Dispersible Tablet Formulation for Lisdexamfetamine Treatment

This pharmaceutical innovation presents a novel dispersible tablet formulation for lisdexamfetamine dimesylate, improving patient compliance and administration flexibility for attention deficit hyperactivity disorder (ADHD) treatment. The dispersible format enables easier administration to patients with difficulty swallowing and provides flexibility in dosing while maintaining the therapeutic efficacy and stability of the active ingredient.

The Problem

Lisdexamfetamine is a standard ADHD treatment that has historically been formulated as capsules or standard tablets, which present challenges for specific patient populations. Patients with difficulty swallowing – including children, elderly individuals, and those with certain medical conditions – may struggle with capsule or tablet administration, leading to missed doses or treatment non-compliance. Caregivers managing pediatric ADHD patients often need flexible dosing options that allow dividing doses appropriately. Existing capsule formulations cannot be easily modified, and standard tablets may not dissolve adequately in liquid formulations some patients prefer. This treatment administration gap leaves certain patient populations without optimal therapeutic options.

What This Invention Does

The innovation develops a dispersible tablet formulation containing lisdexamfetamine dimesylate with specific pharmaceutical excipients selected to enable rapid dispersion in liquid media while maintaining chemical stability and bioavailability. The tablet can be dispersed in water or other liquid vehicles, allowing flexible administration through various routes. The formulation maintains the pharmaceutical properties essential for consistent ADHD symptom management – proper absorption rate, effective plasma concentration achievement, and minimal variability. The dispersible format is particularly valuable for pediatric populations where precise dosing and ease of administration significantly impact treatment outcomes and compliance. Manufacturing processes maintain stability throughout shelf life while supporting efficient industrial-scale production.

Key Features

• Dispersible Format. Tablets rapidly disperse in aqueous vehicles without requiring special equipment or extensive preparation, enabling flexible administration routes.
• Pediatric Accessibility. The dispersible format eliminates swallowing difficulties, making treatment accessible to younger children and providing caregivers with administration flexibility.
• Dosing Flexibility. The tablet format allows convenient dose adjustment by dispersing partial tablets in appropriate liquid volumes, supporting precise therapeutic dosing.
• Stability Maintenance. The formulation maintains chemical integrity of lisdexamfetamine dimesylate throughout the tablet shelf life, ensuring consistent therapeutic efficacy.
• Bioavailability Preservation. Pharmaceutical excipients are selected to ensure dispersible formulations achieve absorption profiles and therapeutic outcomes equivalent to traditional capsule formulations.

Who Is Behind It?

Athena Pharmaceutiques SAS, a French pharmaceutical company, developed this formulation with inventors Mahendra Baliram Chaudhari, Omprakash Doulatram Chandwani, Nitin Pandharinath Nehete, Amol Yuvraj Chaudhari, and Anita Kunal Shahane. Baxter Patent Attorneys Pty Ltd managed the patent application from Sydney. The team represents expertise in pharmaceutical formulation development and drug delivery systems.

Why It Matters

ADHD affects significant populations globally, with treatment rates continuing to increase particularly in pediatric populations. Improving treatment accessibility through better formulations directly impacts patient outcomes and treatment compliance. Dispersible tablet formulations represent an important advancement in drug delivery, expanding therapeutic access to patient populations with specific administration challenges. This is particularly meaningful in pediatric ADHD treatment, where medication compliance significantly predicts academic and behavioral outcomes. The innovation supports pharmaceutical manufacturers in meeting diverse patient needs and supports healthcare providers in optimizing treatment for heterogeneous patient populations with varied administration requirements.

Related Concepts

Lisdexamfetamine is a prodrug converted to d-amphetamine in the body, widely prescribed for ADHD management. Improving its delivery via dispersible tablet formulations addresses a key barrier to treatment adherence for patients – particularly children – who struggle with standard capsule or tablet forms.

The selection of appropriate excipients is fundamental to dispersible tablet development, as they govern both disintegration speed and the bioavailability of the active ingredient. Ensuring equivalent therapeutic outcomes to existing capsule formulations is the central technical challenge in such reformulation work.

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AU 2024267093 was published in the Australian Official Journal of Patents on 19 March 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.