Synergistic bioactive composition for respiratory health

Abstract

The present invention relates to a synergistic bioactive pharmaceutical composition comprising Palmitoylethanolamide and Beta-glucan, along with pharmaceutically acceptable excipients, for improving respiratory health. It includes kits and formulations for preventing, managing or treating of respiratory disorders and conditions involving impaired respiratory function or immune imbalance.

Description

[0001] SYNERGISTIC BIOACTIVE COMPOSITION FOR RESPIRATORY HEALTH

[0002] RELATED APPLICATION:

[0003] The present application claims benefit of the Indian Provisional Application No. IN202421082975 filed on, November 29th, 2024 the entire contents of which are hereby incorporated by reference.

[0004] FIELD OF THE INVENTION:

[0005] The present invention relates to a synergistic bioactive pharmaceutical composition comprising Palmitoylethanolamide and Beta-glucan, along with pharmaceutically acceptable excipients, for improving respiratory health. It includes kits and formulations for preventing, managing or treating of respiratory disorders and conditions involving impaired respiratory function or immune imbalance.

[0006] BACKGROUND OF THE INVENTION:

[0007] Respiratory disorders are a major global health concern, affecting all age groups and contributing to significantly to morbidity, mortality, and healthcare burden. As the respiratory system is constantly exposed to pollutants, allergens and infectious agents, airway integrity and immune function can be compromised. A robust immune is essential to limit pathogen invasion, regulate inflammation, support tissue repair, and prevent progression of acute or chronic respiratory conditions.

[0008] Conventional treatments for respiratory diseases such as bronchodilators, corticosteroids, antibiotics, mucolytics, and antivirals can relieve symptoms but often have drawbacks including side effects, poor patient compliance, symptoms recurrence , and limited impact on underlying immune imbalance. This has created growing interest in bioactive compounds that can support respiratory function through complementary or enhanced mechanisms beyond current therapies. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide with immunomodulatory, anti-inflammatory, and cytoprotective properties, partly mediated through peroxisome proliferator-activated receptor (PPAR) pathways. Studies indicate that PEA helps regulate inflammatory responses and supports immune and respiratory health.

[0009] Studies show that PEA is safe and effective in reducing the incidence and symptoms (Amanda Rao et al., 2023). Research also indicates that PEA combinations such as PEA with phycocyanin exert immunological and antioxidant effects by modulating glutathione levels and cellular defense pathways (Bergandi et al., 2022).

[0010] Beta-glucan, a natural polysaccharide from cereals, fungi, and yeast, is well known for its immune-enhancing properties. It can modulate innate and adaptive immune responses, influence cytokine production, and strengthen host defense mechanisms, thereby supporting overall immune resilience.

[0011] Prior art shows that PEA and beta-glucan individually been studied for immune or respiratory benefits, but no reference disclose a composition comprising palmitoylethanolamide and beta-glucan, in combination with pharmaceutically acceptable excipients, specifically for improving respiratory health. Existing literature also does not describe a kits or dosage-specific formulations using this combination for respiratory therapeutic applications.

[0012] OBJECTIVE OF THE INVENTION:

[0013] The primary object of the present invention is to provide a synergistic bioactive composition comprising of palmitoylethanolamide and beta-glucan.

[0014] Another object of the invention is to provide a synergistic bioactive composition comprising of palmitoylethanolamide and beta-glucan along with pharmaceutically acceptable excipient. One of the objects of the present invention is to provide a synergistic bioactive composition comprising Palmitoylethanolamide, Beta-glucan, and one or more pharmaceutically acceptable excipients for improving respiratory health.

[0015] Another object of the invention is to provide a composition in which the ratio of Palmitoylethanolamide to Beta-glucan is maintained within a defined range to ensure consistent formulation characteristics.

[0016] A further object of the invention is to provide a composition wherein Palmitoylethanolamide and Beta-glucan are present in specific weight-by-weight percentage ranges based on the total weight of the composition.

[0017] Another object of the present invention is to provide a composition comprising Palmitoylethanolamide and Beta-glucan in predetermined amount in the dosage form.

[0018] A further object of the invention is to provide a kit comprising Palmitoylethanolamide, Beta-glucan, and one or more pharmaceutically acceptable excipients, wherein the active ingredients may be presented either in a single composition or as separate compositions for improving respiratory health.

[0019] Another object of the present invention is to provide a formulation wherein the pharmaceutically acceptable excipients are selected from diluents, disintegrants, binders, surfactants, lubricants, polymers, preservatives, antimicrobial agents, glidants, or mixtures thereof. A related object of the invention is to provide compositions wherein the diluent is selected from microcrystalline cellulose, sucrose, lactose, lactose monohydrate, maltodextrin, calcium carbonate, mannitol, sorbitol, or mixtures thereof.

[0020] Another object of the present invention is to provide the composition in a variety of suitable pharmaceutical dosage forms, including sachets, tablets, capsules, powders, granules, suspensions, syrups, or other acceptable delivery formats. A further object is to provide a pharmaceutical composition intended for the treatment or prevention of respiratory disorders, including asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), bronchitis, respiratory infections, airway inflammation, and other immune-related respiratory conditions. Yet another object of the present invention is to provide a pharmaceutical composition comprising defined amounts of Palmitoylethanolamide and Beta-glucan, wherein the combination of these bioactive ingredients offers synergistic support for improving respiratory health.

[0021] Another object is to provide a composition suitable for oral administration, enabling patient-friendly and compliant dosage forms. Another object of the invention is to provide a composition capable of being incorporated into dietary supplement formulas. Yet another object of the invention is to provide compositions that may be co-administered with other therapeutic agents without adversely affecting stability or performance.

[0022] SUMMARY OF THE INVENTION:

[0023] The present invention provides a synergistic bioactive pharmaceutical composition comprising Palmitoylethanolamide and Beta-glucan with pharmaceutically acceptable excipients, for improving respiratory health. It covers formulations with defined ratios, percentage ranges, or dosage ranges of the actives, as well kits supplying them together or separately. The composition may be prepared in various dosage forms, and is intended for preventing , managing , or treating respiratory disorders such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), bronchitis, respiratory infections, airway inflammation. . The invention exhibits synergistic benefits for respiratory health.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 : Phagocytic index

[0026] Figure 2: Total leukocytes

[0027] Figure 3: Monocytes

[0028] Figure 4: Neutrophils

[0029] Figure 5 : Lymphocytes DETAILED DESCRIPTION OF THE INVENTION:

[0030] The following detailed description sets forth various embodiments of the present invention. These embodiments are described in sufficient detail to enable a person skilled in the art to practice the invention. It will be appreciated, however, that alternative embodiments may be utilized and modifications may be made without departing from the scope of the invention. References herein to “an embodiment,” “one embodiment,” or “various embodiments” are not intended to be limiting and may refer to the same or different embodiments. The description that follows is therefore to be understood as illustrative rather than restrictive, with the scope of the invention being defined solely by the appended claims and their legal equivalents.

[0031] Palmitoylethanolamide (PEA) is an endogenous fatty acid amide belonging to the N- acylethanolamine family. It may be used in free form, micronized form, , salts, esters, complexes, or other pharmaceutically acceptable derivatives. PEA contributes to modulation of inflammatory pathways, immune regulation, and protection of respiratory tissues. Micronized and ultra-micronized forms may be employed to enhance solubility, dissolution, and bioavailability.

[0032] Beta-glucan is a polysaccharide that may be derived from cereals such as oats or barley, from yeast, from fungi, or from fermented or semi-synthetic sources, and may be used in purified or standardized form. Beta-glucan contributes to modulation of innate and adaptive immune pathways, enhancement of mucosal immunity, and support of respiratory tissue resilience.

[0033] Respiratory disorders often involve airway inflammation, oxidative stress, immune dysregulation, recurrent infections, hypersensitivity. This invention addresses these multifactorial pathways by combining Palmitoylethanolamide and Beta-glucan in formulations that modulate immune function, strengthen host defense , and promote respiratory wellness. In a primary embodiment, the present invention provides a synergistic bioactive composition comprising Palmitoylethanolamide and Beta-glucan.

[0034] In another embodiment, the invention provides a synergistic bioactive composition comprising Palmitoylethanolamide and Beta-glucan along with one or more pharmaceutically acceptable excipients.

[0035] In another embodiment, the invention provides a synergistic bioactive composition comprising Palmitoylethanolamide, Beta-glucan, and one or more pharmaceutically acceptable excipients for improving respiratory health.

[0036] In one embodiment, the invention provides a pharmaceutical composition comprising Palmitoylethanolamide (PEA) and Beta-glucan, optionally with pharmaceutically acceptable excipients, for improving respiratory health. The composition supports immune balance, modulates inflammation , and enhances respiratory function. In another embodiment, it may be used prophy tactically or therapeutically to improve respiratory performance, reduce susceptibility to respiratory irritants, or manage inflammatory or immune-mediated respiratory conditions.

[0037] In another embodiment, the composition comprises defined amounts (mg) of each ingredient suitable for patient administration. The ratio of Palmitoylethanolamide to Betaglucan may range from about 1 :0.0033 to 1: 12, 1:0.0050 to 1: 10, 1:0.0074 to 1:8.75, 1:0.0076 to 1:7.1429, 1:0.0080 to 1:5.9375, 1:0.0083 to 1:4.5, 1:0.0080 to 1:3.4, 1:0.0083 to 1:2.6666, 1:0.0090 to 1:2.2857 and 1:0.01 to 1:2 depending on the desired therapeutic effect. Within this range, sub-ranges may be selected depending on dosage form, target population, or intended respiratory outcome.

[0038] In another embodiment, the composition comprises Palmitoylethanolamide and Betaglucan in defined weight-by-weight percentage ranges based on the total weight of the composition. Palmitoylethanolamide may be present in an amount ranging from about 1.88 to 99.99, 2.04 to 98.87, 2.12 to 98.76, 2.15 to 98.68 and 2.22 to 98.60, and Beta-glucan in an amount ranging from about 0.14 to 90.91, 0.15 to 88.62, 0.16 to 86.95, 0.17 to 84.51 and 0.18 to 83.86, relative to the total composition.

[0039] In another embodiment, the composition comprises defined milligram quantities of Palmitoylethanolamide and Beta-glucan per unit dose. Palmitoylethanolamide may be present from about 50 mg to 1500 mg, 55 mg to 1400 mg, 60 mg to 1350 mg, 70 mg to 1300 mg, 80 mg to 1250 mg, 100 mg to 1200 mg, 125 mg to 1250 mg, 150 mg to 1200 mg, 175 mg to 1100 mg and 200 mg to 1000 mg and Beta-glucan from about 5 mg to 600 mg, 7 mg to 550 mg, 10 mg to 525 mg, 10 mg to 500 mg, 10 mg to 475 mg, 10 mg to 450 mg, 10 mg to 425 mg and 10 mg to 400 mg based on the total weight of the composition. Such mg- defined compositions may be prepared for once-daily, twice-daily, or other dosing regimens.

[0040] In another embodiment, the invention provides a kit comprising Palmitoylethanolamide, Beta-glucan, and pharmaceutically acceptable excipients. The actives may be supplied as a single composition or as separate components , for sequential or simultaneous administration. The kit may include sachets, tablets, capsules, vials, droppers, measuring devices, or other suitable packaging.

[0041] In another embodiment, pharmaceutically acceptable excipients may be incorporated to ensure stability, manufacturability, solubility, flowability, palatability, bioavailability, and overall performance of the active ingredients. Suitable excipients include diluents, binders, disintegrants, surfactants, lubricants, glidants, preservatives, antioxidants, stabilizers, polymers, sweeteners, flavoring agents, or mixtures thereof.

[0042] Diluents may include microcrystalline cellulose, calcium carbonate, dicalcium phosphate, lactose, lactose monohydrate, sorbitol, mannitol, starch, maltodextrin, pregelatinized starch, croscarmellose sodium, guar gum, xanthan gum, sodium alginate, polyvinylpyrrolidone (PVP), sodium carboxymethyl cellulose (CMC), or mixtures thereof. Binders may include starch, pregelatinized starch, polyvinylpyrrolidone (PVP), methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), sodium alginate, xanthan gum, acacia, or mixtures thereof.

[0043] Disintegrants may include croscarmellose sodium, sodium starch glycolate, crospovidone, starch, microcrystalline cellulose, or mixtures thereof.

[0044] Surfactants may include sodium lauryl sulfate, polysorbate 80, polysorbate 20, sorbitan esters, poloxamers, polyethylene glycol, sodium dodecylbenzene sulfonate, glycerol monostearate, Tween 80, or mixtures thereof.

[0045] Lubricants and glidants may include magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, talc, polyethylene glycol, silicon dioxide, colloidal silica, hydrogenated vegetable oil, sodium benzoate, glyceryl behenate, or mixtures thereof.

[0046] Preservatives may include methylparaben, propylparaben, benzalkonium chloride, benzyl alcohol, sodium benzoate, potassium sorbate, or mixtures thereof.

[0047] Antioxidants may include ascorbic acid, sodium metabisulfite, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherols, or mixtures thereof.

[0048] Polymers and stabilizers may include hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), carbomers, polyethylene glycols (PEGs), polyvinyl alcohol (PVA), or mixtures thereof.

[0049] Sweeteners and flavoring agents may include saccharin sodium, sucralose, aspartame, mannitol, sorbitol, fructose, menthol, or fruit-flavoring agents.

[0050] The pharmaceutical composition may be formulated as sachets, tablets, capsules, powders, granules, suspensions, syrups, emulsions, or reconstitutable powders. Sachets may be formulated for direct consumption or reconstitution. Suspensions may use aqueous or non- aqueous vehicles with suitable suspending agents, stabilizers, surfactants, and preservatives.

[0051] The composition may be used to prevent or treat respiratory disorders such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), bronchitis, respiratory infections, airway inflammation, and other immune -related respiratory conditions.

[0052] In another embodiment, Palmitoylethanolamide and Beta-glucan act synergistically to improve respiratory health, providing enhanced immune modulation, improved inflammatory balance, improved airway comfort, and reduced symptom severity beyond their individual effects.

[0053] The composition may be manufactured by direct compression, wet or dry granulation, blending, capsule or sachet filling, or as suspensions , or syrups.. Palmitoylethanolamide may be synthesized or derived from natural lipids and micronized while beta-glucan may be extracted from cereals, fungi, or yeast, or produced via fermentation and standardized for purity.

[0054] The present invention offers advantages over conventional respiratory health compositions. The defined combination of Palmitoylethanolamide and Beta-glucan provides a synergistic respiratory support beyond the individual components.. It can be formulated in patient- friendly dosage forms, including sachets, tablets, capsules, powders, granules, suspensions, and syrups allowing convenient, consistent dosing and improved compliance enhancing both efficacy and industrial applicability.

[0055] The embodiments described herein are illustrative and not limiting. Variations, modifications, and equivalents that achieve substantially the same technical effect fall within the scope of the invention, which is defined solely by the appended claims and their legal equivalents. EXAMPLES

[0056] In order to further illustrate the present invention, the following examples are provided for the purpose of clarity of understanding. However, it is not intended in any way to limit the scope of present invention, and it is readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the scope of the invention.

[0057] EXAMPLE-1: COMPOSITION

[0058] Following is general composition formula as per the present invention.

[0059] SACHET EXAMPLE-1:

[0060] SACHET EXAMPLE-2: SACHET EXAMPLE-3:

[0061] SACHET EXAMPLE-4:

[0062] SACHET EXAMPLE S: SACHET EXAMPLE-6 : SACHET EXAMPLE-7:

[0063] SACHET EXAMPLE S:

[0064] SACHET EXAMPLE-9: SACHET EXAMPLE-10: SACHET EXAMPLE-11:

[0065] SACHET EXAMPLE-12:

[0066] SACHET EXAMPLE-13: SACHET EXAMPLE-14: General Procedure for preparation for Example-1 to 14:

[0067] 1. All the ingredients were accurately weighed as per the batch formula.

[0068] 2. P-glucan and flavour were sieved through 60 mesh. PEA was sieved through 250- 500 pm screen.

[0069] 3. In a suitable blender, maltodextrin was added first, then p-glucan and PEA was added slowly to avoid dust clouds.

[0070] 4. Half of the colloidal silica was added and mixed for 5-8 minutes at low speed to distribute actives into carrier. Then flavor and sweetener were added and blended for 3-5 min. Remaining silica was added and blended for additional 5-10 minutes.

[0071] 5. The final blend from Step 4 was filled into sachets and sealed.

[0072] 6. Sachets were sealed and packed into suitable packs, labelled, and stored under recommended conditions.

[0073] CAPSULE EXAMPLE- 15:

[0074] CAPSULE EXAMPLE- 16:

[0075] CAPSULE EXAMPLE-17:

[0076] CAPSULE EXAMPLE- 18: CAPSULE EXAMPLE- 19:

[0077] CAPSULE EXAMPLE-20:

[0078] General Procedure for preparation for Example-15 to 20:

[0079] 1. All the ingredients were accurately weighed as per the batch formula.

[0080] 2. PEA, p-glucan, MCC and Colloidal silicon dioxide were sieved through 40-60 mesh. Magnesium stearate was sieved through 60 mesh. 3. PEA + p-glucan + 70% MCC were blended for 8 - 10 minutes in a double-cone or

[0081] V-blender. Remaining MCC + colloidal silica were added and blended for 5 - 7 minutes. Magnesium stearate were added for final lubrication blend for 2 - 3 minutes. 4. The final blend from Step 3 was filled into empty hard-gelatin / vegetarian capsules.

[0082] 5. The finished products were packed into moisture-protective packaging, labelled, and stored under recommended conditions. SYRUP EXAMPLE-21:

[0083] SYRUP EXAMPLE-22:

[0084] SYRUP EXAMPLE-23:

[0085] SYRUP EXAMPLE-24: SYRUP EXAMPLE-25: SYRUP EXAMPLE-26: SYRUP EXAMPLE-27:

[0086] SYRUP EXAMPLE-28:

[0087] SYRUP EXAMPLE-29: SYRUP EXAMPLE-30:

[0088] SYRUP EXAMPLE-31:

[0089] SYRUP EXAMPLE-32: SYRUP EXAMPLE-33: SYRUP EXAMPLE-34:

[0090] General Procedure for preparation for Example-21 to 34:

[0091] 1. About 60% of purified water was heated to 60-70°C in a mixing tank.

[0092] 2. Sucrose, Glycerin / Sorbitol were added and mix until fully dissolved.

[0093] 3. In a separate vessel, Xanthan gum / CMC was dispersed in a small amount of warm water and hydrated for 20 - 30 minutes until uniform.

[0094] 4. The hydrated suspending gel was added into the main tank with continuous mixing.

[0095] 5. Polysorbate 80 was mixed in a small quantity of warm water. PEA was added slowly and homogenized to form a fine slurry. P-Glucan was added and homogenization was continued.

[0096] 6. The active slurry slowly added into the main tank under high-speed agitation and homogenized for 20 - 30 minutes to ensure uniform distribution. Citric acid and sodium benzoate were added and mixed for 10 mins.

[0097] 7. Flavoring agent, color, and sweetener were added to the solution of step 6, and final volume was adjusted with adding purified water.

[0098] 8. The finished products were filled into amber PET / glass bottles, labelled, and stored under recommended conditions.

[0099] TABLET EXAMPLE-35:

[0100] S.No. Ingredients mg per tablet

[0101] TABLET EXAMPLE-36: TABLET EXAMPLE-37:

[0102] TABLET EXAMPLE-38:

[0103] TABLET EXAMPLE-39: TABLET EXAMPLE-40:

[0104] TABLET EXAMPLE-41:

[0105] TABLET EXAMPLE-42:

[0106] TABLET EXAMPLE-43: TABLET EXAMPLE-44:

[0107] TABLET EXAMPLE-45: TABLET EXAMPLE-46:

[0108] TABLET EXAMPLE-47:

[0109] TABLET EXAMPLE-47: General Procedure for preparation for Example- 35 to 47:

[0110] 1. All the ingredients were accurately weighed as per the batch formula.

[0111] 2. PEA, p-glucan, MCC, croscarmellose and povidone were sieved through 40-60 mesh.

[0112] 3. All the actives were blended with 70% of MCC for 10 - 12 min. 4. Binder solution was prepared with dissolving Povidone K-30 in purified water.

[0113] 5. The binder slowly to the blended powder of step 3 in RMG or planetary mixer to form soft granules and dried in a fluid bed dryer.

[0114] 6. Remaining MCC and colloidal silica were blended for 5 mins. Magnesium stearate was added and blended for 2 mins.

[0115] 7. The final blend from Step 6 was compressed to form tablets and hypromellose- based film coating solution uniformly was applied over compressed tablets using a perforated coating pan.

[0116] 8. The finished products were packed into moisture-protective packaging, labelled, and stored under recommended conditions.

[0117] Example 48: Animal study

[0118] Objective: To evaluate the synergistic efficacy of Palmitoylethanolamide and P-glucan on immune parameters related to respiratory health in Wistar rats.

[0119] Study design: Prior to the initiation of the study, all animals (rats) aged 8-9 weeks old at the start of the treatment were acclimatized to laboratory conditions for a minimum period of five days. The animals were then randomly assigned into six groups, with six rats in each group. Immune suppression was induced in all the groups except normal group (Group- 1) through intraperitoneal administration of 30 mg / kg / d cyclophosphamide on day 18, 19 and 20. All animals in the treatment groups received the treatment as per the below:

[0120] *b.wt= body weight, *i.p. = intraperitoneal, *d = day

[0121] Evaluation parameters:

[0122] • Phagocytic index • Total leukocytes counts

[0123] • Monocytes counts

[0124] • Neutrophils counts

[0125] • Lymphocytes counts

[0126] All the data are expressed as mean ± standard deviation (SD) and were analyzed using ANOVA and data showing significance in their variance was subjected to Dunnett’s t-test.

[0127] A p-value of less than 0.05 was considered statistically significant.

[0128] Phagocytic index

[0129] The phagocytic index is a crucial marker of innate immunity representing the capacity of phagocytes to ingest and destroy pathogens. A higher phagocytic index indicates stronger microbial clearance and a more responsive first-line defense. It is commonly used to evaluate the immune-boosting potential of therapeutic agents or nutritional interventions. An increase in phagocytic index indicates the effectiveness of therapy in enhancing immunity and reducing respiratory tract infections. Overall, it serves as a sensitive biomarker for assessing immune status, inflammation, and treatment efficacy. The PEA and P-glucan combination showed a 60% higher phagocytic index compared to the sum of their individual effects, indicating a strong synergistic effect in enhancing immunity.

[0130] 5 Study Result 1 : Phagocytic index

[0131] Total leukocytes counts

[0132] The total leukocyte count is a fundamental indicator of overall immune status reflecting the 10 body’s ability to respond to infections and inflammation. Leukocytes play a central role in identifying, attacking and eliminating invading pathogens. Alterations in total leukocytes count help assess immune activation, suppression or underlying disease conditions. An increase in leukocyte count indicates the effectiveness of therapy in enhancing immunity and reducing respiratory tract infections. Total leukocytes count is widely used as a clinical 15 biomarker to monitor treatment response and overall immune health. The PEA and * glucan combination produced a 55.56% greater increase in total leukocyte count than the sum of their individual effects, demonstrating strong immune-enhancing synergy.

[0133] Study Result 2: Total leukocytes (%)

[0134] Monocytes counts

[0135] Monocytes are key components of the innate immune system responsible for pathogen recognition, phagocytosis and initiation of inflammatory responses. They differentiate into 5 macrophages and dendritic cells which are essential for microbial clearance and antigen presentation. Changes in monocyte levels help assess immune system activation, inflammation or recovery following therapeutic intervention. An increase in monocytes indicates the effectiveness of therapy in enhancing immunity and reducing respiratory tract infections. Monocytes also serve as early responders during infections making their count 10 a valuable indicator of immune readiness. Overall, monocyte levels provide important insights into the body’s innate defense mechanisms and treatment efficacy. Combining PEA with P-glucan resulted in a 60% higher monocyte count than expected from their individual effects, indicating a pronounced synergistic enhancement of immunity.

[0136] 15 Study Result 3: Monocytes (%)

[0137] Neutrophils counts

[0138] Neutrophils are the most abundant white blood cells and act as the body’s first line of 20 defense against bacterial and fungal infections. They rapidly migrate to infection sites where they engulf and destroy pathogens through phagocytosis and release of antimicrobial substances. Neutrophil levels are widely used to assess innate immune strength, inflammation and overall infection response. An increase in neutrophils indicates the effectiveness of therapy in enhancing immunity and reducing respiratory tract infections. Because of their quick response and high activity, neutrophils are reliable markers of immune activation and therapeutic impact. Overall, neutrophil counts provide essential insights into the body’s immediate protective mechanisms. The PEA and P-glucan combination produced a 50% higher neutrophil count than the sum of their individual effects, indicating a strong synergistic enhancement of immunity. Study Result 4: Neutrophils (%)

[0139] Lymphocytes counts

[0140] Lymphocytes are central to adaptive immunity, playing key roles in recognizing, targeting and eliminating specific pathogens. They include T cells, B cells and NK cells which collectively coordinate immune memory, antibody production and targeted cellular defense. Lymphocyte levels help assess immune competence, infection status and the effectiveness of therapeutic interventions. An increase in lymphocytes indicates the effectiveness of therapy in enhancing immunity and reducing respiratory tract infections. Their ability to generate long-term immune memory makes them essential for sustained protection against recurring infections. Overall, lymphocyte counts provide valuable insight into the body’s adaptive immune strength and response to treatment. The synergy between PEA and P-glucan was evident, with the combination yielding a 44.27% greater rise in lymphocyte count than expected from their individual effects. Study Result 5: Lymphocytes (%)

[0141] The results presented herein demonstrate that the present invention provides a synergistic 5 pharmaceutical composition comprising Palmitoylethanolamide and Beta-glucan, representing a clear technical advancement over existing respiratory health formulations. The combination exhibits an unexpected synergistic effect, delivering enhanced respiratory support compared to the individual components administered alone. This synergistic composition is suitable for wide range of pharmaceutical dosage forms, including sachets, 10 tablets, capsules, powders, granules, syrups, and suspensions. The versatility of the formulation enhances patient compliance and allows the compositions to be adapted for diverse respiratory health needs.

[0142] The invention further demonstrates economic and industrial significance. By providing 15 Palmitoylethanolamide and Beta-glucan together in a single synergistic formulation — or in coordinated kit formats — the invention offers a more convenient, efficient, and cost- effective option compared to administering separate compositions. Accordingly, the present invention combines technical benefits with practical and economic advantages and is capable of clear industrial application within the pharmaceutical and nutraceutical 20 sectors.

Claims

I / We claim:

1. A pharmaceutical composition comprising Palmitoylethanolamide, Beta-glucan, and one or more acceptable pharmaceutical excipient for improving respiratory health.

2. The pharmaceutical composition as claimed in claim 1, wherein the ratio of Palmitoylethanolamide to Beta-glucan ranges from 1:0.0033 to 1: 12.

3. The pharmaceutical composition as claimed in claim 1, wherein: Palmitoylethanolamide is present in an amount ranging from 1.88% to 99.99% w / w,Beta-glucan is present in an amount ranging from 0.14% to 90.91 % w / w, based on the total weight of the composition.

4. The pharmaceutical composition as claimed in claim 1, wherein the composition comprises:Palmitoylethanolamide in an amount ranging from 50 mg to 1500mg, Beta-glucan in an amount ranging from 5 mg to 600 mg.

5. A kit comprising Palmitoylethanolamide, Beta-glucan, and one or more acceptable pharmaceutical excipient, wherein:Palmitoylethanolamide is present in an amount ranging from 50 mg to 1500 mg, Beta-glucan is present in an amount ranging from 5 mg to 600 mg, wherein Palmitoylethanolamide and Beta-glucan are either provided in a single composition or as separate compositions within the kit; and wherein the kit is intended for improving respiratory health.

6. The pharmaceutical composition as claimed in claim 1, wherein the one or more pharmaceutically acceptable excipient is selected from diluents, disintegrants, binders, surfactants, lubricants, polymers, preservatives, antimicrobial agents, glidants, or mixtures thereof.

7. The pharmaceutical composition as claimed in claim 6. wherein the diluent is selected from microcrystalline cellulose, sucrose, lactose, lactose monohydrate, maltodextrin, calcium carbonate, mannitol, sorbitol, or mixtures thereof.

8. The pharmaceutical composition as claimed in claim 1, wherein the composition is fdled in a sachet or is formulated as a tablet, capsule, powder, granule, suspension, syrup, or any other suitable dosage form.

9. The pharmaceutical composition as claimed in claim 1, wherein the composition is intended for the treatment or prevention of respiratory disorders selected from asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), bronchitis, respiratory infections, airway inflammation, and other immune-related respiratory conditions.

10. A pharmaceutical composition for improving respiratory health, comprising:Palmitoylethanolamide in an amount ranging from 50mg to 1500 mg, Beta-glucan in an amount ranging from 5 mg to 600 mg, wherein the combination of Palmitoylethanolamide and Beta-glucan exhibits a synergistic effect in improving respiratory health.

Images