Equivalence-by-design: Targeting in Vivo Drug Delivery Profile

Overview

Journal Pharm Res

Specialties Pharmacology
Pharmacy

Date 2008 Oct 29

PMID 18956142

Citations 1

Authors

Mei-Ling Chen

Vincent H L Lee

Affiliations

Soon will be listed here.

Abstract

In the United States (U.S.), drug products are considered therapeutically equivalent if they meet regulatory criteria of pharmaceutical equivalence and bioequivalence. These requirements can be traced back to 1977 when the U.S. Food and Drug Administration (FDA) published the regulations on bioavailability and bioequivalence. Over the years, to keep up with the advancement in science and technology, the FDA has been constantly updating the regulatory approaches to assessing and ensuring equivalence. In view of the recent growth in novel pharmaceutical dosage forms and delivery systems, this paper examines the current framework for documentation of therapeutic equivalence and explores the opportunities of further advancing equivalence methods for complex drug products. It is proposed that equivalence may be established by matching the in vivo drug delivery profile (iDDP) between drug products in comparison. This can be achieved by characterizing the iDDP of the reference formulation with application of an equivalence-by-design approach for pharmaceutical development. Critical variables can be identified to serve as in vitro markers or biomarkers for mapping the desired drug delivery profile in vivo. A multidisciplinary approach may be necessary to develop these markers for characterization of iDDPs.

Citing Articles

Pharmaceutical equivalence by design for generic drugs: modified-release products.

Raw A, Lionberger R, Yu L Pharm Res. 2011; 28(7):1445-53.

PMID: 21387150 DOI: 10.1007/s11095-011-0397-6.

References

Arora S, Ali J, Ahuja A, Khar R, Baboota S . Floating drug delivery systems: a review. AAPS PharmSciTech. 2005; 6(3):E372-90. PMC: 2750381. DOI: 10.1208/pt060347. View

Farinha A, Bica A, Pais J, Toscano M, Tavares P . Bioequivalence evaluation of two omeprazole enteric-coated formulations in humans. Eur J Pharm Sci. 1999; 7(4):311-5. DOI: 10.1016/s0928-0987(98)00043-8. View

Lam Y, Ereshefsky L, Toney G, Gonzales C . Branded versus generic clozapine: bioavailability comparison and interchangeability issues. J Clin Psychiatry. 2001; 62 Suppl 5:18-22; discussion 23-4. View

Newman , Wilding . Imaging techniques for assessing drug delivery in man. Pharm Sci Technol Today. 1999; 2(5):181-189. DOI: 10.1016/s1461-5347(99)00152-2. View

Steffansen B, Nielsen C, Brodin B, Huss Eriksson A, Andersen R, Frokjaer S . Intestinal solute carriers: an overview of trends and strategies for improving oral drug absorption. Eur J Pharm Sci. 2004; 21(1):3-16. DOI: 10.1016/j.ejps.2003.10.010. View

Bogman K, Zysset Y, Degen L, Hopfgartner G, Gutmann H, Alsenz J . P-glycoprotein and surfactants: effect on intestinal talinolol absorption. Clin Pharmacol Ther. 2005; 77(1):24-32. DOI: 10.1016/j.clpt.2004.09.001. View

Meseguer G, Gurny R, Buri P . In vivo evaluation of dosage forms: application of gamma scintigraphy to non-enteral routes of administration. J Drug Target. 1994; 2(4):269-88. DOI: 10.3109/10611869409015908. View

Layer P, Goebell H, Keller J, Dignass A, Klotz U . Delivery and fate of oral mesalamine microgranules within the human small intestine. Gastroenterology. 1995; 108(5):1427-33. DOI: 10.1016/0016-5085(95)90691-6. View

Davis S, Hardy J, Newman S, Wilding I . Gamma scintigraphy in the evaluation of pharmaceutical dosage forms. Eur J Nucl Med. 1992; 19(11):971-86. DOI: 10.1007/BF00175865. View

10.

Burgess D, S Hussain A, Ingallinera T, Chen M . Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USP. Pharm Res. 2002; 19(11):1761-8. DOI: 10.1023/a:1020730102176. View

11.

Su Y, Sinko P . Drug delivery across the blood-brain barrier: why is it difficult? how to measure and improve it?. Expert Opin Drug Deliv. 2006; 3(3):419-35. DOI: 10.1517/17425247.3.3.419. View

12.

Meredith P . Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther. 2003; 25(11):2875-90. DOI: 10.1016/s0149-2918(03)80340-5. View

13.

Brayden D . Controlled release technologies for drug delivery. Drug Discov Today. 2003; 8(21):976-8. DOI: 10.1016/s1359-6446(03)02874-5. View

14.

Hoffmann U, Kroemer H . The ABC transporters MDR1 and MRP2: multiple functions in disposition of xenobiotics and drug resistance. Drug Metab Rev. 2004; 36(3-4):669-701. DOI: 10.1081/dmr-200033473. View

15.

Hugger E, Novak B, Burton P, Audus K, Borchardt R . A comparison of commonly used polyethoxylated pharmaceutical excipients on their ability to inhibit P-glycoprotein activity in vitro. J Pharm Sci. 2002; 91(9):1991-2002. DOI: 10.1002/jps.10176. View

16.

Chen M . Confounding factors for sex differences in pharmacokinetics and pharmacodynamics: focus on dosing regimen, dosage form, and formulation. Clin Pharmacol Ther. 2005; 78(4):322-9. DOI: 10.1016/j.clpt.2005.06.012. View

17.

Schulze J, Waddington W, Eli P, Parsons G, Coffin M, Basit A . Concentration-dependent effects of polyethylene glycol 400 on gastrointestinal transit and drug absorption. Pharm Res. 2004; 20(12):1984-8. DOI: 10.1023/b:pham.0000008046.64409.bd. View

18.

Welage L, Kirking D, Ascione F, Gaither C . Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc (Wash). 2002; 41(6):856-67. DOI: 10.1016/s1086-5802(16)31327-4. View

19.

Adkin D, Davis S, Sparrow R, Huckle P, Wilding I . The effect of mannitol on the oral bioavailability of cimetidine. J Pharm Sci. 1995; 84(12):1405-9. DOI: 10.1002/jps.2600841205. View

20.

Sissung T, Gardner E, Gao R, Figg W . Pharmacogenetics of membrane transporters: a review of current approaches. Methods Mol Biol. 2008; 448:41-62. DOI: 10.1007/978-1-59745-205-2_4. View