Detailed Analysis of the Scope and Claims of United States Patent 4,808,610
Introduction
United States Patent 4,808,610, titled "Mometasone furoate anti-inflammatory cream composition using hexylene glycol," is a significant patent in the field of dermatological treatments. This patent, issued to Schering Corporation, addresses the formulation and application of mometasone furoate, a potent anti-inflammatory steroid, in a topical cream.
Background and Context
Mometasone furoate is a synthetic corticosteroid with anti-inflammatory properties, widely used in the treatment of various dermatological disorders such as contact and allergic dermatitis, eczemas, and psoriasis. However, its poor solubility in water and common solvents posed a challenge in developing a cosmetically elegant and effective topical formulation[1].
Scope of the Patent
The patent focuses on overcoming the solubility issues of mometasone furoate by developing a cream formulation that incorporates hexylene glycol. Here are the key aspects of the patent's scope:
Formulation Components
- The patent describes a cream formulation that includes mometasone furoate, hexylene glycol, and various other ingredients such as emulsifying agents, petrolatum, white petrolatum, titanium dioxide, and aluminum starch octenylsuccinate. These components enhance the solubility and stability of mometasone furoate, making it suitable for topical application[1].
Cosmetic Elegance
- The formulation is designed to have cosmetic elegance, meaning it is aesthetically pleasing and comfortable to use. This is crucial for patient compliance and acceptance[1].
Therapeutic Use
- The cream is intended for the topical treatment of dermatological disorders. It is applied to completely cover the affected area, typically once daily, although less frequent application may be sufficient for maintenance therapy in some patients[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Composition
- The first claim describes the composition of the cream, which includes mometasone furoate, hexylene glycol, and a mixture of other ingredients to form a stable and cosmetically elegant cream[1].
Claim 2: Method of Preparation
- This claim outlines the method of preparing the cream formulation, including the steps of mixing the ingredients and ensuring the uniform distribution of mometasone furoate[1].
Claim 3: Therapeutic Application
- The third claim specifies the therapeutic use of the cream for treating dermatological disorders such as contact and allergic dermatitis, eczemas, and psoriasis[1].
Claim 4: Stability and Solubility
- This claim emphasizes the improved stability and solubility of mometasone furoate in the formulated cream, which is achieved through the use of hexylene glycol[1].
Claim 5: Cosmetic Acceptability
- The fifth claim highlights the cosmetic acceptability of the cream, ensuring it is pleasant to use and does not cause irritation or other adverse effects[1].
Claim 6: Specific Formulation Example
- The final claim provides a specific example of the formulation, detailing the exact percentages of each ingredient and how they are combined to achieve the desired properties[1].
Patent Landscape
The patent landscape surrounding US 4,808,610 is complex and involves several related patents and technologies:
Related Patents
- Other patents, such as US 4,472,393, also disclose compounds and methods related to mometasone furoate and its use in treating inflammatory conditions. These patents often build upon or complement the invention described in US 4,808,610[1][2].
Competing Formulations
- Competitors have developed alternative formulations of mometasone furoate, such as oil-in-water emulsions, which are described in other patents like US 7,312,207. These formulations may offer different advantages or improvements over the original cream composition[2].
International Patents
- The invention is also protected by international patents, such as the European Patent EP 2 962 688 B1, which covers similar compositions and methods for treating dermatological disorders[2].
Impact and Significance
The patent has had a significant impact on the treatment of dermatological disorders:
Clinical Use
- The cream formulation of mometasone furoate has become a standard treatment for various skin conditions, offering effective anti-inflammatory action with minimal side effects[1].
Pharmaceutical Development
- The use of hexylene glycol as a solubilizing agent has influenced the development of other topical formulations, not just for corticosteroids but also for other poorly soluble drugs[1].
Patient Compliance
- The cosmetic elegance of the formulation has improved patient compliance, as the cream is more acceptable and comfortable to use compared to earlier formulations[1].
Key Takeaways
- Improved Solubility: The patent introduces the use of hexylene glycol to enhance the solubility of mometasone furoate in a topical cream.
- Cosmetic Elegance: The formulation is designed to be aesthetically pleasing and comfortable to use.
- Therapeutic Use: The cream is effective in treating various dermatological disorders.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and international protections.
- Impact: The invention has significantly improved the treatment of skin conditions and influenced pharmaceutical development.
FAQs
What is the main challenge addressed by US Patent 4,808,610?
The main challenge addressed is the poor solubility of mometasone furoate in water and common solvents, which hindered the development of an effective and cosmetically elegant topical cream.
What role does hexylene glycol play in the formulation?
Hexylene glycol acts as a solubilizing agent, improving the solubility and stability of mometasone furoate in the cream formulation.
What are the typical applications of the cream formulation?
The cream is used to treat dermatological disorders such as contact and allergic dermatitis, eczemas, and psoriasis.
How often is the cream typically applied?
The cream is usually applied once daily, although less frequent application may be sufficient for maintenance therapy in some patients.
What is the significance of cosmetic elegance in the formulation?
Cosmetic elegance ensures that the cream is aesthetically pleasing and comfortable to use, which improves patient compliance.
Sources
- US Patent 4,808,610 - Mometasone furoate anti-inflammatory cream composition using hexylene glycol.
- European Patent EP 2 962 688 B1 - OIL-IN-WATER EMULSION OF MOMETASONE AND PROPYLENE GLYCOL.
- Patent Analytics - Intellectual Property Law.
