WO2004087111A1

WO2004087111A1 - Oral taste masked pharmaceutical compositions

Info

Publication number: WO2004087111A1
Application number: PCT/IB2004/001036
Authority: WO
Inventors: Harvinder Popli; Pradeep Bhadauria; Sudhir Verma
Original assignee: Ranbaxy Laboratories Limited
Priority date: 2003-04-04
Filing date: 2004-04-05
Publication date: 2004-10-14

Abstract

The present invention relates to oral taste masked pharmaceutical compositions that include a core having an active ingredient coated with a mixture of polymeric film forming binders and inorganic carriers. Also provided are processes for preparing the oral taste masked pharmaceutical composition.

Description

ORAL TASTE MASKED PHARMACEUTICAL COMPOSITIONS

Field of the Invention

The present invention relates to oral taste masked pharmaceutical compositions that include a core having an active ingredient coated with a mixture of polymeric film fonning binders and inorganic carriers. Also provided are processes for preparing the oral taste masked pharmaceutical composition.

Background of the Invention

Pharmaceutical compositions intended for oral use are usually administered either in the form of liquid dosage forms, such as a syrup, suspension, or emulsion, or solid dosage forms, such as a capsule, compressed tablet, granule, etc. A variety of systems for film coating and incorporation of a powder blend into a hard gelatin shell have been widely adapted in the past in order to block the active ingredient from the taste buds. These methods attempted to restrict the bitter taste sensed by the patient.

When the pharmaceutical composition is to be used by geriatric and/or pediatric patient populations, the problem of dysphasia is prevalent, and it becomes imperative for the formulator to take into account the disagreeable taste of the active ingredient. For patient-friendly delivery of bitter tasting active ingredients in liquid or rapid disintegrating dosage forms, work must be done at the particle level in order to mask the unpleasant taste. The prior art is replete with attempts to achieve an effective and commercially viable method of taste masking. While formulating an oral taste masked composition with a taste masking coating, attention must be paid to regulation of the release profile, as the active ingredient may be released too quickly, or conversely, in a delayed manner. Therefore, taste masking is linked to the dosage forms release profile. This profile in an oral taste masked composition depends largely on the percent of weight build up of the coating composition on the core, as well as the type of coating polymers used.

Many methods have been used in the prior art to achieve the taste masking effect, such as the use of ion exchange resins, salt and ester conjugation, lipids, solid dispersions, and microencapsulation by coacervation. The development of an oral solid, rapidly disintegrating formulation requires a coating to be applied on the particles. This coating must have sufficient elastic strength to withstand the compression pressure during tableting in order to avoid rupturing the film. The development of a liquid oral system presents the formulator with several issues. First, the leaching of the active ingredient from the microcapsules may spoil the organoleptic properties. Second, the swelling of the polymeric film may lead to poor physical stability and caking of particles on sedimentation. Finally, by overcoming the first two issues with insoluble film formers, a new difficulty arises while developing a rapid release dosage form. The limited availability of liquid taste masked formulations on the market shows a real need for the development of a taste masking system that is applicable to a wide range of pharmaceutical dosage forms.

U.S. Patent No. 6,197,348 describes a dosage form that utilizes encapsulated particles coated with polymers, such as Eudragit RS and Eudragit RL. Taste masking is achieved as a result of the polymer coatings and a liquid suspending medium having a pH that is adjusted to a point where the active ingredient is insoluble. However, the thickness and type of coating is not sufficient for taste masking.

EP 0458751 discloses compositions containing a core that includes a cyclic amino acid compound. The core is coated with polymeric film forming compounds and hydrophilic fats, fatty acids and waxes.

U.S. Patent No. 4,800,087 discloses a taste masked composition in a chewable dosage form having a controlled release profile. The invention utilizes a combination of polymers to achieve a taste masking coating suitable for incorporation into a chewable dosage form. The composition contains microcapsules which are composed of an active ingredient and a polymer mixture coating having a sufficient elasticity to withstand chewing. The polymeric coating mixture includes one high temperature film forming copolymer and one low temperature film forming copolymer.

U.S. Patent No. 6,139,865 discloses a taste masked microcapsule composition of water soluble active ingredients. The water soluble active ingredients are coacervated in the polymeric material. This technique suffers from several disadvantages. For example, the technique requires the use of hydrocarbons and other organic solvents, such as cyclohexane. These solvents are explosive and present problems in large scale manufacturing. U.S. Application 2002/064563 discloses a taste masked composition of topiramate and a process for its preparation. The process includes preparing core particles which include the active ingredient topiramate, coating with a taste masked mixture to form coated particles, and drying the coated particles.

U.S. Patent No. 6,106,861 discloses a multiparticulate disintegrating tablet which includes excipients and an active ingredient in the form of microcrystals. Only a limited number of active ingredients can be commercially made in the form of microcrystals, and specifically, amorphous powders cannot be utilized in this process.

WO 01/35930 discloses a process for taste masking by granulation of the active ingredient with an aqueous admixture that includes a neutral methacrylic acid ester copolymers and a binder. Taste masking can only be achieved for moderately bitter and poorly soluble active ingredients, but is ineffective for highly bitter and/or soluble active ingredients.

U.S Patent No. 5,084,278 describes a chewable taste masked pharmaceutical composition having a controlled release profile. The composition comprises microcapsules with are made up of an active ingredient core coated with a polymer mixture. The coating includes a blend of ethyl cellulose and polymethacrylic acid ester copolymers.

U.S. Patent No. 6,136,347 describes a pharmaceutical composition which comprises microcapsules wherein the active ingredient is microencapsulated within the microcapsule wall. The active ingredient is present as an anhydrate or its free base form. The composition further utilizes an oily suspension as a vehicle for suspending microparticles coated with a combination of water soluble and water insoluble polymers, thus preventing the interaction of water. However, this dosage form suffers from the disadvantage of poor acceptability due to a sand/oily feel in the mouth. Additionally, it needs a vehicle for reconstitution to be supplied along with the microcapsules It is evident that there is a commercial need for a pharmaceutical dosage form that effectively provides taste masking, without alteration of the release profile. The prior art fails to describe a pharmaceutical composition with a taste masking coating that provides for immediate release of the encapsulated active ingredient in solution, without the problems of leaching or swelling when exposed to an aqueous media in suspension at the typical pH of saliva. Summary of the Invention

In one general aspect there is provided a taste masked pharmaceutical composition that includes a core and a taste masking coating. The core includes a therapeutically effective amount of an active pharmaceutical ingredient. The taste masking coating includes at least one polymeric film forming binder and at least one inorganic carrier.

Embodiments of the composition may include one or more of the following features. For example, the active phannaceutical ingredient may be one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti-inflammatory active ingredients and salts thereof. The active pharmaceutical ingredient may be one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, cefpodoxime, amoxycillin, erythromycin, chlo heniramine, cefuroxime and salts thereof. The active pharmaceutical ingredient may be present in the range of from about 5% w/w to about 90% w/w. The polymeric film forming binder may be one or more of methacrylic acid ester copolymer, poly (ethyl acrylate-co-methyl methacrylate), amino methacrylic acid ester copolymers, ethyl cellulose, hydroxypropyl methylcellulose, cellulose acetate, cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate. The polymeric film forming binder may be present at a concentration ranging from about 10% w/w to about 90% w/w.

The inorganic carrier may be one or more of calcium carbonate, dibasic calcium phosphate, calcium silicate, magnesium carbonate, magnesium silicate, calcium oxide and magnesium oxide. The inorganic carrier may be present at a concentration ranging from about 1% w/w to about 90% w/w. The ratio of the polymeric film forming binder to the inorganic carrier may range from about 40:60 to about 50:50.

The composition may further include one or more pharmaceutically acceptable excipients.

In another general aspect there is provided a process for the preparation of an oral taste masked composition. The process includes forming a core comprising an active pharmaceutical ingredient; forming a taste masking coating by mixing a polymeric film forming binder and an inorganic carrier; and spraying the taste masking coating on the core to obtain said oral taste masked composition. Embodiments of the process may include one or more of the following features. For example, the active pharmaceutical ingredient may be one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti- inflammatory active ingredients and salts thereof. The active pharmaceutical ingredient maybe one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, cefpodoxime, amoxycillin, erythromycin, chlorpheniramine, cefuroxime and salts thereof. The active pharmaceutical ingredient may be present in a range of from about 5% w/w to about 90% w/w. The polymeric film fonning binder may be one or more of methacrylic acid ester copolymer, poly (ethyl acrylate-co-methyl methacrylate), amino methacrylic acid ester copolymers, ethyl cellulose, hydroxypropyl methylcellulose, cellulose acetate, cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate. The polymeric film forming binder may be present at a concentration ranging from about 1% w/w to about 90% w/w.

The inorganic carrier may be one or more of calcium carbonate, dibasic calcium phosphate, calcium silicate, magnesium carbonate, magnesium silicate, calcium oxide and magnesium oxide. The inorganic carrier may be present at a concentration ranging from about 1% w/w to about 90% w/w. The ratio of the film forming binder to the inorganic carrier may range from about 10:90 to about 90:10. The ratio of polymeric film forming binder to inorganic carrier may further range from about 40:60 to about 50:50. The taste masking coating may be about 10% w/w to about 100% w/w of the core.

The process may further include using one or more pharmaceutically acceptable excipients in the dosage form. In another general aspect there is provided a method of treating a condition for which an active pharmaceutical ingredient is prescribed. The method includes administering a taste masked pharmaceutical composition that includes a core and a taste masking coating. The core includes a therapeutically effective amount of the active pharmaceutical ingredient. The taste masking coating includes at least one polymeric film forming binder and at least one inorganic carrier.

Embodiments of the method may include one or more of the following features or the features described above. For example, the active pharmaceutical ingredient may be one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti-inflammatory active ingredients and salts thereof. The active pharmaceutical ingredient may be one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, cefpodoxime, amoxycillin, erythromycin, chlorpheniramine, cefuroxime and salts thereof.

The details of various embodiments of the inventions are set forth in the accompanying description below. Other features and advantages of the inventions will be apparent from the description and the claims. Detailed Description of the Invention

The oral taste masked compositions described herein include a pharmaceutically effective amount of an active ingredient microencapsulated with a coating which is insoluble or non-swellable in the pH range that exists in the mouth. The coating includes a polymeric film fonning binder and a non polymeric, inorganic carrier. The compositions release the contents immediately in the acidic/weakly acidic pH of the stomach.

Furthermore, the coating may simply be of a character that will not release active agents in the limited amount of fluid that exists in the mouth/suspending media. After the microcapsules are swallowed, the low pH environment of the stomach and/or simply the large volume of aqueous fluid will dissolve or swell the coating and allow the encapsulated active ingredient to be released immediately (within a period of about one hour). However, other suitable release profiles which provide controlled, delayed, or pulsed release, based on the active ingredient used, will be considered to be within the scope of the present invention.

The therapeutically effective, active pharmaceutical ingredient as described herein is any active ingredient having disagreeable taste or flavor or that produces any sort of local irritation. The active ingredient may be pharmacologically or chemotherapeutically active itself, or may be converted into a phannacologically or chemotherapeutically active species by a chemical or enzymatic process in the body.

Suitable active phannaceutical ingredients include one or more of antiallergic, anti- inflammatory, antibacterial, antiasthmatics, nonsteroidal anti-inflammatory, antiarthritic, antipsychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, prokinetics, antihypertensives, antianxiety, and nonsteroidal anti-inflammatory active pharmaceutical ingredients and the like.

For example, the active pharmaceutical ingredients may include one or more of antibiotics, such as clarithromycin, ciprofloxacin, cefuroxime axetil, ceφodoxime proxetil, amoxicillin, cefadroxil, moxifloxacin, gatifloxacin and the like; antidiabetics, such as rosiglitazone, pioglitazone, metformin, repaglinide, gliclazide, glibenclamide and the like; antiulcerants, such as ranitidine, cimetidine, famotidine and the like; prokinetics, such as domperidone, cisapride, ondensetran, mosapride and the like; antipyrectics, such as paracetamol, aspirin and the like; anti-arthritics, such as rofecoxib, celecoxib, valdecoxib, nimesulide and the like; nonsteroidal anti-inflammatorys, such as paroxicam ,meloxicam, diclofenac, ibuprofen and the like; antiallergics, such as chlorphenramine, diphenhydramine, ceterizine, loratadine, desloratadine, fexofenadine and the like; antiasthmatics, such as montelukast, zafirlukast, bambuterol, pranlukast, salbutamol and the like; antipsychotics, such as alprazolam, fluoxetine, olanzapine , risperidone and the like; and active ingredients used for the treatment of erectile dysfunction, such as sildenafil citrate and the like.

The active ingredient or its pharmaceutically acceptable salt or ester may be used and will be considered to be within the scope of the invention. The active ingredient may be present in the range of about 5% w/w to about 90% w/w of the oral taste masked composition.

Suitable film forming polymeric binders include polymeric substances having sufficient elasticity and structural stability as a film. The film forming polymeric binder is utilized to enhance the film forming properties of the inorganic non polymeric carriers, which either have poor or no film fonning properties. One prefened film forming binder includes the class of the polymethacrylic acid ester copolymers, and more particularly a neutral polymethacrylic acid ester copolymer. Nonetheless, any other insoluble polymer may be considered suitable depending on the type of release profile sought. In one preferred embodiment of the present invention, an immediate release dosage form, a prefened film forming binder is poly (ethyl acrylate-co- methyl methacrylate) available under the trade name Eudragit NE 30 D as a 30% aqueous dispersion. Eudragit NE 30 D has an elongation of 600% and a minimum film forming temperature of less than room temperature. Properties, such as low glass transition temperature, better film adhesion, and high film, make the use of methacrylic acid copolymers, particularly Eudragit NE 30 D, preferable.

Other suitable film fonning polymeric binders include one or more of cellulose ethers, such as ethyl cellulose, hydroxypropyl methyl cellulose, cellulose esters, such as cellulose acetate, polymers exhibiting pH dependent solubility such as cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, Eudragit E, Eudragit L & Eudragit S, and amino methacrylic acid ester copolymers, such as Eudragit RL, Eudragit RS, Eudragit RD and combination thereof.

The concentration range of the film forming binders may be from about 10% to about 90%, preferably from about 10% to about 60%, and more preferably from about 10% to about 40% of the total weight of the taste masked phannaceutical composition.

The inorganic carriers of the present invention exhibit pH dependent solubility. Suitable inorganic carrier may include one or more of calcium carbonate, dibasic calcium phosphate, calcium silicate, magnesium carbonate, magnesium silicate, calcium oxide, magnesium oxide or a combination thereof. Inorganic carriers, such as calcium carbonate, are practically insoluble in water at a neutral pH. Thus, they maintain sufficient stability against leaching in an aqueous media, but are soluble at a pH range of 1 to 5. They exhibit the highest solubility in an acidic pH of 1 to 2 which results in instantaneous channel formation and the subsequent release of active ingredient. Suitable concentrations of the inorganic carrier range from about 1% to about 90% of the composition. The ratio of the polymeric film forming binder and inorganic carrier may be varied depending on the type of release profile desired. The polymeric film forming binder and inorganic carrier may have a weight ratio in the range of about 10:90 to about 90:10, preferably from about 70:30 to about 30:70, and even more preferably from about 40:60 to about 50:50.

The blend of the polymeric film forming binder and inorganic carrier renders the taste masking coating completely insoluble and non-swellable in a neutral pH. This characteristic makes them more suitable for use in an aqueous suspension and overcomes the inconvenience of supplying a special vehicle for reconstitution, such as in an oil. The present inventions specifically make use of the aqueous-based coating systems that are safe and make environmental regulatory compliance (e.g., EPA) relatively easy compared to non-aqueous based coating systems. Although there is no limitation to the type of water insoluble polymer used, the neutral methacrylic acid ester copolymers were found especially suitable because of their balanced permeability characteristics and hydophilicity. Accordingly, any polymer having similar permeability characteristics will be deemed useful for the invention. Insoluble polymers, such as ethyl cellulose, form films having good physical stability, however, their poor permeability delays the release of the poorly water-soluble active ingredients because the hydrophobicity reduces the exposure of the inorganic carrier to the . microenvironment. This in turn limits channel formation, which delays active phannaceutical ingredient release. According to the invention the process for the preparation of an oral taste masked composition generally includes; a) mixing a polymeric film fonning binder ranging from 1% w/w to 90% w/w and non polymeric inorganic carrier ranging from 1% w/w to 90% w/w, wherein the ratio of the film forming binder and the non polymeric inorganic carrier ranges from 10:90 to 90:10, to obtain a taste masking coating, and b) spraying the taste masking coating on a core that includes active ingredient in the range of 5% w/w to 90% w/w, the taste masking coating forming 10% to 100% of weight of the total weight of the core, to obtain the oral tasted masked composition. The following examples further exemplify the inventions and are not intended to limit the scope of the inventions.

Example 1 Ciprofloxacin Hydrochloride Microcapsules.

Core composition: Ciprofloxacin Hydrochloride 600 gm

Microcrystalline cellulose 100 gm

Polyvinylpynolidone 40 gm

Purified water 200 ml

Coating composition: Ciprofloxacin HC1 cores (#40/60) 150 gm

Eudragit NE 30 D 150 gm

Calcium Carbonate 105 gm

Purified water 300 ml Procedure:

Procedure for forming the core:

Ciprofloxacin Hydrochloride and Microcrystalline Cellulose were mixed in a rapid mixer granulator for 10 minutes and then the mixture was granulated with Polyvinylpyrrolidone solution until the wet mass formed the required consistency. The granulator was operated at a slow speed to obtain granules. The granules were dried at 60°C and the prefened particle size fraction was collected for taste masking coating.

Procedure for coating the core:

The granules were charged in the material chamber of a fluidized bed coater (GPCGl) and the coating parameters were set. The coating dispersion was sprayed until the effective taste masking was achieved. The samples were removed at 70% and 100% coating levels to study the dissolution profile.

The following coating parameters were selected for coating of the core:

Inlets temperature - 55°C to 65°C, exhaust temperature - 25°C to 35°C, spray rate - 15 to 20 gm min, height of partition chamber - 15 mm, distribution plate - B, atomization - 2.25 kg/cm , inlet airflow rate - 1.8 to 2.5

Table 1

Dissolution of ciprofloxacin Hydrochloride Microcapsules. (pH 1.2)

Table 2

Dissolution of Ciprofloxacin Hydrochloride Microcapsules (pH 4)

Table 3

Dissolution of the Ciprofloxacin Hydrochloride microcapsules in water (900 ml).

Example 2 Rapidly Disintegrating Tablets of Ciprofloxacin Hydrochloride

Procedure:

All of the ingredients, except the magnesium stearate, were mixed in a double cone blender for 10 minutes. The granular blend was then lubricated with magnesium stearate and compressed using suitable parameters. The coating composition is the same as described above in Example 1.

Table 4

Dissolution of Ciprofloxacin Hydrochloride Rapidly disintegrating Tablets.

Example 3

Ciprofloxacin base microcapsules

Core Composition:

Ciprofloxacin base 500 gm

Microcrystalline Cellulose 100 gm

Polyvinylpynolidone K-30 40 gm

Purified water 300 ml

Coating Composition:

Ciprofloxacin base cores (#40/60) 150 gm

Eudragit NE 30 D 105 gm

Calcium Carbonate 73.5 gm

Purified water 210 ml Table 5

Dissolution of Ciprofloxacin Microcapsules.

Table 6

Dissolution of Ciprofloxacin Microcapsules.

Table 7

Comparative dissolution of ciprofloxacin microcapsules at different ratios of Eudragit NE

30 D (NE) and Calcium Carbonate (CC).

The build up found to be reasonably sufficient for the effective taste masking. Example 4

Ciprofloxacin for oral suspension

Ciprofloxacin base (below # 60) 125 mg

(As microcapsules from Example 3)

Xanthan Gum 25.0 mg

Aspartame 5.0 mg

Pharma Sugar (#100) 2.0 gm

Titanium dioxide 10.0 mg

Sodium benzoate 10.0 mg

The suspension was reconstituted with boiled and cooled water and evaluated for taste and physical changes; the data is depicted in Table 8.

Table 8

Taste masking studies of Ciprofloxacin Oral suspension

Example 5

Taste Masked Controlled Release Ciprofloxacin HC1 Microcapsules Procedure:

The cores of Example 1 were used for the controlled release coating of the following composition. Significant sustained effect was achieved at,a coating build up of approximately 60%. Ciprofloxacin base cores 150.0 gm (As per Example 1) Aquacoat ECD 30% 200 gm

Calcium carbonate 90 gm

Purified water 250 ml Surprisingly, by replacing the Eudragit NE 30 D with an equivalent or lesser amount of ethylcellulose, the release profile becomes one of sustained release behavior.

Example 6

Taste Masked Microcapsules of Bambuterol. Microcrystalline cellulose spheres 150 gm

(Celphere, FMC) Active ingredient coating

Bambuterol Hydrochloride 40.0 gm

Hydroxypropyl methylcellulose (5 cps) 10.0 gm Isopropyl alcohol 20 ml

D.M. Water 130 ml

Taste masking coating

Active ingredient layered microcapsules 150 gm

Eudragit NE 30 D 75 gm Calcium carbonate 52.5 gm

Procedure:

The active ingredient suspension was layered on the microcrystalline cellulose spheres using a fluidized bed coating. Then the active ingredient-layered microcapsules were further coated with the taste masking coating as described above. Complete taste masking was achieved at approximately 50% to 60% build up. The process used was the same as described above with respect to Example 1.

While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications and combinations of the invention detailed in the text can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims

We Claim: 1. A taste masked pharmaceutical composition comprising: a core comprising a therapeutically effective amount of an active pharmaceutical ingredient; and a taste masking coating, wherein the taste masking coating comprises at least one polymeric film forming binder and at least one inorganic carrier. 2. The composition according to claim 1, wherein the active pharmaceutical ingredient comprises one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti-inflammatory active ingredients and salts thereof. 3. The composition according to claim 1, wherein the active phannaceutical ingredient comprises one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, cefpodoxime, amoxycillin, erythromycin, chlorpheniramine, cefuroxime and salts thereof. 4. The composition according to claim 1, wherein the active pharmaceutical ingredient is present in the range of from about 5% w/w to about 90% w/w. 5. The composition according to claim 1, wherein the polymeric film forming binder comprises one or more of methacrylic acid ester copolymer, poly (ethyl acrylate- co-methyl methacrylate), amino methacrylic acid ester copolymers, ethyl cellulose, hydroxypropyl methylcellulose, cellulose acetate, cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate. 6. The composition according to claim 5, wherein the polymeric film forming binder is present at a concentration ranging from about 10% w/w to about 90% w/w. 7. The composition according to claim 1, wherein the inorganic carrier comprises one or more of calcium carbonate, dibasic calcium phosphate, calcium silicate, magnesium carbonate, magnesium silicate, calcium oxide and magnesium oxide. 8. The composition according to claim 7, wherein the inorganic carrier is present at a concentration ranging from about 1% w/w to about 90% w/w.

. The composition according to claim 1, wherein the ratio of the polymeric film forming binder to the inorganic carrier ranges from about 40:60 to about 50:50. 10. The composition according to claim 1, further comprising one or more pharmaceutically acceptable excipients. 11. A process for the preparation of an oral taste masked composition, the process comprising: forming a core comprising an active pharmaceutical ingredient; forming a taste masking coating by mixing a polymeric film forming binder and an inorganic carrier; and spraying the taste masking coating on the core to obtain said oral taste masked composition. 12. The process according to claim 11, wherein the active pharmaceutical ingredient comprises one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti-inflammatory active ingredients and salts thereof. 13. The process according to claim 11, wherein the active phannaceutical ingredient comprises one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, ceφodoxime, amoxycillin, erythromycin, chlorpheniramine, cefuroxime and salts thereof. 14. The process according to claim 11, wherein the active pharmaceutical ingredient is present in a range of from about 5% w/w to about 90% w/w. 15. The process according to claim 11 , wherein the polymeric film forming binder comprises one or more of methacrylic acid ester copolymer, poly (ethyl acrylate- co-methyl methacrylate), amino methacrylic acid ester copolymers, ethyl cellulose, hydroxypropyl methylcellulose, cellulose acetate, cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate. 16. The process according to claim 11, wherein the polymeric film fonning binder is present at a concentration ranging from about 1% w/w to about 90% w/w.

17. The process according to claim 11, wherein the inorganic carrier comprises one or more of calcium carbonate, dibasic calcium phosphate, calcium silicate, magnesium carbonate, magnesium silicate, calcium oxide and magnesium oxide. 18. The process according to claim 11, wherein the inorganic carrier is present at a concentration ranging from about 1 % w/w to about 90% w/w. 19. The process according to claim 11, wherein the ratio of the film fonning binder to the inorganic carrier ranges from about 10:90 to about 90: 10. 20. The process according to claim 11, wherein the ratio of polymeric film forming binder to inorganic carrier ranges from about 40:60 to about 50:50. 21. The process according to claim 11 , wherein the taste masking coating comprises about 10% w/w to about 100% w/w of the core. 22. The process according to claim 11, further comprising one or more pharmaceutically acceptable excipients. 23. A method of treating a condition for which an active pharmaceutical ingredient is prescribed, the method comprising administering a taste masked pharmaceutical composition comprising: a core comprising a therapeutically effective amount of the active pharmaceutical ingredient; and a taste masking coating, wherein the taste masking coating comprises at least one polymeric film forming binder and at least one inorganic carrier. 24. The method according to claim 23, wherein the active pharmaceutical ingredient comprises one or more of antibiotics, antihistamines, antiarthritics, anti psychotics, tranquillizers, antidiabetics, antipyretics, antiulcerants, antiasthmatics, antihypertensives, antianxiety, nonsteroidal anti-inflammatory active ingredients and salts thereof. 25. The method according to claim 23, wherein the active pharmaceutical ingredient comprises one or more of clarithromycin, ciprofloxacin, acetaminophen, bambuterol, olanzapine, ranitidine, sildenafil, ceφodoxime, amoxycillin, erythromycin, chloφheniramine, cefuroxime and salts thereof.