Mydayis Release Mechanism
Mydayis utilizes a triple-bead delivery system containing three types of drug-releasing beads: immediate-release beads that release medication upon ingestion, and two different delayed-release (DR) beads that release amphetamine at pH 5.5 and pH 7.0, respectively 1.
Detailed Mechanism
The capsule's sophisticated design creates a prolonged pharmacokinetic profile:
- Immediate-release component: Releases the first portion of medication immediately upon ingestion
- First delayed-release beads: Activate at pH 5.5 (approximately 4 hours post-dose)
- Second delayed-release beads: Activate at pH 7.0 (later in the gastrointestinal tract)
This triple-bead system produces peak plasma concentrations approximately 7-10 hours post-dose in pediatric patients and about 8 hours in adults for both d-amphetamine and l-amphetamine 1.
Clinical Pharmacokinetics
The release pattern of Mydayis 37.5 mg provides comparable plasma concentration profiles to taking mixed amphetamine salts extended-release (MAS-ER) 25 mg followed by an immediate-release 12.5 mg dose 8 hours later 1. This design addresses the clinical need for extended symptom control throughout a full day, with duration of action up to 16 hours 2.
The pH-dependent release mechanism means:
- Steady-state is achieved between days 7-8 of dosing
- Mean accumulation ratio is 1.6
- Terminal half-life ranges from 10-11 hours for d-amphetamine and 10-13 hours for l-amphetamine 1
Food Effects
High-fat meals do not affect the extent of absorption but significantly delay Tmax by approximately 5 hours for d-amphetamine (from 7.0 to 12.0 hours) and 4.5 hours for l-amphetamine 1. This delayed absorption may impact symptom control timing, so consistent administration timing relative to meals is advisable.
Clinical Implications
The triple-bead technology represents an evolution from earlier extended-release formulations. Unlike older wax-matrix sustained-release preparations that had delayed onset and lower peak concentrations 3, Mydayis provides both immediate symptom control and extended coverage. The pH-dependent release is less susceptible to gastrointestinal variability compared to osmotic-release systems 4.
Patients should be counseled to avoid alcohol while taking Mydayis, as alcohol consumption may result in more rapid release of the entire dose 1, potentially causing dose dumping and increased risk of adverse effects or overdose.