Patent on extended-release compositions comprising atomoxetine

The following patent on “Extended-release compositions comprising atomoxetine” employs CELLETS® as starter spheres made of Microcrystalline Cellulose. Please, read below a summary.

United States Patent Application 20240299307 focuses on an extended-release formulation of atomoxetine, commonly used for treating ADHD. The patent describes a unique pellet-based drug delivery system designed to control the release of atomoxetine over an extended period. This system aims to reduce the dosing frequency and maintain steady drug levels in the bloodstream, enhancing patient compliance and reducing the side effects associated with fluctuating drug levels.

Key Elements of the Invention:

Pellets: The invention uses pellets as the core of the formulation, each containing atomoxetine or a pharmaceutically acceptable salt like atomoxetine hydrochloride. The pellets are coated with a functional layer that controls the rate and duration of drug release.
Extended Release: The functional coating consists primarily of cellulose acetate-based polymers like cellulose acetate phthalate or cellulose acetate butyrate. This coating slows the drug’s release, allowing for less than 40% of the atomoxetine to be released within the first two hours, ensuring a sustained release for 8 to 20 hours, depending on the coating thickness.
Patient Benefits: The extended-release design minimizes the need for multiple daily doses, improving patient adherence to the treatment. Additionally, it helps maintain consistent therapeutic levels of atomoxetine in the bloodstream, reducing the side effects from rapid peaks and valleys in drug concentration.
Manufacturing Process: The pellets are made by applying a drug layer over a nonpareil seed (such as CELLETS®), followed by an optional sealing layer and a functional coating that dictates the extended-release profile. These pellets can be encapsulated or compressed into tablets.

Function of CELLETS®:

CELLETS® are microcrystalline cellulose spheres commonly used as a core in pellet-based formulations. In this patent, CELLETS® act as inert carriers that provide a solid foundation for the application of atomoxetine and subsequent coatings. Their uniform size and shape ensure consistent layering of the drug and functional coatings, which is crucial for achieving the desired release profile. CELLETS® facilitate the manufacturing of multi-particulate systems where each pellet provides a controlled dose of the active ingredient. By using CELLETS®, the formulation can be tailored for extended-release by controlling the thickness of the drug and polymer layers applied to the surface.

In summary, this patent provides an effective method to enhance the therapeutic benefits of atomoxetine, focusing on an extended-release formulation that improves patient outcomes through consistent drug release and convenient dosing.

Product Information

Product, standard sizes	Size
Cellets 100	100-200 µm
Cellets 200	200-355 µm
Cellets 350	350-500 µm
Cellets 500	500-710 µm
Cellets 700	700-1000 µm
Cellets 1000	1000-1400 µm

Source: ingredientpharm, website Extended-release compositions comprising atomoxetine, https://cellets.com/portfolio-item/cellets/

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