1. A pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome, the pharmaceutical composition comprising of: an antiplatelet selected, ticagrelor, and rosuvastatin as a statin.

2. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of cardiovascular diseases as claimed in claim 1, wherein the antiplatelet is ticagrelor having chemical formula of C23H29F2N6O4S.

3. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the rosuvastatin having chemical formula of C22H28FN3O6S.

4. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of cardiovascular diseases as claimed in claim 1, wherein the ticagrelor and the rosuvastatin is in a ratio of 9:2 respectively.

5. The pharmaceutical composition of ticagrelor antiplatelet and rosuvastatin for treatment of cardiovascular diseases (Acute Coronary Syndrome) as claimed in claim 1.

6. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is in a powder form in sachets and a tablet form.

7. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is formulated for oral administration.

8. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is administered in combination with pharmaceutical beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.

DESC:PHARMACEUTICAL COMPOSITION IN POWDER FORM IN SACHETS AND TABLET OF 90 MG TICAGRELOR + 20 MG ROSUVASTATIN

FIELD OF INVENTION
[0001] The present disclosure relates to pharmaceutical composition for the treatment of acute coronary syndrome , and particularly relates to pharmaceutical composition of ticagrelor and rosuvastatin for treatment of acute coronary syndrome.

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.
[0003] Cardiovascular diseases (CVDs) are one of the leading causes of morbidity and mortality worldwide. Ticagrelor and Rosuvastatin 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 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] The present invention aims to reduce the risk related to Acute Coronary Syndrome. Keeping this in mind, development of pharmaceutical composition comprising a combination of antiplatelet (ticagrelor) and rosuvastatin is disclosed. The active pharmaceutical ingredients used in the composition possess complementary pharmacological properties and have been shown to be effective in reducing the risk related to Acute Coronary Syndrome quicker in powder form.
[0005] The pharmaceutical composition has been developed to provide an improved therapeutic option for the treatment of Acute Coronary Syndrome. Ticagrelor is an antiplatelet agent that prevents blood clots, while rosuvastatin is a lipid-lowering agent that reduces cholesterol levels. The combination of these two active ingredients has been shown to provide synergistic effects in the treatment of Acute Coronary Syndrome.
[0006] 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.
[0007] 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. 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.

OBJECT OF THE INVENTION
[0008] It is an object of the present disclosure which provides a pharmaceutical composition of antiplatelet and rosuvastatin for treatment of Acute Coronary Syndrome.
[0009] It is another object of the present disclosure which provides a combination of ticagrelor and rosuvastatin for synergistic effect.

SUMMARY
[0010] The present disclosure is directed towards a pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome comprising of an antiplatelet selected from P2Y12 inhibitors: clopidogrel, ticagrelor, and prasugrel; rosuvastatin calcium salt as a statin; and excipients.
[0011] In an aspect of the present disclosure, the antiplatelet is ticagrelor having chemical formula of C23H28F2N6O4S.
[0012] In an aspect of the present disclosure, the rosuvastatin having chemical formula of C22H28FN3O6S.
[0013] In an aspect of the present disclosure, the ticagrelor antiplatelet and the rosuvastatin is in a ratio of 9:2 respectively.
[0014] In an aspect of the present disclosure, the excipients include but not limited to, microcrystalline cellulose,lactose monohydrate, croscarmellose sodium, magnesium stearate, (hypromellose, titanium dioxide, talc, and polyethylene glycol 400.)
[0015] In an aspect of the present disclosure, the pharmaceutical composition is in a powder and a tablet form.
[0016] In an aspect of the present disclosure, the pharmaceutical composition is formulated for oral administration.
[0017] In an aspect of the present disclosure, the pharmaceutical composition is administered in combination with pharmaceutical beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.
[0018] 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. Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.

DETAILED DESCRIPTION
[0019] Aspects of the present disclosure relate to pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome.
[0020] 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.
[0021] 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.
[0022] 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.
[0023] In an embodiment of the present disclosure, pharmaceutical composition of antiplatelet and rosuvastatin for treatment of cardiovascular diseases is disclosed. The invention discloses a pharmaceutical composition of ticagrelor and rosuvastatin. The pharmaceutical composition comprises of an antiplatelet selected from aspirin, clopidogrel, ticagrelor, and prasugrel; rosuvastatin calcium salt as a statin; and excipients.
[0024] In an embodiment of the present disclosure, the antiplatelet is ticagrelor having chemical formula of C23H28F2N6O4S. The rosuvastatin having chemical formula of C22H28FN3O6S. The excipients include microcrystalline cellulose,lactose monohydrate, croscarmellose sodium, magnesium stearate,(? hypromellose, titanium dioxide, talc, and polyethylene glycol 400.) The antiplatelet and the rosuvastatin calcium salt is in a ratio of 9:2 respectively. The pharmaceutical composition is in a powder and a tablet form. The pharmaceutical composition is formulated for oral administration.
[0025] Constitution of the pharmaceutical composition:
Ticagrelor (C23H28F2N6O4S) + Rosuvastatin (C22H28FN3O6S)
Powder sachet:
Ticagrelor: 90 mg (molecular weight = 522.02 g/mol)
Rosuvastatin: 20 mg (molecular weight = 481.54 g/mol)
Excipients: q.s. (quantity sufficient)

Tablet:
Ticagrelor: 90 mg (molecular weight = 522.02 g/mol)
Rosuvastatin: 20 mg (molecular weight = 481.54 g/mol)
Microcrystalline cellulose: 50 mg (molecular weight = 101.11 g/mol)
Croscarmellose sodium: 7.5 mg (molecular weight = 155.15 g/mol)
Magnesium stearate: 2.5 mg (molecular weight = 591.27 g/mol)
Hypromellose: 2.5 mg (molecular weight = variable)
Titanium dioxide: 1.5 mg (molecular weight = 79.88 g/mol)
Talc: 1.5 mg (molecular weight = 379.27 g/mol)
Polyethylene glycol 400: 0.5 mg (molecular weight = 400 g/mol)
Note: The molecular weights listed here are approximate and may vary slightly based on the manufacturing process and specific grade of each component used.
[0026] The present invention provides a pharmaceutical composition comprising a combination of 90mg ticagrelor and 20mg rosuvastatin salt in powder and tablet form. The active pharmaceutical ingredients used in the composition are selected from P2Y12 inhibitors clopidogrel, ticagrelor, and prasugrel as antiplatelet and rosuvastatin calcium salt as a statin. The composition is prepared using a suitable method that ensures uniform distribution of the active ingredients throughout the dosage form.
[0027] The pharmaceutical composition comprises a uniform blend of ticagrelor and rosuvastatin, which has been formulated to offer improved bioavailability, uniform absorption, and increased patient compliance. The powder form in sachets and tablets offers several advantages over the existing formulations, including faster onset of action, improved bioavailability, and improved patient compliance. The composition has been developed by combining the two active ingredients in a single dosage form to enhance patient compliance and improve the efficacy of the treatment. The composition includes excipients such as microcrystalline cellulose, sodium starch glycolate, and magnesium stearate to enhance the stability and flowability of the powder.
[0028] The pharmaceutical composition of the present invention can be administered orally, and both the powder and tablet forms can be used to achieve therapeutic benefits. The powder form can be administered by dissolving the composition in a suitable liquid before consumption. The tablet form can be swallowed whole with water. The sachets and tablets dissolve quickly in water, allowing for easy administration and rapid absorption. The composition has been tested in vitro and in vivo, and the results have demonstrated its safety and efficacy in the treatment of cardiovascular diseases.
[0029] The present invention provides a significant improvement over the existing formulations of ticagrelor and rosuvastatin, which are primarily available in tablet form. The novel composition offers a single dosage form that simplifies the administration of the medication and improves patient compliance. The composition has been found to have superior pharmacokinetic properties compared to the existing formulations of ticagrelor and rosuvastatin, including improved bioavailability, uniform absorption, and faster onset of action. (deleted 2 lines from here)
[0030] The invented novel composition offers a single dosage form that offers several advantages over the existing formulations, including faster onset of action, improved bioavailability and uniform absorption(deleted 2 lines). The powder form in sachets and tablets allows for easy administration and provides a convenient dosage form for patients who have difficulty swallowing tablets. The pharmaceutical composition provides a convenient dosage form for patients and is expected to have a significant impact on the treatment of Acute Coronary Syndrome and improve the quality of life of patients.
[0031] The pharmaceutical composition has been developed by combining the two active ingredients in a single dosage form to enhance patient compliance and improve the efficacy of the treatment. The combination of ticagrelor and rosuvastatin has been shown to provide synergistic effects in the treatment of Acute Coronary Syndrome.
[0032] The composition is effective in reducing the risk of Acute Coronary Syndrome..The composition can also be used to prevent the occurrence of cardiovascular events in patients with risk factors such as hypertension, hypercholesterolemia, and diabetes. The composition has been evaluated in various clinical trials, and the results have demonstrated its safety and efficacy. The composition has been found to be effective in the treatment of acute coronary syndromes. The composition can be used as a standalone therapy or in combination with other medications for the treatment of Acute Coronary Syndrome.
[0033] The pharmaceutical composition of the present invention can be packaged in various forms such as sachets, tablets and the like, to suit different needs of patients. The packaging can be made of suitable materials that ensure the stability and shelf life of the composition.
[0034] The pharmaceutical composition for treatment of cardiovascular diseases offers following benefits-
• Reduced risk in Acute Coronary Syndrome. Ticagrelor is a P2Y12 platelet inhibitor that prevents blood clots from forming in the arteries and reduces the risk of cardiovascular events such as heart attacks and strokes. Rosuvastatin is a statin that lowers cholesterol levels and reduces the risk of atherosclerosis.
• Convenience: The composition is available in both powder sachet and tablet forms, making it convenient for patients to take their medication as prescribed.
• Improved medication adherence: By offering multiple dosage forms, patients may find it easier to adhere to their medication regimen, which can improve health outcomes.
• Efficacy: Both of ticagrelor and rosuvastatin has been shown to be effective in old age patient, who cannot chew the medicine, patients on CCU/ICU and Ventilator.
• Cost-effectiveness: The use of a combination medication may be more cost-effective than taking multiple medications separately.
[0035] 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 and rosuvastatin for treatment of Acute Coronary Syndrome, the pharmaceutical composition comprising of: an antiplatelet selected, ticagrelor, and rosuvastatin as a statin.
2. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of cardiovascular diseases as claimed in claim 1, wherein the antiplatelet is ticagrelor having chemical formula of C23H29F2N6O4S.
3. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the rosuvastatin having chemical formula of C22H28FN3O6S.
4. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of cardiovascular diseases as claimed in claim 1, wherein the ticagrelor and the rosuvastatin is in a ratio of 9:2 respectively.
5. The pharmaceutical composition of ticagrelor antiplatelet and rosuvastatin for treatment of cardiovascular diseases (Acute Coronary Syndrome) as claimed in claim 1.
6. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is in a powder form in sachets and a tablet form.
7. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is formulated for oral administration.
8. The pharmaceutical composition of ticagrelor and rosuvastatin for treatment of Acute Coronary Syndrome as claimed in claim 1, wherein the pharmaceutical composition is administered in combination with pharmaceutical beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.