DESC:ATTACHED ,CLAIMS:1. A composition consisting of a fixed dose combination of benzydamine hydrochloride and povidone iodine oral aqueous or hydro-alcoholic solution for gargle or throat spray, wherein said composition comprises,
- Benzydamine hydrochloride in a range of 0.10% to 0.60% w/v,
- Povidone iodine in a range of 0.10% to 2.00% w/v,
- at least one humectant,
- at least one solvent or carrier,
- optionally at least one sweetener,
- optionally at least one stabilizer,
- optionally at least one flavoring agent,
- optionally at least one viscosity enhancer, and
- optionally one or more other pharmaceutically active ingredients.

wherein said the composition is stable and oral use as gargle or as throat spray.

2. The composition as claimed in claim 1, wherein said benzydamine hydrochloride in a range of 0.10% to 0.60% w/v, preferably 0.10 to 0.30%w/v, most preferably 0.10 to 0.15%w/v.

3. The composition as claimed in claim 1, wherein said povidone iodine is in a range of 0.10% to 2.00% w/v, preferably 0.10 to 1.00%w/v, most preferably 0.10 to 0.50%w/v.

4. The composition as claimed in claim 1 or 3, wherein said composition has predetermined available iodine concentration in a range of 0.01 to 0.20%w/v, preferably in the range of 0.01 to 0.10%w/v and most preferably is in a range of 0.01 to 0.05%w/v.

5. The composition as claimed in claim 1, wherein said humectant is selected form a group of chemical or natural humectant or a combination thereof in the range of 1.0 to 90.0%w/v, preferably in a range of 1.0 to 50.0%w/v for gargle, preferably in a range of 80.0 to 90.0 %w/v for throat spray to minimize pungent, irritating or burning sensation along with and enhanced residence time of both active drug constituents in oro - pharyngeal cavity.

6. The composition as claimed in claim 5, wherein said natural humectant is selected from Vegetable Glycerin’s, Aloe vera, Glycerol or any other natural substance imparting humectants property and the Chemical humectant is selected from Glycerin, Sorbitol, Mannitol or a combination thereof or any other ingredients imparting humectants property.

7. The composition as claimed in claim 1, wherein said selective stabilizer is potassium iodide or potassium iodate or a combination thereof, in a range of 0.01 – 0.50% w/v, more preferably potassium iodide in a range of 0.20 – 0.50% w/v.

8. The composition as claimed in claim 1, wherein said flavouring agent is selected from Menthol, Eucalyptus oil, Peppermint, Spearmint or Mint, Ginger, Clove, Cardamon, Citric Acid, methyl salicylate or a combination thereof and any other flavor used to mask bitter salty or Sour taste, preferably in a range of 0.00 – 0.50% w/v.

9. The composition as claimed in claim 8, wherein said flavouring agent is Menthol, Methyl salicylate and Eucalyptus oil or a combination thereof, preferably in a range of 0.05 – 0.50% w/v.

10. The composition as claimed in claim 1, wherein said sweetening agent is selected from Natural sweetening agent and an artificial sweetening agent, such as sodium saccharine, agave nectar, extract of Stevia, acesulfame potassium, aspartame, Salts of glycyrrhizinate, corn syrup, dextrins, dextrose, erythritol, maple syrup, fructose, glucose, galactose, honey, lactose, levulose, maltose, maltodextrins, mannitol, saccharin, sorbitol, stevia, sucralose, sucrose, sugar alcohols, mogrosides, and xylitol or a combination thereof, preferably in a range of 0.01 – 0.10% w/v, more preferably is Sodium Saccharine in the range of 0.01 to 0.05 %w/v.

11. The composition as claimed in claim 1, wherein said solvent or carrier is selected from Ethyl alcohol or Ethanol, Propylene glycol, Purified Water or sterile water for Injection. or a combination thereof. Preferably in and amount of 10.0 – 98.0%v/v, more preferably the solvent or carrier is Purified Water, Propylene glycol, Ethanol or combination thereof in the range of 10.0 – 80.0%v/v (q.s. or up to 100%)

12. The composition as claimed in claim 1, wherein said optional color is any suitable pharmaceutically acceptable colors in order to increase patient acceptance, in a range of concentration, as per requirements; preferably in the range of 0.0 to 0.1%w/v.

13. The composition as claimed in claim 1, wherein said optional viscosity enhancer is selected form Carbomer, Hydroxy propyl cellulose, Hydroxy propylmethyl cellulose, Sodium carboxy methyl cellulose, Poloxomer or any polymer imparting viscosity of preparation.

14. The composition as claimed in claim 1, wherein said Pharmaceutical Active Ingredients include compound , for example propolis and royal jelly of the honeybees, other additives or combination thereof.

15. The composition as claimed in claim 1, wherein said composition provided relief from pain and cleaning or irritation in the oral cavity and throat along with effective anti-bacterial or antiseptic action; or it provides a local soothing effect over an extended period of time, specifically for inhibition of oro-pharyngeal bacterial, viral or fungal growth, treating infections of mouth and throat, such as gingivitis and mouth ulcers or as an adjuvant therapy as a fixed dose pharmaceutical composition; or the composition is used as an adjuvant in combination with other anti-allergic, anti-inflammatory or anti-infective therapy.

16. A process for process for manufacturing of stabilized benzydamine hydrochloride with povidone iodine solution for oral application comprising steps of:
• Solubilization of optional Stabilizer, in a main manufacturing tank, containing solvent or carrier under stirring,
• Solubilization of povidone iodine, in a main manufacturing tank, containing above solution under stirring,
• Solubilization of humectants, in a main manufacturing tank, containing above solution under stirring,
• Optional separate preparation of ‘flavor solution’ by completely solubilizing flavors in a solvent or carrier under stirring and further adding it in a main manufacturing tank,
• Optional separate preparation of ‘sweetener solution’ by completely solubilizing sweeteners in a solvent or carrier under stirring and further adding it in a main manufacturing tank,
• Separate preparation of ‘benzydamine hydrochloride solution’ by completely solubilizing benzydamine hydrochloride in a solvent or carrier under stirring and further adding it in a main manufacturing tank,
• Allowing to stand the above solution for stabilization and standardization to achieve a solution having pH in the range of 1.5 to 4.5,
• Making the final volume of solution by a solvent or carrier to prepare the stable benzydamine hydrochloride with povidone iodine oral solution.

17. The process as claimed in 16, wherein the said stable benzydamine hydrochloride with povidone iodine solution is filled in suitable size and shape containers with suitable dispensing device, to prepare a pharmaceutical dosage form of a medicament for oral application especially in the form of gargle or throat spray, wherein said container is suitable for delivery or distribution of said stable solution into oral cavity in the form of spray or drops or mist or as liquid.

18. A process for manufacturing of stabilized benzydamine hydrochloride with povidone iodine solution comprising the steps of
i. Solubilization of optional Stabilizer by transferring Purified Water to the main Manufacturing Tank ‘A’ by continuous stirring to dissolve the stabilizer completely.
ii. Adding Povidone Iodine into the above main Manufacturing Tank ‘A’ under stirring and continuous stirring till uniform, clear, lump free solution is obtained.
iii. Adding humectants into the above main Manufacturing Tank ‘A’ under stirring and continuous stirring till uniform solution obtain.
iv. Optional Flavor Solution Preparation in a separate tank ‘B’: In Ethanol or any carrier adding flavor such as Eucalyptus Oil and/or Methyl Salicylate and/or Menthol, under gentle stirring to dissolve it completely; transferring contents of Tank B under gentle stirring to main Tank ‘A’, and continuous stirring till uniform solution is obtained.
v. Optional Sweetener Solution Preparation in a separate tank ‘C’: In purified water or carrier adding sodium saccharine under gentle stirring to dissolve it completely; transferring contents of Tank C under gentle stirring to main Tank ‘A’, and continuous stirring till uniform solution is obtained.
vi. Benzydamine hydrochloride Solution Preparation in a separate tank ‘D’: In purified water or ethanol or propylene glycol or a combination thereof, adding benzydamine hydrochloride under gentle stirring to dissolve it completely. transferring contents of Tank D under gentle stirring to main Tank ‘A’, and continuous stirring till uniform solution is obtained.
vii. Standing or keeping the solution of previous step for stabilization, standardization to achieve a stable pH in the range of 1.5 to 4.5.
viii. Making up the final volume of solution with purified water or carrier and further stir the solution to obtain a standardized and stable final bulk solution for oral use.

19. The process and composition of any preceding claim wherein said final composition maintains satisfactory stability at Accelerated stability conditions at 40°C and 75%RH after 6 months storage or 50°C after 30 days or 7 days storage respectively.

20. The process as claimed in claims 16-19, wherein said stable benzydamine hydrochloride and povidone iodine oral solution is the composition as claimed in claims 1-15.

21. The stable benzydamine hydrochloride and povidone iodine oral solution as prepared by the process of claims 16-20.

22. The process for manufacturing of stabilized & standardized benzydamine hydrochloride and povidone iodine oral solution for gargle or throat application substantially as herein described with reference to examples.

23. The stabilized benzydamine hydrochloride and povidone nasal solution composition substantially as herein described with reference to examples.