DESIGN AND PERFORMANCE VERIFICATION OF NEWLY DEVELOPED DISPOSABLE STATIC DIFFUSION CELL FOR DRUG DIFFUSION/PERMEABILITY STUDIES
Keywords:Newly developed diffusion cell, Franz diffusion cell, Biopharmaceutical classification system, Metronidazole, Diclofenac sodium, Fluconazole, Sulfadiazine
Objectives: The present study describes a disposable static diffusion cell for in vitro diffusion studies to achieve better results as compared to well existing Franz diffusion cell (FDC) in terms of the absence of bubbles, variable receptor compartment, ease of handling, and faster results.
Materials and Methods: The cell consists of a cup-shaped donor compartment made of semi permeable that could be either cellophane membrane or, animal skin fitted to a rigid frame, which is supported on a plastic plate that contains a hole for the sample withdrawal. The receptor compartment is a separate unit, and it could be any container up to 500ml volume capacity. The most preferred receptor compartment is glass beaker. In the present study, goatskin was used as semi-permeable membrane and verification of its performance was carried out through diffusion studies using gel formulations of one each of the four-selected biopharmaceutical classification system (BCS) class drugs. Metronidazole, diclofenac sodium, fluconazole, and sulfadiazine were used as model drugs for BCS Class I, II, III, and IV, respectively.
Results: The newly developed diffusion cell (NDDC) was found to provide faster and more reproducible results as compared to FDC. At the time interval of 24 h, the cell was found to exhibit a higher diffusion of metronidazole, diclofenac sodium, fluconazole, and sulfadiazine by 0.65, 0.65, 0.32, and 0.81 folds, respectively. The faster release obtained with NDDC was attributed to a larger surface area of skin as compared to that in FDC.
Conclusion: It was concluded that better reproducibility of results could be achieved with NDDC.
Reddy PS, Bose PS, Sruthi V, Saritha D. Investigation of kondagogu gum to develop transdermal film of repaglinide. Asian J Pharm Clin Res 2018;11:440-5.
Hardainiyan S, Kumar K, Nandy B, Saxena R. Design, formulation and in vitro drug release from transdermal patches containing imipramine hydrochloride as model drug. Int J Pharm Pharm Sci 2017;9:220-5.
Franz T. The finite dose technique as a valid in vitro model for the study of percutaneous absorption. Curr Probl Dermatol 1978;7:58-68.
Farinha A, Toscano C, Campos R, Bica A, Hadgraft J. Permeation of naproxen from saturated solutions and commercialformulations through synthetic membranes. Drug Dev Ind Pharm 2003;29:489-94.
Shah V, Elkins J, Lam S, Skelly J. Determination of in vitro drug release from hydrocortisone creams. Int J Pharm 1989;53:53-9.
Siewert M, Dressman J, Brown C, Shah V. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSci Tech 2003;4:6-13.
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;4:377-85.
Bartosova L, Bajgar J. Transdermal drug delivery in vitro using diffusion cells. Curr Med Chem 2012;19:4671-7.
Bronaugh RL, Stewart RF. Methods for in vitro percutaneous absorption studies IV: The flow-through diffusion cell. J Pharm Sci 1985;74:64-7.
Pendlington RU. Principles and practice skin toxicology. In: Chilcott RP, Price S, editors. In Vitro Percutaneous Absorption Measurements. United Kingdom: John Wiley & Sons Chichester; 2008. p. 129-47.
Yang H, Imbert DC. Inventor; Static Diffusion Cell for Diffusion Sampling Systems. U.S. Patent, Patent No. US 8133721B2; 2011.
Mannam R, Yallamalli I. Pharmacokinetic study of matrix membrane moderated transdermal system of bosentan monohydrate. Asian J Pharm Clin Res 2017;10:255-8.
Yang H, Imbert DC. Inventor; Static Diffusion Cell for Diffusion Sampling Systems. U.S. Patent, Patent No. US 7470535B2; 2008.
Mohammad A. Inventor; Diffusion Cell for Ex - Vivo Pressure - Controlled Trans Corneal Drug Penetration Studies. U. S. Patent, Patent No. US 5789240A; 1998.
Joseph MB, Patrick JR, Mark AT. Inventor; Gel Formulations for Topical Drug Delivery. U. S. Patent, Patent No. US 0015715A1; 2002.
Castro J, Zhang YS, Lee L. Inventor; Transdermal Diffusion Cell Testing Arrangements and Methods, U. S. Patent. Patent No. US 0120215A1; 2011.
Sood S, Jain K, Gowthamarajan K. Optimization of curcumin nanoemulsion for intranasal delivery using design of experiment and its toxicity assessment. Colloids Surf B Biointerfaces 2014;113:330-7.
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