COMPOSITION FOR TREATING BREAST CANCER AND A METHOD THEREOF

Abstract

A composition for treating breast cancer and a method thereof is provided. The composition includes a therapeutic drug encapsulated within a polymer hydrogel (PTX-PAM hydrogel). The PTX-PAM hydrogel provides controlled and sustained release of Paclitaxel, a widely used chemotherapeutic agent with limited solubility and high systemic toxicity. By encapsulating Paclitaxel within the hydrophilic polyacrylamide matrix, the composition improves drug solubility, enhances bioavailability, and reduces the need for toxic solubilizing agents. The composition also minimizes systemic side effects by enabling targeted release at the tumor site, thereby decreasing exposure to healthy tissues. The composition shows significant promise as a biocompatible, efficient, and safer alternative for breast cancer therapy, potentially improving therapeutic outcomes and patient quality of life

Specification

Description:FIELD OF INVENTION
[0001] The present disclosure relates generally to the field of pharmaceutical formulations and drug delivery systems. In particular, the present disclosure pertains to a composition for treating breast cancer and a method thereof.

BACKGROUND
[0002] Breast cancer is one of the most prevalent forms of cancer worldwide and a leading cause of cancer-related mortality among women. Despite advancements in treatment options, including surgery, radiation, and chemotherapy, breast cancer management remains complex, with many patients experiencing limited success or significant side effects from conventional therapies. Chemotherapy, particularly with drugs like Paclitaxel (PTX), plays a critical role in treating breast cancer by targeting rapidly dividing cancer cells. However, chemotherapy's therapeutic impact is often compromised by several key challenges, including drug solubility, bioavailability, and toxicity, which reduce treatment efficacy and increase the risk of adverse effects for patients.
[0003] One of the significant limitations of Paclitaxel (PTX) in clinical use is its poor water solubility. Paclitaxel is a hydrophobic compound, making it difficult to dissolve in aqueous solutions, which complicates its delivery into the body. To address this, conventional formulations often use solvents like Cremophor EL to improve PTX's solubility in intravenous solutions. However, these solvents are known to cause severe side effects, including hypersensitivity reactions, which can lead to life-threatening allergic responses in patients. The reliance on toxic solvents is thus a critical barrier in the effective administration of PTX for cancer therapy.
[0004] In addition to solubility issues, low bioavailability is another significant obstacle in Paclitaxel administration. When administered intravenously, PTX is often rapidly cleared from the bloodstream, leading to suboptimal therapeutic concentrations at the tumor site. This rapid clearance reduces the drug's effectiveness and necessitates higher or more frequent doses, which can further increase the risk of toxicity and side effects. Ensuring adequate bioavailability remains a pressing challenge, as effective drug delivery requires that a consistent therapeutic dose reaches the tumor site and maintains efficacy over time.
[0005] Systemic toxicity is another major drawback associated with Paclitaxel therapy. Due to its non-linear pharmacokinetics, PTX's effects can be unpredictable, often leading to severe side effects in healthy tissues. Common side effects include neurotoxicity, which can cause nerve damage and pain, and nephrotoxicity, which may impair kidney function. The risk of systemic toxicity complicates treatment planning, as healthcare providers must balance the need for effective doses with the potential harm to the patient. This issue underscores the need for more targeted delivery systems to localize PTX at the tumor site while minimizing exposure to other tissues.
[0006] Current formulations of PTX also face challenges in achieving sustained release at the tumor site. The rapid clearance from circulation not only reduces efficacy but also results in peak drug concentrations that fluctuate widely over time, causing cycles of high toxicity followed by subtherapeutic levels. Sustained drug release could potentially maintain a steady therapeutic level at the tumor site, reducing the need for frequent dosing and lowering the risks associated with peak plasma concentrations. However, achieving a controlled and sustained release profile for hydrophobic drugs like PTX has proven challenging with existing technologies.
[0007] Furthermore, the use of traditional delivery mechanisms such as emulsions, liposomes, or micelles for PTX has demonstrated limited success. While these systems can encapsulate PTX, they often lack the ability to precisely control release rates and can sometimes aggregate, leading to unpredictable drug distribution. Additionally, these methods still rely on emulsifying agents or surfactants, which, like Cremophor EL, can elicit unwanted immune responses.
[0008] Patients undergoing chemotherapy often face reduced quality of life due to treatment-associated toxicities. A biocompatible delivery system that reduces the toxic side effects of PTX while maintaining or even enhancing its therapeutic benefits could significantly improve patient comfort, adherence to treatment, and overall outcomes. Such a system would represent a substantial advancement in the field of cancer treatment, particularly in delivering hydrophobic chemotherapeutic agents like Paclitaxel.
[0009] Therefore, there is a need for biocompatible and patient-friendly delivery systems that that can address solubility, bioavailability, toxicity, and release challenges.

OBJECTS OF THE PRESENT DISCLOSURE
[0010] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.
[0011] An object of the present invention is to provide a novel drug delivery system for Paclitaxel (PTX) that enhances its solubility and stability in an aqueous environment.
[0012] An object of the present invention is to create a biocompatible and efficient hydrogel-based delivery system.
[0013] Another object of the present invention is to provide a process for preparing the said delivery system in form of a composition.

SUMMARY
[0014] This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the detailed description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0015] Aspects of the present disclosure relates to pharmaceutical formulations and drug delivery systems, specifically to the development of a polymer hydrogel-based delivery system for the targeted treatment of breast cancer. The polymer hydrogel-based delivery system provides a controlled and sustained release of the therapeutic drug, offering a novel approach to targeted cancer therapy with reduced adverse effects and improved patient outcomes.
[0016] Accordingly, in an aspect, the present disclosure provides a composition for treating breast cancer, comprising a therapeutic drug encapsulated within a polymer hydrogel, wherein the polymer hydrogel provides sustained release of the therapeutic drug.
[0017] In various embodiments, the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v.
[0018] In certain embodiments, the polymer hydrogel is Polyacrylamide (PAM) hydrogel, present in an amount ranging from 0.05 %w/v to 8 %w/v.
[0019] In various embodiments, the polymer hydrogel is highly hydrophilic in nature.
[0020] In another aspect, the present disclosure provides a method for preparing the composition for treating breast cancer, comprising steps of:
a) mixing a therapeutic drug into a solvent to obtain a first solution;
b) dissolving N, N'-methylene-bis-acrylamide and acrylamide in the first solution to obtain a second solution;
c) initiating a free radical polymerization reaction by adding ammonium persulfate (APS) to the second solution; and
d) adding a catalyst to the resulting solution of step c) to optimize polymerization and obtain the therapeutic drug encapsulated within the polyacrylamide hydrogel.
[0021] In various embodiments, the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v.
[0022] In certain embodiments, the N, N'-methylene-bis-acrylamide is added in an amount ranging from 0.05% (w/v) to 5% (w/v).
[0023] In various embodiments, the ammonium persulfate is added in an amount ranging from 0.05% (w/v) to 8% (w/v).
[0024] In certain embodiments, the catalyst is N, N, N', N'-Tetramethylethylenediamine (TEMED), added in an amount ranging from 0.05% (w/v) to 2% (w/v).
[0025] In certain embodiments, the solvent is selected from a group consisting of methanol and water.[0026] In certain embodiments, after adding the catalyst at the step d) the solution is allowed to rest at 30ºC to form the therapeutic drug encapsulated within the polyacrylamide hydrogel.
[0027] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.
BRIEF DESCRIPTION OF DRAWINGS
[0028] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.
[0029] FIG. 1 illustrates an exemplary method for preparing the composition for treating breast cancer, in accordance with an embodiment of the present disclosure.
[0030] FIG. 2 illustrates schematic of the process of synthesis of PTX-PAM hydrogel, in accordance with an embodiment of the present disclosure.
[0031] FIG. 3 illustrates PTX-PAM hydrogel (a) hydrated mass, (b) dried mass, and (c) pulverized dry mass, in accordance with an embodiment of the present disclosure.
[0032] FIG. 4 illustrates PTX-PAM hydrogel showing swelling capacity at different pH, in accordance with an embodiment of the present disclosure.
[0033] FIG. 5 illustrates a graph representing the PTX release profile from PTX-PAM hydrogel, in accordance with an embodiment of the present disclosure.
[0034] FIG. 6 illustrates in vitro cell viability assay using MCF-7 cell line, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION
[0035] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention.
[0036] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0037] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0038] In some embodiments, numbers have been used for quantifying weight percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0039] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0040] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.
[0041] Unless the context requires otherwise, throughout the specification which follow, the word "comprise" and variations thereof, such as, "comprises" and "comprising" are to be construed in an open, inclusive sense that is as "including, but not limited to."
[0042] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[0043] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0044] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0045] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present invention. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0046] It should also be appreciated that the present invention can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[0047] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0048] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements a, b, and c, and a second embodiment comprises elements b and d, then the inventive subject matter is also considered to include other remaining combinations of a, b, c, or d, even if not explicitly disclosed.
[0049] The terms "composition" or "formulation" or "PTX-PAM hydrogel" are used herein interchangeably with same meaning throughout the specification.
[0050] Aspects of the present disclosure relates to pharmaceutical formulations and drug delivery systems, specifically to the development of a polymer hydrogel-based delivery system for the targeted treatment of breast cancer. The polymer hydrogel-based delivery system provides a controlled and sustained release of the therapeutic drug, offering a novel approach to targeted cancer therapy with reduced adverse effects and improved patient outcomes.
[0051] Accordingly, in an aspect, the present disclosure provides a composition for treating breast cancer, including a therapeutic drug encapsulated within a polymer hydrogel, wherein the polymer hydrogel provides sustained release of the therapeutic drug.
[0052] In various embodiments, the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v.
[0053] In certain embodiments, the polymer hydrogel is Polyacrylamide (PAM) hydrogel, present in an amount ranging from 0.05 %w/v to 8 %w/v.
[0054] In certain embodiments, encapsulating Paclitaxel within the PAM hydrogel matrix improves the drug's solubility, reducing the need for harmful solvents, and allowing for a localized, steady release directly at the tumor site. The hydrogel's structure allows Paclitaxel to be gradually released as the matrix swells or degrades, ensuring that therapeutic drug levels are maintained consistently without sudden peaks that can lead to toxicity. The polymer hydrogel also protects Paclitaxel from premature degradation, further enhancing its stability and effectiveness in targeting cancer cells. Because of its biocompatible nature, the hydrogel minimizes adverse reactions, making it safer for the patient. By encapsulating Paclitaxel in this manner, the composition allows for targeted and efficient drug delivery, significantly improving the therapeutic outcomes for breast cancer patients while reducing the systemic side effects often associated with chemotherapy.
[0055] In various embodiments, the polymer hydrogel is highly hydrophilic in nature. The hydrophilic property allows the hydrogel to swell significantly when in contact with water or bodily fluids, which is key for sustained drug release. In the composition, the hydrophilicity of the polymer hydrogel aids in creating a stable, consistent environment for the gradual release of the encapsulated drug, making it especially suitable for applications in drug delivery.
[0056] In another aspect, the present disclosure provides a method for preparing the composition for treating breast cancer. The process involves encapsulating a therapeutic drug within a hydrogel matrix via physical entrapment without the use of toxic solvents.
[0057] FIG. 1 shows the method for preparing the composition for treating breast cancer, including steps of:
a) mixing the therapeutic drug into a solvent to obtain a first solution;
b) dissolving N, N'-methylene-bis-acrylamide and acrylamide in the first solution to obtain a second solution;
c) initiating a free radical polymerization reaction by adding ammonium persulfate (APS) to the second solution; and
d) adding a catalyst to the resulting solution of step c) to optimize polymerization and obtain the therapeutic drug encapsulated within the polyacrylamide hydrogel.
[0058] In various embodiments, the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v.
[0059] In certain embodiments, the N, N'-methylene-bis-acrylamide is added in an amount ranging from 0.05% (w/v) to 5% (w/v). N, N'-methylene-bis-acrylamide and acrylamide are monomers used to form the polyacrylamide (PAM) hydrogel, which help in integrating the drug into the polymer network that forms the PTX-PAM hydrogel.
[0060] In various embodiments, the ammonium persulfate is added in an amount ranging from 0.05% (w/v) to 8% (w/v). APS starts the free radical polymerization reaction, which enables the monomers to link together and form the hydrogel structure, beginning the encapsulation of the drug within the polymer matrix.
[0061] In certain embodiments, the catalyst is N, N, N', N'-Tetramethylethylenediamine (TEMED), added in an amount ranging from 0.05% (w/v) to 2% (w/v). The catalyst ensures the polymerization is efficient and complete, resulting in the therapeutic drug being fully encapsulated within the polyacrylamide hydrogel.
[0062] In certain embodiments, the solvent is selected from a group consisting of methanol and water. The methanol and water each serve to dissolve the drug adequately for uniform distribution, facilitating the encapsulation within the hydrogel matrix.
[0063] In certain embodiments, after adding the catalyst at the step d) the solution is allowed to rest at 30ºC to form the therapeutic drug encapsulated within the polyacrylamide hydrogel. As the monomers polymerize, they create a mesh-like structure that forms the hydrogel. The temperature is kept at 30ºC to provide an optimal, controlled environment that allows the polymer chains to form steadily without causing rapid or uneven reactions. This temperature is suitable for polymerization without denaturing or degrading the drug encapsulated within the gel. During this process, the therapeutic drug (e.g., Paclitaxel) becomes physically trapped within the hydrogel's polymer matrix. The network formed by the hydrogel encapsulates the drug molecules, ensuring they are evenly distributed and securely held within the gel structure. Allowing the solution to rest undisturbed also aids in stabilizing the gel formation. This resting period ensures that the hydrogel forms uniformly, resulting in a stable, biocompatible structure that can provide sustained and controlled drug release when used in breast cancer treatment.
[0064] In one embodiment, the composition or PTX-PAM hydrogel shows excellent swelling behavior in different pH of 2.2, 7.4 and 9.5.
[0065] In one embodiment, the composition or PTX-PAM hydrogel shows slow-release profile in biological buffer of pH 7.4.
[0066] In one embodiment, the prepared PTX-PAM hydrogel is solid and has a jelly-like texture. The PTX-PAM hydrogel has a solid, three-dimensional structure due to the polymerization of acrylamide monomers. This network creates a firm, stable gel that retains its shape, rather than flowing like a liquid. The jelly-like nature of the PTX-PAM hydrogel also supports controlled release of Paclitaxel as the drug diffuses gradually from the gel. The texture aids in delivering the drug over a sustained period, enhancing its effectiveness for breast cancer treatment.
[0067] In an embodiment, the prepared PTX-PAM hydrogel reduces systemic side effects of chemotherapy. By localizing the drug's action, controlling its release, and eliminating the need for harsh solvents, the PTX-PAM hydrogel reduces systemic side effects commonly associated with chemotherapy, such as neurotoxicity, nephrotoxicity, and hypersensitivity reactions, thereby improving the patient's overall treatment experience.
[0068] In an embodiment, the prepared PTX-PAM hydrogel is biocompatible. Biocompatibility indicates that the PTX-PAM hydrogel is made from materials that are non-toxic to cells and tissues. This property minimizes the risk of adverse reactions, such as inflammation, irritation, or allergic responses, making it suitable for medical applications, especially in sensitive areas like tumor sites. The hydrogel is designed to interact gently with the body's immune system, reducing the chance of triggering an immune response. This is crucial because a strong immune reaction could lead to inflammation and other complications that might interfere with the drug's effectiveness. Polyacrylamide, the main component of the hydrogel matrix, is generally well-tolerated by biological tissues once polymerized. This compatibility allows the hydrogel to remain in place, providing a stable platform for sustained drug release without causing damage to surrounding cells. If the hydrogel is eventually broken down or removed from the body, its biocompatible nature ensures that any degradation byproducts will be safe, and they will not harm surrounding tissues or organs.
[0069] In an embodiment, the prepared PTX-PAM hydrogel has high drug loading efficiency. High drug loading efficiency enhances treatment effectiveness by ensuring that sufficient levels of the drug are delivered to the target site, reducing the need for frequent re-dosing.
[0070] In an exemplary embodiment, the treatment of breast cancer may include administering the given composition to the subject or patient with further subjecting the patient to radiation therapy or combination therapy. The combined approach aims to enhance the effectiveness of the treatment by using both the drug-loaded hydrogel and other therapeutic methods to target cancer cells more comprehensively.
While the foregoing description discloses various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope of the disclosure. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
EXAMPLES
The present invention is further explained in the form of the following examples. However, it is to be understood that the foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.
Example 1: Synthesis of PTX-PAM Hydrogel
As shown in FIG. 2, N, N'-methylenebisacrylamide and acrylamide were dissolved in the ethanol/miliQ containing different concentration of paclitaxel. The content is mixed thoroughly and the known amount of ammonium persulphate (APS) is added to the solution for free radical polymerization reaction. A catalyst N, N, N', N'-Tetramethylethylenediamine (TEMED) was added to optimize the hydrogel. The mixture is then allowed to rest at 30 ºC for synthesis of gel (shown in FIG. 3).
Example 2: Swelling Study
The swelling behavior and water entrapment capacity of the PTX-PAM hydrogel was investigated at different pH (pH 2.2, pH 4, pH 9.5). The swelling capacity was determined in percentage. The PTX-PAM hydrogel showed superior swelling capacity at different pH as shown in FIG. 4. At pH 2.2 (acidic) the PTX-PAM hydrogel exhibits the highest swelling capacity, around 1350%, meaning it absorbs more fluid and swells the most in acidic conditions. At pH 7.4 (neutral) the swelling capacity decreases to around 1250%, showing that the hydrogel swells less in neutral conditions than in acidic ones. At pH 9.5 (basic) the swelling capacity is the lowest, around 1150%, indicating that the hydrogel absorbs the least and swells the least in basic conditions.
Example 3: Drug Release Profile
The PTX-PAM hydrogel was studied for sustained cumulative release of the entrapped PTX for a duration of 4 hours in phosphate buffer saline at 37º C and measured by spectrophotometric analysis of the samples collected at 10-minute intervals. The PTX-PAM hydrogel showed sustained cumulative drug release as shown in FIG. 5. In the initial phase, there is a rapid release of Paclitaxel, as seen by the steep rise in the curve. This burst release suggests that a portion of the drug is readily available at the surface of the hydrogel, allowing it to quickly diffuse out. After the initial burst, the release rate slows down, and the curve begins to level off. This indicates a more controlled, sustained release of Paclitaxel from the hydrogel matrix. The hydrogel appears to release the drug gradually, maintaining a steady concentration over time. Around the 200-minute mark, the release reaches a plateau at approximately 25 µg/mL, suggesting that the hydrogel has released most of its Paclitaxel content, and the rate of release significantly decreases.
Example 4: In-vitro Cell Viability Assay
The cytotoxicity of the PTX-PAM hydrogel was evaluated against MCF-7 cells by the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide) assay, as per the standard protocol. Briefly, 5×103 cells/well were seeded into a 96-well plate, following which the cells were allowed to attach for 24 hours. PAM-PTX hydrogel containing different concentrations of drug ranging from 25, 50, 100, 250, 500 μg/mL were maintained. After 48 hours the cells were treated with MTT reagent and the solubilized formazan crystals were measured at 570 nm using a microplate reader. The percentage of cell viability was calculated as follows: -
(Optical density of test group)/(Optical density of control group) X 100
The results shown in FIG. 6 exhibited the IC50 values ranging from 0.17± 0.02 μg/mL.
ADVANTAGES OF THE PRESENT DISCLOSURE
[0077] The PTX-PAM hydrogel provides a sustained and controlled release of Paclitaxel, allowing for consistent therapeutic levels over time, reducing the need for frequent dosing and ensures prolonged drug action at the tumor site.
[0078] By encapsulating Paclitaxel within the hydrogel, the drug is targeted primarily to the cancer site, minimizing its distribution to healthy tissues. The targeted release lowers systemic exposure, reducing potential side effects like nephrotoxicity and neurotoxicity commonly associated with Paclitaxel.
[0079] The hydrophilic nature of the polyacrylamide hydrogel matrix enhances the solubility of Paclitaxel, a hydrophobic drug, improving its bioavailability, enabling better absorption and therapeutic effectiveness in the body without the need for toxic solubilizing agents like Cremophor EL.
[0080] The hydrogel matrix protects Paclitaxel from premature degradation, preserving its potency and stability until it reaches the target area, ensuring a more effective therapeutic dose reaches the tumor cells.
[0081] The PTX-PAM hydrogel is designed to be biocompatible, minimizing adverse reactions in the body.
 

, Claims:1. A composition for treating breast cancer, comprising a therapeutic drug encapsulated within a polymer hydrogel, wherein the polymer hydrogel provides sustained release of the therapeutic drug.
2. The composition as claimed in claim 1, wherein the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v.
3. The composition as claimed in claim 1, wherein the polymer hydrogel is Polyacrylamide (PAM) hydrogel, present in an amount ranging from 0.05 %w/v to 8 %w/v.
4. The composition as claimed in claim 1, wherein the polymer hydrogel is highly hydrophilic in nature.
5. A method for preparing the composition of claim 1, comprising steps of:
a) mixing a therapeutic drug into a solvent to obtain a first solution;
b) dissolving N, N'-methylene-bis-acrylamide and acrylamide in the first solution to obtain a second solution;
c) initiating a free radical polymerization reaction by adding ammonium persulfate (APS) to the second solution; and
d) adding a catalyst to the resulting solution of step c) to optimize polymerization and obtain the therapeutic drug encapsulated within the polyacrylamide hydrogel.
6. The method as claimed in claim 5, wherein the therapeutic drug is Paclitaxel (PTX), present in an amount ranging from 0.05 %v/v to 8 %v/v; wherein the N, N'-methylene-bis-acrylamide is added in an amount ranging from 0.05% (w/v) to 5% (w/v).
7. The method as claimed in claim 5, wherein the ammonium persulfate is added in an amount ranging from 0.05% (w/v) to 8% (w/v).
8. The method as claimed in claim 5, wherein the catalyst is N, N, N', N'-Tetramethylethylenediamine (TEMED), added in an amount ranging from 0.05% (w/v) to 2% (w/v).
9. The method as claimed in claim 5, wherein the solvent is selected from a group consisting of methanol and water.
10. The method as claimed in claim 5, wherein after adding the catalyst at the step d) the solution is allowed to rest at 30ºC to form the therapeutic drug encapsulated within the polyacrylamide hydrogel.

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