivery of amikacin from an aerosolid biodegradable film. The 7th Annual Meeting of the American Association of Pharmaceutical Science, San Antonio, Texas, November:1992;15-20.
15. Cowsar D.R., Tice T.R., Giley R.M., English J.P. Poly(lactide-co-glycolide) microcapsules for controlled release of steroids. Methods Enzymol. 112:1985;101-116.
16. Eldridge J.H., Staas J.K., Gettic A., Marx P.A., Tice T.R., Gilley R.M. Protection against vaginal SIV transmission with microencapsulated vaccine. Science. 260:1993;1323-1326.
17. + Th1 cells. Vaccine. 13:1995;1741-1749.
18. Bittner B., Morlock M., Koll H., Winter G., Kissel T. Recombinant human erythropoietin (rHEPO) loaded poly(lactide-co-glycolide) microspheres: influence of the encapsulation technique and polymer purity on microspheres characteristics. Eur. J. Pharm. Biopharm. 45:1998;295-305.
19. Ando S., Putnam D., Pack D.W., Langer R. PLGA microspheres containing plasmid DNA: preservation of supercoiled DNA via cryopreparation and carbohydrate stabilization. J. Pharm. Sci. 88:1999;126-130.
20. Wang D., Robinson D.R., Kown G.S., Samuel J. Encapsulation of plasmid DNA in biodegradable poly(D,L-lactic-co-glycolic acid) microspheres as a novel approach for immunogene delivery. J. Control. Release. 57:1999;9-18.
21. Fattal E., Vauthier C., Aynie I., Nakada Y., Lambert G., Malvy C., Convreur P. Biodegradable polyalkylcyanoacrylate nanoparticles for the delivery of oligonucleotides. J. Control. Release. 53:1998;137-143.
22. Lewis K.J., Irwin W.J., Akhtar S. Development of a sustained release biodegradable polymer delivery system for site-specific delivery of oligonucleotides: characterization of P(LA-GA) copolymer microspheres in vitro. J. Drug Target. 5:1998;291-302.
23. Humphrey M.J., Ringrose P.S. Peptide and related drugs: a review of their absorption metabolism and excretion. Drug. Metab. Rev. 17:1986;283-310.
24. L Lee V.H., Yamamoto A., Komplella U.B. Mucosal penetration enhancers for facilitation of peptide and protein drug absorption. Crit. Rev. Ther. Drug Carrier Syst. 8:1991;91-192.
25. Merkle H.P. New aspects of pharmaceutical dosage forms for controlled drug delivery of peptides and proteins. Eur. J. Pharm. Sci. 2:1994;19-21.
26. Lehr C. Bioadhesion technologies for the delivery of peptides and protein drugs to GIT. Crit. Rev. Ther. Drug Carrier Syst. 11:1994;119-160.
27. Sarciaux J.M., Acar L., Sado P.A. Using microemulsion formulations for oral drug delivery of therapeutic peptides. Int. J. Pharm. 120:1995;27-136.
28. Pearlman R., Bewley T.A. Wang Y.J., Pearlman R. Stability and Characterisation of Protein and Peptide Drugs: Case Histories. 1993;1-57 Plenum, New York.
29. Manning M.C., Patel K., Borchardt R.T. Stability of protein pharmaceuticals. Pharm. Res. 6:1989;903-918.
30. Volkin D.B., Middaugh C.R. Ahern T.J., Manning M.C. Stability of Protein Pharmaceuticals. Part A: Chemical and Physical Pathways of Protein Degradation. 1992;109-134 Plenum, New York.
31. Zale S.E., Klibanov A.M. Why does ribonuclease irreversibly inactivate at high temperatures? Biochemistry. 25:1986;5432-5443.
32. Johnson O.L., Tracy M.A. Peptide and protein drug delivery. Mathiowitz E. Encyclopedia of Controlled Drug Delivery. Vol. 2:1999;816-833 Wiley, New York.
33. Wang W. Oral protein drug delivery. J. Drug Target. 4:1996;195-232.
34. de Bore A.G., van Hoogdalem E.J., Breimer D.D. Rate controlled rectal peptide drug absorption. Adv. Drug. Deliv. Rev. 8:1992;237-251.
35. Ho N.F.H., Barshun C.L., Burton P.S., Merkle H.P. Mechanistic insights to buccal delivery of proteinaceous substances. Adv. Drug. Deliv. Rev. 8:1992;197-235.
36. Cullander C., Guy R.H. Transdermal delivery of peptides and proteins. Adv. Drug. Deliv. Rev. 8:1992;291-329.
37. Hirai S., Yashiki T., Mima H. Effects of surfactants on the nasal absorption of insulin in rats. Int. J. Pharm. 9:1981;165-172.
38. Lee V.H.L. Ophthalmic delivery of peptides and proteins. Pharm. Technol. April:1987;26-38.
39. Madara J.L., Dharmsathaphorn K. Occluding junction structure-function relationships in a cultured epithelial monolayer. J. Cell. Biol. 101:1985;2124-2133.
40. Modi N.B. Pharmacokinetics and pharmacodynamics of recombinant proteins and peptides. J. Control. Release. 29:1994;269-281.
41. Zhou X.H. Overcoming enzymatic and absorption barriers to non -parenterally administered protein and peptide drugs. J. Control. Release. 29:1994;239-252.
42. Webber W. Mucosal drug delivery: buccal. Mathiowitz E. Encyclopedia of Controlled Drug Delivery. 1999;553-563 Wiley, New York.
43. Potts R.O., Bommannan D., Wong O., Tamada J.A., Riviere J.E., Monteiro-Riviere N.A. Sanders L.M., Hendren R.W. Transdermal Peptide Delivery Using Electroporation in Protein Delivery. 1997;213-228 Plenum, New York, London.
44. Porter C.J., Davies M.C., Davis S.S., Illum L. Microparticulate system for site-specific therapy-bone marrow targeting. Domb A. Site Specific Pharmacotherapy. 1994;Wiley, New York.
45. Davis S.S., Hansrani P. The influence of emulsifying agents on the phagocytosis of lipid emulsions by macrophages. Int. J. Pharm. 23:1985;69-77.
46. Illum L., Davis S.S. Effect of the nonionic surfactant poloxamer 338 on the fate and deposition of polystyrene microspheres following intravenous administration. J. Pharm. Sci. 72:1983;1086-1089.
47. Torchilin V.P., Papisov M.I. Hypothesis: why do PEG coated liposomes circulate so long? J. Liposome Res. 4:1994;725-739.
48. Miller R.A., Brady J.M., Cutright D.E. Degradation rates of oral resorbable implants (polylactates and polyglycolates): rate modification with changes in PLA/PGA copolymers ratio. J. Biomed. Mater. Res. 11:1997;711-719.
49. Murthy R.S.R. Biodegradable polymers. Jain N.K. Controlled and Novel Drug Delivery. 1997;27-51 CBS Publishers and Distributors, New Delhi.
50. Lewis D.H. Controlled release of bioactive agents from lactide/glycolide polymers. Chasin M., Langer R. Biodegradable Polymers as Drug Delivery Systems, Drugs and Pharmaceutical Sciences. 1990;9-41 Marcel Dekker, New York.
51. Lewis D.H. Chasin M., Langer R. Biodegradable Polymers as Drug Delivery Systems. Drugs and Pharmaceutical Sciences. Vol. 45:1990;1-41 Marcel Dekker, New York.
52. Jeyanthi R., Mehta R.C., Thanoo B.C., DeLuca P.P. Effect of processing parameters on the properties of peptide-containing PLGA microspheres. J. Microencapsul. 14:1997;163-174.
53. Timpi R. Ramachandran G.N., Reddi A.H. Biochemistry of Collagen. 1976;55-78 Plenum, New York.
54. Hunter S.K., Andracki M.E., Kreig A.M. Biodegradable microspheres containing group B Streptococcus vaccine: immune response in mice. Am. J. Obstet. Gynecol. 185:2001;1174-1179.
55. Jung T., Koneberg R., Hungerer K.D., Kissel T. Tetanus toxoid microspheres consisting of biodegradable poly(lactide-co-glycolide)- and ABA-triblock-copolymers: immune response in mice. Int. J. Pharm. 234:2002;75-90.
56. Khang G., Cho J.C., Lee J.W., Rhee J.M., Lee H.B. Preparation and characterization of Japanese encephalitis virus vaccine loaded poly(L-lactide-co-glycolide) microspheres for oral immunization. Biomed. Mater. Eng. 9:1999;49-59.
57. Johansen P., Moon L., Tamber H., Merkle H.P., Gander B., Sesardic D. Immunogenicity of single-dose diphtheria vaccines based on PLA/PLGA microspheres in guinea pigs. Vaccine. 18:1999;209-215.
58. Yeh M.K., Liu Y.T., Chen J.L., Chiang C.H. Oral immunogenicity of the inactivated Vibrio cholerae whole cell vaccine encapsulated in biodegradable microparticles. J. Control. Release. 82:2002;237-247.
59. Genta I., Perugini P., Pavanetto F., Maculotti K., Modena T., Casado B., Lupi A., Iadarola P., Conti B. Enzyme loaded biodegradable microspheres in vitro ex vivo evaluation. J. Control. Release. 77:2001;287-295.
60. Fattal E., Couvreur P., Pecquet S. Oral tolerance induced by poly(lactide-co-glycolide) containing B lactoglobulin. Ann. Pharm. Fr. 60:2002;44-49.
61. Zhou S., Deng X., He S., Li X., Jia W., Wei D., Zhang Z., Ma J. Study on biodegradable microspheres containing recombinant interferon-alpha-2a. J. Pharm. Pharmacol. 54:2002;1287-1292.
62. Yeh M.K. The stability of insulin in biodegradable microparticles based on blends of lactide polymers and polyethylene glycol. J. Microencapsul. 7:2000;743-756.
63. Nam Y.S., Song S.H., Choi J.Y., Park T.G. Lysozyme microencapsulation within biodegradable PLGA microspheres: urea effect on protein release and stability. Biotechnol. Bioeng. 70:2000;270-277.
64. Rosas J.E., Pedraz J.L., Hernandez R.M., Gascon A.R., Igartua M., Guzman F., Rodriguez R., Cortes J., Patarroyo M.E. Remarkably high antibody levels and protection against P. falciparum malaria in Aotus monkeys after a single immnunisation of SPf66 encapsulated in PLGA microspheres. Vaccine. 20:2002;1707-1710.
65. Boehm G., Peyre M., Sesardic D., Huskisson R.J., Mawas F., Douglas A., Xing D., Merkle H.P., Gander B., Johansen P. On technological and immunological benefits of multivalent single-injection microsphere vaccines. Pharm. Res. 19:2002;1330-1336.
66. Sturesson C., Artursson P., Ghaderi R., Johansen K., Mirazimi A., Uhnoo I., Svensson L., Albertsson A.C., Carlfors J. Encapsulation of rotavirus into poly(lactide-co-glycolide) microspheres. J. Control. Release. 59:1999;377-389.
67. Han K., Lee K.D., Gao Z.G., Park J.S. Preparation and evaluation of poly(L-lactic acid) microspheres containing rhEGF for chronic gastric ulcer healing. J. Control. Release. 75:2001;259-269.
68. Morlock M., Kissel T., Li Y.X., Koll H., Winter G. Erythropoietin loaded microspheres prepared from biodegradable LPLG-PEO-LPLG triblock copolymers: protein stabilization and in-vitro release properties. J. Control. Release. 56:1998;105-115.
69. Zambaux M.F., Bonneaux F., Gref R., Dellacherie E., Vigneron C. Preparation and characterization of protein C loaded PLA nanoparticles. J. Control. Release. 60:1999;179-188.
70. Jackson J., Liang L., Hunter W., Reynolds M., Sandberg J., Springate C., Burt H. The encapsulation of ribozymes in biodegradable polymeric matrices. Int. J. Pharm. 243:2002;43-47.
71. Blanco-Prieto M.J., Besseghir K., Zerbe O., Andris D., Orsolini P., Heimgartner F., Merkle H.P., Gander B. In vitro and in vivo evaluation of a somatostatin analogue released from PLGA microspheres. J. Control. Release. 67:2000;19-28.
72. Yuksel E., Weinfeld A.B., Cleek R., Waugh J.M., Jensen J., Boutros S., Shenaq S.M., Spira M. De novo adipose tissue generation through long-term, local delivery of insulin and insulin like growth factor-1 by PLGA/PEG microspheres in an in vivo rat model: a novel concept and capability. Plast. Reconstruct. Surg. 105:2000;1721-1729.
73. Kostanski J.W., Thanoo B.C., DeLuca P.P. Preparation, characterization, and in vitro evaluation of 1- and 4-month controlled release orntide PLA and PLGA microspheres. Pharm. Dev. Technol. 5:2000;585-596.
74. King T.W., Patrick Jr C.W. Development and in vitro characterization of vascular endothelial growth factor (VEGF) loaded poly(DL-lactic-co-glycolic acid)/poly(ethylene glycol) microspheres using a solid encapsulation/single emulsion/solvent extraction technique. J. Biomed. Mater. Res. 51:2000;383-390.
75. Cho S.W., Song S.H., Choi Y.W. Effects of solvent selection and fabrication on the characteristics of biodegradable poly(lactide-co-glycolide) microspheres containing ovalbumin. Arch. Pharm. Res. 23:2000;385-390.
76. Zhu K.J., L Jiang H., Du X.Y., Wang J., Xu W.X., Liu S.F. Preparation and characterization of hCG loaded polylactide or poly(lactide-co-glycolide) microspheres using a modified water-in-oil-in water (w/o/w) emulsion solvent evaporation technique. J. Microencapsul. 18:2001;247-260.
77. Li X., Deng X., Huang Z. In vitro protein release and degradation of poly-dl-lactide-poly(ethylene glycol) microspheres with entrapped human serum albumin: quantitative evaluation of the factors involved in protein release phases. Pharm. Res. 18:2001;117-124.
78. Schrier J.A., DeLuca P.P. Recombinant human bone morphogenetic protein-2 binding and incorporation in PLGA microsphere delivery systems. Pharm. Dev. Technol. 4:1999;611-621.
79. Carrasquillo K.G., Stanley A.M., Aponte-Carro J.C., DeJesus P., Costantino H.R., Bosques C.J., Griebenow K. Non-aqueous encapsulation of excipient stabilized spray freeze dried BSA into poly(lactide-co-glycolide) microspheres results in release of native protein. J. Control. Release. 76:2001;199-208.
80. Prabhu S., Sullivan J.L., Betageri G.V. Comparative assessment of in vitro release kinetics of calcitonin polypeptide from biodegradable microspheres. Drug. Deliv. 9:2002;195-198.
81. Kissel T., Brich Z., Bantle S., Lancranjam I., NimmerFall F., Vit P. Parenteral depot systems as the basis of biodegradable polyesters. J. Control. Release. 16:1991;27-34.
82. Hilbert A.K., Fritzsche U., Kissel T. Biodegradable microspheres containing influenza-A vaccine: immune response in mice. Vaccine. 17:1999;1065-1073.
83. Yang Y.Y., Chung T.S., Ng N.P. Morphology, drug distribution and in vitro release profiles of biodegradable polymeric microspheres containing protein fabricated by double emulsion solvent extraction/evaporation method. Biomaterials. 22:2001;231-241.
84. Ogawa Y., Yamamoto M., Takada S., Shimamoto T. Controlled release of leuprolide acetate from polylactic acid or co-polymer ratio of polymer. Chem. Pharm. Bull. 36:1988;1502-1507.
85. Redding T.W., Schally A.V., Tice T.R., Meyers W.E. Long acting delivery systems for peptides: inhibition of rat prostate tumors by controlled release of DTrp6 leutinizing hormone releasing hormone injectable microcapsules. Proc. Natl. Acad. Sci. USA. 81:1984;5845.
86. Carpenter J.F., Pikal M.J., Chang B.S., Randolph T.W. Rational design of stable lyophilized protein formulations: some practical advice. Pharm. Res. 14:1997;969-975.
87. Carpenter J.F., Crowe J.H. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry. 28:1989;3916-3922.
88. Arakawa T., Kita Y., Carpenter J.F. Protein solvent interactions in pharmaceutical formulations. Pharm. Res. 8:1991;285-291.
89. Loftsson T., Brewster M.E. Pharmaceutical applications of cyclodextrins. 1. Drug solubilisation and stabilization. J. Pharm. Sci. 85:1996;1017-1025.
90. Rajewski R.A., Stella V.J. Pharmaceutical applications of cyclodextrins. 2. In vivo drug delivery. J. Pharm. Sci. 85:1996;1142-1169.
91. Charman S.A., Mason K.L., Charman W.N. Techniques for assessing the effects of pharmaceutical excipients on the aggregation of porcine growth hormone. Pharm. Res. 10:1993;954-962.
92. Tsai P.K., Volkin D.B., Dabora J.M., Thompson K.C., Bruner M.W., Gress J.O., Matuszewska B., Keogan M., Bondi J.V., Middaugh C.R. Formulation design of acidic fibroblast growth factor. Pharm. Res. 10:1993;649-659.
93. Thurow H., Geisen K. Stabilization of dissolved proteins against denaturation at hydrophobic interfaces. Diabetologia. 27:1984;212-218.
94. Cunningham B.C., Mulkerrin M.G., Wells J.A. Dimerization of human growth hormone by zinc. Science. 253:1991;545-548.
95. Hanson M.A., Rouan S.K.E. Ahern T.J., Manning M.C. Stability of Protein Pharmaceuticals. Part B: In Vivo Pathways of Degradation and Strategies for Protein Stabilization. 1992;209-233 Plenum, New York.
96. Hora M.S., Rana R.K., Smith F.W. Lyophilised formulations of recombinant tumor necrosis factor. Pharm. Res. 9:1992;33-36.
97. Powell M.F., Sanders L.M., Rogerson A., Si V. Parenteral peptide formulations: chemical and physical properties of native luteinizing hormone-releasing hormone (LHRH) and hydrophobic analogues in aqueous solution. Pharm. Res. 8:1991;1258-1263.
98. Ressing M.E., Jiskoot W., Talsma H., van Ingen C.W., Bwuvery C., Crommelin D.J.A. The influence of sucrose, dextran, and hydroxypropyl-beta-cyclodextrin as lyoprotectants for a freeze-dried mouse IgG2a monoclonal antibody(MN12). Pharm. Res. 9:1992;226-270.
99. Zhu G., Hallery S.R., Schwendemem S.P. Stabilisation of proteins encapsulated in injectable poly(lactide-co-glycolide) polymers. Nat. Biotech. 18:2000;52-57.
100. Johnson O.L., Cleland J.L., Lee H.J., Charnis M., Duenas E., Jaworowicz W., Shepard D., Shahzamani A., Jones A.J., Putney S.D. A month long effect from a single injection of microencapsulated human growth hormone. Nat. Med. 2:1996;795-799.
101. Visscher G.E., Robinson R.L., Argentieri G.J. Tissue response to biodegradable injectable microcapsules. J. Biomater. Appl. 2:1987;118-131.
102. Cleland J.L., Powell M.F., Shire S.J. Development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation. Crit. Rev. Ther. Drug. Carrier Syst. 10:1993;307-377.
103. International Conference On Harmonization, Fed. Regist. 62 (1997) 24302-24309.
104. Niu C.H., Chiu Y.Y. FDA perspective on peptide formulation and stability issues. J. Pharm. Sci. 87:1998;1331-1334.
105. Marchant R.E., Miller K.M., Anderson J.M. In vivo leukocyte interactions with biomer. J. Biomed. Mater. Res. 18:1984;1169-1174.
106. Sewell W.R., Wiland J., Bradford N.C. A new method of comparing ovine catgut with sutures of bovine catgut in 3 species. Surg. Gynecol. Obstet. 100:1955;483.
107. Gourlay S.J., Rice R.M., Hegyeli A.F., Wade C.W.R., Dillon J.G., Jaffe H., Kulkarni R.K. Biocompatibility testing of polymers: in vivo implantation studies. J. Biomed. Mater. Res. 12:1978;219.
108. Bronaugh R.L., Maibach H.I. Klingman A.M., Leyden J.J. Safety and Efficacy of Topical Drugs and Cosmetics. 1982;51 Grune and Stratton, New York.
109. Foster G.V. Klingman A.M., Leyden J.J. Safety and Efficacy of Topical Drugs and Cosmetics. 1982;99 Grune and Stratton, New York.
110. Autian J. Williams D.F. Fundamental Aspects of Biocompatibility. 1983;63 CRC Press, Boca Raton, FL.
111. Imai Y., Watanbe A., Masuhara E. Structure-biocompatibility relationship of condensation polymers. J. Biomed. Mater. Res. 17:1983;905.