DESC:Pharmaceutical composition of Ticagrelor & therapeutic agent Rosuvastatin calcium, atorvastatin and other from the same family in sweetener tablet, candy & lozenges

FIELD OF INVENTION
[0001] The present disclosure relates to a formulation of pharmaceutical composition for treatment of Acute Coronary Syndrome, and particularly relates to a pharmaceutical composition of Ticagrelor & Rosuvastatin, Ticagrelor & Atorvastatin in sweetened palatable form.
BACKGROUND
[0002] 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] Cardiovascular diseases (CVDs) are one of the leading causes of morbidity and mortality worldwide. Ticagrelor and Rosuvastatin, Ticagrelor and Atorvastatin are two drugs that are used in the treatment of Acute Coronary Syndrome. Ticagrelor is an antiplatelet agent that inhibits the P2Y12 receptor on platelets, while Rosuvastatin & Atorvastatin is a lipid-lowering agent that inhibits the HMG-CoA reductase enzyme. The combination of ticagrelor and rosuvastatin has been found to be very – very effective in reducing the risk of major adverse cardiovascular events in patients with acute coronary syndrome (ACS) and dyslipidemia.
[0004] Efforts have been made in the past to provide combination of ticagrelor and type II therapeutic agent such as rosuvastatin for treatment of acute coronary syndrome (ACS). For instance, Patent application no. CN107405325B discloses pharmaceutical compositions with ticagrelor and rosuvastatin for combination therapy. However, these types of pharmaceutical compositions have low medication compliance since some patients feel inconvenient to take them due to unpalatability and difficulty in swallowing.
[0005] Keeping this in mind, development of pharmaceutical composition comprising a combination of antiplatelet (ticagrelor) and a type II therapeutic agent in a sweetened palatable form is disclosed. Therefore, the present disclosure overcomes the above mentioned problem associated with the traditionally available method, any of the above mentioned invention can be used with the presented disclosed technique with or without modification. The present invention provides a pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome.
[0006] 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.
[0007] 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.
[0008] 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.

OBJECTS OF THE INVENTION
[0009] It is an object of the present disclosure which provides a pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome.
[0010] It is another object of the present disclosure to provide constitution of the pharmaceutical composition of Ticagrelor and Rosuvastatin, and Ticagrelor and Atorvastatin in candy form, sweetener tablet, sugar-coated tablet, lozenges, and chewable sugar-coated tablet.
[0011] It is an object of the present disclosure which provides a pharmaceutical composition which combines the cardiovascular benefits of vital active pharmaceutical ingredients (APIs) with the convenience and enjoyment of different administration methods.

SUMMARY
[0012] The present disclosure is directed towards a pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome comprising of Ticagrelor as an antiplatelet; and a therapeutic agent, wherein the pharmaceutical composition is in a sweetened palatable form selected from a candy, a sweetener tablet, a sugar-coated tablet, a gummy, a lozenge, and a chewable sugar-coated tablet.
[0013] In an aspect of the present disclosure, the Ticagrelor has a chemical formula of C23H29F2N6O4S.
[0014] In an aspect of the present disclosure, the type II therapeutic agent is selected from atleast one of rosuvastatin calcium, atorvastatin.
[0015] In an aspect of the present disclosure, the type II therapeutic agent is a statin selected from rosuvastatin and atorvastatin.
[0016] In an aspect of the present disclosure, the rosuvastatin has a chemical formula of C22H28FN3O6S.
[0017] In an aspect of the present disclosure, the atorvastatin has a chemical formula of C33H35FN2O5.
[0018] In another aspect of the present disclosure, the pharmaceutical composition is formulated for oral administration.
[0019] In another aspect of the present disclosure, the pharmaceutical composition is administered in combination with a pharmaceutically acceptable carrier.
[0020] One should appreciate that although the present disclosure has been explained with respect to a defined set of functional modules, any other module or set of modules can be added/deleted/modified/combined and any such changes in architecture/construction of the proposed system are completely within the scope of the present disclosure. Each module can also be fragmented into one or more functional sub-modules, all of which also completely within the scope of the present disclosure.
[0021] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments in which like numerals represent like components.

DETAILED DESCRIPTION
[0022] Aspects of the present disclosure relate to a pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome.
[0023] 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 disclosure as defined by the appended claims.
[0024] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.
[0025] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic. 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.
[0026] The present disclosure provides a pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome. The pharmaceutical composition comprising of Ticagrelor as an antiplatelet; and a type II therapeutic agent. The pharmaceutical composition is in a sweetened palatable form selected from a candy, a sweetener tablet, a sugar-coated tablet, a gummy, a lozenge, and a chewable sugar-coated tablet.
[0027] In an embodiment of the invention, the type II therapeutic agent is selected from one or more of rosuvastatin calcium & atorvastatin.
[0028] The invention provides a drug composition (chewed or disintegrated in the oral cavity prior to swallowing, comprising enteric-sweetener coated tablets, sweetener, candy, sweet lozenges) of ticagrelor and a type II therapeutic agent. The pharmaceutical composition disclosed herein presents an innovative approach to delivering the synergistic therapeutic effects of Ticagrelor and a type II therapeutic agent in a range of palatable and user-friendly forms.
[0029] In an embodiment of the invention, Ticagrelor and Atorvastatin, Ticagrelor and Rosuvastatin are presented in a range of palatable and user-friendly forms, including candy, sweetener, sugar-coated tablet, lozenges, and chewable sugar-coated tablet. It provides synergistic therapeutic effects of Ticagrelor and Atorvastatin, Ticagrelor and Rosuvastatin. This novel composition combines the cardiovascular benefits of vital active pharmaceutical ingredients (APIs) with the convenience and enjoyment of different administration methods.
[0030] This pharmaceutical composition is prepared by mixing ticagrelor and described equations of another therapeutic agent (Rosuvastatin, atorvastatin with pharmaceutically acceptable pharmaceutical carrier, respectively, and packaging two different types of independent pharmaceutical preparations in the same medicine with the new method of sugar coated, sweetener tablet, Sweetener capsules, candy. The pharmaceutical composition of ticagrelor and a type II therapeutic agent such as rosuvastatin sweetener tablet is capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising enteric-sweetener coated tablets, candy, and a binder capable of absorbing ambient moisture, and preferably a matrix comprising directly compressible Sugars or Sugar-alcohols and high intensity sweetener.
[0031] Constitution of the pharmaceutical composition in candy form, sweetener tablet, sugar-coated tablet, gummies, lozenges, and chewable sugar-coated tablet:
a. Ticagrelor (C23H28F2N6O4S) + Rosuvastatin (C22H28FN3O6S)
b. Ticagrelor (C23H28F2N6O4S) + Atorvastatin (C33H35FN2O5)
The pharmaceutical composition in different sweetened palatable form:
[0032] Candy-
The candy formulation encapsulates therapeutic doses of Ticagrelor and Atorvastatin, and Ticagrelor and Rosuvastatin within a solid, flavored confectionery. This delightful form offers an appealing and discreet method of medication administration, making it particularly suitable for individuals who prefer a discreet and convenient approach to their cardiovascular treatment regimen.
[0033] Sweetener-
The sweetener variant of the composition presents a powdered or granulated formulation that can be utilized as a sugar substitute. Beyond its flavor-enhancing properties, this form delivers the therapeutic benefits of Ticagrelor and Atorvastatin, Ticagrelor and Rosuvastatin providing an innovative way to incorporate medication into daily dietary habits.
[0034] Sugar-Coated Tablet-
[0035] In the sugar-coated tablet form, Ticagrelor and Atorvastatin, and Ticagrelor and Rosuvastatin are enclosed within a tablet core, which is then coated with a layer of sugar. This combines the ease of conventional tablet administration with a pleasant taste, promoting ease of swallowing and enhancing overall patient comfort.
[0036] Lozenges-
Medicated lozenges are designed to dissolve gradually in the mouth, releasing the therapeutic agents over time. The Composition of Ticagrelor and Atorvastatin, Ticagrelor and Rosuvastatin lozenges offer a discreet and slow-release method of medication delivery, suitable for patients who prefer a more prolonged administration process.
[0037] Chewable Sugar-Coated Tablet-
The chewable sugar-coated tablet amalgamates the convenience of a chewable formulation with the benefits of a sugar-coated exterior.
[0038] Advantages of pharmaceutical composition -
a. The pharmaceutical composition provides synergistic therapeutic effects of Ticagrelor and type II therapeutic agent in a range of palatable and user-friendly forms.
b. It combines the cardiovascular benefits of vital active pharmaceutical ingredients (APIs) with the convenience and enjoyment of different administration methods.
c. It offers an appealing and discreet method of medication administration.
d. It promotes ease of swallowing and enhances overall patient comfort.
[0039] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. 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.
,CLAIMS:I/We Claim:
1. A pharmaceutical composition of Ticagrelor & Rosuvastatin, Ticagrelor & Atorvastatin in sweetened palatable form for treatment of Acute Coronary Syndrome, the pharmaceutical composition comprising of:
Ticagrelor as an antiplatelet; and
a type II therapeutic agent, Rosuvastatin, Atorvastatin, wherein the pharmaceutical composition is in a sweetened palatable form selected from a candy, a sweetener tablet, a sugar-coated tablet, a gummy, a lozenge, and a chewable sugar-coated tablet.
2. The pharmaceutical composition of Ticagrelor & Rosuvastatin, composition of Ticagrelor & Atorvastatin in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the Ticagrelor has a chemical formula of C23H29F2N6O4S.
3. The pharmaceutical composition in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 1.
4. The pharmaceutical composition in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 1, Where anti platelet is Ticagrelor & wherein the type II therapeutic agent is a statin selected from rosuvastatin and atorvastatin.
5. The pharmaceutical composition in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 4, wherein the rosuvastatin has a chemical formula of C22H28FN3O6S.
6. The pharmaceutical composition in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 4, wherein the atorvastatin has a chemical formula of C33H35FN2O5.
7. The pharmaceutical composition in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is formulated for chewable & oral administration.
8. The pharmaceutical composition of Ticagrelor in sweetened palatable form for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is administered in combination with a pharmaceutically acceptable carrier.
9. The pharmaceutical composition for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition in candy form, sweetener tablet, sugar-coated tablet, gummies, lozenges, and chewable sugar-coated tablet.