Comparative in vitro release profiles of marketed nitroglycerin patches by different dissolution methods

Shah, Vinod P.; Tymes, Norlin W.; Skelly, Jerome P.

doi:10.1016/0168-3659(88)90083-1

Cited by 22 publications

(6 citation statements)

References 1 publication

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“…All dissolution studies were conducted in an adapted USP Apparatus V, also known as Paddle over Disk (POD), traditionally used for transdermal delivery systems (10). All dissolution measurements were performed at 37°C in a 300 mL PBS and 0.2% w/v SDS dissolution media with a stirring speed of 75 rpm.…”

Section: Dissolution Studiesmentioning

confidence: 99%

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

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Shur

Ganley

et al. 2020

AAPS J

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The aim of the study was to develop a robust and standardized in vitro dissolution methodology for orally inhaled drug products (OIDPs). An aerosol dose collection (ADC) system was designed to uniformly deposit the whole impactor stage mass (ISM) over a large filter area for dissolution testing. All dissolution tests were performed under sink conditions in a sodium phosphate buffered saline solution containing 0.2%w/w sodium dodecyl sulphate. An adapted USP Apparatus V, Paddle over Disk (POD), was used throughout the study. The dissolution characteristics of the ISM dose of a commercial metered-dose inhaler (MDI) and a range of dry powder inhaler (DPI) formulations containing inhaled corticosteroids were tested. The uniform distribution of the validated ISM dose considerably reduced drug loading effects on the dissolution profiles for both MDI and DPI formulations. The improvement in the robustness and discriminatory capability of the technique enabled characterization of dissolution rate differences between inhaler platforms and between different DPI product strengths containing fluticasone propionate. A good correlation between in vivo mean absorption time and in vitro dissolution half-life was found for a range of the inhaled corticosteroids. The ADC system and the reproducible in vitro POD dissolution measurements provided a quantitative-based approach for measuring the relationship between the influence of device and the dispersion characteristics on the aerosol dissolution of low solubility compounds. The in vitro dissolution method could potentially be applied as a dissolution methodology for compendial, quality control release testing, and during development of both branded orally inhaled drug products and their generic counterparts.

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Section: Dissolution Studiesmentioning

confidence: 99%

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

Price

Shur

Ganley

et al. 2020

AAPS J

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“…Developed with FDA, USP apparatus 5 is a simple, reproducible method that employs a watch glass-patch-Teflon mesh sandwich assembly coupled with the USP paddle method to determine the release rate of a drug substance from a transdermal patch. The in vitro release profile generated by using apparatus 5 provides a release profile comparable to that obtained by more cumbersome methods needed for USP apparatus 6 and 7 and is thus preferred [6,7]. Procedures utilizing apparatus 5 can be easily automated.…”

Section: In Vitro Release Methods For Transdermal Systemsmentioning

confidence: 98%

“…All brands of nitroglycerin patches exhibit different release characteristics in apparatus 5 because of the different manufacturing technologies employed [6]. This suggests that it is difficult to have a single in vitro release test for all brands of nitroglycerin patches.…”

Section: In Vitro Release Methods For Transdermal Systemsmentioning

confidence: 99%

Importance of In Vitro Drug Release

Shah

Williams

2014

Topical Drug Bioavailability, Bioequivalence, and Penetration

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“…After technical modifications the same principle is applied in apparatuses 5-7 (USP XXII, 4th suppl.) for transdennal patches (5,6) or even for vaginal suppositories (7,8). However, because of the 'single container' nature of the paddle or basket apparatus experimental difficulties can arise (3,9) if a change in pH or a (partial) change in the test medium is required during an investigation, and when studying sparingly soluble drugs or dosage foons that tend to float (particularly aerophilic multiple unit fonns).…”

Section: General Conceptmentioning

confidence: 99%

Perspectives of in vitro dissolution tests in establishing in vivo/in vitro correlations

Siewert¹

1993

Eur. J. Drug Metab. Pharmacokinet.

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Perspectives of in vitro dissolution tests in establishing an in vivo/in vitro correlation are considered at three different levels. The first involves the selection of a drug product, or suitable batch(es), for the correlation study. This requires evaluation of the biopharmaceutical properties of the proposed drug from a profile compiled from a set of dissolution tests under different experimental conditions. These characteristics are needed for properly designing the in vivo study and are also referred to when only a poor correlation is obtained. The second is to define the specific in vitro test system either prospectively, by assessing plausibility of in vitro results, or retrospectively, after interpretation of in vivo data. This distinct test system has to be validated both physically and analytically. The third aspect of dissolution testing for correlations is to provide sound data and derived parameters in consideration of statistical aspects (variability) and of a sufficient number of suitable sampling intervals. In vitro models proposed for the special study of the simulation of food effects on bioavailability are discussed but concluded to be as yet not satisfactory for general application.

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Comparative in vitro release profiles of marketed nitroglycerin patches by different dissolution methods

Cited by 22 publications

References 1 publication

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

Importance of In Vitro Drug Release

Perspectives of in vitro dissolution tests in establishing in vivo/in vitro correlations

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