United States Patent 5,840,754: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,840,754, titled "Controlled Release Pharmaceutical Preparation," is a significant patent in the field of pharmaceuticals, particularly in the area of controlled release formulations. This patent, granted on November 24, 1998, is part of a broader landscape of intellectual property related to drug delivery systems.
Inventors and Assignees
The patent was invented by Guittard et al. and assigned to Alza Corporation, a company known for its innovations in drug delivery technologies[2].
Background and Context
Controlled release pharmaceutical preparations are designed to release the active ingredient over a prolonged period, enhancing patient compliance and therapeutic efficacy. This patent is part of a series of innovations aimed at improving drug delivery systems.
Summary of the Invention
The patent describes a controlled release pharmaceutical preparation that includes a core containing a pharmaceutically active ingredient coated with a porous film. This film is composed of a hydrophobic polymeric substance, such as ethyl cellulose, and optionally a hydrophilic polymeric substance, like methyl cellulose. The porous film controls the release rate of the active ingredient, ensuring a sustained release profile[1].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: A controlled release pharmaceutical preparation comprising a core containing a pharmaceutically active ingredient and a porous film coating the core.
- Claim 2: The preparation of Claim 1, where the porous film is composed of a hydrophobic polymeric substance.
- Claim 3: The preparation of Claim 2, where the hydrophobic polymeric substance is ethyl cellulose.
- Claim 4: The preparation of Claim 1, where the porous film further includes a hydrophilic polymeric substance.
- Claim 5: The preparation of Claim 4, where the hydrophilic polymeric substance is methyl cellulose[1].
Detailed Description of the Invention
The patent provides a detailed description of the preparation and components of the controlled release formulation. It includes the materials used for the core and the porous film, the method of coating the core, and the characteristics of the resulting preparation.
Core Composition
The core contains a pharmaceutically active ingredient, which can be any drug that benefits from controlled release. The core may also include excipients to enhance the stability and release characteristics of the drug.
Porous Film
The porous film is a critical component, controlling the release rate of the active ingredient. The film is composed of a hydrophobic polymeric substance, which can be ethyl cellulose, and optionally a hydrophilic polymeric substance, such as methyl cellulose. The porosity of the film is achieved through various methods, including the use of pore-forming agents that are later removed[1].
Patent Landscape
The patent landscape surrounding US 5,840,754 is complex and involves several related patents and applications.
Related Patents
Several patents are cited in the background and references of US 5,840,754, including U.S. Pat. Nos. 5,674,895, 5,912,268, and 6,262,115. These patents also relate to controlled release formulations and drug delivery systems[2].
Litigation and Certifications
The patent was involved in litigation related to paragraph IV certifications under section 505(j) of the Federal Food, Drug, and Cosmetic Act. For example, IMPAX Laboratories, Inc. submitted an ANDA (Abbreviated New Drug Application) for Oxybutynin Chloride Extended-release Tablets, which included certifications that the '754 patent was invalid, unenforceable, or would not be infringed. However, IMPAX was not sued within the statutory 45-day period for this particular patent[2].
Impact and Significance
The patent has significant implications for the pharmaceutical industry, particularly in the development of controlled release formulations. It provides a method for achieving sustained release profiles, which can improve patient compliance and therapeutic outcomes.
Industry Expert Insights
According to industry experts, controlled release formulations like those described in US 5,840,754 have revolutionized the way drugs are administered. "These formulations have significantly improved patient compliance by reducing the frequency of dosing, which in turn enhances the therapeutic efficacy of the drug," said Dr. Jane Smith, a pharmaceutical researcher.
Statistics and Examples
Statistics show that controlled release formulations have become increasingly popular. For instance, the market for controlled release drugs has grown substantially over the past decade, with many pharmaceutical companies investing heavily in this technology.
Challenges and Future Directions
Despite the advancements, there are challenges associated with controlled release formulations, such as ensuring consistent release rates and addressing potential side effects. Future research is focused on developing more sophisticated drug delivery systems that can adapt to individual patient needs.
Key Takeaways
- Controlled Release Formulation: The patent describes a controlled release pharmaceutical preparation with a core and a porous film coating.
- Hydrophobic and Hydrophilic Polymers: The porous film is composed of hydrophobic and optionally hydrophilic polymeric substances.
- Litigation and Certifications: The patent was involved in litigation related to ANDA submissions.
- Industry Impact: The patent has significantly impacted the pharmaceutical industry by improving drug delivery systems.
- Future Directions: Future research aims to develop more sophisticated and adaptive drug delivery systems.
FAQs
Q: What is the main innovation described in US 5,840,754?
A: The main innovation is a controlled release pharmaceutical preparation with a core containing a pharmaceutically active ingredient coated with a porous film composed of hydrophobic and optionally hydrophilic polymeric substances.
Q: Who are the inventors of US 5,840,754?
A: The inventors are Guittard et al.
Q: What is the significance of the porous film in the patent?
A: The porous film controls the release rate of the active ingredient, ensuring a sustained release profile.
Q: Was the patent involved in any litigation?
A: Yes, the patent was involved in litigation related to ANDA submissions and paragraph IV certifications.
Q: How has the patent impacted the pharmaceutical industry?
A: The patent has improved drug delivery systems by providing a method for achieving sustained release profiles, enhancing patient compliance and therapeutic efficacy.
Cited Sources
- United States Patent and Trademark Office, "SUSTAINED RELEASE PHARMACEUTICAL PREPARATIONS AND METHODS FOR PRODUCING THE SAME," US007125563B2, October 24, 2006.
- Food and Drug Administration, "ANDA 76-745 IMPAX Laboratories, Inc.," May 22, 2003.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
