- Title
- In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams: a novel approach using positive and negative controls
- Creator
- Mudyahoto, Nyengeterai Amanda, Rath, Seeprarani, Ramanah, Ashmita, Kanfer, Isadore
- Date
- 2020
- Type
- text
- Type
- article
- Identifier
- http://hdl.handle.net/10962/149849
- Identifier
- vital:38888
- Identifier
- dx.doi.org/10.14227/DT270120P6
- Description
- The objective was to develop and validate an in vitro release testing (IVRT) method to assess the release of hydrocortisone acetate (HCA) from five topical formulations. A marketed generic cream containing 1% HCA was used as the reference product. Vertical diffusion cells (VDCs) were used to assess and compare the release rates of HCA from cream formulations containing 0.5%, 1%, and 1.5% HCA. The study describes a novel approach to test the discriminatory power by including both positive and negative controls to declare pharmaceutical equivalence or inequivalence. The validated method was found to be sensitive, linear, precise, reproducible, robust, and selective for the analysis of HCA from topical cream products. Equivalence or inequivalence was established based on SUPAC-SS acceptance criteria using a 90% CI with limits of 75–133.33%. The IVRT method was shown to have discriminatory ability to appropriately measure significant differences in drug release from various cream formulations. This approach also provides useful information for the future development of acceptable IVRT methods to assess topical dosage forms for local action containing different drugs.
- Format
- 7 pages, pdf
- Language
- English
- Relation
- Dissolution Technologies, Mudyahoto, N.A., Rath, S., Ramanah, A. and Kanfer, I., 2020. In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams: A Novel Approach Using Positive and Negative Controls. Dissolution Technologies, 27(1). dx.doi.org/10.14227/DT270120P6, Dissolution Technologies volume 27 number 1 February 2020 1521-298X
- Rights
- Publisher
- Rights
- Use of this resource is governed by the terms and conditions of the Dissolution Technologies Statement (http://dissolutiontech.com/about.php)
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Collections
Kanfer, Isadore (Prof)
RU Department of Pharmacy
SDG 03. Good Health and Well-Being
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams.pdf | 692 KB | Adobe Acrobat PDF | View Details Download |