Drug intelligence / Profile preview

Dual-release hydrocortisone

Development stage
Unknown
Lead developer
Takeda
Modality
Drug Delivery Systems
Administration
Oral
01

Overview

Dual-release hydrocortisone is a novel formulation of hydrocortisone designed to mimic the natural circadian rhythm of cortisol secretion in the body. This medication has been developed specifically for the treatment of adrenal insufficiency (AI), providing a more physiological cortisol profile compared to conventional glucocorticoid replacement therapies. ## Formulation and Mechanism Dual-release hydrocortisone consists of an immediate-release coating and an extended-release core in a single tablet[1]. The outer coating allows for rapid initial drug release (within 10 minutes), followed by a steady, slower release from a gel matrix core over the first six to eight hours[4]. The total dose is released and absorbed within 16-18 hours after intake[4]. This unique formulation provides several advantages: - It creates a more physiological cortisol profile throughout the day - It allows for once-daily dosing, improving patient compliance - It avoids the supraphysiological cortisol peaks associated with conventional multi-dose regimens ## Clinical Benefits Studies have demonstrated multiple benefits of switching from conventional glucocorticoid therapy to dual-release hydrocortisone: **Metabolic Improvements:** - Decreased HbA1c levels - Improved lipid profiles (reduced total cholesterol, triglycerides, and LDL cholesterol) - Reduced BMI[3][5] **Inflammatory and Immune Benefits:** - Improved serum inflammatory parameters - Better immunomodulatory effects on peripheral circulating lymphocytes[2] **Quality of Life:** - Significant improvement in patient-reported quality of life - Better treatment compliance due to once-daily dosing[3][5] ## Administration Dual-release hydrocortisone is typically taken once daily in the morning, though some studies have explored fractionated dosing (e.g., 20 mg in the morning and 5 mg in the afternoon)[5]. The medication allows for a reduction in the total daily cortisol dose compared to conventional regimens while maintaining effective control of adrenal insufficiency[3]. In the event of intercurrent illness, patients may be instructed to double their daily dose, with the additional dose taken approximately eight hours after the normal morning dose[4]. ## Safety Profile The dual-release formulation appears to be safe and well-tolerated. By providing more physiological cortisol levels throughout the day, it may reduce the risk of adverse effects associated with conventional glucocorticoid replacement, such as: - Infections - Diabetes mellitus - Cardiovascular disease - Decreased bone mineral density[2][3] This formulation represents a significant advancement in the treatment of adrenal insufficiency, offering improved biochemical control, metabolic parameters, and quality of life compared to conventional hydrocortisone or cortisone acetate regimens.

Brand names
Plenadren
Other names
cortisolhydrocortisone modified-release
02

Targets

GR (Glucocorticoid receptor)

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