In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams: a novel approach using positive and negative controls
- Authors: Mudyahoto, Nyengeterai Amanda , Rath, Seeprarani , Ramanah, Ashmita , Kanfer, Isadore
- Date: 2020
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/149849 , vital:38888 , 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.
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- Date Issued: 2020
The simultaneous determination of trimethoprim, sulphamethoxazole and N4-acetylsulphamethoxazole in biological fluids by high pressure liquid chromatography
- Authors: Gochin, Rosa , Kanfer, Isadore , Haigh, John M
- Date: 1981
- Language: English
- Type: text , Article
- Identifier: vital:6364 , http://hdl.handle.net/10962/d1006064
- Description: The simultaneous determination of trimethoprim, sulphamethoxazole and N4-acetylsulphamethoxazole in serum and urine by high-performance liquid chromatography using sulphafurazole as internal standard is described. The separation was achieved on a reversed-phase column employing acetic acid-methanol as the mobile phase with spectrophotometric detection at 230 nm. Precise simultaneous quantitative analysis of the relative components has been achieved at levels of 0.1 μg/ml for both sulphamethoxazole and its N4-acetyl metabolite using 1 ml of serum or urine.
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- Date Issued: 1981
Assessment of some variables affecting the blanching activity of betamethasone 17-valerate cream
- Authors: Magnus, Ashley D , Haigh, John M , Kanfer, Isadore
- Date: 1980
- Language: English
- Type: text , Article
- Identifier: vital:6396 , http://hdl.handle.net/10962/d1006320
- Description: The effect of concentration and occlusion time on the ability of Betnovate ® cream (betamethasone 17-valerate 0.1%) to produce skin blanching was assessed. Generally, increased concentration or occlusion time produce and increase in the degree of blanching observed, however, a plateau stage is eventually reached where no further increase of blanching occurs.
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- Date Issued: 1980