Accelerated dissolution testing for improved quality assurance

Quist, P.-O; Östling, Göran

doi:10.1016/s0731-7085(02)00048-1

Cited by 13 publications

(7 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…1) (Weiss et al, 2014). In particular, it should be a valuable tool in accelerated in vitro drug release testing (Quist and Östling, 2002;Shen and Burgess, 2012). For IVIVC, the model (Eq.…”

Section: Discussionmentioning

confidence: 99%

“…The curves can be well described by power (2)) and release profile measured at 57°fitted by Eq. (13) showing that dissolution was highly accelerated with a = 3.72 (data from Quist and Östling (2002)). The baseline data (s) (5% GMS) were fitted using the 2IG model (Eq.…”

Section: In Vitro-in Vivo Correlation (Ivivc)mentioning

confidence: 96%

“…Example 1: acceleration by temperature elevation Quist and Östling (2002) studied the acceleration of dissolution of salicylic acid tablets by temperature elevation. First, using the IG model (Eq.…”

Section: In Vitro Dissolutionmentioning

confidence: 99%

“…Here it will be shown that accelerated (decelerated) drug release can be described by a proportional increase (decrease) in fractional dissolution rate, i.e., ak(t) with a constant factor a > 1 (acceleration) or a < 1 (deceleration). The purpose of this article is twofold; firstly, to apply this approach to dissolution processes in vitro by fitting data where drug release is accelerated due to elevated temperature (Quist and Östling, 2002) or decelerated by increasing the content of glyceryl monostearate (GMS) in theophylline tablets (Weiss et al, 2014). Secondly, to show that this modeling concept can be effectively applied to in vitro-in vivo correlation (IVIVC) when in the time scaling approach the relationship between t in vivo and t in vitro , t in vivo = /(t in vitro ), i.e.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Modeling accelerated and decelerated drug release in terms of fractional release rate

Weiß

2015

European Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Section: In Vitro-in Vivo Correlation (Ivivc)mentioning

confidence: 96%

Section: In Vitro Dissolutionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Modeling accelerated and decelerated drug release in terms of fractional release rate

Weiß

2015

European Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

“…Although accelerated dissolution rate analysis (ACDRA) has been used for tablets especially during at-line tests (conducted by the use of process dedicated testing equipment on the production line) [83,84], an in-depth investigation of this technique for controlled release parenterals including implants has not been reported. Of the various parameters (temperature, solvent, ionic strength, pH, enzymes, surfactants and agitation rate) that can be altered, the easiest way to achieve accelerated release has been reported to be an increase in temperature [84].…”

Section: Accelerated In Vitro Release Testingmentioning

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

Injectables

D’Souza

2019

In Vitro Drug Release Testing of Special Dosage Forms

View full text Add to dashboard Cite

Accelerated dissolution testing for improved quality assurance

Cited by 13 publications

References 14 publications

Modeling accelerated and decelerated drug release in terms of fractional release rate

Modeling accelerated and decelerated drug release in terms of fractional release rate

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

Injectables

Contact Info

Product

Resources

About