United States Patent 7,544,370: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,544,370, titled "Pantoprazole multiparticulate formulations," is a significant patent in the pharmaceutical industry, particularly in the field of proton pump inhibitors (PPIs). This patent, assigned to Wyeth, addresses the formulation challenges associated with Pantoprazole, a widely used PPI.
Background of the Invention
Pantoprazole, a benzimidazole derivative, is used as a proton pump inhibitor to treat conditions such as Gastroesophageal Reflux Disease (GERD). However, its acid-labile nature makes it challenging to formulate for oral administration. The patent aims to overcome these challenges by developing stable multiparticulate formulations[2][4].
Scope of the Patent
The scope of the patent is broad and encompasses several key aspects:
Multiparticulate Formulations
The patent describes multiparticulate formulations of Pantoprazole, which include multiple small particles or granules that release the drug in a controlled manner. This formulation is designed to improve stability and bioavailability of the drug[4].
Stability Issues
One of the primary challenges addressed by the patent is the stability of Pantoprazole in various environmental conditions. The formulations described are designed to maintain stability at room temperature and under acidic conditions, which is crucial for the drug's efficacy[2].
Release Characteristics
The patent specifies formulations that ensure appropriate release of Pantoprazole under different pH conditions. This is critical to prevent premature release in the acidic environment of the stomach and ensure the drug reaches the intended site of action in the intestine[4].
Patient Compliance
The multiparticulate formulations also enhance patient compliance by allowing dosing to pediatric patients and those who have difficulty swallowing solid foods. The drug can be administered via oral suspension, making it more versatile[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
The independent claims outline the core aspects of the invention, including the composition of the multiparticulate formulation, the process of preparing it, and the specific characteristics of the formulation such as stability and release profile[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, including the types of excipients used, the method of preparation, and the physical characteristics of the multiparticulates[4].
Key Components of the Formulation
The patent highlights several key components and processes involved in the formulation:
Core and Coat
The multiparticulates consist of a core containing Pantoprazole and a coat that protects the core from acidic environments. The coat is typically made from pH-dependent polymers that dissolve at higher pH levels, allowing the drug to be released in the intestine[4].
Excipients
The formulation includes various excipients such as pH adjusting agents, seal coats, and other polymers that enhance the stability and release characteristics of the drug[4].
Manufacturing Process
The patent describes methods such as mixing, extrusion, and spheronization to produce the multiparticulates. These processes ensure uniformity and consistency in the final product[4].
Patent Landscape
The patent landscape surrounding US 7,544,370 is complex and involves several related patents and publications:
Related Patents
Other patents such as US 7,550,153, US 7,553,498, and US 7,838,027, also assigned to Wyeth, discuss similar multiparticulate formulations of Pantoprazole. These patents collectively provide a comprehensive view of the challenges and solutions in formulating acid-labile drugs[2].
Competing Formulations
Patents like US 8,865,212 assigned to Jubilant Generics Ltd. describe non-multiple unit pellet systems (MOPS) for benzimidazole derivatives, which offer alternative approaches to the multiparticulate formulations described in US 7,544,370[2].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry:
Innovation in Drug Delivery
The development of stable multiparticulate formulations of Pantoprazole has paved the way for innovative drug delivery systems that improve patient compliance and drug efficacy[4].
Competitive Advantage
Companies holding such patents gain a competitive advantage in the market by offering superior formulations that address specific clinical needs and patient preferences[2].
Challenges and Criticisms
While the patent has contributed significantly to the field, there are challenges and criticisms:
Stability and Release Issues
Despite the advancements, stability and release issues under various conditions remain a challenge. Continuous research is needed to optimize these formulations further[2].
Patent Scope and Quality
Debates around patent scope and quality, particularly in the pharmaceutical sector, highlight the need for clear and narrow claims to avoid litigation and ensure innovation[3].
Conclusion
United States Patent 7,544,370 represents a crucial milestone in the development of Pantoprazole formulations. The patent's scope and claims provide a detailed framework for creating stable and effective multiparticulate formulations, addressing key challenges in drug delivery.
Key Takeaways
- The patent describes multiparticulate formulations of Pantoprazole to improve stability and bioavailability.
- It addresses specific challenges such as stability at room temperature and appropriate release under acidic conditions.
- The formulations enhance patient compliance, especially for pediatric patients and those with swallowing difficulties.
- The patent landscape includes related patents and competing formulations that collectively advance the field of PPIs.
- The impact on the pharmaceutical industry includes innovation in drug delivery and a competitive advantage for companies holding such patents.
FAQs
What is the main challenge addressed by US 7,544,370?
The main challenge addressed by US 7,544,370 is the stability and effective release of Pantoprazole, an acid-labile proton pump inhibitor, in various environmental conditions.
How does the multiparticulate formulation improve patient compliance?
The multiparticulate formulation improves patient compliance by allowing the drug to be administered via oral suspension, which is particularly beneficial for pediatric patients and those who have difficulty swallowing solid foods.
What are the key components of the multiparticulate formulation described in the patent?
The key components include a core containing Pantoprazole and a coat made from pH-dependent polymers, along with various excipients such as pH adjusting agents and seal coats.
How does the patent landscape around US 7,544,370 look?
The patent landscape includes related patents from Wyeth and competing formulations from other companies like Jubilant Generics Ltd., which collectively contribute to the advancement of PPI formulations.
What is the impact of this patent on the pharmaceutical industry?
The patent has a significant impact by driving innovation in drug delivery systems, improving drug efficacy, and providing a competitive advantage to companies holding such patents.
Cited Sources:
- United States Patent and Trademark Office. DELAYED RELEASE PHARMACEUTICAL COMPOSITION OF PANTOPRAZOLE AND PROCESS FOR FORMULATION THEREOF. US 10,918,630 B2.
- Justia Patents. Delayed release pharmaceutical composition of pantoprazole and process for formulation thereof. US 20200253946.
- Hoover Institution. Patent Claims and Patent Scope. Working Paper Series No. 16001.
- Google Patents. Pantoprazole multiparticulate formulations. US7544370B2.
