Active compounds release from semisolid dosage forms

Journal of Pharmaceutical Sciences

Volumn 101, Issue 11, 2012, Pages 4032-4045

  Olejnik, Anna ^a   Goscianska, Joanna ^a   Nowak, Izabela ^a  

^a ADAM MICKIEWICZ UNIVERSITY   (Poland)

Author keywords

Active transport; Controlled release; Diffusion; Emulsions; Formulation; Gels; In vitro models; Kinetics

Indexed keywords

APPARATUS; CREAM; DISSOLUTION; DRUG FORMULATION; DRUG RELEASE; GEL; IN VITRO RELEASE TESTING; MATHEMATICAL ANALYSIS; MEMBRANE; OINTMENT; REVIEW; TEMPERATURE MEASUREMENT; VELOCITY;

EID: 84866390939     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23289     Document Type: Review

References (117)

1. Sathe PM, Raw AS, Ouderkirk LA, Yu LX, Husain AS. 2005. Drug product performance, in vitro. In Generic drug product development: Solid oral dosage forms; Shargel L, Kanfer I, Eds. New York City, New York: Marcel Dekker, Inc., pp. 187-209.
2. Azarmi S, Roa W, Lobenberg R. 2007. Current perspectives in dissolution testing of conventional and novel dosage forms. Int J Pharm 328:12-21.
3. Hanson WA. 1982. Overall considerations. In Handbook of dissolution testing; Hanson, WA Ed. Corvallis, Oregon: Pharmaceutical Technology Publications, pp 1-11.
4. FDA SUPAC SS working group. 1997. Guidance for industry. Nonsterile semisolid dosage forms. Scale-up and postapproval changes: Chemistry, manufacturing and controls; in vitro release testing and in vivo bioequivalence documentation.
5. Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibach H, Marques M, Rytting H, Shaw S, Thakker K, Yacobi A. 2009. Topical and transdermal drug products. Pharmacopeial Forum 35:750-764.
6. Zatz JL, Segers JD. 1998. Techniques for measuring in vitro release from semisolids. Dissolution Technol 5:3-13.
7. Zatz JL. 1995. Drug release from semisolids: Effect of membrane permeability on sensitivity to product parameters. Pharm Res 12:787-789.
8. Bonacucina G, Cespi M, Misici-Falzi M, Palmieri GF. 2006. Rheological, adhesive and release characterisation of semisolid Carbopol/tetraglycol systems. Int J Pharm 307:129-140.
9. Yang Y, Wang S, Xu H, Sun Ch, Li X, Zheng J. 2008. Properties of topically applied organogels: Rheology and in vitro drug release. Asian J Pharm Sci 3:175-183.
10. Sawant PD, Luu D, Ye R, Buchta R. 2010. Drug release from hydroethanolic gels. Effect of drug's lipophilicity (log P), polymer-drug interactions and solvent lipophilicity. Int J Pharm 396:45-52.
11. Csoka I, Csanyi E, Zapantis G, Nagy E, Feher-Kiss A, Horvath G. 2005. In vitro and in vivo percutaneous absorption of topical dosage forms: Case studies. Int J Pharm 291:11-19.
12. Buhse L, Kolinski R, Westenberger B, Wokovich A, Spencer J, Chen C, Turujman S, Gautam-Basak M, Kang G, Kibbe A, Heintzelman B, Wolfgang E. 2005. Topical drug classification. Int J Pharm 295:101-112.
13. Bhavsar JD, Brhambhatt VG, Patel MR, Patel KR, Patel NM. 2011. Novel approaches in semisolids. Int J Pharm World Res 2:1-22.
14. Gupta P, Garg S. 2002. Recent advances in semisolid dosage forms for dermatological application. Pharm Technol 26:144-162.
15. Morell JL, Claramonte MD, Vialard A. 1996. Validation of a release diffusion cell for topical dosage forms. Int J Pharm 137:49-55.
16. Corbo M, Shultz TW, Wong GK, Van Buskirk GA. 1993. Development and validation of in vitro release testing methods for semisolid formulations. Pharm Technol 17:112-128.
17. Ng SF, Rouse JJ, Sanderson FD, Meidan V, Eccleston GM. 2010. Validation of a static Franz diffusion cell system for in vitro permeation studies. AAPS PharmSciTech 11:1432-1441.
18. Higuchi T. 1961. Rate of release of medicaments from ointment bases containing drugs in suspension. J Pharm Sci 50:874-875.
19. Roseman TJ, Higuchi WI. 1970. Release of medroxyprogesterone acetate from a silicone polymer. J Pharm Sci 59:354-357.
20. Tojo K. 1985. Intrinsic release rate from matrix-type delivery systems. J Pharm Sci 74:685-687.
21. Bottari F, Di Colo G, Nannipieri E, Saettone MF, Serafini MF. 1977. Release of drugs from ointment bases II: Benzocaine from suspension-type gels. J Pharm Sci 66:926-931.
22. Clement P, Laugel C, Marty JP. 2000. Influence of three synthetic membranes on the release of caffeine from concentrated W/O emulsions. J Control Release 66:243-254.
23. Clement P, Laugel C, Marty JP. 2000. In vitro release of caffeine from concentrated W/O emulsions: Effect of formulation parameters. Int J Pharm 207:7-20.
24. Dias M, Farinfa A, Faustino E, Hadgraft J, Pais J, Toscano C. 1999. Topical delivery of caffeine from some commercial formulations. Int J Pharm 182:41-47.
25. Bolzinger MA, Briancon S, Pelletier J, Fessi H, Chevalier Y. 2008. Percutaneous release of caffeine from microemulsion, emulsion and gel dosage forms. Eur J Pharm Biopharm 68:446-451.
26. Shah VP, Elkins J, Hanus J, Noorizadeh C, Skelly JP. 1991. In vitro release of hydrocortisone from topical preparations and automated procedure. Pharm Res 8:55-59.
27. Shah VP, Elkins J, Skelly JP. 1989. Determination of in vitro drug release from hydrocortisone creams. Int J Pharm 53:53-59.
28. Niemi L, Kahela P, Turakka L. 1989. Effect of water content and type of emulgator on the release of hydrocortisone from o/w creams. Acta Pharm Nord 1:23-30.
29. Sanghvi PP, Collins CC. 1993. Comparison of diffusion studies of hydrocortisone between the Franz cell and the enhancer cell. Drug Dev Ind Pharm 19:1573-1585.
30. Laugel C, Baillet A, Piemi MPY, Marty JP, Ferrier D. 1998. Oil-water-oil multiple emulsions for prolonged delivery of hydrocortisone after topical application: Comparison with simple emulsions. Int J Pharm 160:109-117.
31. Christensen JM, Chuong MC, Le H, Pham L, Bendas E. 2011. Hydrocortisone diffusion through synthetic membrane, mouse skin, and Epiderm™ cultured skin. Arch Drug Inform 4:10-21.
32. Chattaraj SC, Kanfer I. 1995. Release of acyclovir from semi-solid dosage forms: A semi-automated procedure using a simple plexiglass flow-through cell. Int J Pharm 125:215-222.
33. Hwang YJ, Oh C, Oh SG. 2005. Controlled release of retinol from silica particles prepared in O/W/O emulsion-The effect of surfactants and polymers. J Control Release 106:339-349.
34. Kundu SC, Cameron AD, Meltzer NM, Quick TW. 1993. Development and validation of method for determination of in vitro release of retinoic acid from creams. Drug Dev Ind Pharm 19:425-438.
35. Thakker KD, Chern WH. 2003. Development and validation of in vitro release tests for semisolid dosage forms-Case study. Dissolution Technol 10 10-15.
36. Gueroll Z, Hekimoglu S, Demirdamar R, Sumnu M. 1996. Percutaneous absorption of ketoprofen. I. In vitro release and percutaneous absorption of ketoprofen from different ointment bases. Pharm Acta Helv 71:205-212.
37. Chi SC, Jun HW. 1991. Release rates of ketoprofen from poloxamer gels in a membraneless diffusion cell. J Pharm Sci 80:280-283.
38. Gallagher SJ, Trottet L, Heard CM. 2003. Ketoprofen: Release from, permeation across and rheology of simple gel formulations that simulate increasing dryness. Int J Pharm 268:37-45.
39. Tas C, Ozkan Y, Savaser A, Baykara T. 2003. In vitro release studies of chlorpheniramine maleate from gels prepared by different cellulose derivatives. Il Farmaco 58:605-611.
40. Velissaratou AS, Papaioannou G. 1989. In vitro release of chlorpheniramine maleate from ointment bases. Int J Pharm 52:83-86.
41. Babar A, Bhandari RD, Plakogiannis PM. 1991. In-vitro release studies op chlorpheniramine maleate from topical bases using cellulose membrane and hairless mouse skin. Drug Dev Ind Pharm 17:1027-1040.
42. 12 from poly(N-vinyl-2-pyrrolidone-co-acrylic acid) hydrogels. React Funct Polym 62:93-104.
43. Bottari F, DeColo G, Nannipieri E, Saettone MF, Serafini MF. 1974. Influence of drug concentration on in vitro release of salicylic acid from ointment bases. J Pharm Sci 63:1779-1783.
44. Chowhan ZT, Pritchard R. 1975. Release of corticoids from oleaginous bases containing drug in suspension. J Pharm Sci 64:754-759.
45. TM with automated sampling. J Pharm Biomed Anal 17:1225-1233.
46. Segers JD, Zatz JL, Shah VP. 1997. In vitro release of phenol from ointment formulation. Pharm Technol 21:70-81.
47. Badkar A, Talluri K, Tenjarla S, Jaynes J, Banga AK. 2000. In vitro release testing of a peptide gel. Pharm Technol 24:44-52.
48. Rahman MS, Babar A, Patel MK, Plakogiannis FM. 1990. Medicament release from ointment bases: V. Naproxen in-vitro release and in-vivo percutaneous absorption in rabbits. Drug Dev Ind Pharm 16:651-672.
49. Attia DA. 2009. In vitro and in vivo evaluation of transdermal absorption of naproxen sodium. Aust J Basic Appl Sci 3:2154-2165.
50. Ferreira RAM, Seiller M, Grossiord JL, Marty JP, Wepierre J. 1994. Vehicle influence on in vitro release of metronidazole: Role of w/o/w multiple emulsion. Int J Pharm 109:251-259.
51. Muktadir A, Babar A, Cutiea AJ, Plakogiannis FM. 1986. Medicament release from ointment bases: III. Ibuprofen: In-vitro release and in-vivo absorption in rabbits. Drug Dev Ind Pharm 12:2521-2540.
52. Rasool BKA, Abu-Gharbieh EF, Fahmy SA, Saad HS, Khan SA. 2010. Development and evaluation of ibuprofen transdermal gel formulations. Top J Pharm Res 9:355-363.
53. Gopi C, Kumar TMV, Dhanaraju MD. 2010. Design and evaluation of novel ibuprofen gel and its permeability studies. Int J Biopharm 1:82-84.
54. Fang JY, Hwang TL, Leu YL. 2003. Effect of enhancers and retarders on percutaneous absorption of flurbiprofen from hydrogels. Int J Pharm 250:313-325.
55. El Gendy AM, Jun HW, Kassem AA. 2002. In vitro release studies of flurbiprofen from different topical formulations. Drug Dev Ind Pharm 28:823-831.
56. Pandey MS, Belgamwar VS, Surana SJ. 2009. Topical delivery of flurbiprofen from Pluronic lecithin organogel. Indian J Pharm Sci 71:87-90.
57. Bonina FP, Montenegro L. 1994. Vehicle effects on in-vitro heparin release and skin penetration from different gels. Int J Pharm 102:19-24.
58. Gutowska A, Bae YH, Feijen J, Kim SW. 1992. Heparin release from thermosensitive hydrogels. J Control Release 22:95-104.
59. Hinrichs WJL, ten Hoopen HWM, Wissink MJB, Engbers GHM, Feijen J. 1997. Design of a new type of coating for the controlled release of heparin. J Control Release 45:163-176.
60. Ahola MS, Säilynoja ES, Raitavuo MH, Vaahtio MM, Salonen JI, Yli-Urpo AUO. 2001. In vitro release of heparin from silica xerogels. Biomaterials 22:2163-2170.
61. Barry BW. 1983. Dermatological formulations. Percutaneous absorption. In Drugs and the pharmaceutical sciences; Swarbrik, Ed. Vol. 18. New York City, New York: Marcel Dekker, Inc., pp 49-94.
62. Flynn GL, Shah VP, Tenjarla SN, Corbo M, DeMagistris D, Feldman TG. 1999. Assessment of value and applications of in vitro testing of topical dermatological drug products. Pharm Res 16:1325-1329.
63. Shah VP, Elkins J, Shaw S, Hanson R. 2003. In vitro release: Comparative evaluation of vertical diffusion cell system and automated procedure. Pharm Dev Technol 8:97-102.
64. Shah VP, Elkins J, Williams RL. 1999. Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products. Pharm Dev Technol 4:377-385.
65. Shah VP, Elkins J. 1995. In vitro release from corticosteroid ointments. J Pharm Sci 84:1139-1140.
66. Baker RW, Heller J. 1989. Material selection for transdermal delivery systems. In Transdermal drug delivery: Development issues and research initiatives; Hadgraft J, Guys RH, Eds. New York City, New York: Marcel Dekker, Inc., pp 293-311.
67. Guyot M, Fawaz F. 2000. Design and in vitro evaluation of adhesive matrix for transdermal delivery of propranolol. Int J Pharm 204:171-182.
68. Gabiga H, Cal K, Janicki S. 2000. Effect of penetration enhancers on isosorbide dinitrate penetration through rat skin from a transdermal therapeutic system. Int J Pharm 199:1-6.
69. Minghetti P, Cilurzo F, Casiragh A, Molla FA, Montanari L. 1999. Dermal patches for controlled release of miconazole: Influence of drug concentration on the technical characteristics. Drug Dev Ind Pharm 25:679-684.
70. Tsai CJ, Hu LR, Fang JY, Lin HH. 1999. Chitosan hydrogel as a base for transdermal delivery of berberine and its evaluation in rat skin. Biol Pharm Bull 22:397-401.
71. Gale R, Spitze LA. 1981. Permeability of camphor in ethylene vinyl acetate copolymers. In Proceedings of the Eighth International Symposium on Controlled Release of Bioactive Materials. Minneapolis, Minnesota: Controlled Release Society, p 183.
72. Boretos JW, Detmer DE, Donachy JH. 1971. Segmented polyurethane: A polyether polymer II. Two year experience. J Biomed Mater Res 5:373-387.
73. Brain KR, Walters KA, Green DM, Brain S, Loretz LJ, Dressler WE. 2005. Percutaneous penetration of diethanolamine through human skin in vitro: Application from cosmetic vehicles. Food Chem Toxicol 43:681-690.
74. Gabbanini S, Matera R, Beltramini C, Minghetti A, Valgimigli L. 2010. Analysis of in vitro release through reconstructed human epidermis and synthetic membranes of multi-vitamins from cosmetic formulations. J Pharm Biomed Anal 52:461-467.
75. Branka R, Mirjana G, Estelle T-T, Fabrice P, Francoise G. 2009. Simultaneous absorption of vitamins C and E from topical microemulsions using reconstructed human epidermis as a skin model. Eur J Pharm Biopharm 72:69-75.
76. Ng SF, Rouse J, Sanderson D, Eccleston G. 2010. A comparative study of transmembrane diffusion and permeation of ibuprofen across synthetic membranes using Franz Diffusion Cells. Pharmaceutics 2:209-223.
77. Özer Ö, Kidotlessvçak B, Mutlu B, Akay S, Sa lam H, Tömek S. 2007. In vitro release studies on multiple and simple emulsions of tocopherol with Pistacia leaves. Sci Pharm 75:97-109.
78. Rapedius M, Blanchard J. 2001. Comparison of the Hanson Microettet and the Van Kel Apparatus for In Vitro Release Testing of Topical Semisolid Formulations. Pharm Res 18:1440-1447.
79. Edgar KJ, Buchanan CM, Debenham JS, Rundquist PA, Seiler BD, Shelton MC, Tindall D. 2001. Advances in cellulose ester performance and application. Prog Polym Sci 26:1605-1688.
80. Arellano A, Santoyo S, Martn C, Ygartua P. 1998. Surfactant effects on the in vitro percutaneous absorption of diclofenac sodium. Eur J Drug Metab Pharmacokinet 2:307-312.
81. Djordjevic L, Primorac M, Stupar M. 2005. In vitro release of diclofenac diethylamine from caprylocaproyl macrogolglycerides based microemulsions. Int J Pharm 296:73-79.
82. Conaghey OM, Corish J, Corrigan OI. 1998. The release of nicotine from a hydrogel containing ion exchange resins. Int J Pharm 170:215-224.
83. Özsoy Y, Güngör S, Cevher E. 2004. Vehicle effects on in vitro release of tiaprofenic acid from different topical formulations. Farmaco 59:563-566.
84. Smith EW, Haigh J. 1992. In vitro diffusion cell and validation. Acta Pharm Nord 4:171-178.
85. Yoshida H, Tamura S, Toyoda T, Kado K, Ohnishi N, Ibuki R. 2004. In vitro release of Tacrolimus from Tacrolimus ointment and its speculated mechanism. Int J Pharm 270:55-64.
86. Khan G, Frum Y, Sarheed O, Eccleston GM, Meidan VM. 2005. Assessment of drug permeability distribution in two different model skins. Int J Pharm 303:81-7.
87. Frum Y, Eccleston GM, Meidan VM. 2007. Evidence that drug flux through synthetic membranes is assocated with normally distributed permeability coefficients. Eur J Pharm Biopharm 67:434-9.
88. Haigh JM, Smith EW. 1994. The selection and use of natural and synthetic membranes for in vitro diffusion experiments. Eur J Pharm Sci 2:311-330.
89. Chattaraj SC, Kanfer I. 1996. The "insertion cell": A novel approach to monitor drug release from semi-solid dosage forms. Int J Pharm 133:59-63.
90. Liebenberg W, Engelbrecht E, Wessels A, Evarakonda B, Yang W, De Villie MM. 2004. A comparative study of the release of active ingredients from semisolid cosmeceuticals measured with Franz, enhancer or flow-through cell diffusion apparatus. J Food Drug Anal 12:19-28.
91. Ceschel GC, De Filippis P. 1981. Diffusion through artificial lipid barriers of two forms of betamethasone and correlation with in vivo data. Pharm Acta Helv 56:291-295.
92. Van Amerongen IA, De Ronde HAG, Klooster NTM. 1992. Physical-chemical characterization of semisolid topical dosage form using a new dissolution system. Int J Pharm 86:9-15.
93. Skelly JP, Shah VP, Maibach HI, Guy RH, Wester RC, Flynn G. 1987. FDA and AAPS report of the workshop on principles and practices of in vitro percutaneous penetration studies: Relevance to bioavailability and bioequivalence. Pharm Res 4:265-267.
94. Fares MH, Zatz LJ. 1995. Measurement of drug release from topical gels using two types of apparatus. Pharm Technol 19:53-58.
95. Higuchi T. 1963. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci 52:1145-1149.
96. Higuchi WI. 1962. Analysis of data on the medicament release from ointments. J Pharm Sci 51:802-804.
97. Siewert M, Dressman J, Brown CK, Shah VP. 2003. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 4:1-10.
98. European Pharmacopoeia 5.0, 2.9.3. 2005. Dissolution test for solid dosage forms.
99. Franz TJ. 1978. The finite dose technique as a valid in vivo model for the study of percutaneous absorption. Curr Probl Dermatol 7:58-68.
100. Pillai R, Shah VP, Albrecht CF, Chattaraj SC, Flynn G. 2001. Release of hydrocortisone from a cream matrix: Dependency of release on suspension concentration and measurement of solubility and diffusivity. Pharm Dev Technol 6:373-384.
101. Vlachou MD, Rekkas DM, Dallas PP, Choulis NH. 1992. Development and in vitro evaluation of griseofulvin gels using Franz diffusion cells. Int J Pharm 82:47-52.
102. Ueda CT, Shah VP, Derdzinski K, Ewing G, Flynn G, Maibach H, Marques M, Rytting H, Shaw S, Thakker K, Yacobi A. 2010. Topical and transdermal drug products. Dissolution Technol 17 12-25.
103. Keshary PR, Chien YW. 1984. Mechanisms of transdermal controlled nitroglycerinadministration (I): Development of a finite-dosing skin permeation system. Drug Dev Ind Pharm 10:883-913.
104. Flynn LG, Keshary PR, Huang YC. 1983. Comparative controlled skin permeation of nitroglycerin from marketed transdermal delivery systems. J Pharm Sci 72:968-970.
105. Corbo M. 1995. Techniques for conducting in vitro release studies on semisolid formulations. Dissolution Technol 2:3-6.
106. Vankel Technology Group Buyer's Guide. 2005. p 37.
107. Tanjo H, Roemele PEH, Van Veen GH, Stieltjes H, Junginger H, Bodde HE. 1997. New design of a flow-through permeation cell for studying in vitro permeation studies across biological membrane. J Control Release 45:41-47.
108. Marangon A, Bock U, Haltner E. 2009. In vitro release testing for semisolid formulations. Across Barriers 1-5.
109. Liang S, Zhang L, Xu J. 2007. Morphology and permeability of cellulose/chitin blend membranes. J Membr Sci 287:19-28.
110. Tenjarla SN, Kasina R, Puranajoti P, Omar MS, Harris WT. 1999. Synthesis and evaluation of N-acetylprolinate esters-Novel skin penetration enhancers. Int J Pharm 192:147-158.
111. Kasapis S, Norton IT, Ubbik JB. 2009. Modern biopolymer science. Bridging the divide between fundamental treatise and industrial application (chapter 16). Amsterdam, The Netherlands: Elsevier, pp 519-557.
112. Falk B, Garramone S, Shivkumar S. 2004. Diffusion coefficient of paracetamol in a chitosan hydrogel. Mater Lett 58:3261-3265.
113. Martin A, Swarbrick J, Cammarata A. 1991. Physical pharmacy. Mumbai, India: Varghese Publishing House.
114. Gennaro AL. 1990. Remington's pharmaceutical sciences. Easton, Pennsylvania: Mack Publishing Company.
115. Costa P, Lobo JMS. 2001. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 13:123-133.
116. Mockel JE, Lippold BC. 1993. Zero-order drug release from hydrocolloid matrices. Pharm Res 10:1066-1070.
117. Ehtezazi T, Washington C, Melia CD. 2000. First order release rate from porous PLA microspheres with limited exit holes on the exterior surface. J Control Release 66:27-38.