United States Patent 5,098,715: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 5,098,715, titled "Flavored film-coated tablet," was granted on March 24, 1992. This patent is significant in the pharmaceutical industry, particularly in the formulation and coating of oral dosage tablets. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Purpose
The patent addresses the issue of unpleasant-tasting ingredients in pharmaceutical tablets by introducing a flavored thin film coating. This coating enhances the palatability of the tablets, making them more acceptable to patients, especially children and the elderly[1].
Scope of the Invention
Coating Composition and Process
The invention involves a one-step continuous spray-coating process to apply a thin flavored coating to the core tablets. The coating material can include multiple layers such as a polymeric undercoat, a polymeric pigmented second coat, and a polymeric finish coat. This multi-layer approach ensures a smooth, glossy finish and efficient taste perception[1].
Equipment and Parameters
The coating process utilizes equipment like the Masterflex peristaltic pump and ACCELA-COTA pans. The parameters such as inlet air volume, rotation speed of the pan, and temperature are critical and interactive, ensuring even and controlled coating[1].
Taste Perception
A key feature of this invention is the positive taste perception of the flavored coat, which lasts on the tongue for at least five seconds. This duration is sufficient for the tablet to be swallowed before the bitterness of the core tablet becomes objectionable[1].
Claims of the Patent
The patent includes 23 claims that detail various aspects of the invention:
Claim 1: General Description
The first claim describes the flavored film-coated tablet, emphasizing the thin film coating and the core tablet containing unpleasant-tasting ingredients[1].
Claim 2-5: Coating Composition
These claims specify the composition of the coating material, including the use of polymeric materials and the possibility of multiple layers[1].
Claim 6-10: Coating Process
These claims outline the one-step continuous spray-coating process and the equipment used, such as the Masterflex peristaltic pump[1].
Claim 11-15: Parameters and Conditions
These claims detail the interactive parameters like inlet air volume, rotation speed, and temperature that are crucial for the coating process[1].
Claim 16-23: Additional Coatings and Applications
These claims cover additional aspects such as the application of more than one flavored coat, the use of sealing coats, and the compatibility of subsequent coatings with the flavored coating[1].
Patent Landscape
Related Patents and Technologies
The patent landscape in pharmaceutical coatings is extensive, with numerous patents addressing various coating techniques and materials. For instance, U.S. Pat. No. 4,001,390, cited in the patent, discusses the use of multiple layers of coating to achieve smooth and glossy tablets[1].
Global Patent System
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service can help in understanding the global reach and related patents of the flavored film-coated tablet invention[4].
Administrative Challenges
The Leahy-Smith America Invents Act (AIA) introduced administrative procedures like inter partes review (IPR) and post-grant review (PGR) that can challenge the validity of patents. These procedures, managed by the Patent Trial and Appeal Board (PTAB), provide a faster and less expensive alternative to judicial proceedings for challenging patent validity[2].
Impact on the Pharmaceutical Industry
Patient Compliance
The flavored film-coated tablet improves patient compliance by making unpleasant-tasting medications more palatable. This is particularly important for pediatric and geriatric patients who often struggle with bitter tastes[1].
Manufacturing Efficiency
The one-step continuous spray-coating process enhances manufacturing efficiency by providing a uniform and reproducible coating. This process can be scaled up using larger equipment, making it suitable for industrial production[1].
Key Takeaways
- Flavored Coating: The patent introduces a flavored thin film coating to improve the palatability of pharmaceutical tablets.
- Coating Process: A one-step continuous spray-coating process is used, which can be scaled up for industrial production.
- Taste Perception: The flavored coating ensures positive taste perception lasting at least five seconds.
- Patent Claims: The patent includes 23 claims detailing the composition, process, and parameters of the coating.
- Global Relevance: The invention is part of a broader global patent landscape, with tools like the Global Dossier facilitating international patent analysis.
FAQs
What is the main purpose of the flavored film-coated tablet patent?
The main purpose is to improve the palatability of pharmaceutical tablets containing unpleasant-tasting ingredients.
How is the flavored coating applied?
The flavored coating is applied using a one-step continuous spray-coating process.
What equipment is used in the coating process?
Equipment such as the Masterflex peristaltic pump and ACCELA-COTA pans are used.
How long does the positive taste perception of the flavored coat last?
The positive taste perception lasts for at least five seconds.
Can the coating process be scaled up for industrial production?
Yes, the process can be scaled up using larger equipment like larger ACCELA-COTA pans.
Sources
- US5098715A - Flavored film-coated tablet - Google Patents
- The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- Search for patents - USPTO
- 35 USC 282: Presumption of validity; defenses - U.S. Code House
