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Biorelevant in-vitro performance testing of orally administered dosage forms.
J Pharm Pharmacol. 2012 Jul; 64(7):919-30.JP

Abstract

OBJECTIVES

This review focuses on the evolution and current status of biorelevant media and hydrodynamics, and discusses the usefulness of biorelevant performance testing in the evaluation of specific dosage form related lumenal processes.

KEY FINDINGS

During the last 15 years our knowledge of the gastrointestinal environment (including the lower gut) has improved dramatically and biorelevant media composition and, to a lesser extent, biorelevant hydrodynamics, have been refined. Biorelevant dissolution/release testing is useful for the evaluation of formulation and food effects on plasma levels after administration of immediate release dosage forms containing low solubility compounds and after administration of extended release products. Lumenal disintegration times of immediate release dosage forms and the bile acid sequestering activity of resins in the lumen can also be successfully forecasted with biorelevant in vitro testing.

SUMMARY

Biorelevant in-vitro performance testing is an important tool for evaluating intralumenal dosage form performance. Since the formulation of new active pharmaceutical ingredients for oral delivery is more challenging than ever before, efforts to improve the predictability of biorelevant tests are expected to continue.

Authors+Show Affiliations

Department of Pharmaceutical Technology, Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.No affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

22686340

Citation

Reppas, Christos, and Maria Vertzoni. "Biorelevant In-vitro Performance Testing of Orally Administered Dosage Forms." The Journal of Pharmacy and Pharmacology, vol. 64, no. 7, 2012, pp. 919-30.
Reppas C, Vertzoni M. Biorelevant in-vitro performance testing of orally administered dosage forms. J Pharm Pharmacol. 2012;64(7):919-30.
Reppas, C., & Vertzoni, M. (2012). Biorelevant in-vitro performance testing of orally administered dosage forms. The Journal of Pharmacy and Pharmacology, 64(7), 919-30. https://doi.org/10.1111/j.2042-7158.2012.01474.x
Reppas C, Vertzoni M. Biorelevant In-vitro Performance Testing of Orally Administered Dosage Forms. J Pharm Pharmacol. 2012;64(7):919-30. PubMed PMID: 22686340.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Biorelevant in-vitro performance testing of orally administered dosage forms. AU - Reppas,Christos, AU - Vertzoni,Maria, Y1 - 2012/03/27/ PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2012/10/6/medline SP - 919 EP - 30 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 64 IS - 7 N2 - OBJECTIVES: This review focuses on the evolution and current status of biorelevant media and hydrodynamics, and discusses the usefulness of biorelevant performance testing in the evaluation of specific dosage form related lumenal processes. KEY FINDINGS: During the last 15 years our knowledge of the gastrointestinal environment (including the lower gut) has improved dramatically and biorelevant media composition and, to a lesser extent, biorelevant hydrodynamics, have been refined. Biorelevant dissolution/release testing is useful for the evaluation of formulation and food effects on plasma levels after administration of immediate release dosage forms containing low solubility compounds and after administration of extended release products. Lumenal disintegration times of immediate release dosage forms and the bile acid sequestering activity of resins in the lumen can also be successfully forecasted with biorelevant in vitro testing. SUMMARY: Biorelevant in-vitro performance testing is an important tool for evaluating intralumenal dosage form performance. Since the formulation of new active pharmaceutical ingredients for oral delivery is more challenging than ever before, efforts to improve the predictability of biorelevant tests are expected to continue. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/22686340/Biorelevant_in_vitro_performance_testing_of_orally_administered_dosage_forms_ L2 - https://doi.org/10.1111/j.2042-7158.2012.01474.x DB - PRIME DP - Unbound Medicine ER -