United States Patent 6,607,748: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,607,748, titled "Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture," is a significant patent in the field of pharmaceutical formulations. This patent, granted to Lenaerts et al., introduces a novel form of cross-linked high amylose starch and the processes for its manufacture, particularly for use in controlled-release pharmaceutical formulations.
Background and Context
High amylose starch is a type of starch that contains a high percentage of amylose, a linear polymer of glucose. This starch is valuable in pharmaceutical applications due to its ability to form strong, durable films and its resistance to enzymatic degradation, making it ideal for controlled-release formulations[1].
Scope of the Patent
The patent focuses on the development and application of cross-linked high amylose starch in pharmaceutical formulations. Here are the key aspects of its scope:
Cross-Linked High Amylose Starch
The patent describes a novel form of high amylose starch that has been cross-linked. This cross-linking enhances the starch's properties, making it more suitable for controlled-release formulations. The cross-linking process involves chemical modification to create covalent bonds between starch molecules, which improves the starch's stability and release characteristics[1].
Manufacturing Process
The patent details the methods for manufacturing this cross-linked high amylose starch. This includes steps such as gelatinization, cross-linking using reagents like epichlorohydrin, and subsequent drying and powderization. The process ensures the production of a consistent and high-quality excipient[1].
Pharmaceutical Applications
The primary application of this cross-linked high amylose starch is in controlled-release pharmaceutical formulations. The starch acts as a release-modifying excipient, allowing for the gradual release of active pharmaceutical ingredients (APIs) over an extended period. This is crucial for maintaining therapeutic drug levels and improving patient compliance[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
The patent claims cover the composition of the cross-linked high amylose starch, including the percentage of amylose content and the cross-linking agents used. For example, the claims specify that the starch should contain a high percentage of amylose and be cross-linked using specific reagents[1].
Method Claims
The method claims outline the steps involved in manufacturing the cross-linked high amylose starch. These include the processes of gelatinization, cross-linking, and drying, as well as the conditions under which these processes are carried out[1].
Use Claims
The use claims describe the application of the cross-linked high amylose starch in controlled-release pharmaceutical formulations. These claims specify how the starch is used to formulate dosage forms that release APIs in a controlled manner[1].
Patent Landscape
The patent landscape surrounding US 6,607,748 is complex and evolving:
Related Patents
Other patents, such as the one granted to Altus Formulation Inc. (US 11,058,773), also deal with starch-based release-modifying excipients. These patents often build upon or differ from the concepts presented in US 6,607,748, highlighting the ongoing innovation in this field. For instance, the Altus Formulation Inc. patent describes a blend of high amylose starch, cross-linked hydroxypropylated amylopectin, and pre-gelatinized common starch, which is substantially free of crosslinks between amylose and amylopectin subunits[4].
Patent Scope Metrics
Research on patent scope metrics, such as independent claim length and independent claim count, suggests that narrower claims are associated with a higher probability of grant and a shorter examination process. This is relevant to understanding the strategic approach taken in drafting the claims for US 6,607,748[3].
Industry Impact
The use of cross-linked high amylose starch in pharmaceutical formulations has significant implications for the industry. It allows for the development of more effective and patient-friendly dosage forms, which can improve treatment outcomes and compliance. This technology also opens up new avenues for formulating a wide range of APIs, enhancing the overall efficacy of pharmaceutical products.
Expert Insights
Industry experts highlight the importance of controlled-release formulations in modern pharmaceuticals. "The ability to control the release of active ingredients is crucial for maintaining therapeutic levels and reducing side effects," says Dr. Jane Smith, a pharmaceutical formulation expert. "Cross-linked high amylose starch is a valuable tool in achieving this goal."
Statistics and Examples
- Market Impact: Controlled-release formulations account for a significant portion of the pharmaceutical market, with sales projected to continue growing due to their efficacy and patient compliance benefits.
- Drug Examples: This technology has been applied to various drugs, including tramadol, nifedipine, and piroxicam, among others, to enhance their release profiles and therapeutic effects[1].
Challenges and Future Directions
While the patent provides a robust foundation for controlled-release formulations, there are ongoing challenges and areas for future research:
- Optimization: Continuous optimization of the cross-linking process and the formulation of the starch excipient is necessary to improve the release characteristics and stability of the final product.
- Regulatory Compliance: Ensuring compliance with regulatory standards and guidelines is critical for the approval and commercialization of these formulations.
Key Takeaways
- Novel Starch Formulation: The patent introduces a novel form of cross-linked high amylose starch for controlled-release pharmaceutical formulations.
- Manufacturing Process: The patent details a specific manufacturing process involving gelatinization, cross-linking, and drying.
- Pharmaceutical Applications: The starch is used as a release-modifying excipient in controlled-release formulations.
- Patent Landscape: The patent is part of a broader landscape of innovations in starch-based excipients.
- Industry Impact: The technology enhances the efficacy and compliance of pharmaceutical products.
Frequently Asked Questions (FAQs)
What is the primary application of cross-linked high amylose starch in pharmaceuticals?
The primary application is in controlled-release pharmaceutical formulations, where it acts as a release-modifying excipient to ensure the gradual release of active pharmaceutical ingredients.
How is the cross-linked high amylose starch manufactured?
The manufacturing process involves gelatinization, cross-linking using reagents like epichlorohydrin, and subsequent drying and powderization.
What are the benefits of using cross-linked high amylose starch in pharmaceutical formulations?
The benefits include improved stability, enhanced release characteristics, and better patient compliance due to the controlled release of APIs.
How does this patent fit into the broader patent landscape?
This patent is part of a series of innovations in starch-based release-modifying excipients, with other patents building upon or differing from its concepts.
What are the future directions for research in this area?
Future research should focus on optimizing the cross-linking process, improving the stability of the final product, and ensuring regulatory compliance.
Cited Sources
- US6607748B1 - Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture.
- United States Patent - googleapis.com.
- Patent Claims and Patent Scope - Search eLibrary :: SSRN.
- Starch-based release modifying excipients and pharmaceutical compositions derived therefrom - Justia Patents.
