Biopharmaceutical classification system: A strategic tool for oral drug delivery technology
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Abstract
drug substance. The recent developments have also enabled us to predict the solubility and permeability characteristics of the drug molecule in the early development stages so that the necessary structural changes can be made to the molecule in order to optimize the pharmacokinetic parameters.The BCS has also got a place in various guidance documents of regulatory mportance. This article reviews the criteria for classifying drugs according to the BCS and discusses further potential
applications of the BCS, including the developments of new drugs and controlled release products.
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References
Khan GM. Controlled release oral dosage forms: Some recent advances
in matrix type drug delivery systems. The Science 2001;1:350-54.
Sachan NK, Singh D. Evaluation of dried pulp from Carica papaya fruits
as disintegrating agents in the formulation of metformin hydrochloride
dispersible tablets. Journal of Assam Science Society 2006;46:20-2.
Amidon GL, Lennerlas H, Shah VP, Crison JR. A theoretical basis for
a biopharmaceutic drug classification: The correlation of in vitro
drug product dissolution and in vivo bioavailability. Pharm Res
;12:413- 0.
Dressman J, Butler J, Hempenstall J, Reppas C. The BCS: Where Do We
Go from Here? Pharmaceutical Technology 2001; 7:68-76. Available:
www.pharmaportal.com
Center for drug evaluation, FDA “Guidance for Industry on Dissolution
Testing of Immediate Release Solid Oral Dosage forms†1997.
Center for drug evaluation, FDA “Guidance for Industry on the Waiver
of in vivo Bioavailability and Bioequivalence for Immediate Release
Solid Oral Dosage forms based on Biopharmaceutical Classification
system†2000.
Johnson SR, Zheng Weifan. Recent progress in computational prediction
of aqueous solubility and absorption. AAPS J 2006;8 :E27-40.
Sharma, J.L. Dictionary of Chemistry. New Delhi India: CBS Publishers
and Distributors; 1997. p. 558-60.
Ahuja, A., Khar, R.K. and Ali, J. Dosage Form Design. 1st ed. N.D. India:
Birla Publications Pvt. Ltd.; 2004. p. 3-11.
Yu LX, Carlin AS, Hussain AS. Feasibility study of intrinsic dissolution
rate as an alternative method to determine BCS solubility membership.
AAPS annual meeting 2000.
Draft Guidance for Industry, “Waiver of in vivo Bioavailability and
Bioequivalence Studies for Immediate Release Solid Oral Dosage
Forms containing certain Active Moieties/Active Ingredients based on
a Biopharmaceutic Classification Systemâ€. CDER/FDA 1999.
British Pharmacopoeia Electronic version: Appendix I D. Buffer
Solutions. London: The Stationary Office; 2003.
Devane J. Oral drug delivery technology: Addressing the solubility/
permeability paradigm, Pharmaceutical Technology. 1998; 11:68-74.
Dressman J.B. Physiological aspects of the design of dissolution tests,
in: Amidon G, Robinson J. Williams R. (eds.), Scientific foundation for
regulating drug product quality. Alexandria, VA: AAPS Press. 1997;155-65.
Lobenberg R, Amidon GL. Modern bioavailability, bioequivalence and
biopharmaceutics classification system. New scientific approaches
to international regulatory standards. Eur J Pharm Biopharm 2000;
:3-12.
Rinaki E, Valsami G, Macheras P. Quantitative biopharmaceutics
classification system: The central role of dose/solubility ratio. Pharm
Res 2003;20:1917-25.
Bergström CA, Strafford M, Lazorova L, Avdeef A, Luthman K,
Artursson P. Absorption classification of oral drugs based on molecular
surface properties. J Med Chem 2003;46:558-70.
Mirja, T. and Gray V.A. Meeting report: Conference on Dissolution,
Bioequivalence and Bioavailability. Dissolution Technology 2004;11:25- .
Verma RK, Garg S. Current status of drug delivery technologies and
future directions. Pharmaceutical Technology (online) 2001; 25(2):1-14.
Jorgensen WL, Duffy EM. Prediction of drug solubility from structure.
Adv Drug Deliv Rev 2002;54:355-66.
LobelL M, Sivrajah V. In silico prediction of aqueous solubility, human
plasma protein binding and volume of distribution of compounds from
calculated pKa and AlogP98 values. Mol Divers 2003;7:69-87.
Lipinsky CA, Lombordo F, Dominy BW, Feeney PJ. Experimental and
computational approaches to estimate solubility and permeability
in drug discovery and development settings. Adv Drug Deliv Rev
;23:3-26.
Wikling IR, Prior DV. Remote controlled capsules in human drug
absorption (HAD) studies. Crit Rev Ther Drug Carrier Syst 2003;20:405-31.