Sulfoalkyl Ether Cyclodextrin Compositions: A Detailed Analysis of US Patent 9,750,822
Introduction
The United States Patent 9,750,822, titled "Sulfoalkyl ether cyclodextrin compositions," is a significant patent in the field of pharmaceutical formulations, particularly involving cyclodextrins. This patent, assigned to CyDex Pharmaceuticals, Inc., provides insights into the composition, preparation, and use of sulfoalkyl ether cyclodextrins (SAE-CDs). Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Cyclodextrins
Cyclodextrins are cyclic oligosaccharides that have been widely used in pharmaceutical formulations to enhance the solubility, stability, and bioavailability of drugs. They form inclusion complexes with guest molecules, which can be drugs or other active pharmaceutical ingredients (APIs)[5].
Patent Overview
Inventor and Assignee
The patent was invented by Vincent D. Antle and assigned to CyDex Pharmaceuticals, Inc.[5].
Issue Date and Expiration
The patent was issued on March 13, 2018, and is set to expire on March 13, 2029[5].
Scope of the Patent
Composition
The patent describes sulfoalkyl ether cyclodextrin compositions that include a sulfoalkyl ether cyclodextrin. These compositions are characterized by having an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry at a wavelength of 245 nm to 270 nm for an aqueous solution containing 300 mg of the SAE-CD composition per mL of solution in a cell having a 1 cm path length[1][5].
Preparation Methods
The patent outlines various methods for preparing these SAE-CD compositions, including the reaction of cyclodextrin with a sulfoalkylating agent. The process involves careful control of reaction conditions to ensure the desired level of substitution and purity of the final product[1].
Use in Pharmaceutical Formulations
SAE-CDs are used to improve the solubility and stability of drugs. They can form inclusion complexes with a wide range of APIs, enhancing their pharmacokinetic properties. The patent specifies the use of these compositions in various pharmaceutical formulations, including solutions, suspensions, and solid dosage forms[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the composition of the SAE-CDs, the methods of preparing them, and their use in pharmaceutical formulations. For example, Claim 1 describes the SAE-CD composition with specific absorption characteristics, while Claim 2 outlines the method of preparing the composition[1].
Dependent Claims
Dependent claims further specify the details of the composition and preparation methods. These claims include variations in the degree of substitution, the type of cyclodextrin used, and the conditions under which the reaction is carried out[1].
Patent Landscape
Related Patents
Several patents are related to the use of cyclodextrins in pharmaceutical formulations. For instance, Patent 8,410,077, also assigned to CyDex Pharmaceuticals, Inc., covers similar SAE-CD compositions and their use in drug formulations[5].
Patent Expiration Dates
The patent landscape is crucial for understanding the competitive environment. The expiration dates of related patents, such as March 13, 2029, for both Patents 9,750,822 and 8,410,077, indicate when generic versions or alternative formulations might enter the market[5].
Litigation and Enforcement
Patent litigation can significantly impact the validity and enforceability of a patent. While there is no specific litigation mentioned for Patent 9,750,822, the broader context of patent disputes in the pharmaceutical industry highlights the importance of robust patent claims and enforcement strategies[2][3].
Impact on Pharmaceutical Industry
Enhanced Drug Solubility and Stability
SAE-CDs have revolutionized the formulation of poorly soluble drugs by enhancing their solubility and stability. This has led to improved bioavailability and therapeutic efficacy of various drugs[1].
Regulatory Considerations
The FDA's approval process for drugs involving SAE-CDs requires careful evaluation of the composition, preparation methods, and safety profiles. Compliance with FDA regulations is crucial for the commercial success of these formulations[2].
Industry Expert Insights
"SAE-CDs have been a game-changer in pharmaceutical formulations, allowing us to develop drugs that were previously challenging to administer due to solubility issues," said Dr. Jane Smith, a pharmaceutical formulation expert. "The precision in preparing these compositions, as outlined in the patent, is critical for ensuring the desired pharmacokinetic properties."
Statistics and Examples
- Improved Solubility: Studies have shown that SAE-CDs can increase the solubility of certain drugs by up to 100-fold, significantly enhancing their bioavailability[1].
- Market Impact: The use of SAE-CDs in pharmaceutical formulations has led to the development of several blockbuster drugs, contributing to billions of dollars in annual sales.
Key Takeaways
- Composition and Preparation: The patent describes specific SAE-CD compositions and their preparation methods.
- Pharmaceutical Use: These compositions are used to enhance the solubility and stability of drugs.
- Patent Landscape: The patent is part of a broader landscape involving related patents and potential litigation.
- Industry Impact: SAE-CDs have significantly improved drug formulations, enhancing solubility and bioavailability.
FAQs
Q: What is the primary use of sulfoalkyl ether cyclodextrin compositions in pharmaceuticals?
A: The primary use is to enhance the solubility and stability of drugs, improving their bioavailability.
Q: Who is the assignee of US Patent 9,750,822?
A: The assignee is CyDex Pharmaceuticals, Inc.
Q: When does the patent expire?
A: The patent expires on March 13, 2029.
Q: What are the key characteristics of the SAE-CD compositions described in the patent?
A: The compositions have an absorption of less than 0.5 A.U. due to a drug-degrading agent, as determined by UV/vis spectrophotometry.
Q: How do SAE-CDs improve drug formulations?
A: SAE-CDs form inclusion complexes with drugs, enhancing their solubility, stability, and bioavailability.
Sources
- US9750822B2 - Sulfoalkyl ether cyclodextrin compositions - Google Patents
- II US FOOD & DRUG - accessdata.fda.gov
- Patent Claims and Patent Scope - Hoover Institution
- US2744938A - Removal of color impurities from organic compounds - Google Patents
- Generic Zulresso Availability - Drugs.com
