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Profiling in vitro drug release from subcutaneous implants: a review of current status and potential implications on drug product development.
Biopharm Drug Dispos. 2006 May; 27(4):157-70.BD

Abstract

This review presents current methods and strategies for studying the release characteristics of drugs from subcutaneous implant dosage forms. Implants are dosage forms that are subcutaneously placed with the aid of surgery or a hypodermic needle, and are designed to release drugs over a prolonged period of time. In most cases, the objective of a release test is to identify sufficiently discriminatory procedures that in turn would provide data to set meaningful specifications. Additional information obtained from successful in vitro-in vivo correlations (IVIVC) and accelerated drug release tests are extremely useful during drug product development. Although several workers have employed different methods to monitor drug release from these dosage forms, the use of the compendial Apparatus 4 (flow-through) device has been recommended in a publication on FIP/AAPS Guidelines for drug release testing of modified release dosage forms. However, most of method development with this device has focused on oral immediate or controlled release dosage forms and little published information is available on implants. Two recent reports on workshops provide useful information on methods to evaluate drug release from controlled-release parenterals such as implants, including IVIVC and accelerated release testing. Details on such studies, however, are generally not found in the literature; possibly because of the high proprietary value of methodologies for establishing release specifications of implant dosage forms. This article reviews the current status of methodologies used in the investigation of drug release from subcutaneous implants with an emphasis on mechanistic, product development and regulatory perspectives.

Authors+Show Affiliations

Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, VA 23298-0533, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

16416503

Citation

Iyer, Sunil S., et al. "Profiling in Vitro Drug Release From Subcutaneous Implants: a Review of Current Status and Potential Implications On Drug Product Development." Biopharmaceutics & Drug Disposition, vol. 27, no. 4, 2006, pp. 157-70.
Iyer SS, Barr WH, Karnes HT. Profiling in vitro drug release from subcutaneous implants: a review of current status and potential implications on drug product development. Biopharm Drug Dispos. 2006;27(4):157-70.
Iyer, S. S., Barr, W. H., & Karnes, H. T. (2006). Profiling in vitro drug release from subcutaneous implants: a review of current status and potential implications on drug product development. Biopharmaceutics & Drug Disposition, 27(4), 157-70.
Iyer SS, Barr WH, Karnes HT. Profiling in Vitro Drug Release From Subcutaneous Implants: a Review of Current Status and Potential Implications On Drug Product Development. Biopharm Drug Dispos. 2006;27(4):157-70. PubMed PMID: 16416503.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Profiling in vitro drug release from subcutaneous implants: a review of current status and potential implications on drug product development. AU - Iyer,Sunil S, AU - Barr,William H, AU - Karnes,H Thomas, PY - 2006/1/18/pubmed PY - 2006/10/27/medline PY - 2006/1/18/entrez SP - 157 EP - 70 JF - Biopharmaceutics & drug disposition JO - Biopharm Drug Dispos VL - 27 IS - 4 N2 - This review presents current methods and strategies for studying the release characteristics of drugs from subcutaneous implant dosage forms. Implants are dosage forms that are subcutaneously placed with the aid of surgery or a hypodermic needle, and are designed to release drugs over a prolonged period of time. In most cases, the objective of a release test is to identify sufficiently discriminatory procedures that in turn would provide data to set meaningful specifications. Additional information obtained from successful in vitro-in vivo correlations (IVIVC) and accelerated drug release tests are extremely useful during drug product development. Although several workers have employed different methods to monitor drug release from these dosage forms, the use of the compendial Apparatus 4 (flow-through) device has been recommended in a publication on FIP/AAPS Guidelines for drug release testing of modified release dosage forms. However, most of method development with this device has focused on oral immediate or controlled release dosage forms and little published information is available on implants. Two recent reports on workshops provide useful information on methods to evaluate drug release from controlled-release parenterals such as implants, including IVIVC and accelerated release testing. Details on such studies, however, are generally not found in the literature; possibly because of the high proprietary value of methodologies for establishing release specifications of implant dosage forms. This article reviews the current status of methodologies used in the investigation of drug release from subcutaneous implants with an emphasis on mechanistic, product development and regulatory perspectives. SN - 0142-2782 UR - https://www.unboundmedicine.com/medline/citation/16416503/Profiling_in_vitro_drug_release_from_subcutaneous_implants:_a_review_of_current_status_and_potential_implications_on_drug_product_development_ L2 - https://doi.org/10.1002/bdd.493 DB - PRIME DP - Unbound Medicine ER -