1. A sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises: o a biodegradable polymer matrix, o an active pharmaceutical ingredient (API) for the treatment of glaucoma, o a rate-controlling membrane, o and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye.

2. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA).

3. The sustained-release ophthalmic drug delivery system for glaucoma of claim 2, wherein said polylactic-co-glycolic acid (PLGA) has a lactide to glycolide ratio ranging from 50:50 to 75:25.

4. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said active pharmaceutical ingredient comprises a prostaglandin analog.

5. The sustained-release ophthalmic drug delivery system for glaucoma of claim 4, wherein said prostaglandin analog is latanoprost.

6. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said rate-controlling membrane comprises a hydrogel.

7. The sustained-release ophthalmic drug delivery system for glaucoma of claim 6, wherein said hydrogel is formed from polyvinyl alcohol (PVA).

8. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said carrier vehicle comprises an isotonic solution.

9. The sustained-release ophthalmic drug delivery system for glaucoma of claim 8, wherein said isotonic solution comprises a phosphate-buffered saline (PBS).

10. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix further comprises an anti-inflammatory agent.

11. The sustained-release ophthalmic drug delivery system for glaucoma of claim 10, wherein said anti-inflammatory agent is dexamethasone. Dated 30 December 2024 Pallavi Sinha IN/PA- 4068 Agent for the Applicant Sustained-Release Ophthalmic Drug Delivery System for Glaucoma Abstract Disclosed is a sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises a biodegradable polymer matrix, an active pharmaceutical ingredient (API) for the treatment of glaucoma, a rate-controlling membrane, and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye. Dated 30 December 2024 Pallavi Sinha IN/PA- 4068 Agent for the Applicant , C , Claims:Claims :

1. A sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises: o a biodegradable polymer matrix, o an active pharmaceutical ingredient (API) for the treatment of glaucoma, o a rate-controlling membrane, o and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye.

2. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA).

3. The sustained-release ophthalmic drug delivery system for glaucoma of claim 2, wherein said polylactic-co-glycolic acid (PLGA) has a lactide to glycolide ratio ranging from 50:50 to 75:25.

4. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said active pharmaceutical ingredient comprises a prostaglandin analog.

5. The sustained-release ophthalmic drug delivery system for glaucoma of claim 4, wherein said prostaglandin analog is latanoprost.

6. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said rate-controlling membrane comprises a hydrogel.

7. The sustained-release ophthalmic drug delivery system for glaucoma of claim 6, wherein said hydrogel is formed from polyvinyl alcohol (PVA).

8. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said carrier vehicle comprises an isotonic solution.

9. The sustained-release ophthalmic drug delivery system for glaucoma of claim 8, wherein said isotonic solution comprises a phosphate-buffered saline (PBS).

10. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix further comprises an anti-inflammatory agent.

11. The sustained-release ophthalmic drug delivery system for glaucoma of claim 10, wherein said anti-inflammatory agent is dexamethasone. Dated 30 December 2024 Pallavi Sinha IN/PA- 4068 Agent for the Applicant

Description:Sustained-Release Ophthalmic Drug Delivery System for Glaucoma
Field of the Invention
[0001] The present disclosure generally relates to ophthalmic drug delivery systems. Further, the present disclosure particularly relates to a sustained-release ophthalmic drug delivery system for glaucoma.
Background
[0002] The background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Ophthalmic drug delivery systems have become crucial in the treatment of various eye diseases. Such systems are particularly important for chronic conditions such as glaucoma, where consistent and controlled drug administration is necessary to manage intraocular pressure and prevent vision loss. The need for effective and sustained delivery of therapeutic agents to the eye has led to the development of various ophthalmic drug delivery technologies.
[0004] One well-known approach involves eye drops containing active pharmaceutical ingredients. Such a method, while straightforward, suffers from poor bioavailability and rapid clearance from the eye, requiring frequent administration to maintain therapeutic levels. This can be inconvenient for patients and may lead to non-compliance with prescribed treatment regimens. Moreover, such frequent administration can lead to systemic absorption and associated side effects.
[0005] Another known technique utilizes ocular inserts that are placed in the eye to provide sustained drug release. While ocular inserts address the issue of frequent administration, such devices can cause discomfort and foreign body sensation in the eye. Additionally, the insertion and removal of such devices often require clinical intervention, adding to the treatment burden on patients and healthcare providers.
[0006] Various state-of-the-art systems have been developed to address these issues. For example, nanoparticles and microparticles have been employed to deliver drugs to the eye. These systems enhance drug bioavailability and provide sustained release; however, challenges such as aggregation, stability, and potential toxicity of these particles remain unresolved. Furthermore, the manufacturing complexity and cost associated with these advanced delivery systems can be significant drawbacks.
[0007] Microneedle-based ocular drug delivery systems have also been explored. Such systems enable precise delivery of drugs into the ocular tissues, enhancing bioavailability and providing sustained release. Nevertheless, the invasiveness of such methods, coupled with the risk of infection and the requirement for specialized administration techniques, limit their widespread application.
[0008] In light of the above discussion, there exists an urgent need for solutions that overcome the problems associated with conventional systems and/or techniques for delivering therapeutic agents to the eye in a controlled and sustained manner for the treatment of glaucoma.
[0009] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
Summary
[00010] Various objects, features, and advantages of the disclosed subject matter can be more fully appreciated with reference to the following detailed description of the disclosed subject matter when considered in connection with the following drawings, in which like reference numerals identify like elements.
[00011] The present disclosure generally relates to ophthalmic drug delivery systems. Further, the present disclosure particularly relates to a sustained-release ophthalmic drug delivery system for glaucoma.
[00012] In an aspect, the present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises a biodegradable polymer matrix, an active pharmaceutical ingredient (API) for the treatment of glaucoma, a rate-controlling membrane, and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye. The system enables prolonged therapeutic effects and reduced administration frequency, enhancing patient compliance and therapeutic outcomes.
[00013] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA). The system utilizing PLGA enhances the biodegradability and biocompatibility, improving safety and effectiveness.
[00014] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said polylactic-co-glycolic acid (PLGA) has a lactide to glycolide ratio ranging from 50:50 to 75:25. Such a specific ratio enables optimized degradation rate and sustained release profile.
[00015] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said active pharmaceutical ingredient comprises a prostaglandin analog. The inclusion of a prostaglandin analog enhances intraocular pressure reduction and treatment efficacy.
[00016] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said prostaglandin analog is latanoprost. Latanoprost as an API enhances the therapeutic effect and safety profile for glaucoma treatment.
[00017] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said rate-controlling membrane comprises a hydrogel. The incorporation of a hydrogel enhances controlled release characteristics and patient comfort.
[00018] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said hydrogel is formed from polyvinyl alcohol (PVA). Polyvinyl alcohol (PVA) hydrogel enhances the mechanical stability and biocompatibility of the system.
[00019] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said carrier vehicle comprises an isotonic solution. Such an isotonic solution enhances ocular tolerance and comfort during administration.
[00020] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said isotonic solution comprises a phosphate-buffered saline (PBS). The phosphate-buffered saline (PBS) enhances physiological compatibility and stability of the system.
[00021] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said biodegradable polymer matrix further comprises an anti-inflammatory agent. The inclusion of an anti-inflammatory agent enhances the therapeutic effect by reducing inflammation.
[00022] The present disclosure provides a sustained-release ophthalmic drug delivery system for glaucoma, wherein said anti-inflammatory agent is dexamethasone. Dexamethasone enhances the anti-inflammatory effect, improving overall therapeutic outcomes.
Brief Description of the Drawings
[00023] The features and advantages of the present disclosure would be more clearly understood from the following description taken in conjunction with the accompanying drawings in which:
[00024] FIG. 1 illustrates an architectural diagram of a sustained-release ophthalmic drug delivery system for glaucoma, in accordance with the embodiments of the present disclosure. FIG. 2 illustrates a sequence diagram for a sustained-release ophthalmic drug delivery system for glaucoma, in accordance with the embodiments of the present disclosure.
Detailed Description
[00025] The following is a detailed description of exemplary embodiments to illustrate the principles of the invention. The embodiments are provided to illustrate aspects of the invention, but the invention is not limited to any embodiment. The scope of the invention encompasses numerous alternatives, modifications and equivalent; it is limited only by the claims.
[00026] In view of the many possible embodiments to which the principles of the present discussion may be applied, it should be recognized that the embodiments described herein with respect to the drawing figures are meant to be illustrative only and should not be taken as limiting the scope of the claims. Therefore, the techniques as described herein contemplate all such embodiments as may come within the scope of the following claims and equivalents thereof.
[00027] The detailed description is described with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The use of the same reference numbers in different instances in the description and the figures may indicate similar or identical items.
[00028] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00029] The present disclosure generally relates to ophthalmic drug delivery systems. Further, the present disclosure particularly relates to a sustained-release ophthalmic drug delivery system for glaucoma.
[00030] Pursuant to the "Detailed Description" section herein, whenever an element is explicitly associated with a specific numeral for the first time, such association shall be deemed consistent and applicable throughout the entirety of the "Detailed Description" section, unless otherwise expressly stated or contradicted by the context.
[00031] The term biodegradable polymer matrix as used throughout the present disclosure relates to a matrix composed of biodegradable materials that encapsulate the active pharmaceutical ingredient. The system comprises a biodegradable polymer matrix. The biodegradable polymer matrix encapsulates the active pharmaceutical ingredient (API), ensuring controlled and sustained release of the API over time. The use of biodegradable materials enables the gradual breakdown of the matrix within the body, eliminating the need for surgical removal and reducing long-term side effects.
[00032] The term active pharmaceutical ingredient (API) as used throughout the present disclosure relates to the active compound intended for the treatment of glaucoma. The system comprises an active pharmaceutical ingredient for the treatment of glaucoma. Said active pharmaceutical ingredient interacts with ocular tissues to reduce intraocular pressure, providing therapeutic benefits essential for managing glaucoma. The API's encapsulation within the biodegradable polymer matrix ensures its sustained release, maintaining therapeutic levels over extended periods.
[00033] The term rate-controlling membrane as used throughout the present disclosure relates to a membrane that regulates the rate at which the active pharmaceutical ingredient is released from the biodegradable polymer matrix. The system comprises a rate-controlling membrane. Said rate-controlling membrane modulates the release rate of the active pharmaceutical ingredient, ensuring a consistent and prolonged therapeutic effect. The membrane's properties, such as porosity and thickness, can be tailored to achieve the desired release profile, enhancing the system's effectiveness.
[00034] The term carrier vehicle as used throughout the present disclosure relates to a vehicle suitable for ophthalmic administration that facilitates the delivery of the drug delivery system to the eye. The system comprises a carrier vehicle suitable for ophthalmic administration. Said carrier vehicle ensures the proper delivery and distribution of the drug delivery system within the ocular environment. The carrier vehicle can include isotonic solutions that are compatible with the eye's natural physiology, enhancing comfort and minimizing irritation upon administration.
[00035] The system described herein addresses the need for a sustained-release ophthalmic drug delivery system for glaucoma. The combination of a biodegradable polymer matrix, an active pharmaceutical ingredient for glaucoma treatment, a rate-controlling membrane, and a carrier vehicle suitable for ophthalmic administration, ensures prolonged therapeutic effects, reduced administration frequency, and improved patient compliance. The biodegradable polymer matrix encapsulates the active pharmaceutical ingredient, while the rate-controlling membrane regulates its release rate, and the carrier vehicle facilitates the system's administration to the eye.
[00036] The term polylactic-co-glycolic acid (PLGA) as used throughout the present disclosure relates to a biodegradable copolymer composed of lactic acid and glycolic acid. The biodegradable polymer matrix comprises PLGA, providing biocompatibility and controlled degradation rates, making it suitable for sustained-release drug delivery applications in ophthalmology.
[00037] The term lactide to glycolide ratio as used throughout the present disclosure relates to the molar ratio of lactic acid to glycolic acid units within the PLGA copolymer. The PLGA in the biodegradable polymer matrix has a lactide to glycolide ratio ranging from 50:50 to 75:25, optimizing the polymer's degradation rate and the release profile of the active pharmaceutical ingredient.
[00038] The term prostaglandin analog as used throughout the present disclosure relates to a class of compounds that mimic the activity of prostaglandins and are used to lower intraocular pressure. The active pharmaceutical ingredient comprises a prostaglandin analog, enhancing the therapeutic efficacy in treating glaucoma by effectively reducing intraocular pressure.
[00039] The term latanoprost as used throughout the present disclosure relates to a specific prostaglandin analog used in the treatment of glaucoma. The prostaglandin analog is latanoprost, known for its effectiveness in reducing intraocular pressure and its favorable safety profile, thus providing significant therapeutic benefits.
[00040] The term hydrogel as used throughout the present disclosure relates to a network of polymer chains that are hydrophilic, often used as a rate-controlling membrane in drug delivery systems. The rate-controlling membrane comprises a hydrogel, ensuring a controlled and sustained release of the active pharmaceutical ingredient, improving the system's therapeutic performance.
[00041] The term polyvinyl alcohol (PVA) as used throughout the present disclosure relates to a synthetic polymer used to form hydrogels. The hydrogel is formed from polyvinyl alcohol (PVA), providing excellent mechanical properties and biocompatibility, enhancing the durability and effectiveness of the rate-controlling membrane.
[00042] The term isotonic solution as used throughout the present disclosure relates to a solution with the same osmotic pressure as body fluids, making it suitable for ophthalmic administration. The carrier vehicle comprises an isotonic solution, ensuring compatibility with the eye's natural environment and minimizing irritation upon administration.
[00043] The term phosphate-buffered saline (PBS) as used throughout the present disclosure relates to a buffer solution commonly used in biological research. The isotonic solution comprises phosphate-buffered saline (PBS), providing a stable and physiologically compatible medium for the carrier vehicle, enhancing the comfort and efficacy of the ophthalmic drug delivery system.
[00044] The term anti-inflammatory agent as used throughout the present disclosure relates to a substance that reduces inflammation. The biodegradable polymer matrix further comprises an anti-inflammatory agent, providing additional therapeutic benefits by reducing inflammation associated with glaucoma.
[00045] The term dexamethasone as used throughout the present disclosure relates to a corticosteroid used as an anti-inflammatory agent. The anti-inflammatory agent is dexamethasone, known for its potent anti-inflammatory effects, thus enhancing the overall therapeutic efficacy of the sustained-release ophthalmic drug delivery system.

[00046] The sustained-release ophthalmic drug delivery system for glaucoma provides several technical benefits that enhance the efficacy and usability of glaucoma treatments. The biodegradable polymer matrix encapsulates the active pharmaceutical ingredient (API), which allows for controlled and sustained release of the medication, thereby maintaining therapeutic levels over an extended period. This design reduces the frequency of administration required, improving patient compliance and ensuring consistent treatment outcomes. Furthermore, the inclusion of a rate-controlling membrane ensures precise regulation of the API release rate, thereby preventing spikes in drug concentration that could lead to adverse effects.
[00047] When the biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA), additional advantages are realized. PLGA's biocompatibility and adjustable degradation rate, influenced by the lactide to glycolide ratio, optimize the sustained release profile of the API. This tailored degradation rate, particularly with a lactide to glycolide ratio ranging from 50:50 to 75:25, allows for precise control over the drug release kinetics, enhancing therapeutic efficacy and minimizing side effects.
[00048] The use of a prostaglandin analog as the active pharmaceutical ingredient, and specifically latanoprost, provides targeted reduction of intraocular pressure, which is crucial for glaucoma management. The prostaglandin analog's encapsulation within the PLGA matrix ensures a consistent and prolonged therapeutic effect, further supported by the hydrogel-based rate-controlling membrane. Polyvinyl alcohol (PVA) hydrogels, in particular, offer excellent biocompatibility and mechanical stability, ensuring reliable performance of the drug delivery system.
[00049] The carrier vehicle, comprising an isotonic solution such as phosphate-buffered saline (PBS), facilitates the comfortable and effective administration of the system to the eye. This compatibility with the eye's natural osmotic pressure minimizes irritation and enhances patient comfort. The incorporation of an anti-inflammatory agent like dexamethasone within the biodegradable polymer matrix provides additional therapeutic benefits by reducing inflammation, thereby addressing multiple aspects of glaucoma treatment in a single, sustained-release system. This multi-functional approach not only streamlines the treatment process but also maximizes the overall therapeutic benefit to the patient.
[00050] FIG. 1 illustrates an architectural diagram of a sustained-release ophthalmic drug delivery system for glaucoma, in accordance with the embodiments of the present disclosure. The system comprises a biodegradable polymer matrix, which houses an active pharmaceutical ingredient. The biodegradable polymer matrix enables controlled degradation over time, ensuring a consistent release of the active pharmaceutical ingredient. The active pharmaceutical ingredient is encapsulated within the matrix and is released through a rate-controlling membrane. The rate-controlling membrane regulates the diffusion rate of the drug, ensuring a steady therapeutic level is maintained. This membrane is integral to achieving sustained drug release. The entire assembly is contained within a carrier vehicle, which facilitates the administration to the eye. This carrier vehicle ensures that the drug delivery system can be conveniently and effectively applied to the ocular surface. Such a sustained-release system enhances patient compliance by reducing the frequency of administration and ensures prolonged therapeutic effect, thereby providing an effective treatment for glaucoma.
[00051] FIG. 2 illustrates a sequence diagram for a sustained-release ophthalmic drug delivery system for glaucoma, in accordance with the embodiments of the present disclosure. The system commences with a biodegradable polymer matrix, which encapsulates the active pharmaceutical ingredient (API). The encapsulation within the biodegradable polymer matrix enables controlled and gradual degradation, ensuring a prolonged release of the API. The API is released through a rate-controlling membrane that regulates the diffusion rate, thereby maintaining a consistent therapeutic level over an extended period. This regulation is critical for achieving sustained drug delivery. The rate-controlling membrane is integrated with a carrier vehicle, which facilitates the effective administration of the system to the eye. The carrier vehicle ensures that the entire assembly can be conveniently and accurately delivered to the ocular surface. Such a design enhances patient compliance by reducing the frequency of administration and ensures continuous therapeutic effect, thereby providing an efficient treatment method for glaucoma.Further, while operations are depicted in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while several specific implementation details are contained in the above discussions, these should not be construed as limitations on the scope of the subject matter described herein, but rather as descriptions of features that may be specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
[00052] The term “memory,” as used herein relates to a volatile or persistent medium, such as a magnetic disk, or optical disk, in which a computer can store data or software for any duration. Optionally, the memory is non-volatile mass storage such as physical storage media. Furthermore, a single memory may encompass and in a scenario wherein computing system is distributed, the processing, memory and/or storage capability may be distributed as well.
[00053] Throughout the present disclosure, the term ‘server’ relates to a structure and/or module that include programmable and/or non-programmable components configured to store, process and/or share information. Optionally, the server includes any arrangement of physical or virtual computational entities capable of enhancing information to perform various computational tasks.
[00054] Throughout the present disclosure, the term “network” relates to an arrangement of interconnected programmable and/or non-programmable components that are configured to facilitate data communication between one or more electronic devices and/or databases, whether available or known at the time of filing or as later developed. Furthermore, the network may include, but is not limited to, one or more peer-to-peer network, a hybrid peer-to-peer network, local area networks (LANs), radio access networks (RANs), metropolitan area networks (MANS), wide area networks (WANs), all or a portion of a public network such as the global computer network known as the Internet, a private network, a cellular network and any other communication system or systems at one or more locations.
[00055] Throughout the present disclosure, the term “process”* relates to any collection or set of instructions executable by a computer or other digital system so as to configure the computer or the digital system to perform a task that is the intent of the process.
[00056] Throughout the present disclosure, the term ‘Artificial intelligence (AI)’ as used herein relates to any mechanism or computationally intelligent system that combines knowledge, techniques, and methodologies for controlling a bot or other element within a computing environment. Furthermore, the artificial intelligence (AI) is configured to apply knowledge and that can adapt it-self and learn to do better in changing environments. Additionally, employing any computationally intelligent technique, the artificial intelligence (AI) is operable to adapt to unknown or changing environment for better performance. The artificial intelligence (AI) includes fuzzy logic engines, decision-making engines, preset targeting accuracy levels, and/or programmatically intelligent software.

Claims
I/We Claim:
1. A sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises:
o a biodegradable polymer matrix,
o an active pharmaceutical ingredient (API) for the treatment of glaucoma,
o a rate-controlling membrane,
o and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye.
2. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA).
3. The sustained-release ophthalmic drug delivery system for glaucoma of claim 2, wherein said polylactic-co-glycolic acid (PLGA) has a lactide to glycolide ratio ranging from 50:50 to 75:25.
4. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said active pharmaceutical ingredient comprises a prostaglandin analog.
5. The sustained-release ophthalmic drug delivery system for glaucoma of claim 4, wherein said prostaglandin analog is latanoprost.
6. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said rate-controlling membrane comprises a hydrogel.
7. The sustained-release ophthalmic drug delivery system for glaucoma of claim 6, wherein said hydrogel is formed from polyvinyl alcohol (PVA).
8. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said carrier vehicle comprises an isotonic solution.
9. The sustained-release ophthalmic drug delivery system for glaucoma of claim 8, wherein said isotonic solution comprises a phosphate-buffered saline (PBS).
10. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix further comprises an anti-inflammatory agent.
11. The sustained-release ophthalmic drug delivery system for glaucoma of claim 10, wherein said anti-inflammatory agent is dexamethasone.

Dated 30 December 2024 Pallavi Sinha
IN/PA- 4068
Agent for the Applicant

Sustained-Release Ophthalmic Drug Delivery System for Glaucoma
Abstract
Disclosed is a sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises a biodegradable polymer matrix, an active pharmaceutical ingredient (API) for the treatment of glaucoma, a rate-controlling membrane, and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye.
Dated 30 December 2024 Pallavi Sinha
IN/PA- 4068
Agent for the Applicant , C , Claims:Claims
I/We Claim:
1. A sustained-release ophthalmic drug delivery system for glaucoma, wherein the system comprises:
o a biodegradable polymer matrix,
o an active pharmaceutical ingredient (API) for the treatment of glaucoma,
o a rate-controlling membrane,
o and a carrier vehicle suitable for ophthalmic administration, wherein said biodegradable polymer matrix encapsulates said active pharmaceutical ingredient, said rate-controlling membrane regulates the release rate of said active pharmaceutical ingredient, and said carrier vehicle facilitates the administration of said system to the eye.
2. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix comprises polylactic-co-glycolic acid (PLGA).
3. The sustained-release ophthalmic drug delivery system for glaucoma of claim 2, wherein said polylactic-co-glycolic acid (PLGA) has a lactide to glycolide ratio ranging from 50:50 to 75:25.
4. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said active pharmaceutical ingredient comprises a prostaglandin analog.
5. The sustained-release ophthalmic drug delivery system for glaucoma of claim 4, wherein said prostaglandin analog is latanoprost.
6. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said rate-controlling membrane comprises a hydrogel.
7. The sustained-release ophthalmic drug delivery system for glaucoma of claim 6, wherein said hydrogel is formed from polyvinyl alcohol (PVA).
8. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said carrier vehicle comprises an isotonic solution.
9. The sustained-release ophthalmic drug delivery system for glaucoma of claim 8, wherein said isotonic solution comprises a phosphate-buffered saline (PBS).
10. The sustained-release ophthalmic drug delivery system for glaucoma of claim 1, wherein said biodegradable polymer matrix further comprises an anti-inflammatory agent.
11. The sustained-release ophthalmic drug delivery system for glaucoma of claim 10, wherein said anti-inflammatory agent is dexamethasone.

Dated 30 December 2024 Pallavi Sinha
IN/PA- 4068
Agent for the Applicant