In Vitro Topographical Characterization as a Predictor of in Vivo Controlled Release Quinidine Gluconate Bioavailability

Skelly, Jerome P.; Yau, Martin K.T.; Elkins, Jerome; Yamamoto, Lawrence A.; Shah, Vinod P.; Barr, William H.

doi:10.3109/03639048609065853

Cited by 18 publications

(1 citation statement)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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

View full text Add to dashboard Cite

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.

show abstract

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

View full text Add to dashboard Cite

show abstract

Pharmaceutical Dissolution Testing: Fundamentals and Essential Applications (An Overview)

2022

Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence

View full text Add to dashboard Cite

Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet

Martinez

Pelsor

Shah

et al. 1990

Biopharm & Drug Disp

Self Cite

View full text Add to dashboard Cite

Quinidine gluconate 324 mg sustained release tablets (Quinaglute) was administered as a single dose to 15 healthy male subjects following an overnight fast, immediately following a high fat (HF) breakfast or immediately following a low fat (LF) breakfast. Serum samples were obtained over a 48 h period and analyzed for quinidine content using a high performance liquid chromatographic assay. Under the conditions of the study, both the rate and extent of quinidine bioavailability was significantly affected by food. The extent of bioavailability was statistically significantly greater (p less than 0.05) following both the HF and LF meals as compared to that in the fasted state. Rate of bioavailability was significantly enhanced following the LF meal as compared to that of the other two treatment groups. Although peak concentrations were greater and time to peak concentrations somewhat later following the HF meal versus those under fasting conditions, these differences were not statistically significant. In addition, the characteristics of the serum concentration-time profile (as defined by the number, magnitude, and time of occurrence of the multiple absorption maxima) was unique for each of the three treatment groups. Possible mechanisms underlying these results are explored.

show abstract

In Vitro Topographical Characterization as a Predictor of in Vivo Controlled Release Quinidine Gluconate Bioavailability

Cited by 18 publications

References 1 publication

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

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

Pharmaceutical Dissolution Testing: Fundamentals and Essential Applications (An Overview)

Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet

Contact Info

Product

Resources

About