Topographical Dissolution Characterization for Controlled Release Products - a New Technique

Skelly, Jerome P.; Yamamoto, Lawrence A.; Shah, Vinod P.; Yau, Martin K.T.; Bart, W. H.

doi:10.3109/03639048609065852

Cited by 15 publications

(1 citation statement)

References 5 publications

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“…For oral controlled-release dosage forms, a multidimensional approach involving pH as the primary factor has been reported to be a better predictor of in vivo performance [77,78]. During the bioequivalence characterization of implants however, it may not bear relevance unless a significant change in the microenvironment at Site for implantation the implantation site occurs.…”

Section: Development Of Ivivc For Implantsmentioning

confidence: 99%

Profiling in vitro drug release from subcutaneous implants: a review of current status and potential implications on drug product development

Iyer¹,

Barr²,

Karnes³

2006

Biopharm & Drug Disp

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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.

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Section: Development Of Ivivc For Implantsmentioning

confidence: 99%