Dissolution and Drug Release Testing

2016 ◽  
pp. 1397-1434
Keyword(s):  
Drug Release ◽  
Release Testing

In vitro drug release testing of controlled release veterinary drug products

2000 ◽  
pp. 311-332 ◽  
Author(s):  
Michael J. Rathbone ◽  
Jingjian Shen ◽  
Colin R. Ogle ◽  
Shane Burggraaf ◽  
Craig R. Bunt
Keyword(s):  
Controlled Release ◽  
Drug Release ◽  
Veterinary Drug ◽  
In Vitro Drug Release ◽  
Drug Products ◽  
Release Testing

Development and evaluation of accelerated drug release testing methods for a matrix-type intravaginal ring

2017 ◽  
Vol 110 ◽  
pp. 1-12 ◽  
Author(s):  
Anna Externbrink ◽  
Karin Eggenreich ◽  
Simone Eder ◽  
Stefan Mohr ◽  
Klaus Nickisch ◽  
...  
Keyword(s):  
Drug Release ◽  
Testing Methods ◽  
Matrix Type ◽  
Intravaginal Ring ◽  
Release Testing

Drug release testing methods of polymeric particulate drug formulations

2013 ◽  
Vol 43 (4) ◽  
pp. 259-266 ◽  
Author(s):  
Sarmila Amatya ◽  
Eun Ji Park ◽  
Jong Hoon Park ◽  
Joon Sik Kim ◽  
Eunyoung Seol ◽  
...  
Keyword(s):  
Drug Release ◽  
Drug Formulations ◽  
Testing Methods ◽  
Release Testing

Synthesis of antibiotic-loaded interporous hydroxyapatite blocks by vacuum method and in vitro drug release testing

Biomaterials ◽  
1998 ◽  
Vol 19 (7-9) ◽  
pp. 817-819 ◽  
Author(s):  
Mansho Itokazu ◽  
Wenyi Yang ◽  
Takaaki Aoki ◽  
Akira Ohara ◽  
Naoki Kato
Keyword(s):  
Drug Release ◽  
In Vitro Drug Release ◽  
Vacuum Method ◽  
Release Testing

Unattended, robotic drug-release testing of enterically coated aspirin

1986 ◽  
Vol 58 (11) ◽  
pp. 2316-2320 ◽  
Author(s):  
R. J. Eckstein ◽  
Grover D. Owens ◽  
M. A. Baim ◽  
D. A. Hudson
Keyword(s):  
Drug Release ◽  
Release Testing

scholarly journals Assessment of “Sameness” and/or Differences between Marketed Creams Containing Miconazole Nitrate Using a Discriminatory in vitro Release Testing (IVRT) Method

2020 ◽  
Vol 88 (1) ◽  
pp. 6
Author(s):  
Potiwa Purazi ◽  
Seeprarani Rath ◽  
Ashmita Ramanah ◽  
Isadore Kanfer
Keyword(s):  
Drug Release ◽  
In Vitro Release ◽  
Vertical Diffusion ◽  
Discriminatory Ability ◽  
Miconazole Nitrate ◽  
Performance Verification Test ◽  
Semi Solid ◽  
Vitro Release ◽  
Release Testing

In vitro release testing (IVRT) provides an efficient method for the evaluation of drug release from semi-solid formulations. The aim of this research was to develop and validate a discriminatory IVRT system using vertical diffusion cells (VDCs) to assess generic topical products containing miconazole nitrate (MCZ). A comprehensive approach addressing all essential suitability criteria supporting the reliability of IVRT results was applied. These include mechanical validation of the VDCs, a performance verification test (PVT), validation of the analytical method (HPLC) used to quantify the drug release and validation of the IVRT method to confirm its precision, reproducibility, discriminatory ability, and robustness. Two marketed generic products were tested and assessed in accordance with the acceptance criteria for “sameness” in the FDA’s SUPAC-SS guidance which requires that the 90% confidence interval (CI) should fall within the limits of 75%–133.33%. One product was found to be in vitro equivalent to the reference product whereas the other was not. The results confirmed the suitability of the IVRT method to accurately measure the release of MCZ from topical cream products and, importantly, demonstrated the necessary discriminatory ability to assess “sameness”/differences of dermatological creams containing MCZ. Furthermore, the developed IVRT method was able to detect differences between formulations, which may be attributed to qualitative (Q1) and quantitative (Q2) properties and the microstructure and arrangement of matter (Q3).

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