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In-vitro dissolution methods for controlled release parenterals and their applicability to drug-eluting stent testing.
J Pharm Pharmacol. 2012 Jul; 64(7):969-85.JP

Abstract

OBJECTIVES

Dissolution testing is a powerful tool for the characterization of dosage form performance in vitro under standardized conditions. In spite of the increasing number of parenterally administered medicinal products, currently there are no compendial dissolution test methods designed especially for these types of dosage forms. In addition to classical drug delivery systems, drug/device combination products, such as drug-eluting stents, are being used increasingly.

KEY FINDINGS

This review describes the current methods that are used most often for in-vitro dissolution testing of parenteral dosage forms, i.e. the 'sample and separate' methods, the 'dialysis' methods, and the 'flow-through' methods, with a special emphasis on whether these methods can be used for drug-eluting stent testing. In the light of current regulatory requirements and with the exploding costs of preclinical and clinical development, test systems that include biorelevant parameters and are predictive of in-vivo performance are increasingly important. Published attempts to take biorelevant conditions into consideration in the design of dissolution test apparatus developed for parenteral dosage forms, including a method that was designed to emulate the embedding and flow-conditions at the site of stent implantation, have been outlined in this review.

SUMMARY

In spite of the large quantity of highly potent controlled release parenteral products marketed today, there is still a lack of suitable methods for in vitro dissolution testing for these dosage forms especially with regard to biorelevant testing conditions. For dosage forms implanted into tissues it seems of major importance to reproduce the transport forces which are predominant in vivo (diffusive versus convective) in the in-vitro experimental setup.

Authors+Show Affiliations

Institute of Pharmacy, Biopharmaceutics and Pharmaceutical Technology, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

22686343

Citation

Seidlitz, Anne, and Werner Weitschies. "In-vitro Dissolution Methods for Controlled Release Parenterals and Their Applicability to Drug-eluting Stent Testing." The Journal of Pharmacy and Pharmacology, vol. 64, no. 7, 2012, pp. 969-85.
Seidlitz A, Weitschies W. In-vitro dissolution methods for controlled release parenterals and their applicability to drug-eluting stent testing. J Pharm Pharmacol. 2012;64(7):969-85.
Seidlitz, A., & Weitschies, W. (2012). In-vitro dissolution methods for controlled release parenterals and their applicability to drug-eluting stent testing. The Journal of Pharmacy and Pharmacology, 64(7), 969-85. https://doi.org/10.1111/j.2042-7158.2011.01439.x
Seidlitz A, Weitschies W. In-vitro Dissolution Methods for Controlled Release Parenterals and Their Applicability to Drug-eluting Stent Testing. J Pharm Pharmacol. 2012;64(7):969-85. PubMed PMID: 22686343.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In-vitro dissolution methods for controlled release parenterals and their applicability to drug-eluting stent testing. AU - Seidlitz,Anne, AU - Weitschies,Werner, Y1 - 2012/02/07/ PY - 2012/6/13/entrez PY - 2012/6/13/pubmed PY - 2012/10/6/medline SP - 969 EP - 85 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 64 IS - 7 N2 - OBJECTIVES: Dissolution testing is a powerful tool for the characterization of dosage form performance in vitro under standardized conditions. In spite of the increasing number of parenterally administered medicinal products, currently there are no compendial dissolution test methods designed especially for these types of dosage forms. In addition to classical drug delivery systems, drug/device combination products, such as drug-eluting stents, are being used increasingly. KEY FINDINGS: This review describes the current methods that are used most often for in-vitro dissolution testing of parenteral dosage forms, i.e. the 'sample and separate' methods, the 'dialysis' methods, and the 'flow-through' methods, with a special emphasis on whether these methods can be used for drug-eluting stent testing. In the light of current regulatory requirements and with the exploding costs of preclinical and clinical development, test systems that include biorelevant parameters and are predictive of in-vivo performance are increasingly important. Published attempts to take biorelevant conditions into consideration in the design of dissolution test apparatus developed for parenteral dosage forms, including a method that was designed to emulate the embedding and flow-conditions at the site of stent implantation, have been outlined in this review. SUMMARY: In spite of the large quantity of highly potent controlled release parenteral products marketed today, there is still a lack of suitable methods for in vitro dissolution testing for these dosage forms especially with regard to biorelevant testing conditions. For dosage forms implanted into tissues it seems of major importance to reproduce the transport forces which are predominant in vivo (diffusive versus convective) in the in-vitro experimental setup. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/22686343/In_vitro_dissolution_methods_for_controlled_release_parenterals_and_their_applicability_to_drug_eluting_stent_testing_ DB - PRIME DP - Unbound Medicine ER -