United States Patent 5,776,432: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,776,432, titled "Beclomethasone Solution Aerosol Formulations," was granted on July 7, 1998, to inventors Schultz et al. This patent is significant in the field of pharmaceutical aerosol formulations, particularly for respiratory treatments. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Beclomethasone 17,21-dipropionate is a corticosteroid commonly used in inhalation aerosols for treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The invention described in this patent aims to improve the formulation and stability of beclomethasone aerosols.
Scope of the Invention
The patent focuses on the development of solution aerosol formulations containing beclomethasone 17,21-dipropionate. The key aspects of the invention include:
Formulation Components
- The formulations consist of beclomethasone 17,21-dipropionate as the active ingredient.
- A hydrofluorocarbon (HFC) propellant, preferably 1,1,1,2-tetrafluoroethane, which constitutes about 80 to 99 percent by weight of the total formulation[4].
- A cosolvent, such as ethanol, to assist in the dissolution of the medicament in the propellant.
Preparation Method
The formulations are prepared by dissolving the active ingredient in the cosolvent, metering the solution into an aluminum vial, and then pressure-filling the vial with the HFC propellant[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the aerosol formulation comprising beclomethasone 17,21-dipropionate, an HFC propellant, and a cosolvent, with specific weight percentages of the components[4].
Dependent Claims
- Subsequent claims detail various aspects such as the preferred range of the propellant's weight percentage, the absence of surfactants, and the use of specific actuators and valves[4].
Patent Landscape: Related Patents and Technologies
International Patent Family
The patent is part of an international patent family, with corresponding applications and grants in other countries, such as Mexico (MX9203481A)[4].
Prior Art and Citations
The patent cites prior art related to aerosol formulations but introduces a novel combination of components and a method of preparation that enhances the stability and respirable fraction of the aerosol[4].
Global Dossier and IP5 Offices
For a comprehensive view, the Global Dossier service provided by the USPTO allows users to access the file histories of related applications from participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA)[1].
Impact on the Pharmaceutical Industry
Improvements in Formulation
The invention has contributed significantly to the development of more stable and effective aerosol formulations for respiratory treatments. The use of HFC propellants and a cosolvent like ethanol has improved the respirable fraction of the aerosol, making it more efficient for patients[4].
Regulatory Compliance
The patent aligns with regulatory requirements and safety standards, ensuring that the formulations are substantially free of surfactants and other unwanted components[4].
Economic and Market Implications
Market Dominance
Patents like US 5,776,432 can provide a competitive edge in the market by protecting innovative formulations and manufacturing processes. This can lead to market dominance and higher revenue for the patent holders.
Research and Development
The detailed information on claims and scope provided by datasets like the Patent Claims Research Dataset can facilitate further research and development in the field of pharmaceutical aerosols[3].
Search and Analysis Tools
USPTO Resources
Tools such as the Patent Public Search, Global Dossier, and Patent Examination Data System (PEDS) are crucial for conducting thorough searches and analyses of patents like US 5,776,432[1].
International Databases
Access to international patent databases through services like PATENTSCOPE by WIPO and esp@cenet by the EPO is essential for a global perspective on the patent landscape[1].
Key Takeaways
- Innovative Formulation: The patent introduces a novel solution aerosol formulation for beclomethasone 17,21-dipropionate using HFC propellants and a cosolvent.
- Improved Stability: The formulation enhances the stability and respirable fraction of the aerosol, making it more effective for respiratory treatments.
- Regulatory Compliance: The patent ensures compliance with safety standards by being substantially free of surfactants.
- Market Impact: The patent can provide a competitive edge and contribute to market dominance in the pharmaceutical industry.
- Research and Development: The detailed claims and scope data can facilitate further innovation in pharmaceutical aerosols.
FAQs
What is the main innovation of US Patent 5,776,432?
The main innovation is the development of a solution aerosol formulation for beclomethasone 17,21-dipropionate using hydrofluorocarbon propellants and a cosolvent like ethanol.
How does the formulation improve the respirable fraction of the aerosol?
The use of HFC propellants and a cosolvent enhances the dissolution of the medicament, leading to a higher respirable fraction and improved efficacy.
What are the key components of the formulation?
The key components include beclomethasone 17,21-dipropionate, an HFC propellant (preferably 1,1,1,2-tetrafluoroethane), and a cosolvent (such as ethanol).
Is the patent part of an international patent family?
Yes, the patent has corresponding applications and grants in other countries, such as Mexico.
How can one access detailed information on the claims and scope of this patent?
Detailed information can be accessed through the USPTO's Patent Public Search, Global Dossier, and other international patent databases.
Cited Sources:
- USPTO - Search for patents.
- United States Patent [191 - googleapis.com].
- Patent Claims Research Dataset - USPTO.
- US5776432A - Beclomethasone solution aerosol formulations - Google Patents.
- Pharmaceutical aerosol formulations containing fluoroalkanes ... - PubChem.
