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Extended release compositions comprising pyridostigmine

Patent on extended release compositions comprising pyridostigmine

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

US Patent 20240299305 addresses an extended-release formulation of pyridostigmine, a drug primarily used to treat myasthenia gravis (MG). The goal of the patent is to create a dosage form that prolongs the drug’s therapeutic effects while minimizing side effects like dose dumping (a rapid release of the drug that can cause adverse effects). The patent describes a gastroretentive drug delivery system, designed to float and remain in the stomach for a longer time, thereby ensuring gradual release and absorption.

A key aspect of this patent is the use of CELLETS®, which are small, inert core particles used as carriers in pharmaceutical formulations. These CELLETS® serve as a starter sphere for the extended-release composition, being coated with layers of active ingredients like pyridostigmine and other substances that control the drug’s release rate. The formulation is intended to provide a controlled, steady release of pyridostigmine, improving patient outcomes by maintaining a stable plasma concentration of the drug for up to 24 hours.

The dosage form also incorporates components like a gas-generating agent, which enables the tablet to float in the stomach, and a water-soluble hydrophilic polymer that swells upon contact with gastric fluids, preventing the tablet from passing through the digestive system too quickly. This gastroretentive property is vital to ensure that the drug stays in the stomach long enough to achieve the desired extended release.

By utilizing CELLETS® and other advanced components, the patent aims to reduce the frequency of administration (allowing for once-daily dosing) and improve patient compliance, which is especially important for MG patients who need consistent, long-term management of their symptoms.

Document information

Document Type and Number:  (“Extended release compositions comprising pyridostigmine”)
Kind Code: A1

Inventors:

Vaka, Siva Ram Kiran (Piscataway, NJ, US)
Desai, Dipen (Basking Ridge, NJ, US)
Phuapradit, Wantanee (Lewes, DE, US)
Shah, Navnit H. (Monmouth Junction, NJ, US)
Shelke, Namdev B. (Hillsborough, NJ, US)

Disclaimer

This text was generated by chatGPT engine version GPT‑4o, on Oct 18, 2024. Image was generated with Adobe Firefly.

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Extended-release compositions comprising atomoxetine
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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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Document information

Document Type and Number:
Kind Code: A1

Inventors:

Tu, Yu-hsing (West Windsor, NJ, US)
Chalamuri, Shanmuka Harish (Plainsboro, NJ, US)
Kathala, Kalyan (Monroe, NJ, US)
Perumal, Ashok (Monmouth Junction, NJ, US)
Lee, James A. (West Windsor, NJ, US)

Disclaimer

This text was generated by chatGPT engine version GPT‑4o, on Oct 18, 2024. Image was generated with Adobe Firefly.

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