Pharmaceutical composition of loratadine and method of preparation therof

Abstract

Disclosed is a pharmaceutical composition comprising loratadine and one or more pharmaceutically acceptable excipients, fruit powders, gelling agent and other additives The additives may include buffering agenting agents, binders, stabilizing agents, solubilizing agents, colorants, sweetening agents, preservatives, coating agents, flavoring agents and diluents. The present disclosure provides for loratadine, where the buccal absorption is faster as well as the active ingredients in gum can be absorbed directly through the mucous membranes in the mouth, reducing the drawbacks of the conventional gummies which encounters the challenges of very high thermal stress of the cooking process especially where the active ingredients subject to significant chemical and / or physical degradation during the manufacturing process. The present disclosure further provides a method (100) of formulating the gummy dosage pharmaceutical composition for loratadine.

Description

[0001] PHARMACEUTICAL COMPOSITION OF LORATADINE AND METHOD OF PREPARATION THEROF

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to pharmaceutical composition. More particularly the present invention relates to gummy dosage pharmaceutical composition of Loratadine and method of producing the pharmaceutical composition of Loratadine.

[0004] BACKGROUND

[0005] Loratadine is an antihistamine medication used primarily to treat allergies and to relieve symptoms such as sneezing, runny nose, itchy or watery eyes, and itching of the nose or throat. Loratadine works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is a tricyclic antihistamine, which acts as a selective inverse agonist of peripheral histamine Hl receptors. Loratadine comes under the class of second-generation histamine antagonists. Amongst, desloratadine, levocetirizine, cetirizine, fexofenadine and terfenadine, loratadine is the weakest potency compound. However, the onset of action varies significantly, and clinical efficacy is not always directly related to only the Hl receptor potency, as concentration of free drug at the receptor must also be considered. Loratadine also shows anti-inflammatory properties independent of Hl receptors. The effect is exhibited through suppression of the NF-KB pathway, and by regulating the release of cytokines and chemokines, thereby regulating the recruitment of inflammatory cells.

[0006] Loratadine can be formulated into various oral dosage forms, including regular tablets, orally disintegrating tablets, chewable tablets, and syrups, catering to different patient preferences and needs. Also, for pediatric use syrups and chewable tablets are particularly useful for children who may have difficulty swallowing pills. Also, as a second-generation antihistamine, loratadine is preferred, because it is less likely to cause drowsiness compared to first-generation antihistamines, making it suitable for daytime use.

[0007] As a second-generation antihistamine, it is less likely to cross the blood-brain barrier, reducing the likelihood of drowsiness compared to first-generation antihistamines. Loratadines come in tablet, syrup, capsule and chewable tablet forms. Loratadine also comes in combination formulations with extended-release such as the combination of loratadine with a decongestant (like pseudoephedrine) for additional relief of nasal congestion. Also, a need exists for compositions that provide suitable nutritional supplementation and that have satisfactory patient compliance. Such compositions may be used, for example, before and during pregnancy. US20070286875 discloses an oral liquid formulation including an effective amount of loratadine, or a pharmaceutically acceptable salt or metabolite thereof; and a pharmaceutically acceptable carrier including a mono- or poly-hydroxy phenol component, a solubilizing agent and a chelating agent and methods of preparing and administering such formulations.

[0008] US20030215495A1 discloses a pharmaceutical composition containing loratadine and derivatives thereof which is suitable for use in soft capsule dosage forms that includes loratadine and derivatives thereof in a pharmaceutically effective amount; and a solvent system comprising a mixture of medium chain fatty acids. The compositions also permit high concentrations of solubilized loratadine per total fill volume and thereby permit the use of smaller capsules to deliver the same dosage of drug. The said composition a cannot be chewed and but only provides a soft gelatin capsule using gelatin for direct oral administration.

[0009] EP3793519 relates to an oral delivery tablet suitable for active pharmaceutical ingredients comprising a population of particles, the population of particles comprising directly compressible (DC) sugar alcohol particles, non-directly compressible (non-DC) sugar alcohol particles and particles comprising gum base, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in induced saliva generation upon mastication of the tablet, wherein the tablet is designed to be masticated into a coherent residual containing water-insoluble components. The said formulation involves preparation of granules using gum base ingredients in powder form.

[0010] CN101461811 A relates to a loratadine orally disintegrating tablet consisting of a special preparation and a preparation method thereof. The loratadine orally disintegrating tablet contains pharmaceutical excipients such as a disintegrant, a filling agent, an adhesive, a flavoring agent, a sweetening agent, a lubricating agent and so on, and can be used for the treatment of anaphylactic diseases.

[0011] US2005214365 discloses a pharmaceutical composition for oral administration comprising of an anti-allergic effective amount of loratadine in a pharmaceutically acceptable carrier medium consisting essentially of a proprietary disintegrant, an amount of lubricant talc, an amount of lubricant sodium stearyl fumarate, an amount of lubricant magnesium stearate, an amount of lubricant silicon dioxide, an amount of sweetening agent acesulfate potassium, an amount of flavor anise dry flavor, and an amount of flavor mint dry sufficient to provide dissolution of at least about 80% by weight of the pharmaceutical composition in about 45 minutes. KR1017360380000 relates to a chewing gum formulation comprising antihistamine, and more specifically, to a chewing gum formulation comprising as an active ingredient: an antihistamine agent, which is one selected from cetirizine hydrochloride, astemizole, loratadine, and bepotastine hydrochloride; a gum base; at least one sweetening agent selected from xylitol, mannitol, erythritol, maltitol, sucralose, aspartame, and acesulfame potassium; at least one slip agent selected from magnesium stearate, stearic acid, sodium starch glycolate, colloidal silicon dioxide, and talc; and a flavoring agent. It further includes complex granulation processes which involve mixing of powder materials, granulation with granulation fluid, drying, sizing, and compression.

[0012] Researchers work on better delivery systems for loratadine administration that can overcome the drawbacks of delivery systems currently available. Generally, incorporating APIs (Active Pharmaceutical Ingredients) can affect the taste and texture of the gum, making it less palatable. Thus, achieving a balance between therapeutic efficacy and consumer acceptability can be difficult and APIs have a bitter taste that is challenging to mask, requiring the use of additional flavorings and sweeteners.

[0013] Gummy dosage forms are particularly effective for enabling compliant dosing in children, elder populations, patients with dysphagia and pregnant women as they provide a palatable, chewable base and can incorporate active ingredient(s) that are of very low dose. The sublingual and buccal absorption is faster where active ingredients in gum can be absorbed directly through the mucous membranes in the mouth, leading to faster onset of action compared to tablets, which need to be digested and metabolized. Further, by bypassing the gastrointestinal tract and liver, the active ingredients in gum may reach systemic circulation more rapidly and efficiently. Gum based formulations are easier to consume for people who have difficulty swallowing tablets, such as children and the elderly. Gum can be flavored to improve taste, making it more pleasant to consume than tablets, which can have a bitter or unpleasant taste and it can mask active ingredients such that flavor and sweetness of gum can effectively mask the taste of active pharmaceutical ingredients.

[0014] Furthermore, pharmaceutical compositions in the gummy dosage forms offer rapid drug absorption from the pre-gastric area namely, the mouth, pharynx, and esophagus leading to a swift onset of action. This is particularly beneficial in situations requiring ultra-rapid relief, such as motion sickness, sudden allergic reactions, or coughing episodes. These gummies can accommodate high drug loads and are robust enough to endure the manufacturing process and subsequent handling. Pharmaceutical compositions available currently in the gummy dosage forms have previously been produced by compounding a variety of ingredients such as sugars, corn syrup, water, gelatin, flavors, and other sweeteners then cooking the mixture at high temperatures (120°C -240° C.) before depositing the cooked mixture into preformed moulds. The incorporation of the active ingredients can be facilitated only during the initial compounding step prior to cooking where due to the very high thermal stress of the cooking process, the active ingredients can be subject to significant chemical and / or physical degradation during the manufacture of gummies. Further, ensuring a uniform distribution of the active ingredient throughout the gum can be challenging, leading to variability in the dose delivered with each piece. Also, during the complex manufacturing process maintaining consistency in dose and quality requires precise control results in increasing complexity and cost.

[0015] Loratadine, which is mostly used as an oral prescription by doctors which is effective in relieving symptoms of allergic rhinitis (such as sneezing, runny nose, and itchy eyes) and chronic urticaria (hives), making it a popular choice for these common allergic conditions. While oral formulations are the most common, alternative formulations (e.g., topical or injectable) are less practical or necessary for loratadine due to its pharmacological profile and the nature of the conditions it treats. Also, loratadine which has a good oral bioavailability such that it is well-absorbed when taken by mouth. This ensures that an effective concentration of the drug reaches the bloodstream to exert its therapeutic effects.

[0016] Therefore, there is a need in the art to provide a novel gummy dosage form for loratadine, where the buccal absorption is faster as well as the active ingredients in gum can be absorbed directly through the mucous membranes in the mouth, leading to faster onset of action, and reduce the drawbacks of the conventional gummies which encounters the challenges of very high thermal stress of the cooking process especially where the active ingredients subject to significant chemical and / or physical degradation during the manufacturing process.

[0017] SUMMARY

[0018] In one aspect of the present disclosure, pharmaceutical composition is provided.

[0019] In some aspects of the present disclosure, pharmaceutical composition comprising: loratadine ranging from 0.1 - 5.0% w / w (weight / weight) of the pharmaceutical composition; fruit powders ranging from 0.1 -5.0 % w / w; and one or more pharmaceutical excipients that is selected from a gelling agent in a range of 0.5 - 5 % w / w of the pharmaceutical composition selected from a group including: Carrageenan, Pectin, Xanthan Gums, Lucust bean Gum and other gelling agents derived from non-animal source. In some aspects of the present disclosure, pharmaceutical composition includes additives such as thickening agent -5-90% w / w, buffering agent - 0.01 - 0.5 % w / w, stabilizing agents - 0.01-0.5% w / w, binder- 0.1 - 2.0 % w / w, preservatives - 0.01 -0.2 % w / w, sweetening agents- 0.1 - 1.0 % w / w, solubilizing agents - 5 -30 % w / w, diluents- 0.1 - 5.0 % w / w, coloring agents - 0.01 -1.0 % w / w, flavoring agents- 0.1 -2.0 % w / w, and purified water-5 -30 %

[0020] In some aspects of the disclosure, the pharmaceutical composition includes thickening agent selected from a group comprising sugar alcohols, but not limited to, maltitol, Sorbitol, Xylitol, and polyols.

[0021] In some aspects of the disclosure, the pharmaceutical composition includes stabilizing agent selected from a group comprising Trisodium citrate, sodium citrate, citric acid and corresponding salts.

[0022] In some aspects of the disclosure, the pharmaceutical composition includes buffering agenting agent selected from a group comprising citric acid monohydrate, lactic acid, malic acid, tartaric acid.

[0023] In some aspects of the disclosure, the pharmaceutical composition includes preservatives that are selected from a group forming potassium sorbate and sodium benzoate.

[0024] In some aspects of the disclosure, the pharmaceutical composition includes binder is selected from a group including com and maize starch.

[0025] In some aspects of the disclosure, the pharmaceutical composition includes diluent selected from a group including mannitol powder sorbitol, xylitol and polyols.

[0026] In some aspects of the disclosure, the pharmaceutical composition includes coating agent is selected from a group including xylitol, maltitol, mannitol, sorbitol.

[0027] In some aspects of the disclosed pharmaceutical composition, coloring agents are selected from a group includes carrot extract, beet rot extract, carotene, anthocyanin and natural red colours.

[0028] In some aspects of the disclosure, the pharmaceutical composition includes sweetening agent selected from a group including sucralose, stevia, monk fruit, sacharrin sodium, aspartame, neotame and all artificial sweetners. In some aspects of the disclosure, the pharmaceutical composition includes flavoring agents selected from a group including pink guava, apple, orange, all berry flavors selected from natural and natural identical grades.

[0029] In some aspects of the disclosure, the pharmaceutical composition is in gummy dosage form.

[0030] In some aspects of the disclosure, the pharmaceutical composition includes loratadine in solubilized form entrapped in the gel matrix structure, providing a more palatable chewable formulation.

[0031] In second aspect of the present disclosure, a method of preparing a pharmaceutical composition for loratadine is provided.

[0032] The method includes preparation of a first mixture by heating Maltitol liquid at 110°C to get the brix between 80 to 88° and dissolving preservative and the binder starch to obtain a first mixture. The method further includes mixing the gelling agent, additives and fruit powders with purified water in a vessel and heating the slurry with 95°C temperature to obtain a second mixture. The method further includes dissolving Loratadine in purified water and add to the second mixture obtained in previous step to obtain a third mixture. The method further includes mixing the third mixture in to the first mixture at a temperature of 90-100°C to obtain a fourth mixture. The method further includes mixing the sweetening agents in purified water and transferring to the fourth mixture at a temperature of 90-100°C to get the fifth mixture. The method further includes dissolving citric acid monohydrate in purified water separately to prepare a citric acid solution and was added to the fifth mixture under continuous stirring. The method further includes adding colouring agents and flavoring agents at temperature 90 - 100°C and pH 3.0-3.8, maintaining the brix at 65-75° to obtain a final suspension. The method further includes transferring the final suspension to a deposition tank at 85 - 90°C depositing in mold). The method further includes cooling the collected gummies below 10°C and drying the collected gummies at 40°± 5°C till water content reaches 10.0-15.0%.

[0033] In some aspects of the present disclosure, the temperature is maintained between 60-120°C preventing physical degradation during the manufacturing process.

[0034] BRIEF DESCRIPTION OF DRAWINGS

[0035] The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawing, Figure 1 illustrates a flowchart that depicts a method of preparation of a gummy dosage pharmaceutical composition, in accordance with an aspect of the present disclosure.

[0036] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure. Thus, the following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, known details are not described in order to avoid obscuring the description.

[0038] References to one or an embodiment in the present disclosure can be references to the same embodiment or any embodiment; and, such references mean at least one of the embodiments.

[0039] Reference to "one embodiment", "an embodiment", “one aspect”, “some aspects”, “an aspect” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others.

[0040] The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided.

[0041] A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any example term. Likewise, the disclosure is not limited to various embodiments given in this specification. Without intent to limit the scope of the disclosure, examples of instruments, apparatus, methods and their related results according to the embodiments of the present disclosure are given below. Note that titles or subtitles may be used in the examples for convenience of a reader, which in no way should limit the scope of the disclosure. Unless otherwise defined, technical and scientific terms used herein have the meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions will control.

[0042] Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or can be learned by practice of the herein disclosed principles. The features and advantages of the disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the disclosure will become more fully apparent from the following description and appended claims, or can be learned by the practice of the principles set forth herein.

[0043] As mentioned before there is a need for a technology / solution that overcomes the problems associated with loratadine formulations whereby providing a pharmaceutical composition ensuring even distribution and to avoid degradation of the active ingredients and can be flavored to improve taste, and with a better texture, making it more pleasant to consume than tablets, and other oral formulations that generally can have a bitter or unpleasant taste.

[0044] Also, pharmaceutical composition of the present disclosure provides ease of use which is a gummy dosage form that is easier to consume for people who have difficulty swallowing tablets, such as children and the elderly.

[0045] Further, the said pharmaceutical composition is lightweight, easy to carry, and can be consumed without water, making it convenient for on-the-go use.

[0046] Also, the said pharmaceutical composition form provides a pleasant experience where the act of chewing can be comfortable and habit-forming, potentially improving adherence to medication regimens and can be easily integrated into daily routines, increasing the likelihood of noncompromised use.

[0047] In addition, the pharmaceutical composition upon intake stimulates saliva production, which helps in improving oral hygiene upon intake and continuously delivering the active ingredient, unlike tablets that provide a single, immediate dose. The present disclosure provides a pharmaceutical composition pharmaceutical composition includes Loratadine that is easily administered to an infant or adult. For people with dysphagia (difficulty swallowing), these compositions are an excellent alternative to conventional tablets.

[0048] In some aspects of the invention, loratadine is an active ingredient, along with the other pharmaceutical excipients of the pharmaceutical composition.

[0049] In some aspects of the invention, loratadine in solubilized form entrapped in the gel matrix structure, providing a more palatable chewable formulation.

[0050] The sources and geographical origins of the biological material (banana powder, carrot powder, beetroot powder, pink guava powder) used in the invention as follows:

[0051] Banana powder was procured from Bio-med Ingredients. Fruit powders are procured from Exberry Netherland, Flavours such as Pink guava were procured from Norex.

[0052] The term "gummies" is intended to include chewing gum, troches, candy, lozenges and all shapes of gummies dosage forms.

[0053] In some aspects of the present disclosure may provide a gummy dosage pharmaceutical composition includes loratadine, fruit powders and pharmaceutical excipients comprise of gelling agent either alone or in combination with multiple gelling agent, and other additives.

[0054] In some aspects of the present disclosure, loratadine in the pharmaceutical composition may range from 0.1 -0.5 % w / w.

[0055] In some aspects of the present disclosure, fruit powders in the pharmaceutical composition may range from 0.1 -5.0 % w / w.

[0056] In some aspects of the present disclosure, the pharmaceutical excipients comprise of gelling agent in a concentration range of 0.5 - 5 % w / w of the composition that can be either alone or in combination with multiple gelling agent, and other additives.

[0057] In some aspects of the present disclosure, the gelling agents comprises of Carrageenan, Pectin, Xanthan Gums, Lucust bean Gum and other gelling agents derived from non-animal source.

[0058] In some aspects of the present disclosure, further comprises one or more excipients selected from the group consisting of emulsifiers, buffering agenting agents, binders, stabilizing agents, solubilizing agents, lubricating agents, preservatives, opaquing agents, colorants, sweetening agents, lubricants, preservatives, coating agents, glazing agents, flavouring agents and diluents.

[0059] In some aspects of the present disclosure, the pharmaceutical composition further comprises other additives includes buffering agent - 0.01 - 0.5 % w / w.

[0060] In some aspects of the present disclosure, the pharmaceutical composition pharmaceutical composition further comprises other additives includes stabilizing agents - 0.01-0.5% w / w.

[0061] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes thickening agents - 5-90% w / w.

[0062] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes binder- 0.1 - 2.0 % w / w.

[0063] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes preservatives - 0.01 -0.2 % w / w.

[0064] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes sweetening agents- 0.1 - 1.0 % w / w.

[0065] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes solubilizing agents - 5 -30 % w / w.

[0066] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes diluents- 0.1 - 5.0 % w / w.

[0067] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes coloring agents - 0.01 -1.0 % w / w.

[0068] In some aspects of the present disclosure, the pharmaceutical composition further includes other additives includes flavoring agents- 0.1 -2.0 % w / w.

[0069] In some aspects of the present disclosure, the stabilizing agent may include, but not limited to trisodium citrate and citric acid. In some aspects of the present disclosure, buffering agents may include, but are not limited to citric acid monohydrate, lactic acid, malic acid, tartaric acid.

[0070] In some aspects of the present disclosure, thickening agents may include, but not limited to maltitol liquid, sorbitol, xylitol and all polyols, sugar alcohols.

[0071] In some aspects of the present disclosure, preservatives may include, but not limited to, potassium sorbate and sodium benzoate.

[0072] In some aspects of the present disclosure, binders may include, but are not limited to, com and maize starch.

[0073] In some aspects of the present disclosure, diluents may include, but are not limited to, mannitol powder, sorbitol, xylitol and all polyols.

[0074] In some aspects of the present disclosure, coating agents may include, but are not limited to, xylitol, maltitol, mannitol, sorbitol.

[0075] In some aspects of the present disclosure, coloring agents may include, but not limited to, carrot, beet root, carotene, anthocyanin and all available natural red colours.

[0076] In some aspect of the present disclosure, sweetening agents may include, but not limited to, sucralose, stevia, monk fruit, sodium saccharine, aspartame, neotame and all artificial sweeteners.

[0077] In some aspects of the present disclosure, flavoring agents may include, but not limited to, pink guava, strawberry, orange, lemon selected from natural and natural identical grades.

[0078] Figure 1 illustrates a flowchart that depicts a method 100 for preparation of the pharmaceutical composition, in accordance with an aspect of the present disclosure. The method 100 includes the following steps:

[0079] At step 102, heating maltitol liquid at 110°C to get the brix between 80 to 88° and dissolving preservative and the binder starch to obtain a first mixture.

[0080] At step 104, mixing the gelling agent, additives and fruit powders with purified water in a vessel and heating the slurry with 95°C temperature to obtain a second mixture.

[0081] At step 106, dissolving Loratadine in purified water and add to the second mixture obtained in step (104) to obtain a third mixture. At step 108, mixing the third mixture of step (106) in to the first mixture at a temperature 90-100°C to obtain a fourth mixture.

[0082] At step 110, mixing the sweetening agents in purified water and transfer to the fourth mixture at a temperature of 90-100°C to get a fifth mixture.

[0083] At step 112, dissolving citric acid monohydrate in purified water separately to prepare a citric acid solution and was added to the fifth mixture under continuous stirring.

[0084] At step 114, adding colouring agents and flavoring agents at temperature 90 - 100°C and pH 3.0-3.8, maintaining the brix at 65-75° to obtain a final suspension.

[0085] At step 116, transferring the final suspension to a deposition tank at 85 - 90°C depositing in mold.

[0086] At step 118, cooling the collected gummies below 10°C and drying the collected gummies at 40°± 5°C till water content reaches to 10.0-15.0%.

[0087] Yet the other embodiment in the present disclosure is to provide a method of formulating the pharmaceutical composition comprising of heating maltitol liquid at 110°C to get the brix between 80 to 88° and dissolving preservative and the binder starch to obtain a first mixture. Further, mixing the gelling agent, additives and fruit powders with purified water in a vessel and heating the slurry with 95°C temperature to obtain a second mixture and dissolving Loratadine in purified water and add to the second mixture to obtain a third mixture. Further, mixing the third mixture to the first mixture at a temperature of 90-100°C to obtain a fourth mixture.

[0088] Further, mixing the sweetening agents in purified water and transferred to the fourth mixture at a temperature of 90-100°C and adding colouring agents and flavouring agents at temperature 90 - 100°C and pH 3.0-3.8, maintaining the brix at 65-75° to obtain a final suspension which is transferred to a deposition tank at 85 - 90°C depositing in mold. Further, cooling the collected gummies below 10°C and drying the collected gummies at 40°± 5°C till water content reaches to 10.0-15.0%.

[0089] Example 1:

[0090] The below table shows an exemplary embodiment for the pharmaceutical composition of the disclosure.

[0091] Example 2:

[0092] 68.26% w / w of maltitol liquid was heated at 110°C in a vessel to get the brix between 80 to 88°. Further potassium sorbate (0.03%w / w) and corn / maize starch (0.68% w / w) were added to dissolve completely to prepare the maltitol liquid syrup forming a first mixture. Gelling agents, fruit powder and the other additives such as pectin (2.05% w / w), banana powder (1.02%), trisodium citrate (0.07% w / w), & xylitol (0.34%) were mixed in purified water in S.S Vessel and the slurry was heated at 95°C, to obtain a smooth, free-flow, translucent gummy based slurry forming the second mixture. Further, loratadine was dissolved in purified water separately to which second mixture was added and mixed well, thus forming a third mixture. Further the gummy based slurry of the third mixture was mixed with maltitol syrup at a temperature between 90-100°C to obtain a fourth mixture. Further, the sweetening agent’s sodium saccharine / sucralose (0.34% w / w), xylitol powder (2.05% w / w) mixed well in purified water and transferred in to the fourth mixture at a temperature between 90°C to 100°C to get a fifth mixture. Citric acid monohydrate was dissolved in purified water in a separate SS Vessel to prepare a citric acid solution and was added to fifth mixture under continuous stirring. To this natural red colour (0.03% w / w) and pink guava flavor (0.68%) were added and mixed well by maintaining the temperature between 90 - 100°C and the actual temperature was recorded. pH and Brix Value of the slurry were checked and recorded (pH Limit: 3.00 to 3.80 and Brix of the slurry where Brix: Limit: 65° to 75°) to get a final suspension.

[0093] Further, the final suspension was deposited into the deposition tank at a temperature maintained between 85 - 90°C. The suspension was deposited into the mold through piston pump targeting to deliver the required average weight.

[0094] The cooling tunnel temperature was maintained below 10°C and the cooled and ejected gummies were collected into the perforated trays for drying. The collected gummies were dried at 40°± 5 °C until water content reaches between 10.0-15.0%.

[0095] Example 3:

[0096] 5% w / w of maltitol liquid was heated at 110°C in a vessel to get the brix between 80 to 88°. Further potassium sorbate (0.01% w / w) and com / maize starch (0.1% w / w) were added to dissolve completely to prepare the maltitol liquid syrup forming a first mixture. Gelling agents, banana(fruit) powder and the other additives such as pectin / carrageenan(0.5% w / w), banana powder(0.1% w / w), trisodium citrate(0.01% w / w), & xylitol(0.1% w / w) were mixed in purified water (5% w / w) in S.S Vessel and the slurry was heated at 95°C, to obtain a smooth, free-flow, translucent gummy based slurry forming the second mixture. Further, loratadine (0.01% w / w) was dissolved in purified water separately to which second mixture was added and mixed well, thus forming a third mixture. Further the gummy based slurry of the third mixture was mixed with maltitol syrup at a temperature between 90-100°C to obtain a fourth mixture. Further, the sweetening agent’s sodium saccharine / sucralose (0.1% w / w), xylitol powder (0.1 % w / w) mixed well in purified water and transferred in to the fourth mixture at a temperature between 90°C to 100°C to get a fifth mixture. Citric acid monohydrate (0.1% w / w) was dissolved in purified water in a separate SS Vessel to prepare a citric acid solution and was added to fifth mixture under continuous stirring. To this natural red colour (0.01% w / w) and pink guava flavor (0.1%) were added and mixed well by maintaining the temperature between 90 - 100°C and the actual temperature was recorded. pH and Brix Value of the slurry were checked and recorded (pH Limit: 3.00 to 3.80 and Brix of the slurry where Brix: Limit: 65° to 75°) to get a final suspension. Further, the final suspension was deposited into the deposition tank at a temperature maintained between 85 - 90°C. The suspension was deposited into the mold through piston pump targeting to deliver the required average weight.

[0097] The cooling tunnel temperature was maintained below 10°C and the cooled and ejected gummies were collected into the perforated trays for drying. The collected gummies were dried at 40°± 5 °C until water content reaches between 10.0-15.0%. Example 4

[0098] 90% w / w of maltitol liquid was heated at 110°C in a vessel to get the brix between 80 to 88°. Further potassium sorbate (0.2% w / w) and com / maize starch (2.0% w / w) were added to dissolve completely to prepare the maltitol liquid syrup forming a first mixture. Gelling agents, banana(fruit) powder and the other additives such as pectin / carrageenan (5% w / w), banana powder(5% w / w), trisodium citrate(0.05 % w / w), & xylitol(5 % w / w) were mixed in purified water (30% w / w) in S.S Vessel and the slurry was heated at 95°C, to obtain a smooth, free-flow, translucent gummy based slurry forming the second mixture. Further, loratadine (0.5% w / w) was dissolved in purified water separately to which the second mixture was added and mixed well, thus forming a third mixture. Further the gummy based slurry of the third mixture was mixed with maltitol syrup at a temperature between 90- 100°C to obtain a fourth mixture. Further, the sweetening agent’s sodium saccharine / sucralose (1.0% w / w) and mannitol / xylitol powder (5 % w / w) mixed well in purified water and transferred in to the fourth mixture at a temperature between 90°C to 100°C to get a fifth mixture. Citric acid monohydrate (0.5% w / w) was dissolved in purified water in a separate SS Vessel to prepare a citric acid solution and was added to fifth mixture under continuous stirring. To this natural red colour (1.0% w / w) and pink guava flavor (2.0% w / w) were added and mixed well by maintaining the temperature between 90 - 100°C and the actual temperature was recorded. pH and Brix Value of the slurry were checked and recorded (pH Limit: 3.00 to 3.80 and Brix of the slurry where Brix: Limit: 65° to 75°) to get a final suspension.

[0099] The implementation set forth in the foregoing description does not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. Further features and / or variations can be provided in addition to those set forth herein. For example, the implementation described can be directed to various combinations and sub combinations of the disclosed features and / or combinations and sub combinations of the several further features disclosed above. In addition, the logic flows depicted in the accompanying figures and / or described herein do not necessarily require the order shown, or sequential order, to achieve desirable results. Other implementations may be within the scope of the following claims.

Claims

LAIM:

1. A pharmaceutical composition comprises: loratadine ranging from 0.1 -0.5 % w / w (weight / weight) of the pharmaceutical composition; fruit powders ranging from 0.1 -5.0 % w / w of the pharmaceutical composition; and one or more pharmaceutical excipients that is selected from a gelling agent in a range of 0.5 - 5 % w / w of the pharmaceutical composition.

2. The pharmaceutical composition as claimed in claim 1, wherein the gelling agent is selected from a group comprising: Carrageenan, Pectin, Xanthan Gums, Lucust bean Gum and other gelling agents derived from non-animal source.

3. The pharmaceutical composition as claimed in claim 1, further comprising additives such as thickening agent -5-90% w / w, buffering agent - 0.01 - 0.5 % w / w, stabilizing agents - 0.01- 0.5% w / w, binder- 0.1 - 2.0 % w / w, preservatives - 0.01 -0.2 % w / w, sweetening agents- 0.1 - 1.0 % w / w, solubilizing agents - 5 -30 % w / w, diluents- 0.1 - 5.0 % w / w, coloring agents - 0.01 -1.0 % w / w, and flavoring agents- 0.1 -2.0 % w / w.

4. The pharmaceutical composition as claimed in claim 1, wherein thickening agent is selected from a group comprising sugar alcohols such as maltitol, Sorbitol, Xylitol, or polyols.

5. The pharmaceutical composition as claimed in claim 1, wherein the stabilizing agent is selected from a group comprising Trisodium citrate, sodium citrate, citric acid, or corresponding salts.

6. The pharmaceutical composition as claimed in claim 1, wherein buffering agenting agent is selected from a group comprising citric acid monohydrate, lactic acid, malic acid, or tartaric acid.

7. The pharmaceutical composition as claimed in claim 1, wherein, preservative is selected from a group comprising potassium sorbate or sodium benzoate.

8. The pharmaceutical composition as claimed in claim 1, wherein binder is selected from a group comprising com or maize starch.

9. The pharmaceutical composition as claimed in claim 1, wherein diluent is selected from a group comprising mannitol powder sorbitol, xylitol, or polyols.

10. The pharmaceutical composition as claimed in claim 1, wherein coating agent is selected from a group comprising xylitol, maltitol, mannitol, or sorbitol.

11. The pharmaceutical composition as claimed in claim 1, wherein coloring agent is selected from a group comprising carrot extract, beet rot extract, carotene, anthocyanin, and natural red colours.

12. The pharmaceutical composition as claimed in claim 1, wherein sweetening agent is selected from a group comprising sucralose, stevia, monk fruit, saccharine sodium, aspartame, neotame and all artificial sweetners.

13. The pharmaceutical composition as claimed in claim 1, wherein flavoring agents is selected from a group comprising pink guava, apple, orange, berry flavors selected from natural and natural identical grades.

14. The pharmaceutical composition as claimed in claim 1, wherein the said composition is in gummy dosage form.

15. The pharmaceutical composition as claimed in claim 1, wherein the loratadine is in solubilized form entrapped in gel matrix structure, providing a more palatable chewable formulation.

16. A method (100) of preparing a pharmaceutical composition for loratadine comprising: preparation (102) of a first mixture by heating Maltitol liquid at 110°C to get the brix between 80 to 88° and dissolving preservative and the binder starch to obtain a first mixture; mixing (104) the gelling agent, additives and fruit powders with purified water in a vessel and heating the slurry with 95°C temperature to obtain a second mixture; dissolving (106) Loratadine in purified water and add to the second mixture obtained in step (104) to obtain a third mixture; mixing (108) the third mixture of step (106) in to the first mixture (step 102) at a temperature 90-100°C to obtain a fourth mixture;mixing (110) the sweetening agents in purified water and transferred to the fourth mixture at a temperature of 90-100°C (110) to get the fifth mixture. dissolving (112) citric acid monohydrate in purified water separately to prepare a citric acid solution and was added to the fifth mixture under continuous stirring; adding colouring agents and flavoring agents (114) at temperature 90 - 100°C and pH 3.0-3.8, maintaining the brix at 65-75° to obtain a final suspension; transferring the final suspension (116) to a deposition tank at 85 - 90°C depositing in mold; and cooling the collected gummies below 10°C and drying (118) the collected gummies at 40°± 5°C till water content reaches to 10.0-15.0%.

17. The method (100) of preparing a pharmaceutical composition as claimed in claim 16, wherein the temperature is maintained at 60-120°C preventing physical degradation during the manufacturing process.

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