WO2022069952A1

WO2022069952A1 - Process for preparing orodispersible film suitable for diverse active ingredients

Info

Publication number: WO2022069952A1
Application number: PCT/IB2021/051174
Authority: WO
Inventors: Geeta LULLA; Meenakshi Shadangi
Original assignee: Lulla Geeta; Meenakshi Shadangi
Priority date: 2020-11-24
Filing date: 2021-02-12
Publication date: 2022-04-07

Abstract

The present invention relates to the platform technology for providing orodispersible films comprising active ingredient belonging to different classes without having need to develop different processes for different compositions comprising different drugs or active ingredients every time yet the resultant orodispersible film to have essential desired attributes including good appearance, smoothness, palatable taste by effectively masking undesirable taste of active ingredient, appropriate folding endurance, and requisite fast disintegration time in mouth. The present disclosure provides a common platform process suitable for different classes of active ingredients selected from but not limiting to pharmaceutical drugs which can be prescription (Rx) drugs or over the counter active ingredients including nutraceutical ingredients, vitamins, hormones, herbal ingredients, or other active ingredients.

Description

PROCESS FOR PREPARING ORODISPERSIBLE FILM SU ITABLE FOR DIVERSE

ACTIVE INGREDIENTS

FIELD OF INVENTION

[0001] The present disclosure relates to the platform technology for providing orodispersible films. In particular, the present disclosure provides a common platform process for preparing orodispersible films of desired attributes comprising active ingredient belonging to different classes without having need to develop different processes for different compositions comprising different drugs or active ingredients every time.

BACKGROUND OF THE INVENTION

[0002] Patient acceptance of a dosage form is of paramount importance for its compliance, for example for the regular and correct intake of the dosage form. Commonly used oral dosage forms like tablet and capsule may cause problems during swallowing leading to discomfort and non-acceptability of such dosage form by patients. Especially for children, adolescents, elderly and persons suffering from dysphagia or mental illness, swallowing deficiencies are known for tablets or capsules. This may result in non-adherence or undesired modification of the dosage form by the patient. Crushing or dissolving of the solid oral dosage form to avoid swallowing, may affect essential performance characteristics such as the dissolution and absorption behavior or stability of the drug, besides incorrect or insufficient dosing due to loss and wastage of drug during crushing and dissolving. As an alternate to conventional tablets and capsules, oral disintegrating tablets may overcome the swallowing challenges but aspiration concerns still remain.

[0003] Liquid formulations, can address and help circumvent the swallowing problems, but other problems like inaccurate dosing, unacceptable organoleptic characteristics like taste and smell, as well as issues of drug stability may arise. Liquid dosage forms are also difficult to administer into children and also difficult to consume during travelling.

[0004] Challenges with conventional tablets, capsules and liquid dosage forms can be excluded by using oral film preparations. Orally disintegrating film commonly called as orodispersible film, a fixed dose formulation can be easily consumed by the patients. Water is not needed for its administration which is a big advantage to children and elderly person and person who are travelling.

[0005] Several critical acceptance issues, which may seem less important for tablets, capsules or liquids like muco-adhesion to the oral cavity and mouthfeel of film can be important during the development of formulation. Similarly, nonuniformity of film, bitter or unpleasant taste of active ingredient are common shortcomings of orodispersible films.

[0006] Further, as compared to other conventional dosage from like tablets, orodispersible films are moisture sensitive and hygroscopic in nature affecting the stability and hence requiring special care and control of environmental condition during the processing. Other critical considerations during the process development of orodispersible films, which have remained challenge so far include excessive frothing during mixing of different ingredients for preparing a solution; peeling of films; rigidity of films; segregation of components of the resultant films; and cracking or breaking of films during processing, packaging and transportation. These factors result into wastage and loss due to removal of unsatisfactory film portions making final products costly, and films with undesired characteristics.

[0007] Thus, there remains an unmet need in the art of formulation of orodispersible films for a process which can address the shortcomings of the existing manner of preparation. Further, owing to the growing popularity of orodispersible films day-by-day, since this promising and progressive dosage form overcomes some therapeutic obstacles, such as impaired swallowing, and offers exceptional drug delivery benefits to patients including the possibility to adapt the dosing requirements for a subset of patients, orodispersible films indeed, are the most transformational alternatives to conventional dosage forms such as tablets and capsules. The orodispersible films are already considered as a unique Rx (prescription drug) dosage form by the US FDA and similarly considered as an acceptable dosage form for prescription drugs by other drug authorities in jurisdictions across the world. In addition to prescription drugs, the orodispersible film can be promising dosage form for vitamins, nutraceuticals, or the like active ingredients as well. This has further necessitated an urgent need for a common platform process suitable for different compositions for preparing orodispersible film comprising different Rx drugs or other active ingredients.

OBJECTS OF THE INVENTION

[0008] An object of the present disclosure is to provide a common platform process suitable for array of active ingredients belonging to different classes to provide an orodispersible film without having a need to develop different processes for different compositions comprising different drugs or active ingredients each time.

[0009] It is one of the objects of the present disclosure to provide a common platform process for preparing orodispersible films, wherein the process can help overcome one or more challenges relating to excessive frothing during mixing of solutions of different ingredients; peeling of films; rigidity of films; segregation of constituents into resultant films; and cracking or breaking of films during processing, packaging and transportation.

[00010] It is one object of the present disclosure is to provide a common platform process for preparing an orodispersible film having desired essential attributes like smoothness of surface, appearance, and appropriate taste masking

[00011] It is another object of the present disclosure is to provide a common platform process for preparing an orodispersible film having desired folding endurance and requisite disintegration time.

SUMMARY

[00012] In an aspect, the present disclosure provides a common platform process suitable for an array of active ingredients belonging to different classes to provide an orodispersible film without having need to develop different processes for different compositions comprising different drugs or active ingredients.

[00013] In an aspect, the present disclosure provides a common platform process suitable for different classes of active ingredients selected from but not limiting to pharmaceutical drugs which can be prescription (Rx) drugs or over the counter active ingredients including nutraceutical ingredients, vitamins, hormones, herbal ingredients, or other active ingredients.

[00014] In one aspect the present disclosure provides a common platform process for preparing an orodispersible film suitable for different drugs such that the resultant orodispersible film has essential attributes including appearance, surface smoothness, and desired taste.

[00015] In another aspect the present disclosure provides a common platform process for preparing an orodispersible film having appropriate folding endurance, and requisite disintegration time.

[00016] In one aspect the present disclosure provides a a common platform process for preparing orodispersible films, wherein the process can help overcome one or more challenges of excessive frothing during mixing of different ingredients for preparing a solution; peeling of films; rigidity of films; segregation of components of the resultant films; and cracking or breaking of films during processing, packaging and transportation.

[00017] In one aspect the present disclosure provides a common platform process for preparing an orodispersible film suitable for active ingredients different, in which the process comprises:

(i) providing a solution of an active ingredient in water; (ii) providing a suspension of a first polymer in water at a temperature ranging from about 60°C to about 80°C;

(iii) including a second polymer into the suspension of the first polymer;

(iv) adding to the solution of the active ingredient, the suspension comprising the first polymer and the second polymer while maintaining the temperature ranging from about 60°C to about 80°C and mixing both the solutions for a period ranging from about 10 mins to about 30 mins to provide a suspension;

(v) providing a solution of a surfactant in water;

(vi) including a plasticizer polymer into the solution of the surfactant;

(vii) adding to the suspension obtained in step (iv), the solution comprising the surfactant and the plasticizer, and mixing for a period of about 30 mins to about 90 minutes to provide a homogenous suspension and allowing the suspension to stand for a period of about 5 hours to about 8 hours; and

(viii) pouring the suspension obtained in step (vii) over a film forming plate preheated at a temperature ranging from about 50°C to about 60°C and allowing the suspension to dry under the continuous circulation of hot air at a temperature ranging from about 50°C to about 60°C to provide the orodispersible film having a moisture content of about 10% to about 12%.

[00018] In an aspect the present disclosure provides a common platform process suitable for active ingredients belonging to different classes selected from but not limiting to pharmaceutical drugs that can be prescription (Rx) drugs or over the counter drugs, nutraceutical ingredients, vitamins, hormones, herbal value-added materials, or other active ingredients.

[00019] In one aspect, in the common platform process, the first polymer employed can be selected from but not limiting to HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol or the like.

[00020] In one aspect, in the common platform process, the second polymer employed can be selected from but not limiting to HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol or the like.

[00021] In one aspect, in the common platform process, the surfactant employed can be a pharmaceutically acceptable non-ionic surfactant.

[00022] In one aspect, in the common platform process, the plasticizer employed can be selected from but not limiting to polyethylene glycol, propylene glycol, and glycerin. [00023] In one aspect, in the common platform process further comprises subsequent to the addition of the solution comprising the surfactant and the plasticizer, adding suitable pharmaceutically acceptable excipients to improve organoleptic characteristics of the orodispersible film. The pharmaceutically acceptable excipients to improve organoleptic characteristics can be selected from but not limiting to coloring agent, flavoring agent, sweetening agent or the like.

[00024] In another aspect the present disclosure provides a common composition suitable for different active ingredients for providing orodispersible film without affecting the attributes of the finished product.

[00025] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description and appended claims. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[00026] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[00027] Figure 1: Depicts excessive frothing in a solution obtained by mixing of all the ingredients of the placebo composition Fl as per the known processes as per Example 1A.

[00028] Figure 2: Depicts no excessive frothing and minimal air bubble formation in the suspension formed as per the process in accordance with Example 1 using the placebo composition F2 as per one of the exemplary embodiments of the present disclosure.

[00029] Figure 3: Depicts the film formed by mixing of all the ingredients of the placebo composition Fl and casted without standing the resultant solution overnight and dried at drying conditions of 80°C for 20 minutes as per the known process as per Example 1A showing excessive air bubbles and peeling in the formed film.

[00030] Figure 4: Depicts the film formed by mixing of all the ingredients of the placebo composition Fl and casted after standing the resultant solution overnight and casted at 80°C for 20 minutes as per the known process conditions as per Example 1A, showing the formed film to be rigid, friable with uneven distribution and segregation of constituents as well as increased undesirable peeling. [00031] Figure 5: Depicts the film formed by mixing of all the ingredients of the placebo composition Fl of Example 1A and casted after standing the resultant solution overnight and casted at 60°C until dry (drying conditions as per the process of the present invention), the formed film did not show undesirable peeling but still suffering from drawback of non- uniform and segregation of contents.

[00032] Figure 6: Depicts the film formed by mixing of all the ingredients of the placebo composition F3 comprising a dye and casted after standing the resultant solution overnight and casted on a plate pre-heated at 80°C and dried for 10 minutes, the formed film showed undesirable excessive cracking.

[00033] Figure 7: Fig. 7a depicts an orodispersible film of the placebo composition F2 and prepared as per the process of the present invention as per Example 1, as can be seen from Fig. 7a, the film is translucent, with smooth surface and no segregation of content and no peeling; Fig. 7b is the same film lifted from one comer showing the desired attributes like translucency, smoothness of surface, uniform appearance, and requisite folding endurance; and Fig. 7c is the film held in hands showing translucency, smoothness of surface, uniform appearance, and flexibility of film corroborating the film to possess desired folding endurance.

[00034] Figure 8: Fig. 8a depicts a cut piece of the orodispersible film of the placebo composition F2 and prepared as per the process of the present invention as per Example 1 folded with hand proving appropriate folding endurance along with other desired attributes; Fig. 8b depicts the cut piece of the film placed on a flat surface showing desired attributes in terms of translucency, smoothness and uniformity.

[00035] Figure 9: depicts orodispersible films obtained in accordance with some of the exemplary embodiments of the present invention comprising different active ingredients; Fig. 9a is an orodispersible film comprising melatonin, Fig. 9b is an orodispersible film comprising curcumin, Fig. 9c is an orodispersible film comprising folic acid, Fig. 9d is an orodispersible film comprising ginseng, and Fig. 9e is an orodispersible film comprising Iron. [00036] Figure 10: Graphs depicting assessment by volunteers of different organoleptic features of the placebo film as per Example 2 Combination-I of the present invention: Fig. 10a is a graph elucidating assessment of appearance; Fig. 10b is a graph elucidating assessment of smoothness of surface; and Fig. 10c is a graph elucidating assessment of taste.

[00037] Figure 11: Graphs depicting assessment by volunteers of different organoleptic features of the placebo film as per Example 2 Combination-II of the present invention: Fig. I la is a graph elucidating assessment of appearance; Fig. 11b is a graph elucidating assessment of smoothness of surface; and Fig. 11c is a graph elucidating assessment of taste. [00038] Figure 12: Graphs depicting assessment by volunteers of different organoleptic features of the placebo film as per Example 2 Combination-Ill of the present invention: Fig. 12a is a graph elucidating assessment of appearance; Fig. 12b is a graph elucidating assessment of smoothness of surface; and Fig. 12c is a graph elucidating assessment of taste. [00039] Figure 13: Graphs depicting assessment by volunteers of different organoleptic features of the sildenafil citrate film as per Example 2 Combination-I of the present invention: Fig. 13a is a graph elucidating assessment of appearance; Fig. 13b is a graph elucidating assessment of smoothness of surface; and Fig. 13c is a graph elucidating assessment of taste.

[00040] Figure 14: Graphs depicting assessment by volunteers of different organoleptic features of the caffeine film as per Example 2 Combination-Ill of the present invention: Fig. 14a is a graph elucidating assessment of appearance; Fig. 14b is a graph elucidating assessment of smoothness of surface; and Fig. 14c is a graph elucidating assessment of taste.

DETAILED DESCRIPTION OF THE INVENTION

[00041] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be understood that the present disclosure includes all such variations and modifications. The disclosure also includes all such steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any or more of such steps or features.

[00042] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”

[00043] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. [00044] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[00045] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” When the term “about” in place preceding any numerical value, the term “about” can mean + 10% of said numerical value. Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.

[00046] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.

[00047] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability.

[00048] All methods described herein can be performed in suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[00049] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[00050] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[00051] Various terms are used herein. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[00052] The present disclosure relates to a process for preparing an orodispersible film suitable for different classes of active ingredients without having to design and develop separate processes

[00053] every time for each drug, thereby serving as a common platform process.

[00054] The present disclosure further relates to providing a common composition for formulating orodispersible film of different active ingredients without affecting the attributes of the finished product.

[00055] The present disclosure is directed to provide a common platform process for preparing orodispersible films suitable for different active ingredients and at the same time overcome one or more challenges relating to excessive frothing during mixing of different ingredients for preparing a solution; peeling of films; rigidity of films; segregation of components of the resultant films; and cracking or breaking of films during processing, packaging and transportation.

[00056] In one embodiment the present disclosure provides a common platform process for preparing an orodispersible film suitable for ingredient such that the resultant orodispersible film have desired essential attributes including appearance, folding endurance, and requisite faster disintegration.

[00057] In one embodiment the present disclosure provides a common platform process for preparing a stable orodispersible film with minimized presence of air bubbles, uniformity of content, and appropriate taste masking.

[00058] In one embodiment the present disclosure provides a common platform process for preparing an orodispersible film suitable for different active ingredients, in which the process comprises:

(i) providing a solution of an active ingredient in water;

(ii) providing a suspension of a first polymer in water at a temperature ranging from about 60°C to about 80°C; (iii) including a second polymer into the suspension of the first polymer;

(iv) adding to the solution of the active ingredient, the solution comprising the first polymer and the second polymer, while maintaining the temperature ranging from about 60°C to about 80°C and mixing both the solutions for a period ranging from about 10 mins to about 30 mins to provide a suspension;

(v) providing a solution of a surfactant in water;

(vi) including a plasticizer polymer into the solution of the surfactant;

(vii) adding to the suspension of polymers obtained in step (iv) the solution obtained in step (vi) comprising the surfactant and the plasticizer, and mixing for a period of about 30 mins to about 90 minutes to provide a homogenous suspension and allowing the suspension to stand for a period of about 5 hours to about 8 hours; and

(viii) pouring the suspension obtained in step (vii) over a film forming plate at a temperature ranging from about 50°C to about 60°C and allowing the suspension to dry under the continuous circulation of hot air at a temperature ranging from about 50°C to about 60°C to provide the orodispersible film having a moisture content of about 10% to about 12%.

[00059] The solution as obtained in various steps of the process in accordance with present disclosure can be a solution comprising completely dissolved ingredients, or can be a dispersion or a suspension of the dispersed or suspended particles of ingredients in the water milieu.

[00060] In an embodiment the present disclosure provides a common platform process suitable for different classes of active ingredients selected from but not limiting to pharmaceutical drugs, nutraceutical ingredients, vitamins, hormones, herbal value-added materials, or other active ingredients.

[00061] In an embodiment, the pharmaceutical drug can be selected from prescription (Rx) drugs or over the counter drug.

[00062] In one embodiment, the pharmaceutical drug can be selected from dexamethasone, loperamide HC1, prednisolone sodium phosphate, folic acid, amlodipine besylate, sildenafil citrate, procyclidine hydrochloride, rivaroxaban, montelukast sodium, apixaban, tadalafil, ondansetron hydrochloride, and ibuprofen.

[00063] In one embodiment, the nutraceutical ingredients, vitamins, hormones, herbal value-added materials, or other over the counter active ingredients can be selected from but not limiting to extract of lycopene, astaxanthin, iron, biotin, vitamin B12, vitamin D3, vitamin K2, melatonin, bamboo extract, Tinospora cordifolia extract, ginseng clove oil, P- Caryophyllene, curcumin, piperine, nicotine, caffeine, lycopene, simethicone, or the like. [00064] The process in accordance with the present disclosure is suitable for preparing an orodispersible film of active ingredients in low dose.

[00065] In one embodiment, the amount of active ingredient to be used in the common platform process of the present disclosure can range from about 0.5 mg to 200 mg.

[00066] In one embodiment, the amount of active ingredient to be used in the common platform process of the present disclosure can range from about 0.5 mg to 50 mg.

[00067] In one embodiment, the percentage concentration of the active ingredient to be used in the common platform process of the present disclosure can range from about 0.5% to 85 % by weight basis.

[00068] In one embodiment, the amount of active ingredient dexamethasone can range from about 0.5 mg to about 8 mg, loperamide HC1 can range from about 2 mg to about 4 mg, prednisolone sodium phosphate can range from about 2.5 mg to about 10 mg, folic acid can range from about 0.4 mg to about 5 mg, amlodipine besylate can range from about 2.5 mg to about 10 mg, sildenafil citrate can range from about 20 mg to about 100 mg, procyclidine hydrochloride can range from about 2.5 mg to about 10 mg, rivaroxaban can range from about 2.5 mg to about 20 mg, montelukast sodium can range from about 4 mg to about 10 mg, apixaban can range from about 2.5 mg to about 5 mg, tadalafil can range from about 2.5 mg to about 20 mg, ondansetron hydrochloride can range from about 4 mg to about 8 mg, and ibuprofen can range from about 62.5 mg to 125 mg.

[00069] In one embodiment, the amount of active ingredient dexamethasone can be about 4 mg, loperamide HC1 can be about 2 mg, prednisolone sodium phosphate can be about 10 mg, folic acid can be about 5 mg, amlodipine besylate can be about 5 mg, sildenafil citrate can be about 50 mg, procyclidine hydrochloride can be about 5 mg, rivaroxaban can be about 2.5 mg, montelukast sodium can be about 5 mg, apixaban can range from about 2.5 mg to about 5 mg, tadalafil can be about 20 mg, ondansetron hydrochloride can be about 20 mg, and ibuprofen can range from about 50 mg to about 100 mg.

[00070] In one embodiment, the amount of active ingredient lycopene can range from about 5 mg to about 40 mg, astaxanthin can range from about 2 mg to about 12 mg, caffeine can range from about 30 mg to about 100 mg, iron polysaccharide complex can range from about 50 mg to about 100 mg, biotin can range from about 2 mg to about 8 mg, vitamin B12 can range from about 1000 mcg to about 2000 mcg, vitamin D3 can range from about 1000 IU to about 6000 IU, vitamin K2 can range from about 2 mcg to about 300 mcg, melatonin can range from about 1 mg to about 10 mg, bamboo extract can range from about 50 mg to about 150 mg, Tinospora cordifolia extract can range from about 50 mg to about 100 mg, ginseng extract can range from about 15 mg to about 35 mg, clove oil can range from about 8 mg to about 10 mg, curcumin can range from about 50 mg to about 100 mg, piperine can range from about 5 mg to about 20 mg, nicotine can range from about 2 mg to about 22 mg, and Simethicone can range from about 62.5 mg to about 125 mg.

[00071] In one embodiment, the amount of active ingredient lycopene can be about 20 mg, astaxanthin can be about 10 mg, caffeine can be about 40 mg, iron polysaccharide complex can be about 32 mg, biotin can be about 5 mg, vitamin B12 can be about 1500 mcg, vitamin D3 can be about 1000 IU, vitamin K2 can be to about 200 mcg, melatonin can be about 5 mg, bamboo extract can range from about 50 mg to about 150 mg, Tinospora cordifolia extract can be about 50 mg, ginseng extract can be about 25 mg, clove oil can be about 10 mg, curcumin can range from about 50 mg to about 100 mg, piperine can be about 15 mg, nicotine can be about 2.5 mg, caffeine can be about 40 mg, and simethicone can be about 62.5 mg.

[00072] In certain embodiments, the active ingredient may be micronized prior to adding to water to obtain desired attributes in the resultant orodispersible film.

[00073] In certain embodiments, the active ingredient may be first mixed with hot water, plasticizer or surfactant prior to adding into water to provide solution or suspension of active ingredient in water.

[00074] In one embodiment, in the common platform process of the present disclosure, the first polymer employed can be selected from but not limiting to HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol or the like.

[00075] In one preferred embodiment, in the common platform process of the present disclosure, the first polymer employed is hydroxypropyl methyl cellulose.

[00076] The hydroxypropyl methyl cellulose used can be of different grades depending upon the viscosity suitable for low dose active ingredient or the high dose active ingredient.

[00077] In one embodiment the hydroxypropyl methyl cellulose used can have the viscosity ranging from about 4 cP to about 6 cP, or about 14 cP to about 16 cP depending upon the dose of the active ingredient.

[00078] In one embodiment the hydroxypropyl methyl cellulose used can have the viscosity ranging from about 4 cP to about 6 cP, when the dose of the active ingredient is low, ranging from about 0.5 mg to about 15 mg by weight. [00079] In one embodiment the hydroxypropyl methyl cellulose used can have the viscosity ranging from about 14 cP to about 16 cP, when the dose of the active ingredient is high, ranging from about 16 mg to about 100 mg by weight.

[00080] In one embodiment, in the common platform process of the present disclosure, the second polymer employed can be selected from but not limiting to HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol or the like.

[00081] In one preferred embodiment, the first polymer is hydroxypropyl methyl cellulose.

[00082] In certain embodiment, in the common platform process of the present disclosure, the second polymer employed can be selected from but not limiting to HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol (PVA)or the like.

[00083] In one embodiment, in the common platform process of the present disclosure, the second polymer employed can be selected from but not limiting to HPC (hydroxypropyl cellulose), maltodextrin, polyvinyl alcohol (PVA)or the like.

[00084] In one preferred embodiment, the first polymer is hydroxypropyl methyl cellulose and the second polymer is polyvinyl alcohol.

[00085] In another preferred embodiment, the first polymer is hydroxypropyl methyl cellulose and the second polymer is HPC (hydroxypropyl cellulose).

[00086] In still another preferred embodiment, the first polymer is hydroxypropyl methyl cellulose and the second polymer is maltodextrin.

[00087] In one embodiment, in the common platform process of the present disclosure, the concentration of hydroxypropyl methyl cellulose can range from about 2 % to 95 %, preferably from about 10 % to about 70 %, more preferably from about 30 % to about 60 %, and even more preferably from about 40 % to about 60 % .

[00088] In one embodiment in the common platform process of the present disclosure, the concentration of hydroxypropyl cellulose can range from about 1 % to 25 %, preferably from about 2 % to about 10 %.

[00089] In one embodiment in the common platform process of the present disclosure, the concentration of maltodextrin can range from about 5 % to 20 %

[00090] In one embodiment in the common platform process of the present disclosure, the concentration of polyvinyl alcohol can range from about 10% to about 50%.

[00091] In one embodiment in the common platform process of the present disclosure, the concentration of polyvinyl alcohol can range from about 25% to about 35%. [00092] In one embodiment, in the common platform process of the present disclosure, the surfactant employed can be a pharmaceutically acceptable surfactant non-ionic surfactant.

[00093] The non-ionic surfactant can be selected from but not limiting to a class of polyol esters, polyoxyethylene esters, sodium lauryl sulfate, or poloxamers; wherein the polyol esters can be selected from glycol, glycerol esters and sorbitan derivatives including fatty acid esters of sorbitan and ethoxylated derivatives thereof.

[00094] The sorbitan derivative can be selected from but not limiting to sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan mono-oleate, sorbitan tristearate, sorbitan trioleate, or a pharmaceutically acceptable surfactant.

[00095] The ethoxylated derivatives of sorbitan can be selected from but not limiting to polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan mono-oleate, polyoxyethylene sorbitan tristearate, and polyoxyethylene sorbitan tri-oleate.

[00096] In one embodiment, in the common platform process of the present disclosure, the surfactant employed can be selected from but not limited to sorbitan monolaurate, polyoxyethylene sorbitan monolaurate, and sodium lauryl sulfate.

[00097] In one embodiment in the common platform process of the present disclosure, the concentration of surfactant employed can range from about 0.1% to about 10%, preferably ranging from about 0.5% to about 5%, and more preferably ranging from about 1% to about 3%.

[00098] In the common platform process of the present disclosure, the plasticizer employed can be selected from but not limiting to polyethylene glycol, propylene glycol, and glycerin.

[00099] In one embodiment, in the common platform process of the present disclosure, the plasticizer employed can be selected from but not limiting to Polyethylene glycol 400, polyethylene glycol 4000, and glycerin.

[000100] In one embodiment in the common platform process of the present disclosure, the concentration of plasticizer employed can range from about 1% to about 30%, preferably ranging from about 5% to about 25%.

[000101] In one embodiment, the common platform process of the present invention further comprises subsequent to the addition of the solution comprising the surfactant and the plasticizer, adding suitable pharmaceutically acceptable excipients to improve organoleptic characteristics of the orodispersible film. The pharmaceutically acceptable excipients to improve organoleptic characteristics can be selected from coloring agent, flavoring agent, sweetening agent or the like. [000102] In one embodiment, the common platform process of the present invention further comprises maintaining the viscosity of the final solution in step (vii) by adding water.

[000103] In one embodiment, the viscosity of the final solution in step (vii) is maintained in a range from about 500 cP to 2500 cP.

[000104] In one embodiment, the mixing in step (vii) is carried out at the speed of about 1000 rpm to about 1500 rpm with a suitable stirrer.

[000105] In one embodiment drying of the suspension in step (viii) of the process in accordance with the present disclosure is carried out under the continuous circulation vertically and horizontally of hot air at a temperature ranging from about 50°C to about 60°C for period of about 45 minutes to about 90 minutes, preferably for a period of about one hour to provide the orodispersible film having a moisture content of about 10% to about 12%.

[000106] In one preferred embodiment drying of the suspension in step (viii) of the process in accordance with the present disclosure is carried out under the continuous circulation vertically and horizontally of hot air at a temperature not exceeding a temperature of 60°C.

[000107] The common platform process in accordance with the present disclosure provides orodispersible films which are not rigid but flexible having desirable folding endurance, stable, uniform in appearance, desired organoleptic characteristics and having appropriate disintegration time.

[000108] The present disclosure satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

[000109] Although the subject matter has been described in considerable detail with reference to certain preferred embodiments thereof, other embodiments are possible.

ADVANTAGES OF THE PRESENT INVENTION

[000110] The present disclosure provides a common platform process suitable for different classes of active ingredients to provide an orodispersible film without having need to develop different processes for different compositions for different drugs or active ingredients.

[000111] The common platform process in accordance with the present disclosure was surprisingly found to overcome challenges such as excessive frothing of the dispersion obtained after mixing of the active ingredient, film forming polymers, plasticizer and water as per the conventional or known processes.

[000112] The common platform process of the present disclosure obviates drawbacks such as peeling of the film; formation of two layers; cracking and breaking of film during processing or packaging; rigidity of films; inadequate taste masking; non-uniformity and segregation of constituents in the film as observed with known processes for preparing the orodispersible films.

[000113] The common platform process in accordance with the present disclosure provides orodispersible films which are not rigid but flexible having desirable folding endurance, stable, uniform in appearance, having desired organoleptic characteristics and appropriate disintegration time.

[000114] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.

Comparative Examples 1A and IB and Example 1

Orodispersible films with placebo compositions formed as per conventional processes (Examples 1A and IB) and orodispersible films with placebo compositions formed in accordance with the present disclosure (Example 1):

[000115] Orodispersible films were prepared as per the known process as per the comparative Example 1A and IB and as per the Example 1 of the present invention. The placebo compositions Fl and F3 were used for preparing film as per the known process and the placebo composition F2 was used for preparing film as per the process of the present disclosure.

Table 1. Placebo Compositions with only polymers without any active ingredient:

(i) Preparation of orodispersible film as per Comparative Example 1A with Composition Fl: [000116] In a container weighted quantity of HPMC, HPC, PEG 400, polysorbate 20, polyvinylpyrrolidone K 30 and purified water (composition Fl) were added and stirred for 30 min using lab stirrer at 1500 to 3000 rpm for homogeneous dispersion preparation. Excessive frothing was observed in the resultant solution (Fig. 1). The dispersion was allowed to stand overnight (more than 12 hours). Films were casted using film casting machine in uniform thickness before and after standing the solution overnight at 80°C for 20 minutes (drying conditions as per the known process) as well at 60°C for 60 minutes (drying condition as per the process of the present invention). The film formed before standing and dried as per the known drying conditions at 80°C for 20 minutes showed the film to have excessive air bubbles as well as undesirable peeling (Fig. 3). The film casted after standing the solution of polymers and plasticizer overnight and casted at 80°C for and dried for 20 minutes were rigid, friable, showed uneven distribution and segregation of constituents as well as increased undesirable peeling (Fig. 4). The film casted after standing the solution of polymers and plasticizer overnight and casted at 60°C for 60 minutes did not show undesirable peeling but still film suffered to undesirable attribute of non-uniform and segregation of contents (Fig. 5).

(ii) Preparation of orodispersible film as per Comparative Example 1A with Composition F3: [000117] In a container weighted quantity of HPMC, maltodextrin, polysorbate 20, glycerin, sucralose, strawberry flavor, erythrosine dye and purified water were added and stirred for 30 min using lab stirrer at 1500 to 3000 rpm for homogeneous dispersion preparation. Excessive frothing was observed in the resultant solution. The dispersion was allowed to stand overnight (more than 12 hours). Films were casted using film casting machine in uniform thickness on a plate pre-heated at 80°C and dried for 10 minutes, the formed film showed undesirable excessive cracking (fig. 6).

[000118] These results show that as per the convention process, the films formed were not of desired characteristics and suffered from one or more above mentioned drawbacks.

(iii) Preparation of orodispersible film as per Example 1 (present invention) with Composition F2:

[000119] A solution of HPMC was prepared in water at a temperature ranging from about 70°C to about 80°C and mixed for 10 minutes. HPC was added to the solution of HPMC and mixed to provide homogenous solution. A solution of polysorbate 20 was prepared in sufficient quantity of water and mixed thoroughly. PEG 400 was added to the solution of polysorbate 20 and mixed to provide a homogenous solution. The solution containing of polymers HPMC and HPC and the solution containing PEG 400 and polysorbate 20 were mixed to obtain homogenous solution. The viscosity of the solution was maintained at about 1500 cP to about 1500 cP by adding water. The pH of the solution was about 5 to 7. No frothing was observed as such, minimal air bubbles were formed (Fig. 2). The mixed solution was allowed to stand for the period of 5-7 hours and poured over a film forming plate at 60°C and was dried at the same temperature under circulation of hot air for period of about 60 minutes to obtain the orodispersible film having 10-12% moisture content. As can be seen from Fig. 7a, the film is translucent, with smooth surface and no segregation of content and no peeling; Fig. 7b shows the same film lifted from one comer showing the film to have the desired attributes like translucency, smoothness of surface, uniform appearance, and requisite folding endurance; and Fig. 7c shows the film held in hands, the film showed translucency, smoothness of surface, uniform appearance, and flexibility corroborating the film to possess desired folding endurance. Further, Fig. 8a depicts a cut piece of the orodispersible film prepared as per the process of the present invention as per Example 1 using the placebo composition F2, as can be seen, the film can be easily folded proving the film to have appropriate folding endurance along with other desired attributes; and Fig. 8b depicts the cut piece of the film placed on a flat surface showing desired attributes in terms of translucency, uniform appearance and smoothness in surface.

[000120] Thus, the film formed in accordance with the present invention did not suffer from undesirable peeling, segregation of content, non-uniform appearance and uneven or cracked surface. The film obtained in accordance with the present invention had the uniformly distributed content and had desired characteristics as illustrated with Figs. 7a-7c and Figs. 8a- 8b as explained above and as can be seen from below Table 2.

Table 2. Features of orodispersible films - Comparative Example 1A and Example 1:

*: Disintegration with disintegration equipment with Disc [000121] From the above Table 2 as well as Figs. 3-6, it can be seen that the film formed as per Comparative Example 1 suffered from undesirable peeling during the process, the film formed was rigid, had non-uniform appearance with segregation content, surface with cracking and had a very low folding endurance. The orodispersible film as per the present disclosure did not suffer from such shortcomings but exhibited much superior characteristics as already elucidated with Figs. 7a-7c and unexpectedly showed much higher folding endurance as can be seen from the above Table 2.

Example 2

Orodispersible films formed in accordance with the present invention with compositions comprising different combinations of polymers:

[000122] Orodispersible films were formed in accordance with the present disclosure incorporating different types of active ingredients individually and using different combinations of the first polymer and second polymers as per Combination-I comprising HPMC and PVA, Combination-II comprising HPMC and HPC and Combination-Ill comprising HPMC and maltodextrin. Compositions are provided in Table 3, 4 and 5 below:

Table 3. Combination-I comprising HPMC and PVA:

Table 4. Combination-II comprising HPMC and HPC:

Table 5. Combination-Ill comprising HPMC and maltodextrin:

Process for preparation of Orodispersible films

[000123] Orodispersible films were prepared using compositions as per Tables 3-5 with the following process in accordance with the present disclosure:

[000124] Solution of an active ingredient as per Tables 3-5 were individually dissolved or suspended in purified water. To properly dissolve or disperse the active ingredients, some of the active ingredients were micronized. In certain cases of water insoluble active ingredients, they were mixed with water with addition of surfactant polysorbate 20 or plasticizer PEG 400 and mixed to provide a homogenous suspension of active ingredient. For example, loperamide was added with PEG 400 and mixed prior to adding to water, the same treatment was also followed for amlodipine, caffeine was added with hot water, clove oil was first mixed with Tween 20 and mixed with water, the same treatment was followed for melatonin as well as curcumin for providing the final solution or suspension of active ingredient. Solution of HPMC was prepared by adding HPMC in water at a temperature ranging from about 60°C to about 80°C and mixed for 10 minutes. Second polymer selected from PVA, HPC or maltodextrin as per Tables 3-5 was added in the solution of HPMC at the same temperature and mixed thoroughly to provide the solution of two polymers. Said solution of combination of two polymers I, II, or III was added to the solution or suspension of the active ingredient and mixed while maintaining the temperature ranging from about 60°C to about 80°C and mixing both the solutions for a period ranging from about 10 mins to about 30 mins to provide a uniform suspension. A solution of polysorbate 20 was prepared in sufficient quantity of water and mixed thoroughly. PEG 400 was added to the solution of polysorbate 20 and mixed to provide a homogenous solution. The solution comprising active ingredient and combination of polymers I, II, or III and the solution containing PEG 400 and polysorbate 20 were mixed to obtain homogenous solution. The viscosity of the resultant solution including combination of polymers I, II, or III as per compositions F1-F10 was maintained at about 1500 cP to about 2000 cP by adding water. The viscosity of the resultant solution including combination of polymers III as per compositions F11-F15 was maintained at about 500 cP to about 1500 cP by adding water. The resultant solution was mixed for a period of about 45 mins to about 60 minutes at rpm of about 1000 rpm to 1500 rpm using a mechanical stirrer to provide a homogenous suspension. No frothing was observed as such, minimal air bubbles were formed. The mixed solution was allowed to stand for the period of 5-7 hours and poured over a film forming plate pre-heated at 60°C and was dried at the same temperature under circulation of hot air for period of about 60 minutes to obtain the orodispersible film having 10-12% moisture content. Orodispersible films formed were then evaluated for their physical and mechanical features, and disintegration time, which have been reported in Tables 6-8 respectively.

Table 6. Characteristic features of the orodispersible films as per Combination-I

*Disintegration with disintegration equipment with Disc

Table 7. Characteristic features of the orodispersible films as per Combination-II

*: Disintegration with disintegration equipment with Disc

Table 8. Characteristic features of the orodispersible films as per Combination-Ill

*: Disintegration (with disintegration equipment with Disc)

[000125] The orodispersible films comprising the active ingredient belonging to different classes and combinations of polymers as per Combinations-I to III and prepared as per the process of the present invention, were surprisingly found to exhibit much superior characteristics such as uniform appearance and desired folding endurance as well as very short disintegration time in mouth. The same is evident from the above Tables 6-8. [000126] Additionally, pictures of orodispersible films (Figs. 9a-9e) show the films obtained in accordance with the present invention of exemplary active ingredient such as melatonin, curcumin, ginseng, and iron. These exemplary films are found to have desirable attributes like uniform appearance proving even distribution of contents, and smoothness of surface. The same illustrate that the process of the present invention using combination of polymers is capable of providing orodispersible films of active ingredients like hormones, nutraceutical value added herbal ingredients, vitamins and minerals, which otherwise is difficult to provide owing to the requirement of the high dose of such active ingredients. [000127] The data as provided in above Tables 6-8 and Figs. 9a-9e demonstrate that the process of the present invention utilizing combinations of polymers I to III is suitable for providing orodispersible films of varied active ingredients belonging to different classes, such as prescriptions drugs, hormones, vitamins and nutraceutical ingredients. Not only the present invention avoids need for developing separate processes suitable for different types of active ingredients bur also provides orodispersible films having desired characteristic features.

Example 3

Assessment of organoleptic characteristics of the orodispersible films provided in accordance with the present invention:

[000128] Assessment of organoleptic characteristics was carried out of the organoleptic characteristics features of the orodispersible films prepared as per the process of the present invention as per Example 2 using the placebo compositions without any active ingredients as well as two compositions comprising the bitter active ingredient, the one comprising sildenafil citrate and the other comprising caffein. The composition of bitter active ingredient sildenafil citrate comprised of polymers as per combinations I and the composition of the bitter active ingredient caffein comprised of polymers as per combinations III. The assessment was carried out by performing a blind test of the orodispersible films by 10 volunteers for different organoleptic characteristic features like appearance, smoothness of surface and taste. All the ratings were given within a range of 1 to 5, wherein: 1 -Worst, 2- below average, 3- average, 4- good, 4.25 - very good, 4.5 - better, 4.75 - Excellent, 5-best. Graphs were made with the data collected from the test for separate organoleptic properties that is appearance, smoothness of surface and taste. As can be seen from Figs. 10a- 10c, Hal le, and 12a- 12c, the volunteers scored the orodispersible placebo films comprising polymers combinations-I-III to be around 4 to more than 4 proving the placebo films to have remarkable organoleptic characteristics of overall appearance and smoothness of surface and were well accepted in respect of taste. Further, Figs. 13a-13c and 14a-14c, the volunteers even found the orodispersible films of bitter drugs like sildenafil citrate and caffein to have impressive appearance and smoothness of surface as well as very agreeable test proving the process of the present invention and compositions comprising combinations of polymer to be successful in masking very bitter taste and provide films with superior quality.

[000129] Overall, the present invention provides a novel and inventive common platform process suitable for various active ingredients belonging to different classes for providing orodispersible films with desired attributes and overcoming shortcomings of the existing processes.

[000130] From the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein merely for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention and should not be construed so as to limit the scope of the invention or the appended claims in any way.

Claims

We Claim:

1. A common platform process for preparing an orodispersible film suitable for different active ingredients, in which the process comprises:

(i) providing a solution of an active ingredient in water;

(ii) providing a suspension of a first polymer in water at a temperature ranging from about 60°C to about 80°C;

(iii) including a second polymer into the suspension of the first polymer;

(v) providing a solution of a surfactant in water;

(vi) including a plasticizer polymer into the solution of the surfactant;

(vii) adding to the suspension obtained in step (iv) the solution comprising the surfactant and the plasticizer, and mixing for a period of about 30 mins to about 90 minutes to provide a homogenous suspension and allowing the suspension to stand for a period of about 5 hours to about 8 hours; and

(viii) pouring the suspension obtained in step (vii) over a film forming plate -heated at a temperature ranging from about 50°C to about 60°C and allowing the suspension to dry under the continuous circulation of hot air at a temperature ranging from about 50°C to about 60°C to provide the orodispersible film having a moisture content of about 10% to about 12%.

2. The common platform process as claimed in claim 1, wherein the active ingredient is selected from the group consisting of a pharmaceutical drug, nutraceutical ingredient, vitamin, hormone, and herbal value-added material.

3. The common platform process as claimed in claim 1, wherein the active ingredient is selected from dexamethasone, loperamide HC1, prednisolone sodium phosphate, folic acid, amlodipine besylate, sildenafil citrate, procyclidine hydrochloride, rivaroxaban, montelukast sodium, apixaban, tadalafil, ondansetron hydrochloride, ibuprofen, lycopene, astaxanthin, iron, biotin, vitamin B12, vitamin D3, vitamin K2, melatonin, bamboo extract, Tinospora cordifolia extract, ginseng clove oil, P-Caryophyllene, curcumin, piperine, nicotine, caffeine, and simethicone.

4. The common platform process as claimed in claim 1, wherein the active ingredient is present in concentration ranging from 0.5% to 85 % by weight basis.

5. The common platform process as claimed in claim 1, wherein the active ingredient is present in low dose ranging from 0.5 mg to 200 mg, preferably ranging from 0.5 mg to 50 mg.

6. The common platform process as claimed in claim 4, wherein the amount of active ingredient dexamethasone is in the range from 0.5 mg to 8 mg, loperamide HC1 is in the range from about 2 mg to 4 mg, prednisolone sodium phosphate is in the range from 2.5 mg to 10 mg, folic acid is in the range from 0.4 mg to 5 mg, amlodipine besylate is in the range from 2.5 mg to 10 mg, sildenafil citrate is in the range from 20 mg to 100 mg, procyclidine hydrochloride is in the range from 2.5 mg to 10 mg, rivaroxaban is in the range from 2.5 mg to 20 mg, montelukast sodium is in the range from 4 mg to 10 mg, apixaban is in the range from 2.5 mg to 5 mg, tadalafil is in the range from 2.5 mg to 20 mg, ondansetron hydrochloride is in the range from 4 mg to 8 mg, and ibuprofen is in the range from 50 mg to 100 mg, lycopene is in the range from 5 mg to 40 mg, astaxanthin is in the range from 2 mg to 12 mg, caffeine is in the range from 30 mg to 100 mg, iron polysaccharide complex is in the range from about 50 mg to about 100 mg, biotin is in the range from 5 mg to 10 mg, vitamin B12 is around 1000 mcg, vitamin D3 is in the range from 1000 IU to 6000 IU, vitamin K2 is in the range from 2 mcg to 300 mcg, melatonin is in the range from 1 mg to 10 mg, bamboo extract is in the range from 50 mg to 150 mg, Tinospora cordifolia extract is in the range from 50 mg to 100 mg, ginseng extract is in the range from 25 mg to 200 mg, Clove oil is in the range from 8 mg to 10 mg, Curcumin is in the range from 50 mg to 125 mg, piperine is in the range from 10 mg to 15 mg, nicotine is in the range from 2 mg to 22 mg, and simethicone is in the range from 62.5 mg to 125 mg.

7. The common platform process as claimed in claim 1, wherein for providing the solution of the active ingredient, the active ingredient is optionally micronized or mixed with a plasticizer, surfactant or hot water prior to mixing with water.

8. The common platform process as claimed in claim 1, wherein the first or the second polymer is selected from HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), maltodextrin, and polyvinyl alcohol.

9. The common platform process as claimed in claim 1 or 8, wherein the first polymer employed is hydroxypropyl methyl cellulose having viscosity ranging from about 4cP to 6 cP or 14 cP to 16 cP depending upon the dose of the active ingredient.

10. The common platform process as claimed in claim 9, wherein the viscosity of the hydroxypropyl methyl cellulose is in the range from about 4 cP to about 6 cP, when the dose of the active ingredient is ranging from about 0.5 mg to about 15 mg by weight.

11. The common platform process as claimed in claim 9, wherein the viscosity of the hydroxypropyl methyl cellulose is in the range from about 14 cP to about 16 cP, when the dose of the active ingredient is ranging from about 16 mg to about 100 mg by weight.

12. The common platform process as claimed in claim 1, wherein the second polymer is selected from HPMC (hydroxypropyl methyl cellulose), HPC (hydroxypropyl cellulose), polyvinyl alcohol, and maltodextrin; preferably selected from HPC (hydroxypropyl cellulose), polyvinyl alcohol, and maltodextrin.

13. The common platform process as claimed in claim 1, wherein the first polymer is hydroxypropyl methyl cellulose and the second polymer is polyvinyl alcohol; or the first polymer is hydroxypropyl methyl cellulose and the second polymer is HPC; or the first polymer is hydroxypropyl methyl cellulose and the second polymer is maltodextrin.

14. The common platform process as claimed in claim 13, wherein the concentration of hydroxypropyl methyl cellulose is in the range from 2 % to 95 %, preferably from 10 % to 70 %, more preferably from 30 % to 60 %, and even more preferably from 40 % to t 60 %; the concentration of hydroxypropyl cellulose is in the ranges from about 1 % to 25 %, preferably from about 2 % to about 10 %; the concentration of polyvinyl alcohol is in the range from about 10% to about 50%, preferably from 25% to 35%, and the concentration of maltodextrin is in the range from 5 % to 20 %

15. The common platform process as claimed in claim 1, wherein the surfactant is a pharmaceutically acceptable surfactant non-ionic surfactant selected from sorbitan monolaurate, polyoxyethylene sorbitan monolaurate, and sodium lauryl sulfate.

16. The common platform process as claimed in claim 1 or 13, wherein the surfactant is in the concentration ranging from 0.1% to 10%, preferably from 0.5% to 5%, and more preferably from 1% to 3%.

17. The common platform process as claimed in claim 1, wherein the plasticizer is selected from Polyethylene glycol 400, polyethylene glycol 4000, propylene glycol, and glycerin.

18. The common platform process as claimed in claim 1 or 17, wherein the plasticizer is in the concentration ranging from 1% to 30%, and preferably 5% to 25%.

19. The common platform process as claimed in claim 1, wherein the process further comprises subsequent to the addition of the solution comprising the surfactant and the plasticizer in step (vii), adding suitable pharmaceutically acceptable excipients selected from coloring agent, flavoring agent, and sweetening agent to improve organoleptic characteristics of the orodispersible film.

20. The common platform process as claimed in claim 1, wherein the process further comprises maintaining the viscosity of the final solution in step (vii) in a range from about 500 cP to 2500 cP by adding water.

21. The common platform process as claimed in claim 1, wherein the step (viii) of the process is carried out under the continuous vertical and horizontal circulation of hot air at a temperature ranging from about 50°C to about 60°C for period of about 45 minutes to about 90 minutes; preferably for a period of about one hour.