A ready-to-use non-aqueous oral solution of angiotensin 11 receptor blocker

Abstract

The invention relates to a non-aqueous oral solution comprising: losartan potassium in an amount of 0.01 mg / mL to 50 mg / mL, such as 10 mg / mL; a solubiliser, such as polyethylene glycol 400 in an amoun

Description

The present invention contemplates a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker. The present invention also provides a method of preparing a ready-to-use nonaqueous oral solution of angiotensin II receptor blocker. The present invention contemplates a ready-to-use non-aqueous oral solution of losartan. The present invention also provides a method of preparing a ready-to-use non-aqueous oral solution of losartan. BACKGROUND OF THE INVENTION Angiotensin receptor blockers (ARBs), such as irbesartan, valsartan, losartan, candesartan, azilsartan, olmesartan, and telmisartan are medications utilized for managing conditions like hypertension, heart failure, chronic kidney disease, and post-heart attack recovery. These drugs function as angiotensin II receptor antagonists, effectively controlling blood pressure and supporting cardiac health. ARBs function by inhibiting the effects of angiotensin II, a hormone known for its vasoconstrictive properties that elevate blood pressure. Angiotensin II also promotes salt and water retention, exacerbating hypertension. These medications work by antagonizing ATI receptors, which are prevalent in the heart, blood vessels, and kidneys. By blocking angiotensin II from binding to these receptors, ARBs effectively reduce blood pressure and mitigate potential cardiac and renal damage. One of the most common medications prescribed for high blood pressure (hypertension) is losartan. Losartan potassium, a pharmaceutically acceptable salt of losartan, is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone, and practically insoluble in chloroform. The melting point of losartan potassium is between 270 °C to 276 °C. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium, the first of a new class of anti-hypertensives, is an angiotensin II receptor (Type ATI) antagonist. Angiotensin II, which is formed from angiotensin I in a reaction catalysed by angiotensin-converting enzyme (ACE, kinase II), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan potassium is also known as 2-butyl-4-chloro-l-[p-(o-U / -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22CIKN6O and it has the following structural formula: Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients. It may be used alone or in combination with other antihypertensive agents. The usual starting dose of losartan potassium is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g. patients treated with diuretics) and patients with a history of hepatic impairment. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. If blood pressure is not controlled by losartan potassium alone, a low dose of a diuretic may be added. COZAAR® is available in US as tablets for oral administration containing either 25 mg, 50 mg, or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. COZAAR® is also mentioned about preparation of suspension (For 200 mL of a 2.5 mg / mL suspension). The preparation of suspension is as follows: Add 10 mL of purified water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg COZAAR® tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50 / 50 volumetric mixture of Ora-Plus® and Ora-Sweet® SF. Add 190 mL of the 50 / 50 Ora-Plus® / Ora-Sweet® SF mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8 °C (36-46 °F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator. COZ AAR® 2.5 mg / mL powder and solvent for oral suspension are also available in UK as powder for reconstitution. Each sachet contains 500 mg of losartan potassium powder. A medical or healthcare professional / pharmacist mixes each sachet with 200 mL of solvent to create a suspension. One mL of suspension contains 2.5 mg of losartan potassium. COZAAR® powder is a white to off-white powder. After suspension in solvent, COZAAR® is an off-white liquid. In the UK, COZAAR® is marketed as a kit that includes powder and solvent for oral suspension and is packaged in a kit containing: One foil sachet filled with powder equal to 500 mg losartan potassium; One 473 mL bottle of solvent; One 240 mL bottle with a child resistant closure for mixing the suspension; One 10 mL oral dosing syringe; One push-in bottle adaptor. The other ingredients are as follows: Powder: microcrystalline cellulose, lactose monohydrate, pregelatinised maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Solvent: microcrystalline cellulose, carboxymethylcellulose sodium, citric acid anhydrous, purified water, xanthan gum, methyl hydroxybenzoate, sodium phosphate monobasic monohydrate, potassium sorbate, carrageenan calcium sulfate, trisodium phosphate, flavor berry citrus sweet, glycerin, propyl hydroxybenzoate, sodium citrate anhydrous, saccharin sodium, sorbitol antifoam AF emulsion (Contains water, poly dimethyl siloxane, C-14-18, mono- and di-glycerides, polyethylene glycol stearate, and polyethylene glycol). The shelf life is 2 years without reconstitution and after reconstitution: 4 weeks only and need to keep the prepared suspension in a refrigerator (at 2-8 °C) for up to 4 weeks for storage and also need to discard the excess solvent not used in the preparation of the suspension. Patient acceptability of a drug or medicine is a key aspect in the development of any pharmaceutical formulations of any drug or medicine. Children and older adults differ in many aspects from the other age subsets of the population and require particular considerations in medication acceptability. Especially when it is about solid oral formulations like tablets and capsules, paediatric patient, geriatric patients as well as patients in ICU, poses difficulty swallowing. In such cases, if any drug or medicine is available only in solid oral form, it will be difficult for the healthcare professional to deal with it. As per one practice in hospitals, they usually prepare extemporaneous liquid formulation by crushing available tablets or emptying the content of capsule formulation in the vehicle and adding sweetener and another one or more ingredients to convert it into a liquid suspension formulation for such patients. However, that practice is not the solution and also requires a technical skilled person to carry out the whole process, and also in the end there is the possibility of dose error. The powder is prepared into a suspension with water or other reconstitution liquids before administration, and the excess liquid suspension must be disposed of immediately. This can lead to incorrect dose preparations, wasted doses, or incorrect reconstitution errors due to non-medical professionals formulating the wrong concentration of the powder for oral suspension. Further, any excess powder and suspension may contain bacterial contamination or significant degradants if stored for subsequent doses. In the case of losartan, mainly the solid form that is tablet formulation is available and most of the liquid formulations needs reconstitution. U.S. Patent No. 5,138,069 discloses the active compound as a useful angiotensin II blocker, and its activity in treating hypertension and congestive heart failure. The active ingredient can be administered orally in solid dosage forms, such as capsules, tablets, and powders, or in liquid dosage forms, such as elixirs syrups, and suspensions. It can also be administered parenterally, in sterile liquid dosage forms. Liquid dosage forms for oral administration can contain colouring and flavouring to increase patient acceptance. U.S. Patent No. 5,266,583 discloses a metabolite of losartan. The metabolite may be utilized in compositions such as tablets, capsules, or elixirs for oral administration. A syrup or elixir may contain the metabolite, sucrose as a sweetening agent, methyl and propyl parabens as preservatives, a dye, and a flavoring such as cherry or orange flavor. US20070026026 Al describes and claims an oral liquid composition of losartan, or a pharmaceutically acceptable salt or metabolite thereof, and at least one pharmaceutically acceptable carrier and a phosphate-containing buffer comprising sodium phosphate, potassium phosphate, or a mixture thereof in an amount sufficient to provide a pH of about 6 or higher. Processes of preparing such compositions and methods of administering such compositions are also included. PCT Application No. WO2009112800 describes the losartan composition suitable for oral administration, said composition containing a pharmaceutically acceptable salt of losartan and a carrier agent, and one or more pH modifying or buffering agents include any combination of citric acid, sodium citrate, disodium hydrogen phosphate or sodium dihydrogen phosphate., The losartan salt forming a suspension with said carrier agent having the pH of the composition is less than 7. U.S. Patent No. 11890273 describes relates oral liquid pharmaceutical compositions in the form of water-based suspension of losartan or pharmaceutically acceptable salts thereof which has a pH of about 7 using pH modifying agent. Further also provides powder compositions for reconstitution to provide a liquid formulation. The compositions of the prior art include unacceptable amounts of water. In light of the existing prior arts, it can be concluded that losartan potassium, a pharmaceutically acceptable salt of losartan, is generally given to patients in a solid dosage form, which can be difficult for some patients to swallow and sometimes in the liquid dosage form like water-based solution or suspension or powder for reconstitution. The powder for reconstitution has some disadvantages like it requires reconstitution or dilution to use, and due to this, there are chances of dosing error. Once reconstituted, the suspension has limited stability and must be used within a few hours or days. In addition, contaminants may be introduced into the suspensions during reconstitution, which compromising patient safety. The losartan in the liquid solution form is typically completely dissolved in an aqueous solution to form a particle-free solution. However, a problem with known losartan solutions is that the losartan tends to degrade over time to form dimer degradation products. Hence, liquid dosage forms have more of a challenge because of the solubility and stability characteristics of losartan, as well as the various excipients, in different solvents. Also, losartan potassium has a bitter taste which is difficult to mask even with strong flavoring or sweetening agents. The above-mentioned prior art compositions comprising liquid dosage formulations have certain drawbacks such as dissolution of the drug, use of water leading to degradation, and reduced stability. There are many factors associated with the risk of currently approved product, like a) materials required for the reconstitution or dilution may be available at home but it may difficult to remember during travel to obtain all the listed items like if any lack of items may result in postponed or omission of the dose and substitutions may result in exposure to verify the complete dissolution of the powder or may further difficulty in reconstituting or measuring a correct dose, b) incorrect volume of reconstitution liquid, c) incomplete dissolution of powder, d) incorrect dosage, e) may choose different solution while taking the dose, and f) chances of contamination and product degradation is high. In view of the foregoing, it would be desirable to have suitable oral liquid compositions of angiotensin II receptor blocker with improved dissolution and stability properties as an additional treatment option. The angiotensin II receptor blocker may be losartan. Therefore, there is a serious need in society to provide a non-aqueous oral liquid solution, using minimal ingredients, and its stable during shelflife. The present invention addresses the problems of the prior arts by providing a non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) that is stable for the long term and can be conveniently administered orally. The inventors in the present invention have made efforts to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) and provides the many advantages like right concentration by using the single syringe and stable over the period of time. OBJECTIVE OF THE INVENTION The main objective of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan). The other main objective of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) which is stable. Another objective of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) which is safe and effective. One other objective of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) which provides patient compliance. Yet another object of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) which is ready to use. Yet another object of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) which is free from water. SUMMARY OF THE INVENTION The present invention is all about a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker. The present invention provides a ready-to-use non-aqueous oral solution of losartan (e.g., losartan potassium). In a first aspect, the present invention provides a ready-to-use, non-aqueous oral solution, comprising: losartan potassium in an amount of 0.01 mg / mL to about 50 mg / mL; a solubilizer; a thickening agent; one or more pharmaceutically acceptable excipients; and a vehicle comprising glycerin. The main aspect of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprising therapeutically effective amount of losartan potassium, a solubilizer, a thickening agent, a preservative, and one or more pharmaceutically acceptable excipients. Yet another aspect of the present invention is to provide a process for the preparation of a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker. In an aspect, the present invention provides a process for the preparation of a ready-to-use non-aqueous oral solution of losartan e.g., losartan potassium. DESCRIPTION OF THE INVENTION Before elaborating on the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified examples or process parameters that may, of course, vary. It is also to be understood that the terminology used herein is to describe particular embodiments of the invention only, and is not intended to limit the scope of the invention in any manner. The detailed description set forth below is intended as a description of exemplary embodiments and is not intended to represent the only forms in which the exemplary embodiments may be constructed and / or utilized. The description sets forth the functions and the sequence of steps for constructing and / or operating the exemplary embodiments. However, it is to be understood that the same or equivalent functions and sequences that may be accomplished by different exemplary methods are also intended to be encompassed within the spirit and scope of the invention. As defined herein, all scientific and technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any process and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. As stated in the present invention herein, the singular forms “a,” “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise. The term “about” is used synonymously with the term “approximately.” As one of ordinary skill in the art would understand, the exact boundary of “about” will depend on the component of the composition. Illustratively, the use of the term “about” indicates that values slightly outside the cited values, i.e., plus or minus 0.1% to 10%, which are also effective and safe. Thus, compositions slightly outside the cited ranges are also encompassed by the scope of the present claims. As stated herein the word “RTU” refers to ready-to-use and can interchangeably use for “ready-to-use” phrase. As stated herein, that it follows in a transitional phrase or in the body of a claim, the terms “comprise(s)” and “comprising” are to be interpreted as having an open-ended meaning. That is, the terms are to be interpreted synonymously with the phrases “having at least” or “including at least”. When used in the context of a process, the term “comprising” means that the process includes at least the recited steps, but may include additional steps. When used in the context of a composition, the term “comprising” means that the composition includes at least the recited features or components, but may also include additional features or components. As stated herein, that it follows in a transitional phrase or in the body of a claim, the term “consisting of’ excludes any element, step, or ingredient not specified in the claim or description. “Consisting of’ defined as “closing the claim or description to the inclusion of materials other than those recited except for impurities ordinarily associated therewith”. One will understand that the expression “consisting of’ may replace the expression “comprising” for a claimed formulation, process, or method. As stated herein, that it follows in a transitional phrase or in the body of a claim, the term “consisting essentially of’ limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. One will further understand that the expression “consisting essentially of’ may replace the expression “comprising” for a claimed formulation, process or method. In the application, effective amounts are generally those amounts listed as the ranges or levels of ingredients in the descriptions, which follow hereto. A “therapeutically effective amount” or “effective amount” is the amount of a pharmaceutical agent to achieve a pharmacological effect. The term “therapeutically effective amount” includes, for example, a prophylactically effective amount. As used herein, the term “therapeutically effective amount” can be understood to include an amount of Losartan potassium that is effective in preventing or ameliorating or treating a condition requiring antihypertensive therapy. As used herein, the term “active agent” can be understood to include any substance or formulation or combination of substances or formulations of matter which, when administered to a human or animal subject, induces a desired pharmacologic and / or physiologic effect by local and / or systemic action. The terms are used interchangeably herein: “active pharmaceutical agent (API)”, "active", "drug", and "active ingredient". As used herein, the terms “dose” and “dosage” can be understood to mean a specific amount of active or therapeutic agents for administration. As used herein, the term “excipient” can be understood to include any inert substance combined with an active agent such as losartan potassium to prepare a convenient dosage form. As used herein, the term “glycerin” can be interchangeably used with term “glycerol” as both are same. As per one preferred embodiment, the “oral solution” as mentioned herein is defined as the liquid dosage form that has no suspended particles and its a clear liquid solution. As per one embodiment, the formulation of the present invention is ready-to-use, i.e. ready to be administered directly to a patient for a treatment, without the step such as reconstitution or dilution. In some embodiments, the ready-to-use, non-aqueous oral solution has a water content of less than 1% w / w. In some embodiments, the ready-to-use, non-aqueous oral solution excludes a buffering agent. In some embodiments, the ready-to-use, non-aqueous oral solution excludes a pH adjusting agent. In some embodiments, the ready-to-use, non-aqueous oral solution has a water content of less than 1% w / w and excludes a buffering agent and a pH adjusting agent. In some embodiments, the present invention provides a ready-to-use, non-aqueous oral solution, comprising: losartan potassium in an amount of 10 mg / mL; a solubilizer comprising polyethylene glycol 400; a thickening agent; one or more pharmaceutically acceptable excipients; and a vehicle comprising glycerin, wherein the ready-to-use, non-aqueous oral solution has a water content of less than 1% w / w and excludes a buffering agent and a pH adjusting agent. The main embodiment of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker, wherein angiotensin II receptor blocker is losartan potassium. In one aspect, disclosed herein relates to a ready-to-use, non-aqueous oral solution of losartan potassium. Another main embodiment of the present invention is to provide a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprising a therapeutically effective amount of losartan potassium, a solubilizer, a thickening agent, a preservative, and one or more pharmaceutically acceptable excipients. As per one preferred embodiment of the present invention provides a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprising a therapeutically effective amount of losartan potassium for the treatment of a cardiac conditions like hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients, wherein losartan potassium may be used alone or in combination with other antihypertensive agents. As per one preferred embodiment the term “free of water” is defined as the said formulation is completely devoid of water. This is because, in the presence of water, the losartan potassium tends to degrade and result in an unstable product on storage. The term “free of water” and “non-aqueous” are interchangeably herein. An embodiment disclosed herein may be associated with the expression “free of water” where the amount of water in the formulation is less than about 1% w / w, about 0.5% w / w, about 0.4% w / w, about 0.3% w / w, about 0.25% w / w, about 0.2% w / w, about 0.1% w / w, about 0% w / w, or 0% w / w (i.e., the formulation is completely devoid of water). One will appreciate that the water content expressed in percent by weight (i.e., % w / w) is based on the total weight of the formulation. Thus, for example, 1% w / w corresponds to 1 g of H2O in 100 g of the formulation. In one aspect, the ready-to-use non-aqueous oral solution as per the present invention does not include water, buffer (For example, phosphate buffer, citrate buffer), or pH adjusting agents (For example, NaOH, HC1), solubilizer (For example, propylene glycol [PG]), preservatives (For example, alkyl esters of p-hydroxybenzoic acid which includes methyl paraben, propyl paraben, ethyl paraben etc.), polymer (For example, polyvinylpyrrolidone or povidone, hydroxypropyl methylcellulose or hypromellose, cyclodextrin, hydroxy ethyl cellulose), chelating agent (For example, ethylenediaminetetraacetic acid or EDTA, or a salt thereof), and sweetener (For example, saccharin sodium). One skilled in the art will appreciate that povidone (aka, polyvinylpyrrolidone (or PVP)) is available commercially (e.g., Kollidon®) with different grades that relate generally to the weight average molecular weight (Mw). For example, Kollidon® 25 (aka PVPK25) has a Mw of from 28,000 Daltons (Da) to 34,000 Da, Kollidon® 30 (aka PVPK30) has a Mw of from 44,000 Da to 54,000 Da, while Kollidon® 90 (aka PVPK90) has a Mw of from 900,000 Da to 1,200,000 Da. The term “losartan” as used herein is in the form of potassium salt. In the whole specification, wherever losartan is mentioned is to be interpreted as losartan potassium only. As per one embodiment, said angiotensin II receptor blocker can be selected from olmesartan, telmisartan, valsartan, losartan, irbesartan, candesartan, azilsartan, and eprosartan. As per one embodiment, losartan relates to losartan potassium. In one aspect, the ready-to-use, non-aqueous oral solution comprises losartan potassium. As per a preferred embodiment, losartan potassium is used as angiotensin II receptor blocker. As per one preferred embodiment, the amount of losartan potassium may range from about 0.01 mg / ml to about 50 mg / ml, preferably about 0.01 mg / ml to 40 mg / ml, more preferably about 0.1 mg / ml to 30 mg / ml, most preferably about 1 mg / ml to 20 mg / ml or any range in between, such as for example 1 mg / ml, 5 mg / ml, 10 mg / ml, 15 mg / ml, 20 mg / ml, 25 mg / ml, 30 mg / ml, 35 mg / ml, 40 mg / ml, 45 mg / ml, and 50 mg / ml. In one embodiment, the ready-to-use, non-aqueous oral solution comprises losartan potassium in an amount of about 5 mg / mL to about 15 mg / mL. In one embodiment, the ready-to-use, non-aqueous oral solution comprises losartan potassium in an amount of about 10 mg / mL. As per one embodiment, the “solubilizer” used in the present invention is defined as an agent that increases the solubility of a losartan potassium. Solubilizers can increase the bioavailability of active pharmaceutical ingredients. Typical solubilizers include organic and inorganic alkalis, which act by the process of alkaline hydrolysis, and certain mineral acids that affect solubilization by acidic oxidation. As per one embodiment, said solubilizer can be selected from, but not limited to, alcohols such as ethanol, polyethylene glycols (PEG), glycerine, triacetin, dimethyl sulfoxide (DMSO), benzyl benzoate, or any combination thereof. As per one embodiment, polyethylene glycols (PEG) can be selected from PEG 200, PEG 400, PEG 600, PEG 1500, PEG 4000, and PEG 6000. In one embodiment, the solubilizer is PEG 400. As per a preferred embodiment, PEG 400 is used as a solubilizer. According to one preferred embodiment, the amount of solubilizer (e.g. polyethylene glycol 400) may present in range from about 50 mg / ml to about 500 mg / ml, preferably the range from about 50 mg / ml to about 300 mg / ml, preferably the range from about 50 mg / ml to about 250 mg / ml, more preferably the range from about 50 mg / ml to about 200 mg / ml, most preferably the range from about 70 mg / ml to about 150 mg / ml or any range in between, such as for example 50 mg / ml, 60 mg / ml, 70 mg / ml, 80 mg / ml, 90 mg / ml, 100 mg / ml, 110 mg / ml, 115 mg / ml, 120 mg / ml, 140 mg / ml, 160 mg / ml, 180 mg / ml, 200 mg / ml, 250 mg / ml, 300 mg / ml, 400 mg / ml, and 500 mg / ml. In one aspect, the solubilizer comprises PEG 400 in an amount of about 115 mg / mL. In one aspect, a variable amount of PEG 400-to-glycerin may be used, such that the weight ratio of PEG 400-to-glycerin in the oral solution disclosed herein ranges from about 5:95 to about 50:50 and all values in between, such as 10:90, 15:85, 20:80, 25:75, 30:70, 35:65, 40:60, and 45:55. In yet another aspect, the weight ratio of PEG 400-to-glycerin in the oral solution disclosed herein ranges from about 5:95 to 15:85. As per one embodiment, the “thickening agent” used in the present invention is defined as an agent that can increase the viscosity of a liquid without substantially changing its other properties. As per one embodiment, said thickening agent can be selected from methylcellulose, bentonite, hectorite, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium aluminum silicate, xanthan gum, acacia, tragacanth, alginates, guar gum, colloidal silicon dioxide, or any combination thereof. As per a preferred embodiment, xanthan gum is used as a thickening agent. According to one preferred embodiment, the amount of thickening agent (e.g., xanthan gum) may present in the range from about 0.01 mg / ml to about 15 mg / ml, preferably the range from about 0.01 mg / ml to about 12 mg / ml, preferably the range from about 0.01 mg / ml to about 10 mg / ml, preferably the range from about 0.05 mg / ml to about 10 mg / ml, more preferably the range from about 0.1 mg / ml to about 10 mg / ml, most preferably the range from about 0.5 mg / ml to about 10 mg / ml or any range in between, such as for example 0.1 mg / ml, 0.3 mg / ml, 0.5 mg / ml, 0.7 mg / ml, 0.9 mg / ml, 1 mg / ml, 1.1 mg / ml, 1.2 mg / ml, 1.3 mg / ml, 1.4 mg / ml, 1.5 mg / ml, 1.7 mg / ml, 2 mg / ml, 4 mg / ml, 6 mg / ml, 8 mg / ml, 10 mg / ml, 12 mg / mL, and 15 mg / ml. In some embodiments, the thickening agent comprises xanthan gum in an amount of about 1.5 mg / mL. As per one embodiment, the “preservative” used in the present invention is defined as a substance or a chemical that is added to products to prevent decomposition by microbial growth or by undesirable chemical changes. Herein the words “preservatives” and “antimicrobial agent” are used interchangeably. As per one embodiment, said preservative can be selected from, but not limited to, sorbic acid, sodium sorbate, potassium sorbate, benzoic acid, and benzoates such as sodium benzoate, nitrates, lactic acid, or any combination thereof. In some embodiments, the preservative comprises sodium benzoate. As per a preferred embodiment, sodium benzoate is used as a preservative. According to one preferred embodiment the amount of preservative (e.g., sodium benzoate) may present in the range from about 0.01 mg / ml to about 20 mg / ml, preferably the range from about 0.01 mg / ml to about 15 mg / ml, preferably the range from about 0.01 mg / ml to about 12 mg / ml, more preferably the range from about 0.01 mg / ml to about 10 mg / ml, most preferably the range from about 0.01 mg / ml to about 5 mg / ml or any range in between, such as for example 0.01 mg / ml, 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 0.7 mg / ml, 0.9 mg / ml, 1 mg / ml, 2 mg / ml, 5 mg / ml, 7 mg / ml, 9 mg / ml, 11 mg / ml, 13 mg / ml, 15 mg / ml, and 20 mg / ml. In some embodiments, the preservative comprises sodium benzoate in an amount of about 0.4 mg / mL. As per one embodiment, the “sweetener” is added to additives that are used or intended to be used either to impart a sweet taste to a pharmaceutical formulation. As per one embodiment, the said sweetener is selected from sucrose, fructose, lactose, maltose, sucralose, maltitol, aspartame, acesulfame potassium (Ace-K), neotame, advantame, or any combination thereof. As per a preferred embodiment, the sweetener comprises sucralose. As per a preferred embodiment, sucralose is used as a sweetener. According to one preferred embodiment, the amount of sweetener (e.g., sucralose) may present in the range from about 0.01 mg / ml to about 15 mg / ml, preferably the range from about 0.01 mg / ml to about 10 mg / ml, preferably the range from about 0.1 mg / ml to about 10 mg / ml, more preferably the range from about 0.1 mg / ml to about 5 mg / ml, most preferably the range from about 0.5 mg / ml to about 3 mg / ml or any range in between, such as for example 0.01 mg / ml, 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 0.7 mg / ml, 0.9 mg / ml, 1 mg / ml, 2 mg / ml, 5 mg / ml, 7 mg / ml, 9 mg / ml, 11 mg / ml, 13 mg / ml, and 15 mg / ml. As per an embodiment, the sweetener comprises sucralose in an amount of about 1 mg / mL. As per one embodiment, the “flavoring agent” as used herein in the present invention are defined as pharmaceutical additives that are added to improve the taste or odour of a pharmaceutical dosage form. As per one embodiment the flavoring agents can be selected from but not limited to vanilla, citrus oil, including lemon, orange, grape, lime and grapefruit, and fruit essences, including apple, banana, orange pear, peach, strawberry, raspberry, cherry, plums pineapple, apricot, frozen peppermint, tutti frutti flavor and so forth and the like, or any combination thereof. In some embodiments, the flavoring agent comprises frozen peppermint. As per a preferred embodiment, frozen peppermint is used as a flavoring agent. According to one preferred embodiment, the amount of flavoring agent (e.g., frozen peppermint) may present in the range from about 0.01 mg / ml to about 15 mg / ml, preferably the range from about 0.01 mg / ml to about 10 mg / ml, preferably the range from about 0.01 mg / ml to about 5 mg / ml, more preferably the range from about 0.05 mg / ml to about 5 mg / ml, most preferably the range from about 0.05 mg / ml to about 2 mg / ml or any range in between, such as for example 0.01 mg / ml, 0.05 mg / ml, 0.1 mg / ml, 0.2 mg / ml, 0.3 mg / ml, 0.4 mg / ml, 0.5 mg / ml, 0.7 mg / ml, 0.9 mg / ml, 1 mg / ml, 2 mg / ml, 5 mg / ml, 7 mg / ml, 9 mg / ml, 11 mg / ml, 13 mg / ml, and 15 mg / ml. As per an embodiment, the flavoring agent comprises frozen peppermint in an amount of about 1 mg / mL. As per one embodiment, the “humectant” as used herein in the present invention is defined as a hygroscopic substance used to minimize water loss and to prevent the drying out of different types of products. As per one embodiment, the said humectant is selected from glycerine, hyaluronic acid, salicylic acid, alpha hydroxy acids (AHAs), such as glycolic acid and lactic acid, honey or any combinations thereof. As per a preferred embodiment, glycerin is used as a humectant. As per one embodiment, glycerin also acts as a vehicle. In some embodiments, the vehicle comprises glycerin. According to one preferred embodiment, the amount of humectant or vehicle may be present in sufficient quantity to make up the final volume. According to one preferred embodiment, the amount of glycerin may be present in sufficient quantity to make up the final volume. In one aspect, the amount of vehicle (e.g., glycerin) may be present in the range from about 50 % w / v to about 95 % w / v, and all values in between, such as about 52 % w / v, about 54 % w / v, about 56 % w / v, about 58 % w / v, about 60 % w / v, about 62 % w / v, about 64 % w / v, about 66 % w / v, about 68 % w / v, about 70 % w / v, about 72 % w / v, about 74 % w / v, about 76 % w / v, about 78 % w / v, about 80 % w / v, about 82 % w / v, about 84 % w / v, about 86 % w / v, about 88 % w / v, about 90 % w / v, about 92 % w / v, and about 94 % w / v. As per one embodiment, the one or more pharmaceutically acceptable excipients are selected from the group comprising of preservatives, viscosity enhancer or viscosity enhancing agent, solubilizer or solubilizing agent, sweetener or sweetening agent, wetting agents, co-solvent, flavor or flavours, vehicle, suspending agents or thickening agent, taste masking agents, antioxidants, stabilizers, colorants and any other excipient known to the art for making formulations, or any combination thereof. In one aspect, one or more pharmaceutically acceptable excipients is selected from group consisting of preservative, a sweetener, a flavour or a combination thereof. As per another main embodiment of the present invention, the process of preparation of a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises steps: (a) Adding the vehicle to a vessel; (b) Adding solubilizer into the glycerin-containing mixing vessel of step (a) with continuous stirring; (c) Adding preservative into the solution obtained in step (b) with continuous stirring; (d) Adding sweetener into the solution obtained in step (c) with continuous stirring; (e) Adding losartan potassium (API) into the solution obtained in step (d) with continuous stirring; (f) Adding xanthan gum in glycerin in a separate vessel to prepare a slurry; (g) Adding slurry obtained in step (f) in the solution obtained in step (e); (h) Adding flavoring agent into solution obtained in step (g) under continuous stirring; (i) Adjusting the volume of bulk solution into the mixing vessel using a vehicle with continuous stirring; (j) Filtering bulk solution obtained in step (i) to get a clear solution; (k) Storing the final formulation obtained in step (j) in the suitable container. According to one embodiment of the present invention, a ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 0.01 mg / ml to 50 mg / ml losartan potassium, 50 mg / ml to 500 mg / ml solubilizer, 0.01 mg / ml to 15 mg / ml thickening agent, 0.01 mg / ml to 20 mg / ml preservative, 0.01 mg / ml to 15 mg / ml sweetener, 0.01 mg / ml to 15 mg / ml flavoring agent, and glycerin. According to one embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 1 mg / ml to 15 mg / ml losartan potassium, 70 mg / ml to 150 mg / ml solubilizer, 0.5 mg / ml to 10 mg / ml thickening agent, 0.01 mg / ml to 5 mg / ml preservative, 0.5 mg / ml to 3 mg / ml sweetener, 0.5 mg / ml to 3 mg / ml flavoring agent, and glycerin. According to most preferred embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 10 mg / ml losartan potassium, 115 mg / ml solubilizer, 1.5 mg / ml thickening agent, 0.40 mg / ml preservative, 1 mg / ml sweetener, 1 mg / ml flavoring agent, and glycerin. According to the most preferred embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 10 mg / ml losartan potassium, 115 mg / ml solubilizer, 1.5 mg / ml thickening agent, 0.40 mg / ml preservative, 1 mg / ml sweetener, 1 mg / ml flavoring agent, and glycerin; wherein the non-aqueous oral solution is free of buffer, pH adjusting agents, propylene glycol [PG], alkyl esters of p-hydroxybenzoic acid, povidone, hydroxypropyl methylcellulose, hydroxyethyl cellulose, saccharin sodium. According to most preferred embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 10 mg / ml losartan potassium, 115 mg / ml Polyethylene glycol 400, 1.5 mg / ml Xanthan Gum, 0.40 mg / ml Sodium benzoate, 1 mg / ml Sucralose, 1 mg / ml Frozen peppermint, and glycerin. According to most preferred embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprises 10 mg / ml losartan potassium, 115 mg / ml Polyethylene glycol 400, 1.5 mg / ml Xanthan gum, 0.40 mg / ml Sodium benzoate, 1 mg / ml Sucralose, 1 mg / ml Frozen peppermint, and glycerin; wherein the non-aqueous oral solution is free of buffer, pH adjusting agents, propylene glycol [PG], alkyl esters of p-hydroxybenzoic acid, povidone, hydroxypropyl methylcellulose, hydroxy ethyl cellulose, saccharin sodium. Another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, comprising: about 1 mg / mL to about 15 mg / mL losartan potassium, about 70 mg / mL to about 150 mg / mL solubilizer, about 0.5 mg / mL to about 10 mg / mL thickening agent, about 0.01 mg / mL to about 5 mg / mL preservative, about 0.5 mg / mL to about 3 mg / mL sweetener, about 0.5 mg / mL to about 3 mg / mL flavoring agent, and glycerin. And yet another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, comprising: about 10 mg / mL losartan potassium, about 115 mg / mL solubilizer, about 1.5 mg / mL thickening agent, about 0.40 mg / mL preservative, about 1 mg / mL sweetener, about 1 mg / mL flavoring agent, and glycerin. And a further embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, comprising: about 10 mg / mL losartan potassium, about 115 mg / mL solubilizer, about 1.5 mg / mL thickening agent, about 0.40 mg / mL preservative, about 1 mg / mL sweetener, about 1 mg / mL flavoring agent, and glycerin; wherein the non-aqueous oral solution is free of (or excludes) a buffering agent (e.g., sodium phosphate buffer, potassium phosphate buffer, a sodium citrate buffer, and the like), a pH adjusting agent (e.g., NaOH and / or HC1), propylene glycol, an alkyl ester of p-hydroxybenzoic acid, povidone (e.g., PVP K30 and PVP K90), hydroxypropyl methylcellulose, hydroxyethyl cellulose, and saccharin sodium. Another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, comprising: 10 mg / mL losartan potassium, 115 mg / mL polyethylene glycol 400, 1.5 mg / mL xanthan gum, 0.40 mg / mL sodium benzoate, 1 mg / mL sucralose, 1 mg / mL frozen peppermint, and glycerin. Another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, consisting of: about 10 mg / mL losartan potassium, about 115 mg / mL polyethylene glycol 400, about 1.5 mg / mL xanthan gum, about 0.40 mg / mL sodium benzoate, about 1 mg / mL sucralose, about 1 mg / mL frozen peppermint, and glycerin. Another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, consisting of: losartan potassium in an amount of about 10 mg / mL; a solubilizer comprising polyethylene glycol 400 in an amount of about 115 mg / mL; a thickening agent comprising xanthan gum in an amount of about 1.5 mg / mL; one or more pharmaceutically acceptable excipients selected from the group consisting of a preservative, a sweetener, a flavoring agent, or a combination thereof; and a vehicle glycerin. Yet another embodiment disclosed herein relates to a ready-to-use, non-aqueous oral solution, comprising about 10 mg / mL losartan potassium, about 115 mg / mL polyethylene glycol 400, 1.5 mg / mL xanthan gum, 0.40 mg / mL sodium benzoate, 1 mg / mL sucralose, 1 mg / mL frozen peppermint, and glycerin; wherein the non-aqueous oral solution is free of (or excludes) a buffering agent (e.g., sodium phosphate buffer, potassium phosphate buffer, a sodium citrate buffer, and the like), pH adjusting agent (e.g., NaOH and / or HC1), propylene glycol, an alkyl ester of p-hydroxybenzoic acid, povidone (e.g., PVP K30 and PVP K90), hydroxypropyl methylcellulose, hydroxy ethyl cellulose, and saccharin sodium. According to one embodiment of the present invention, the ready-to-use non-aqueous oral solution of angiotensin II receptor blocker (e.g., losartan) is independent of the pH effect and hence no need to add any buffer or pH adjusting agent to maintain the pH and still provide a stable formulation. According to one embodiment, the present invention can be taken orally and ready to use. According to one embodiment, the formulation disclosed herein may be administered orally. According to one embodiment, a ready-to-use non-aqueous oral solution of losartan potassium is stable for at least 1 month, 3 months, and 6 months at 40 °C ± 2 °C / NMT 25 % RH or 25 °C ± 2 °C / 60 % RH ± 5 % RH. NMT = not more than. According to one embodiment, a ready-to-use non-aqueous oral solution of losartan potassium is stable at -20°C ± 5°C under stress conditions of UV light. According to one embodiment, the total impurities are less than 1.0 % and any single impurities are less than 0.2 % after 1 month, 3 months, and 6 months storage at 40 °C ± 2 °C / NMT 25 % RH or 25 °C ± 2 °C / 60 % RH ± 5 % RH. According to one embodiment, a ready-to-use, non-aqueous oral solution of losartan potassium has a not more than 1.0 % losartan related total impurities after storage at 40 ± 2°C and NMT 25% ± 5% RH or 25 ± 2°C and 60% ± 5% RH for 6 months. According to one embodiment, a ready-to-use, non-aqueous oral solution of losartan potassium has a not more than 0.2 % any single unknown impurity after storage at 40 ± 2°C and NMT 25% ± 5% RH or 25 ± 2°C and 60% ± 5% RH for 6 months. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fasted condition which provides a mean ± SD of pharmacokinetic profiles as mentioned below: Tmax (h): 0.500 (0.333 - 2.667); Cmax (ng / mL): 806.187 ± 362.8349; AUCo-t (ng.h / mL): 1530.980 ± 948.0597; AUCo / (ng.h / mL): 1560.022 ± 1013.3460; Ti / 2 (h): 2.777 ± 1.7685. In some embodiments, the single dose is about 100 mg. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fasted condition which provides a geometric least square ranges of pharmacokinetic profiles like maximum plasma concentration (Cmax) from about 300 ng / mL to about 1200 ng / ml; area under the plasma concentration versus time curve from time 0 to the last measurable concentration time (AUCo-t) from about 800 ng.h / mL to 1800 ng.h / mL; and area under the plasma concentration versus time curve from time 0 to infinity (AUCo / ) from about 800 ng.h / mL to 1800 ng.h / mL. In some embodiments, the single dose is about 100 mg. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fasted condition which provides a geometric least square means of pharmacokinetic profiles like maximum plasma concentration (Cmax) 729.456 ng / mL; area under the plasma concentration versus time curve from time 0 to the last measurable concentration time (AUCo-t) 1352.590 ng.h / mL; and area under the plasma concentration versus time curve from time 0 to infinity (AUCo / ) 1369.275 ng.h / mL. In some embodiments, the single dose is about 100 mg. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject has a T / R ratio of from 50 % to 125 %, wherein T is a Cmax-value of the dose after administration to a human, and wherein R is a Cmax-value of a tablet comprising 100 mg losartan potassium (COZAAR®) after administration to the human. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject has a T / R ratio of from 80 % to 125 %, wherein T is a Cmax-value of the dose after administration to a human, and wherein R is a Cmax-value of a tablet comprising 100 mg losartan potassium (COZAAR®) after administration to the human. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fed condition which provides a mean ± SD of pharmacokinetic profiles as mentioned below: Tmax(h): 1.517 (0.333 -5.333); Cmax (ng / mL): 391.357 ± 119.2530; AUCo-t(ng.h / mL): 1261.942 ± 332.9989; AUC0 / (ng.h / mL): 1273.174 ± 336.8092; Ti / 2 (h): 1.971 ±0.8227. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fed condition which provides a geometric least square ranges of pharmacokinetic profiles like maximum plasma concentration (Cmax) from about 100 ng / mL to about 700 ng / ml; area under the plasma concentration versus time curve from time 0 to the last measurable concentration time (AUCo-t) from about 800 ng.h / mL to 1600 ng.h / mL; and area under the plasma concentration versus time curve from time 0 to infinity (AUCo / ) from about 800 ng.h / mL to 1600 ng.h / mL. In some embodiments, the single dose is about 100 mg. According to one embodiment, the said ready-to-use non-aqueous oral solution of losartan solution, when administered as a single dose to a subject under fed condition which provides a geometric least square means of pharmacokinetic profiles like maximum plasma concentration (Cmax) 374.396 ng / mL; area under the plasma concentration versus time curve from time 0 to the last measurable concentration time (AUCo-t) 1210.894 ng.h / mL; and area under the plasma concentration versus time curve from time 0 to infinity (AUCo / ) 1221.448 ng.h / mL. In some embodiments, the single dose is about 100 mg. The following examples, which include preferred embodiments, will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for illustrative discussion of preferred embodiments of the invention. The invention may be defined according to the following numbered clauses: 1. A ready-to-use non-aqueous oral solution of angiotensin II receptor blocker comprising: losartan potassium; a solubilizer; a thickening agent; and one or more pharmaceutically acceptable excipients; and a vehicle comprising glycerin. 2. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein losartan potassium is present in an amount of about 10 mg / ml. 3. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the solubilizer is selected from ethanol, polyethylene glycol, glycerine, triacetin, DMSO, benzyl benzoate, or any combination thereof. 4. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the solubilizer is polyethylene glycol. 5. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the solubilizer is polyethylene glycol 400. 6. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the solubilizer is polyethylene glycol 400 present in an amount of about 115 mg / ml. 7. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the thickening agent is selected from methylcellulose, bentonite, hectorite, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium aluminum silicate, xanthan gum, acacia, tragacanth, alginates, guar gum, colloidal silicon dioxide, or any combination thereof. 8. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the thickening agent is xanthan gum. 9. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the thickening agent is xanthan gum present in an amount of about 1.5 mg / ml. 10. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the one or more pharmaceutically acceptable excipients is selected from the group comprising of preservatives, sweetener, wetting agents, co-solvent, flavor or flavours, suspending agents, taste masking agents, antioxidants, stabilizers, or any combination thereof. 11. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the non-aqueous oral solution is free of buffer, pH adjusting agents, propylene glycol [PG], alkyl esters of p-hydroxybenzoic acid, povidone, hydroxypropyl methylcellulose, hydroxyethyl cellulose, saccharin sodium. 12. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the ready to use non-aqueous oral solution is stable at 40 °C ± 2 °C and NMT 25 % RH ± 5 % RH or 25 °C ± 2 °C and 60 % RH ± 5 % RH at least for 6 months. 13. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, wherein the non-aqueous oral solution is stable at 40 °C ± 2 °C and NMT 25 % RH ± 5 % RH or 25 °C ± 2 °C and 60 % RH ± 5 % RH at least for 6 months and total impurities present in the non-aqueous oral solution are not more than 1.0 % and any unspecified impurities are not more than 0.2 % after the storage for 6 months. 14. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, when administered as a single dose to a subject, which provides a T / R ratio of from 50 % to 125 %, wherein T is a Cmax-value of the dose after administration to a human, and wherein R is a Cmax-value of a tablet comprising 100 mg losartan potassium after administration to the human. 15. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, when administered as a single dose to a subject under fast condition which provides a mean ± SD of pharmacokinetic profiles as mentioned below: Tmax (h): 0.500 (0.333 - 2.667); Cmax (ng / mL): 806.187 ± 362.8349; AUCo-t (ng.h / mL): 1530.980 ± 948.0597; AUCo, (ng.h / mL): 1560.022 ± 1013.3460; and Ti / 2 (h): 2.777 ± 1.7685. 16. The ready-to-use non-aqueous oral solution of angiotensin II receptor blocker of clause 1, when administered as a single dose to a subject under fed condition which provides a mean ± SD of pharmacokinetic profiles as mentioned below: Tmax(h): 1.517 (0.333 -5.333); Cmax (ng / mL): 391.357 ± 119.2530; AUCo-t (ng.h / mL): 1261.942 ± 332.9989; AUCo-oo (ng.h / mL): 1273.174 ± 336.8092; and Ti / 2 (h): 1.971 ± 0.8227. EXAMPLES EXAMPLE 1: SOLUBILITY STUDY OF LOSARTAN POTASSIUM The solubility of losartan potassium below pH 5.5 was checked in the present of different solubilizers and pH modifying agent. The results are as follows in Table 1: Batch Number Composition Observations SI Losartan Potassium 10 mg / mL, Citrate buffer 50 mM 60 % v / v, PEG 400 40 % v / v Insoluble (Milky white insoluble particles) S2 Losartan Potassium 10 mg / mL, Citrate buffer 50 mM 60 % v / v, Propylene glycol 40 % v / v Insoluble (Milky white insoluble particles) S3 Losartan Potassium 10 mg / mL, Citrate buffer 50 mM 60 % v / v, Glycerin 40 % v / v Insoluble (Milky white insoluble particles) S4 Losartan Potassium 10 mg / mL, Citrate buffer 50 mM 90 % v / v, Labrasol 10 % v / v Insoluble (Milky white insoluble particles) S5 Losartan Potassium 10 mg / mL, Citrate buffer 50 mM 95 % v / v, Tween 5 % v / v Insoluble (Milky white insoluble particles) Table 1: Solubility study of losartan potassium in presence of dil ‘ferent solubilizers and pH modifying agent The findings indicated that losartan potassium showed insolubility across all tested solubilizers. EXAMPLE 2: SOLUBILITY STUDY OF LOSARTAN POTASSIUM WITH DIFFERENT CONCENTRATION OF SOLUBILIZERS The losartan exhibited insolubility in tested solubilizers, hence, further study was conducted to investigate the impact of different solubilizers concentration and pH modifying agent on the solubility of losartan potassium. The results are as follows in Table 2: Batch Number Composition Observations S6 Losartan Potassium 10 mg / mL, PEG 400 20 % v / v, Glycerin 30 % v / v, 100 mM citrate buffer 50 % v / v Insoluble (Milky white insoluble particles) S7 Losartan Potassium 10 mg / mL, PEG 400 16 % v / v, Glycerin 25 % v / v, Liquid sorbitol 16 %, 100 mM citrate buffer 42 % v / v Insoluble (Milky white insoluble particles) S8 Losartan Potassium 10 mg / mL, PEG 400 25 % v / v, Glycerin 15 % v / v, Liquid sorbitol 60 %, 10 % citric acid to adjust pH 4 Insoluble (Milky white insoluble particles) S9 Losartan Potassium 10 mg / mL, PEG 400 25 % v / v, Glycerin 15 % v / v, Liquid sorbitol 60 %, 2.5 % citric acid to adjust pH 4.85 Clear Solution Table 2: Solubility study of losartan potassium in presence of difl ’erent solubilizers concentration and pH modifying agent It was inferred that a clear solution was achieved by combining PEG 400 and glycerin when adjusting the pH below 5 with a 2.5 % citric acid solution. Citric acid was included in the formulation to assess its impact on enhancing the solubility of the active pharmaceutical ingredient (API) in the non-aqueous base. An increase in the content of an unspecified impurity was observed, which was attributed to the presence of water in the citric acid buffer. Given the presence of the increased impurity content in the presence of water, a decision was made to minimize (and / or eliminate) water content. Based on these and other results showing degradation in the presence of water, a decision was made to utilize a non-aqueous formulation. However, the formulation was finalized pH-independent, and therefore, no pH-modifying agents were added in further trials. EXAMPLE 3: COMPARATIVE DISSOLUTION TRIALS OF FORMULATION WITH VARIED EXCIPIENTS The study was conducted to check effect of varied excipients on dissolution profile of the formulation as compared to reference product. Batch No. Bl B2 B3 B4 Ingredients Quantity (mg / mL) Losartan Potassium 10.00 10.00 10.00 10.00 PEG - 400 113.00 113.00 113.00 113.00 Sodium benzoate 1.00 1.00 1.00 1.00 Sucralose 1.00 1.00 1.00 1.00 Xanthan gum - 0.25 0.50 0.50 PVP K90 - 5.0 10.0 - PVP K30 - - - 10.0 Frozen peppermint 1.00 1.00 1.00 1.00 Glycerin Q.S to 1 mL Q.S to 1 mL Q.S to 1 mL Q.S to 1 mL Table 3: Dissolution trial with different concentration and grade of PVP with varied concentration of xanthan gum Result: Media Deaerated water Volume 900 mL Apparatus USP type - II Paddle RPM 50 RPM Dissolution Average % Drug Release Time (Min) 10 20 30 45 60 RLD COZAAR® 100 mg 35 51 79 95 97 Bl 99 99 99 99 98 B2 65 96 97 97 96 B3 65 95 99 99 99 B4 75 98 98 99 99 5 Table 4: Results of dissolution trial with different concentration and grade of PVP with varied concentration of xanthan gum In the comparison of dissolution profiles among different batches, batch B4 containing PVP K30 (10 mg / mL) and xanthan gum (0.5 mg / mL) demonstrated higher cumulative % drug release than batch B3, which contained PVP K90 (10 mg / mL) and xanthan gum (0.5 mg / mL). Similarly, batch B2, 10 formulated with PVP K90 (5 mg / mL) and xanthan gum (0.25 mg / mL), exhibited a dissolution profile similar to that of batch B3. Notably, batch Bl, which did not contain xanthan gum or PVP K90 / PVP K30, displayed faster dissolution compared to all other batches with varying grades and concentrations of PVP and xanthan gum. Hence these batches were further evaluated. EXAMPLE 4: BIO STUDY OF BATCH Bl TO CHECK BIOAVAILABILITY AND PHARMACOKINETIC / PHARMACODYNAMIC PARAMETERS WITH REFERENCE PRODUCT (COZAAR®) The results of bio study of batch Bl with reference product are as follows: Parameters Geometric Least Squares Mean % ISCV 90% CI (T) (R) T / R (%) Cmax (ng / mL) 1007.629 918.893 109.66 38.30 83.07-144.75 AUC (ng*hr / mL) 1288.548 1332.386 96.71 8.87 90.5-103.35 able 5: Results of bio study of Batch Bl Based on the results, it was observed that the 90 % confidence interval for Cmax was skewed towards the upper limit (144.75 %). Therefore, this formulation was excluded from further consideration. EXAMPLE 5: BIO STUDY OF BATCH WITH XANTHAN GUM WITH AND WITHOUT PVP WITH REFERENCE PRODUCT (COZAAR®) The bio study was conducted for formulations containing xanthan gum with and without PVP K90 with reference product. Batch No. B5 B2 Ingredients mg / mL mg / mL Losartan potassium 10.00 10.00 Polyethylene glycol 400 113.0 113.0 Sodium benzoate 1.00 1.00 Sucralose 1.00 1.00 Xanthan Gum 2.0 0.25 PVP K90 - 5.00 Frozen peppermint 1.00 1.00 Glycerin Q.S. to 1 mL Q.S. to 1 mL Tab e 6: Formulation details for bio study Result: Parameters Geometric Least Squares Mean % ISCV 90% CI (T) (R) T / R (%) Cmax (ng / mL) 635.993 695.073 91.50 31.154 79.36-105.49% AUC (ng*hr / mL) 883.158 974.198 90.65 22.988 82.97-99.05% Table 7: Geometric least squares mean and 90% CI of batch B5 vs reference product Parameters Geometric Least Squares Mean % ISCV 90% CI (T) (R) T / R (%) Cmax (ng / mL) 754.497 695.015 108.56 31.154 95.15-123.86% AUC (ng*hr / mL) 867.822 972.584 89.23 22.988 82.20-96.85% Table 8: Geometric least squares mean and 90% CI of batch B2 vs reference product Based on the results, it was observed that the 90 % confidence interval for Cmax was slightly lower for batch B5 and slightly higher for batch B2. The use of PVP K90 resulted in prolonged dissolution times and increased formulation viscosity, leading to its exclusion from selection. Consequently, batch B5 was chosen for further development with a reduced concentration of xanthan gum. Additionally, minor adjustments were made to the concentrations of xanthan gum and PEG 400 to achieve the desired outcomes. Further, preservative efficacy testing (PET) was conducted for higher to lower concentration of sodium benzoate, and based on the results of the PET studies, concentration of sodium benzoate was optimised. EXAMPLE 6: COMPARATIVE DISSOLUTION TRIALS WITH DIFFERENT CONCENTRATION OF THICKENING AGENT The study aimed to evaluate how concentration of xanthan gum affect the release of the losartan potassium (API) in comparison to the reference product (COZAAR®). Batch No. B6 | B5 Ingredients Quantity (mg / ml) Losartan Potassium 10.00 10.00 PEG - 400 113.00 113.00 Sodium benzoate 1.00 1.00 Sucralose 1.00 1.00 Xanthan gum 1.00 2.00 Frozen peppermint 1.00 1.00 Glycerin Q.S to 1 mL Q.S to 1 mL Table 9: Composition details for dissolution trial with different concentration of thickening agent Result: Media Deaerated water Volume 900 mL Apparatus USP type - II Paddle RPM 50 RPM Dissolution Average % Drug Release Time (Min) 10 15 30 45 60 RLD COZAAR® 100 mg 35 51 79 95 97 B6 - Xanthan gum -1.0 mg / ml 74 92 97 97 97 B5 - Xanthan gum - 2.0 mg / ml 61 81 97 96 96 Table 10: Results of comparative dissolution trials with different concentration of thickening agent Based on the results, it was noted that there is a trend of decreasing cumulative % drug release with higher concentrations of xanthan gum. This indicates that xanthan gum can effectively be utilized to regulate the release of losartan potassium, potentially achieving extended-release characteristics. 5 EXAMPLE 7: FORMULATION OF A NON-AQUEOUS ORAL SOLUTION OF LOSARTAN POTASSIUM (B7) Sr. No. Ingredients Quantity (mg / mL) 1 Losartan potassium 0.01-50 2 Sodium benzoate 0.01-20 3 Xanthan gum 0.01-15 4 Sucralose 0.01-15 5 Frozen peppermint 0.01-15 6 Polyethylene glycol 400 50-500 7 Glycerin Q.S. Table 11: Formulation of a ready-to-use non-aqueous oral solution of losartan potassium (B7) 10 EXAMPLE 8: FORMULATION OF A NON-AQUEOUS ORAL SOLUTION OF LOSARTAN POTASSIUM (B8) Sr. No. Ingredients Quantity (mg / mL) 1 Losartan potassium 1-15 2 Sodium benzoate 0.01-5 3 Xanthan Gum 0.5-10 4 Sucralose 0.5-3 5 Frozen peppermint 0.5-3 6 Polyethylene glycol 400 70-150 7 Glycerin Q.S. Table 12: Formulation of a ready-to-use non-aqueous oral solution of losartan potassium (B8) 15 EXAMPLE 9: FORMULATION OF A NON-AQUEOUS ORAL SOLUTION OF LOSARTAN POTASSIUM (B9) Sr. No. Ingredients Quantity (mg / mL) Quantity (% w / v) 1 Losartan potassium 10.00 1 2 Sodium benzoate 0.40 0.04 3 Xanthan Gum 1.50 0.15 4 Sucralose 1.00 0.1 5 Frozen peppermint 1.00 0.1 6 Polyethylene glycol 400 115.0 11.5 7 Glycerin Q.S. to 1 mL Q.S. to 100% Table 13: Formulation of a ready-to-use non-aqueous oral so ution of losartan potassium (B9) Procedure: a) Glycerin was added in a vessel having a temperature; b) Polyethylene glycol 400 was added into the glycerin-containing mixing vessel of step (a) with continuous stirring; c) Sodium benzoate was added into the solution obtained in step (b) with continuous stirring; d) Sucralose was added into the solution obtained in step (c) with continuous stirring; e) Losartan potassium (API) was added into the solution obtained in step (d) with continuous stirring; f) Xanthan gum was added in glycerin in a separate vessel to prepare a slurry; g) The slurry obtained in step (f) was added to the solution obtained in step (e); h) Frozen peppermint was added into the solution obtained in step (g) under continuous stirring; i) The volume of bulk solution was adjusted into the mixing vessel using glycerin with continuous stirring; j) The bulk solution obtained in step (i) was filtered to get a clear solution; k) The final formulation obtained in step (j) was stored in the suitable container. EXAMPLE 10: THERMAL STABILITY STUDY The stability study was conducted for 3 and 6 months at 40 °C / NMT 25 % RH &25 °C / 60 % RH. Result: Batch No. Formulation B9 Pack Details 185 CC HDPE bottle packed in secondary white box Test parameters Storage condition Initial 40°C±2°C / NMT 25% RH 25°C±2°C / 60±5%RH IM 3M 6M IM 3M 6M Specification Invert Invert Invert Invert Invert Invert Description A clear colorless to light yellow color solution. Clear Colorless Solution Clear Colorless Solution Clear Colorless Solution Clear Colorless Solution Clear Colorless Solution Clear Colorless Solution Clear Colorless Solution Assay of Losartan Potassium 95.0% to 105.0% of labelled amount 102.80% 99.60% 100.60% 99.90% 100.60% 100.60% 100.60% Assay of Sodium benzoate 90.0% to 110.0% of labelled amount 103.40% 101.10% 102.30% 101.50% 101.00% 101.00% 101.00% Related Substances Single Any BQL BQL 0.06 0.11 BQL BQL 0.05 maximum unknown impurity unspecified Impurity: NMT 0.2% Total impurities Total impurities: NMT 1.0% 0.0 0.0 0.06 0.11 0.0 0.0 0.5 Table 14: Results of thermal stability study of formulation B9 The results indicates that the final formulation was found to be stable at 40 °C ± 2°C / NMT 25 % & 25°C ± 2°C / 60 ± 5% RH at least for 6 months. EXAMPLE 11: PHOTOSTABILITY STUDIES A photostability study was performed on the formulation B9. Result: Batch No Formulation B9 Test Specification / Limits Initial HDPE bottle (Primary pack) Clear PET bottle Description A clear colorless to light yellow color solution. A clear colorless solution. A clear colorless solution. A clear colorless solution. Assay of Losartan Potassium 95.0% to 105.0% of labelled amount 98.4 99.5 97.2 Assay of Sodium benzoate 90.0% to 110.0% of labelled amount 99.3 100.3 98.1 Related substances Single maximum unknown impurity A) Any unspecified impurity: NMT 0.2%, B) Total impurities: NMT 0.55% BQL BQL 0.06 Total impurities ND ND 0.06 *NMT- Not more than; BQL - Below limit of quantification; ND - Not detected Table 15: Results of photostability study of formulation B9 The results indicates that the final formulation was found to be stable at photostability condition. EXAMPLE 12: FREEZE-THAW STUDY Freeze-thaw studies were performed at a temperature cycle of -20°C ± 5°C for 2 days followed by 40°C ± 2°C for 2 days. Result: Batch No. Formulation B9 Test Specification / Limits Initial rd At the end of 3 cycle) Description A clear colorless to light yellow color solution. A clear colorless solution. A clear colorless solution. Assay of Losartan Potassium 95.0% to 105.0% of labelled amount 98.3 98.2 Assay of Sodium benzoate 90.0% to 110.0% of labelled amount 98.8 98.5 Related substances Single maximum unknown impurity A) Any unspecified impurity: NMT 0.2%, B) Total impurities: NMT 0.55% BQL BQL Total impurities ND ND - NMT- Not more than; BQL - Below limit of quantification. Table 16: Results of the freeze-thaw study 5 The results indicated that the final formulation was found to be stable at freeze-thaw conditions. EXAMPLE 13: COMPARATIVE STUDY OF BATCH B9 OF PRESENT INVENTION WITH SOLUTION COMPOSITIONS DISCLOSED IN US11890273 B2 (EXAMPLE 4, 5, 10,11, AND 12) AND US20070026026 Al (EXAMPLE 3) 10 Example as per present invention Example as per US2007002 6026 Al Examples as per US11890273 B2 Ingredient Batch B9 Ex. 3 Ex. 4 Ex. 5 Ex. 10 Ex. 11 Ex. 12 Quantity (mg / ml) Losartan potassium 10 12.5 10 10 10 10 10 Preservative Sodium Benzoate -0.40 - MP& PP MP&PP Sodium Benzoate -2 MP& PP MP& PP Thickening agent Xanthan gum -1.50 - HEC HPMC& Xanthan gum - 1 Xanthan gum - 2.5 - - pH Adjusting agent - KPB NaOH PB - PB PB Chelating agent - - DSE - - - - Sweetening agent Sucralose - 1 Saccharin sodium Sucralo se - 4 - Sucralos -5 - - Flavouring agent Frozen Peppermi nt - 1 - - - - - - Solubilising agent PEG 400 - 115 PG and Glycerin - PEG 400 - 25 &PG - PEG 400 -25 &PG - Crystallization Inhibitor - - - Povidone &HPMC PVP K30 - - Vehicle Glycerin (Q.S. to 1 mL) Glycerin Purified water Purified water Glycerin Punfi ed water Water PH - 8.2 6 Not mentione d Not mentione d Not menti oned Not mention ed Water (% w / w) «=1 =12<a» >=90 =80-90 >=2.4(b) =80-90 >=90 Notes and Abbreviations: (a) Delmarre's Ex. 3 solution uses aqueous potassium phosphate buffer, which serves as the source of water, (b) Kolla's Ex. 10 solution dissolves losartan potassium in water, initially, and then adds the remaining excipients. The estimated amount of water is based on reports that losartan potassium is freely soluble in water. See Remington's, 212. MP: Methyl Paraben; PP: Propyl Paraben; PG: Propylene glycol; PB: Phosphate Buffer; HEC: Hydroxy Ethyl Cellulose; KPB: Potassium Phosphate Buffer; DSE: Disodium edetate; HPMC: Hydroxy Propyl Methyl Cellulose (Hypromellose) Table 17: Comparison of batch B9 with solution compositions disclosed in examples of US11890273 B2 and US20070026026 Al Table 17 shows that batch B9 of the non-aqueous oral solution as per the present invention does not contain buffering agents, pH modifiers or pH adjusting agents, parabens, chelating agents, purified water, propylene glycol [PG] or crystallization inhibitors, hydroxypropyl methylcellulose, hydroxy ethyl cellulose. Despite the absence of these excipients, the formulation remains stable, safe and effective. This demonstrates that the solution prepared as per present invention maintains stability even in the absence of pH modifiers or buffering agents. EXAMPLE 14: PHARMACOKINETIC STUDY OF BATCH B9 OF PRESENT INVENTION WITH REFERENCE PRODUCT (COZAAR® TABLET) Bioavailability study under fasting condition: An open label, balanced, randomized, two-treatment, four-period, two-sequence, single oral dose, full replicate comparative bioavailability study of losartan potassium 10 mg / ml (Administered as 100 mg / 10 ml) oral solution of batch B9 was conducted with 100 mg of COZAAR® tablets in normal, healthy, adult human volunteers under fasting condition. Result: Parameters (Units) Mean ± SD (Untransformed Data) Test Product - T (N = 69 Observations) Reference Product - R (N = 69 Observations) Tmax (h)# 0.500 (0.333-2.667) 1.250 (0.333 -5.000) Cmax (ng / mL) 806.187 ±362.8349 858.961 ±449.0213 AUCo-t (ng.h / mL) 1530.980 ±948.0597 1664.487 ± 1068.3865 AUCo-m (ng.h / mL) 1560.022 ± 1013.3460 1689.837 ± 1114.6129 Zz(l / h) 0.310 ± 0.1110 0.321 ±0.1124 Ti / 2(h) 2.777 ± 1.7685 2.596 ± 1.4939 AUC_%Extrap_obs (%) 1.220 ± 1.3686 1.110 ± 1.2216 R2 adjusted 0.990 ±0.0117 0.986 ±0.0174 # - Tmax is represented as median (min-max) value Table 18: Descriptive statistics of formulation means for losartan 5 Relative Bioavailability analysis: Relative bioavailability analysis (i.e. geometric least squares means, ratio, 90 % confidence interval, 95 % upper confidence bound and power) of Test Product - T vs. Reference Product - R for losartan are summarized in the following table: 10 Parameters Geometric Least Squares Menas 90 % Confidence Interval 95 % Upper Confidence Bound Power (%) Test Product - T(N = 69 Observations) Reference Product - R (N=69 Observations) Ratio (T / R) % InCmax 729.456 755.417 96.6 N / AP -0.0568 N / AP InAUCo-t 1352.590 1455.594 92.9 89.19-96.81 N / AP 100.0 InAUCo / 1369.275 1471.837 93.0 89.32-96.90 N / AP 100.0 Table 19: Relative bioavailability results for losartan As per results, the test product has demonstrated bioavailable to the Reference product with respect 15 tO Cmax, AUCo-t and AUCo / . Bioavailability study under fed condition: An open label, balanced, randomized, two-treatment, four-period, two-sequence, single oral dose, full replicate comparative bioavailability study of losartan potassium 10 mg / ml (administered as 100 mg / 10 ml) oral solution of batch B9 was conducted with 100 mg COZAAR® tablets in normal, healthy, adult human volunteers under fed condition. Result: Parameters (Units) Mean ± SD (Untransformed Data) Test Product - T (N = 67 Observations) Reference Product - R (N = 67 Observations) Tmax (h)# 1.517 (0.333 - 5.333) 4.333 (0.667-6.033) Cmax (ng / mL) 391.357 ± 119.2530 686.390 ±285.9055 AUCo-t (ng.h / mL) 1261.942 ±332.9989 1379.713 ±409.5859 AUG, , (ng.h / mL) 1273.174 ±336.8092 1393.984 ±413.3287 Zz(l / h) 0.397 ±0.1206 0.390 ± 0.1315 Ti / 2(h) 1.971 ±0.8227 2.034 ±0.8537 AUC_%Extrap_obs (%) 0.871 ±0.4207 1.038 ±0.6812 R2 adjusted 0.990 ±0.0100 0.982 ±0.0194 # - Tmax is represented as median (min-max) value Table 20: Descriptive statistics of formulation means for losartan Relative Bioavailability analysis: Relative bioavailability analysis (i.e. geometric least squares means, ratio, 90 % confidence interval, and power) of Test Product - T vs. Reference Product - R for losartan are summarized in the following table: Parameters Geometric Least Squares Menas 90 % Confidence Interval Power (%) Test Product - T (N = 67 Observations) Reference Product - R (N=67 Observations) Ratio (T / R) % InCmax 374.396 634.747 59.0 52.32-66.49 92.3 InAUCo-t 1210.894 1329.911 91.1 88.46-93.72 100.0 InAUCo / 1221.448 1343.663 90.9 88.34-93.55 100.0 Table 21: Relative bioavailability results for losartan As per results, the test product has demonstrated bioavailable to the reference product with respect tO Cmax, AUCo-t and AUCo-<

Claims

1. A non-aqueous oral solution, comprising:losartan potassium in an amount of 0.1 mg / mL to 30 mg / mL;a solubilizer;a thickening agent;one or more pharmaceutically acceptable excipients; and a vehicle comprising glycerin.

2. The oral solution of any preceding claim, wherein the losartan potassium is present in an amount of 10 mg / mL.

3. The oral solution of any preceding claim, wherein the solubilizer is selected from PEG 200, PEG 400, PEG 600, PEG 1500, PEG 4000, and PEG 6000; wherein the solubilizer is PEG 400.

4. The oral solution of claim 1, wherein the solubilizer comprises polyethylene glycol 400 in an amount of from 50 mg / mL to 500 mg / mL.

5. The oral solution of claim 1 or claim 4, wherein the solubilizer comprises polyethylene glycol 400 in an amount of 115 mg / mL.

6. The oral solution of any preceding claim, wherein the non-aqueous oral solution has a water content of less than 1% w / w and excludes a buffering agent and a pH adjusting agent.

7. The oral solution of any preceding claim, wherein the thickening agent is selected from methylcellulose, bentonite, hectorite, microcrystalline cellulose, sodium carboxymethylcellulose, magnesium aluminum silicate, xanthan gum, acacia, tragacanth, alginates, guar gum, colloidal silicon dioxide, or any combination thereof.

8. The oral solution of any preceding claim, wherein the thickening agent comprises xanthan gum.

9. The oral solution of any preceding claim, wherein the thickening agent comprises xanthan gum in an amount of 1.5 mg / mL.

10. The oral solution of any preceding claim, wherein the one or more pharmaceutically acceptable excipients is selected from a preservative, a sweetener, a wetting agent, a co-solvent, a flavorant, a suspending agent, a taste masking agent, an antioxidant, a stabilizer, or any combination thereof.

11. The oral solution of any preceding claim, wherein the oral solution excludes propylene glycol, an alkyl ester of p-hydroxybenzoic acid, povidone, hydroxypropyl methylcellulose, hydroxyethyl cellulose, and saccharin sodium.

12. The oral solution of any preceding claim, wherein the water content is less than 0.5% w / w.

13. The oral solution of any preceding claim, wherein the water content is less than 0.2% w / w.

14. The oral solution of any preceding claim, wherein the water content is less than 0.1% w / w.

15. The oral solution of any preceding claim, whereinthe losartan potassium is present in an amount of 10 mg / mL;the solubilizer comprises polyethylene glycol 400 in an amount of 115 mg / mL; andthe thickening agent comprises xanthan gum in an amount of 1.5 mg / mL.

16. The oral solution of any preceding claim, wherein the solubilizer comprises polyethylene glycol 400 and a weight ratio of polyethylene glycol 400 to glycerin in the oral solution is from 5:95 to 15:85.IntellectualPropertyOfficeApplication GB2511258.2Search report under Section 17 of the Patents Act 1977Date search completed: 12 August 2025Claims searched: 1-20International classificationSubclass and subgroup Valid from A61K31 / 4178 01 / 01 / 2006 A61K9 / 00 01 / 01 / 2006 A61P9 / 10 01 / 01 / 2006 A61P9 / 14 01 / 01 / 2006Field of searchWorldwide search of patent documents classified in the following areas of the IPC:A61K, A61PDatabases used in the preparation of this search report:INTERNET; SEARCH-NPL; SEARCH-PATENTDocuments considered to be relevantPatent literatureCategory Relevant Document of relevanceclaimsIntellectual Property Office is an operating name of the Patent Officewww.gov.uk / ipoA - US 2007 / 0026026 A1 DELMARRE, See example 3 Non-patent literature Category Relevant claims Document of relevanceCategoriesLetter or DescriptionsymbolX Document indicating lack of novelty or inventive step.Y Document indicating lack of inventive step, if combined with anotherdocument of the same category.& Member of the same patent family. A Document indicating technological background. P Document published on or after the priority date but before the fling date of the present application. E Earlier application published on or after the filing date of the present application.