Pharmacokinetics and Bioavailability Study of a Prednisolone Tablet as a Single Oral Dose in Bangladeshi Healthy Volunteers

Bashar, Tafsir; Apu, Mohd Nazmul Hasan; Mostaid, Shaki; Islam, Saiful; Hasnat, Abul

doi:10.1177/1559325818783932

Cited by 13 publications

(10 citation statements)

References 18 publications

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“…Rather, the outcomes observed in the present study represent those associated with real-world, individualized dosing for each steroid type at CCHMC. Beyond differences in dosing, other potential differences between deflazacort and prednisone, including greater reduction of interferon gamma levels [39] and potential immunomodulatory effects [39][40][41][42], or lower protein binding and nonaffinity for transcortin and potential impacts on bioavailability in muscle fibers [43][44][45][46], could be speculated to impact functional outcomes, but were not investigated in the present study.…”

Section: Limitationsmentioning

confidence: 99%

Real-world outcomes of long-term prednisone and deflazacort use in patients with Duchenne muscular dystrophy: experience at a single, large care center

et al. 2020

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Aim: To assess outcomes among patients with Duchenne muscular dystrophy receiving deflazacort or prednisone in real-world practice. Methods: Clinical data for 435 boys with Duchenne muscular dystrophy from Cincinnati Children’s Hospital Medical Center were studied retrospectively using time-to-event and regression analyses. Results: Median ages at loss of ambulation were 15.6 and 13.5 years among deflazacort- and prednisone-initiated patients, respectively. Deflazacort was also associated with a lower risk of scoliosis and better ambulatory function, greater % lean body mass, shorter stature and lower weight, after adjusting for age and steroid duration. No differences were observed in whole body bone mineral density or left ventricular ejection fraction. Conclusion: This single center study adds to the real-world evidence associating deflazacort with improved clinical outcomes.

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Section: Limitationsmentioning

confidence: 99%

Real-world outcomes of long-term prednisone and deflazacort use in patients with Duchenne muscular dystrophy: experience at a single, large care center

et al. 2020

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“…Cytokine release was not suppressed 48 and 96 h after the first prednisolone administration. This may be explained by the pharmacokinetic profile of prednisolone which is complex in humans (17). Prednisolone is rapidly absorbed and available between 80% and 100% after oral intake.…”

Section: Discussionmentioning

confidence: 99%

Oral prednisolone suppresses skin inflammation in a healthy volunteer imiquimod challenge model

et al. 2023

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Imiquimod (IMQ) is a topical agent that induces local inflammation via the Toll-like receptor 7 pathway. Recently, an IMQ-driven skin inflammation model was developed in healthy volunteers for proof-of-pharmacology trials. The aim of this study was to profile the cellular, biochemical, and clinical effects of the marketed anti-inflammatory compound prednisolone in an IMQ model. This randomized, double-blind, placebo-controlled study was conducted in 24 healthy volunteers. Oral prednisolone (0.25 mg/kg/dose) or placebo (1:1) was administered twice daily for 6 consecutive days. Two days after treatment initiation with prednisolone or placebo, 5 mg imiquimod (IMQ) once daily for two following days was applied under occlusion on the tape-stripped skin of the back for 48 h in healthy volunteers. Non-invasive (imaging and biophysical) and invasive (skin punch biopsies and blister induction) assessments were performed, as well as IMQ ex vivo stimulation of whole blood. Prednisolone reduced blood perfusion and skin erythema following 48 h of IMQ application (95% CI [−26.4%, −4.3%], p = 0.0111 and 95% CI [−7.96, −2.13], p = 0.0016). Oral prednisolone suppressed the IMQ-elevated total cell count (95% CI [−79.7%, −16.3%], p = 0.0165), NK and dendritic cells (95% CI [−68.7%, −5.2%], p = 0.0333, 95% CI [−76.9%, −13.9%], p = 0.0184), and classical monocytes (95% CI [−76.7%, −26.6%], p = 0.0043) in blister fluid. Notably, TNF, IL-6, IL-8, and Mx-A responses in blister exudate were also reduced by prednisolone compared to placebo. Oral prednisolone suppresses IMQ-induced skin inflammation, which underlines the value of this cutaneous challenge model in clinical pharmacology studies of novel anti-inflammatory compounds. In these studies, prednisolone can be used as a benchmark.

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“…Aloe vera extract is obtained. Then the extract was filtered by using a mesh-100 and preservative was added in the filtrate (6)(7)(8)(9).…”

Section: Extraction Of Aloe Vera Juicementioning

confidence: 99%

Formulation and Evaluation of Oral Solution for Rheumatoid Arthritis

Ali¹,

Naz

Saif³

et al. 2022

IJPIHS

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Background: Arthritis is becoming more prevalent with time in Pakistan. An autoimmune and inflammatory condition, rheumatoid arthritis mostly affects the joints. Since most immune suppressants are injectable, it was very difficult for patients to follow their treatment regimen on a daily basis. Aims: To develop a liquid dosage form with minimal adverse drug reactions (ADRs) associated with immuno-suppressants. Methodology: For this purpose, a combination of aloe vera with anti-inflammatory effects and prednisolone with immunosuppressant effects is used. Firstly, aloe vera extract was taken and blended with distilled water, sweetened with sucralose and added in prednisolone solution along with other excipients. The results of efficacy, density, viscosity and specific gravity were as within ranges. Result: There is no discoloration and cloudiness. The results of efficacy, density, viscosity and specific gravity were as within ranges. Conclusion: Aloe juice has synergistic effects as an anti-inflammatory agent. This combination lessened the ADRs associated with prednisolone, however it doesn’t compromise the therapeutic effects.

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Pharmacokinetics and Bioavailability Study of a Prednisolone Tablet as a Single Oral Dose in Bangladeshi Healthy Volunteers

Cited by 13 publications

References 18 publications

Real-world outcomes of long-term prednisone and deflazacort use in patients with Duchenne muscular dystrophy: experience at a single, large care center

Real-world outcomes of long-term prednisone and deflazacort use in patients with Duchenne muscular dystrophy: experience at a single, large care center

Oral prednisolone suppresses skin inflammation in a healthy volunteer imiquimod challenge model

Formulation and Evaluation of Oral Solution for Rheumatoid Arthritis

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