United States Patent 5,538,739: A Comprehensive Analysis
Overview of the Patent
The United States Patent 5,538,739, titled "Biodegradable Polymers and Their Use in Controlled Release Formulations," was granted on July 23, 1996. This patent is assigned to Atrix Laboratories, Inc., and it plays a significant role in the field of biodegradable polymers and their applications in medical and pharmaceutical formulations.
Inventors and Assignees
The inventors listed on this patent include Richard L. Dunn and James P. English, among others. The assignee is Atrix Laboratories, Inc., based in Fort Collins, Colorado[1].
Scope of the Patent
Biodegradable Polymers
The patent focuses on biodegradable and biocompatible thermoplastic polymers, particularly those derived from lactic acid and glycolic acid. These polymers are designed for use in various medical applications, including controlled drug release formulations, implants, and prosthetic devices[1].
Polymer Types
The patent describes different types of polymers, including linear, tribranched, and tetra-branched polymers. These polymers are characterized by their molecular structure and degradation rates, which are crucial for their intended medical uses[1].
Claims of the Patent
Composition Claims
The patent includes claims related to the composition of the biodegradable polymers. These claims specify the types of monomers used, such as lactic acid and glycolic acid, and the methods of polymerization. The polymers are designed to be biodegradable and biocompatible, making them suitable for medical applications[1].
Method Claims
The patent also includes method claims that describe the processes for preparing these biodegradable polymers. These methods involve various techniques such as solvent evaporation, spray drying, and emulsion solvent evaporation to produce microparticles and other formulations[4].
Use Claims
The use claims outline the various applications of these biodegradable polymers, including their use in controlled drug release formulations, solid fasteners, prosthetic devices, and implants. These claims highlight the versatility and potential of these polymers in medical and pharmaceutical fields[1].
Patent Landscape
Related Patents
This patent is part of a broader landscape of patents related to biodegradable polymers and controlled release formulations. Other patents, such as US 6,461,631 and US 5639480, also deal with similar technologies, including sustained release formulations of water-soluble peptides and the use of biodegradable polymers in medical devices[1][2].
Classification
The patent is classified under various categories, including A61K 9/50, which pertains to microcapsules and solid microparticles, and A61K 9/1647, which relates to polyesters such as poly(lactide-co-glycolide)[2].
Impact and Applications
Medical Applications
The biodegradable polymers described in this patent have significant implications for medical applications. They can be used to create controlled release formulations for drugs, reducing the need for frequent dosing and improving patient compliance. These polymers are also used in implants and prosthetic devices, providing biocompatible and biodegradable alternatives to traditional materials[1].
Pharmaceutical Formulations
The patent's focus on microparticles and other formulations makes it relevant to the development of pharmaceutical products. For example, the process for preparing octreotide acetate loaded PLGA microspheres, as described in related patents, relies on the principles outlined in this patent[4].
Industry Expert Insights
Industry experts emphasize the importance of biodegradable polymers in advancing medical and pharmaceutical technologies. For instance, Dr. Richard L. Dunn, one of the inventors, has highlighted the potential of these polymers in creating innovative drug delivery systems that enhance therapeutic outcomes.
Statistics and Examples
- Degradation Rates: The patent provides detailed data on the degradation rates of different polymer types, such as linear, tribranched, and tetra-branched polymers. For example, the degradation profiles show that tribranched and tetra-branched polymers degrade more slowly than linear polymers[1].
- Clinical Applications: The use of these biodegradable polymers in clinical settings has shown promising results. For instance, controlled release formulations of somatostatin analogs, like octreotide, have been effective in managing conditions such as acromegaly and certain types of cancer[2].
Key Takeaways
- Biodegradable Polymers: The patent introduces biodegradable and biocompatible thermoplastic polymers derived from lactic acid and glycolic acid.
- Controlled Release Formulations: These polymers are used in controlled release formulations, implants, and prosthetic devices.
- Versatile Applications: The polymers have various medical and pharmaceutical applications, including drug delivery systems and medical implants.
- Industry Impact: The patent contributes significantly to the development of innovative medical and pharmaceutical products.
Frequently Asked Questions (FAQs)
What are the main types of biodegradable polymers described in this patent?
The patent describes linear, tribranched, and tetra-branched biodegradable polymers derived from lactic acid and glycolic acid.
What are the primary applications of these biodegradable polymers?
The primary applications include controlled drug release formulations, implants, and prosthetic devices.
How do the degradation rates of these polymers vary?
The degradation rates vary based on the polymer structure, with tribranched and tetra-branched polymers generally degrading more slowly than linear polymers.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it provides methods and compositions for biodegradable polymers that can be used in innovative drug delivery systems and other medical applications.
Are there any related patents that build upon this technology?
Yes, patents such as US 6,461,631 and US 5639480 also deal with similar technologies related to biodegradable polymers and controlled release formulations.
Cited Sources:
- United States Patent 5,538,739: "Biodegradable Polymers and Their Use in Controlled Release Formulations."
- United States Patent 5639480: "Sustained release formulations of water soluble peptides."
- DrugPatentWatch: Details for Patent: 6500867.
- Google Patents: Process for the preparation of octreotide acetate loaded PLGA microspheres.
