Technical Note: Hydrocortisone as a Performance Verification Test Reference Standard for In Vitro Release Testing

Klein, Ryan R.; Bechtel, Jenna L.; Burchett, Kris; Thakker, Kailas

doi:10.14227/dt170410p37

Cited by 9 publications

(8 citation statements)

References 5 publications

(4 reference statements)

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“…It has been reported that artificial cellulose membranes give a higher reproducibility of results than natural porcine membranes due to the method of preparation of the natural membrane. Porcine membranes, due to their lipophilic nature, may be better permeable to some substances, whereas artificial films may be more beneficial to other substances [37][38][39][40][41]. The porcine membrane-the skin of the ear-was used for ACTH permeation study.…”

Section: Corticotropin Release Study From the Hydrogel Ointmentsmentioning

confidence: 99%

Influence of Concentration on Release and Permeation Process of Model Peptide Substance-Corticotropin-From Semisolid Formulations

2020

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The transdermal route of administration of drug substances allows clinicians to obtain a therapeutic effect bypassing the gastrointestinal tract, where the active substance could be inactivated. The hormonal substance used in the study-corticotropin (ACTH)-shows systemic effects. Therefore, the study of the effect of the type of ointment base and drug concentration on the release rate and also permeation rate in in vivo simulated conditions may be a valuable source of information for clinical trials to effectively optimize corticotropin treatment. This goal was achieved by preparation ointment formulation selecting the appropriate ointment base and determining the effect of ACTH concentration on the release and permeation studies of the ACTH. Semi-solid preparations containing ACTH were prepared using Unguator CITO e/s. The release study of ACTH was tested using a modified USP apparatus 2 with Enhancer cells. The permeation study was conducted with vertical Franz cells. Rheograms of hydrogels were made with the use of a universal rotational rheometer. The dependence of the amount of released and permeated hormone on the ointment concentration was found. Based on the test of ACTH release from semi-solid formulations and evaluation of rheological parameters, it was found that glycerol ointment is the most favourable base for ACTH. The ACTH release and permeation process depends on both viscosity and ACTH concentration. The higher the hormone concentration, the higher the amount of released ACTH but it reduces the amount of ACTH penetrating through porcine skin.

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Section: Corticotropin Release Study From the Hydrogel Ointmentsmentioning

confidence: 99%

Influence of Concentration on Release and Permeation Process of Model Peptide Substance-Corticotropin-From Semisolid Formulations

2020

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“…The PVT was performed by using 1% hydrocortisone cream (Emo-Cort ® , GlaxoSmithKline Inc., Mississauga, ON, Canada) applied on Tuffryn membranes [17,18]. Two IVRT runs were performed, each with six VDCs in parallel, by stirring the receptor medium at 600 rpm and maintaining the receptor medium temperature at 32 ± 1 • C. Prior to the commencement of the experiment, the receptor chambers were filled with degassed receptor medium consisting of ethanol: water (30:70 v/v) and VDC system were allowed to equilibrate at 32 ± 1 • C for approximately 30 min.…”

Section: Performance Verification Test (Pvt)mentioning

confidence: 99%

A Validated IVRT Method to Assess Topical Creams Containing Metronidazole Using a Novel Approach

Rath

Kanfer

2020

Pharmaceutics

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An IVRT method was developed and validated to confirm its reproducibility, precision, sensitivity, selectivity, accuracy, robustness, and reliability. A novel approach was used to demonstrate the appropriateness of the IVRT method to accurately assess “sameness” between topical products and to confirm that the methodology applied also possesses the requisite discriminatory power to detect differences should such differences exist between products. In the first instance, the reference product (Metrocreme®) containing 0.75% metronidazole (MTZ) was tested against itself as a positive control, to accurately demonstrate “sameness”, where the results met the relevant acceptance criteria falling within the limits of 75–133.33% in accordance with the FDA’s SUPAC-SS guidance. In addition, two specially prepared creams containing 25% less and 26% more MTZ, i.e., 0.563% and 0.945%, served as negative controls and were compared against the reference product. Neither of these creams fell within the “sameness” acceptance criteria, thereby confirming the discriminatory ability of the IVRT method to detect differences between MTZ products. Furthermore, another cream containing 0.75% MTZ tested against the reference product was shown to be pharmaceutically equivalent to the reference product. These results confirm the appropriateness of the IVRT method as a valuable tool for use in the development of topical MTZ products intended for local action and indicate the potential for general use with other topical products.

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“…It has been reported that artificial cellulose membranes give more reproducible results than natural pork membranes due to the way the natural membrane is prepared. Due to their lipophilic nature, porcine membranes may be more permeable to some substances, whereas artificial ones may be more beneficial to other substances [45][46][47][48][49]. In turn, the use of hairless mouse skin leads to overstated results [50].…”

Section: In Vitro Drug Release Profiles Of the Ointmentsmentioning

confidence: 99%

Development and Study of Semi-Solid Preparations Containing the Model Substance Corticotropin (ACTH): Convenience Application in Neurodegenerative Diseases

2020

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Corticotropin (ACTH, previously an adrenocorticotropic hormone) is used in the diagnosis and treatment of pituitary gland disorders, adrenal cortex disorders, and other diseases, including autoimmune polymyositis, systemic lupus erythematosus, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. So far, the ointment dosage form containing ACTH for use on the skin is unknown. Therefore, it seems appropriate to develop a semi-solid formulation with corticotropin. Emulsion ointments were prepared using an Unguator based on the cream base Lekobaza® containing corticotropin in different concentrations, and then the physical and chemical parameters of the ointment formulations, such as pH, spreadability, rheological properties, and texture analysis, were evaluated. In addition, a USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the selected formulations. All the ointments obtained were characterized by good spreadability and viscosity. An analysis of the ointment texture was performed and the dependence of the tested parameters on the ACTH content in the ointment was demonstrated. Examination of the structure of the ointment showed that a high concentration of ACTH increases the hardness and adhesiveness of the ointment. In turn, it adversely affects the cohesiveness and elasticity of the ointments tested. The results of the release study showed that ACTH is released the fastest from the formulation with the lowest concentration, while the slowest from the ointment with the highest concentration of ACTH.

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Technical Note: Hydrocortisone as a Performance Verification Test Reference Standard for In Vitro Release Testing

Cited by 9 publications

References 5 publications

Influence of Concentration on Release and Permeation Process of Model Peptide Substance-Corticotropin-From Semisolid Formulations

Influence of Concentration on Release and Permeation Process of Model Peptide Substance-Corticotropin-From Semisolid Formulations

A Validated IVRT Method to Assess Topical Creams Containing Metronidazole Using a Novel Approach

Development and Study of Semi-Solid Preparations Containing the Model Substance Corticotropin (ACTH): Convenience Application in Neurodegenerative Diseases

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