United States Patent 5,082,668: A Comprehensive Analysis
Introduction
United States Patent 5,082,668, titled "Controlled-release system with constant pushing source," is a significant innovation in the field of drug delivery systems. This patent, granted to inventors who developed a novel osmotic device, has far-reaching implications for the administration of beneficial agents, particularly those that are difficult to deliver in a controlled manner.
Background and Context
The patent addresses a critical need in pharmaceuticals: the delivery of beneficial agents at a controlled and constant rate over a prolonged period. Traditional delivery systems often face challenges with agents that have varying solubilities or are highly potent and require precise dosing[1].
Key Components of the Invention
Osmotic Device Structure
The invention involves an osmotic device with a semipermeable wall surrounding a compartment. This compartment contains two key compositions:
- First Composition: This includes a beneficial agent, an osmopolymer, and optionally an osmagent. The beneficial agent can range from insoluble to very soluble in aqueous and biological fluids.
- Second Composition: This comprises an osmopolymer and an optional osmagent but is free of the beneficial agent. The second composition acts as a constant pushing means to deliver the first composition[1].
Mechanism of Action
The device operates by imbibing external fluid across the semipermeable wall, which causes the hydrogel in the second composition to expand. This expansion exerts a constant force against the first composition, pushing it through a passageway and ensuring a controlled release of the beneficial agent. The design ensures that the delivery rate is maintained over time, even for agents with varying solubilities[1].
Scope and Claims
Primary Claims
The patent claims cover the osmotic device as a whole, including its structure and the method of delivering the beneficial agent. Key claims include:
- The device's compartmentalized structure with two compositions.
- The use of a semipermeable wall and passageway for controlled release.
- The mechanism involving the expansion of a hydrogel to push the beneficial agent out of the device[1].
Secondary Claims
Secondary claims extend to specific applications and variations of the device, such as:
- The use of different types of osmopolymers and osmagents.
- The delivery of various beneficial agents, including drugs that are difficult to administer due to their solubility or potency.
- The integration of the device into different forms, such as oral or implantable delivery systems[1].
Patent Landscape Analysis
Existing Patents and Technologies
The patent landscape in the field of controlled-release drug delivery systems is rich with innovations. Other patents, such as those related to oral controlled release formulations for sedative and hypnotic agents, highlight the ongoing efforts to improve drug delivery mechanisms[2].
Trends and Key Players
The trend in this field is towards more precise and controlled delivery systems. Key players include pharmaceutical companies and research institutions that are continuously developing new technologies to address the challenges of drug delivery. The analysis of citations and evolution of patents in this domain reveals a strong focus on improving the efficacy and safety of drug administration[3].
Competitive Landscape
The competitive landscape is characterized by a high level of innovation, with multiple players vying to develop the most effective controlled-release systems. The patent in question represents a significant advancement, particularly in its ability to handle beneficial agents with diverse solubility profiles. This innovation positions the inventors and their associated entities as key players in the market[3].
Impact and Applications
Therapeutic Benefits
The controlled-release system described in the patent offers several therapeutic benefits, including:
- Improved Efficacy: By delivering drugs at a constant rate, the system ensures that the therapeutic levels of the drug are maintained over a prolonged period.
- Enhanced Patient Compliance: The system reduces the need for frequent dosing, making it easier for patients to adhere to their treatment regimens.
- Reduced Side Effects: The controlled release minimizes the peaks and troughs associated with traditional dosing, potentially reducing side effects[1].
Industrial and Commercial Implications
The invention has significant industrial and commercial implications:
- Market Dominance: Companies that adopt this technology can gain a competitive edge in the pharmaceutical market.
- Regulatory Approvals: The controlled-release mechanism can facilitate easier regulatory approvals due to its predictable and consistent delivery profile.
- Cost Savings: By improving efficacy and reducing the need for frequent dosing, the system can lead to cost savings for both manufacturers and patients[3].
Challenges and Future Directions
Technical Challenges
While the invention is a major breakthrough, there are technical challenges to consider, such as:
- Material Compatibility: Ensuring that the materials used in the device are compatible with the beneficial agent and the biological environment.
- Scalability: Scaling up the production of these devices while maintaining their efficacy and consistency[1].
Future Innovations
Future innovations in this field may include:
- Advanced Materials: The development of new materials that can enhance the performance and durability of the osmotic device.
- Personalized Medicine: Tailoring the controlled-release system to individual patient needs based on genetic profiles or specific health conditions[3].
Key Takeaways
- Innovative Design: The patent introduces a novel osmotic device with a dual composition system for controlled drug release.
- Therapeutic Benefits: The system ensures a constant and controlled delivery of beneficial agents, improving efficacy and patient compliance.
- Market Impact: The invention has significant implications for the pharmaceutical industry, offering a competitive edge and potential cost savings.
- Future Directions: Future research should focus on addressing technical challenges and exploring new materials and applications.
FAQs
Q: What is the primary mechanism of the controlled-release system described in US Patent 5,082,668?
A: The primary mechanism involves an osmotic device with a semipermeable wall and two compositions. The second composition expands to push the first composition, containing the beneficial agent, through a passageway at a controlled rate.
Q: What types of beneficial agents can be delivered using this system?
A: The system can deliver beneficial agents that are insoluble to very soluble in aqueous and biological fluids, including highly potent drugs that require precise dosing.
Q: How does the device ensure a constant release rate?
A: The device ensures a constant release rate through the continuous expansion of a hydrogel in the second composition, which exerts a constant force against the first composition, pushing the beneficial agent out of the device.
Q: What are the therapeutic benefits of this controlled-release system?
A: The system offers improved efficacy, enhanced patient compliance, and reduced side effects by maintaining therapeutic drug levels over a prolonged period.
Q: What are the potential industrial and commercial implications of this invention?
A: The invention can lead to market dominance, easier regulatory approvals, and cost savings for pharmaceutical companies and patients.
