DESC:Field of the invention
The present invention relates to immediate release pharmaceutical compositions comprising a tyrosine kinase inhibitor. More particularly, the present invention relates to immediate release compositions comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients and process for preparing such compositions.

Background of the invention
Osimertinib (AZD9291) is an EGFR tyrosine kinase inhibitor (TKI) chemically known as N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide.
Osimertinib as a mesylate salt is approved in the form of tablets and marketed by AstraZeneca under the brand name TAGRISSO®. The tablets are approved in the strengths of 40 and 80 mg.
Osimertinib is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
WO 2013/014448 A1 discloses Osimertinib and its pharmaceutically acceptable salts including the mesylate salt. This reference further discloses that Osimertinib can be used in the treatment of different types of cancers which include, but are not limited to, ovarian cancer, cervical cancer, colorectal cancer, breast cancer, pancreatic cancer, glioma, glioblastoma, melanoma, prostate cancer, leukaemia, lymphoma, non- Hodgkins lymphoma, gastric cancer, lung cancer, hepatocellular cancer, gastric cancer, gastrointestinal stromal tumour (GIST), thyroid cancer, bile duct cancer, endometrial cancer, renal cancer, anaplastic large cell lymphoma, acute myeloid leukaemia (AML), multiple myeloma, melanoma and mesothelioma.

WO 2015/101791 A1 discloses a pharmaceutical composition comprising:
(a) from 2 to 70 parts of the Agent;
(b) from 5 to 96 parts of two or more pharmaceutical diluents;
(c) from 0 to 15 parts of one or more pharmaceutical disintegrants;
(d) from 0 to 1.5 parts of one or more pharmaceutical solubilising agents; and
(e) from 0 to 3 parts of one or more pharmaceutical lubricants;
wherein all parts are by weight and the sum of the parts (a)+(b)+(c)+(d)+(e)=100; and
wherein one of the two or more pharmaceutical diluents is microcrystalline cellulose wherein the microcrystalline cellulose makes up from 7 to 30 wt% of the two or more pharmaceutical diluents (b). This reference clearly discloses that the composition should contain two or more diluents of which one diluent is microcrystalline cellulose and further exemplifies different compositions of Osimertinib prepared by dry granulation or direct compression.
WO 2015/101791 further discloses that AZD9291 exhibits significant pH dependent solubility and moderate permeability. For example, AZD9291 (in free base form) has been found to have >80x higher solubility in simulated gastric fluid (SGF, pH=1.3) relative to human intestinal fluid (HIF, pH=7.9). In such cases, where the solubility of a drug varies with pH, and particularly when the solubility is highest at acidic pH, there is a problem that the drug may precipitate from solution as it passes through the gastrointestinal tract. Drugs need to be in solution in order to be absorbed, so such precipitation can lead to variability in the extent and/or rate of absorption of the drug. For the mesylate salt of AZD9291, the solubility at intestinal pH is significantly higher than that of AZD9291 in free base form. A solution of AZD9291 mesylate, once formed, appeared to be stable without precipitation over a period of at least 24 hours. It also discloses that a simple 'blend in capsule' formulation of AZD9291 mesylate with microcrystalline cellulose was expected to have favourable characteristics including rapid and complete dissolution across the physiological pH range, and accordingly, it was hoped that the use of the mesylate salt of AZD9291 in a simple 'blend in capsule' formulation with microcrystalline cellulose would avoid all of the above-mentioned problems.
WO 2016/105582 A1 discloses a solid oral dosage form comprising (a) a compound that is an irreversible covalent kinase inhibitor, and/or a pharmaceutically acceptable salt thereof; (b) means for release of the compound and/or the pharmaceutically acceptable salt thereof in one or more mammalian intestinal sites selected from the jejunum and ileum; and, (c) a pharmaceutically acceptable excipient.
WO 2017/216584 A1 discloses a composition comprising a modified microcrystalline cellulose excipient and an active pharmaceutical ingredient, wherein the modified microcrystalline cellulose excipient has a surface area of from about 2 to about 60 m2/g and further discloses that the active pharmaceutical ingredient is selected from group of drugs including Osimertinib.
The above prior art references discloses different immediate release compositions comprising Osimertinib and at least one diluent. None of the references discloses Osimertinib compositions which are free of a diluent. The inventors of the present invention have surprisingly found that a tablet composition comprising Osimertinib which is free of diluent showed comparable/better dissolution with respect to the marketed tablet dosage forms of Osimertinib which contain one or more diluents.

Objective of the invention
The main objective of the present invention relates to immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof.
The present invention also relates to an immediate release tablet composition comprising Osimertinib mesylate and one or more pharmaceutically acceptable excipients.
The present invention also relates to a process for the preparation of immediate release tablet composition comprising Osimertinib mesylate and one or more pharmaceutically acceptable excipients having comparable dissolution properties, content uniformity, stability and equivalent bioavailability w.r.t commercialized Osimertinib tablet dosage form.

Summary of the invention
Accordingly, the present invention provides an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression and wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.

Detailed description of the invention
The present invention relates to an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.
The present invention further relates to an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression and wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression and wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression and wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by wet granulation.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by wet granulation and wherein the composition is free of a diluent.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by dry granulation.
The present invention also relates to an immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by dry granulation and wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by direct compression and wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by wet granulation.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by wet granulation and wherein the composition is free of a diluent.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by dry granulation.
The present invention also relates to an immediate release tablet composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is prepared by dry granulation and wherein the composition is free of a diluent.
In an embodiment, “Osimertinib” according to the present invention includes but not limited to Osimertinib free base and its pharmaceutically acceptable salts, ethers, esters, prodrugs, polymorphs and derivatives thereof.
In another embodiment, the pharmaceutically acceptable salt of Osimertinib is a mesylate salt.
As used herein, the term “% w/w” refers to the weight of the component based on the total weight of a composition comprising the component.
“Pharmaceutically acceptable excipient/s” are the components added to pharmaceutical formulation to facilitate manufacture, enhance stability, control release, enhance product characteristics, enhance bioavailability, enhance patient acceptability, etc.
In another embodiment, the composition according to the present invention comprises Osimertinib or a pharmaceutically acceptable salt thereof in an amount of about 70-95% w/w, preferably about 75-90% w/w and more preferably about 75-80% w/w of the composition.
In another embodiment, the composition according to the present invention further comprises one or more pharmaceutically acceptable excipients which include but not limited to disintegrants, binders, glidants and lubricants. These excipients may be present intragranularly or extragranularly.
Binders according to the present invention include but not limited to hydroxypropyl methylcellulose (Hypromellose), hydroxypropyl cellulose, polyvinylpyrrolidone, gelatin, ethyl cellulose, polyvinyl alcohol, pregelatinized starch, carboxymethyl cellulose, sodium alginate, povidone (polyvinyl pyrrolidone), copovidone, microcrystalline cellulose, gelatin, polymethacrylates and the like or combinations thereof. The binder can be used in the range of about 0-20% w/w of the composition.
Disintegrants according to the present invention include but not limited to starches or modified starches such as pregelatinized starch, croscarmellose sodium, carmellose sodium, carmellose calcium, povidone (polyvinyl pyrrolidone), copovidone, crospovidone (Crosslinked polyvinyl pyrrolidone), sodium starch glycolate, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, alginic acid, and the like or combinations thereof. The disintegrant can be used in the range of about 0-25% w/w of the composition.
Glidants according to the present invention include but not limited to silica, colloidal silicon dioxide, talc and magnesium silicate and mixtures thereof. The glidants can be used in the range of 0-10% w/w of the composition.
Lubricants according to the present invention include but not limited to stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, zinc stearate, glyceryl mono fatty acid, glyceryl monostearate, glyceryl dibehenate, glyceyryl palmito stearic ester, hydrogenated castor oil and mixtures thereof. The Lubricants and/or glidants can be used in the range of 0-10% w/w of the composition.
In another embodiment of the present invention, Osimertinib may be present in crystalline form or amorphous form.
In another embodiment, the present invention provides an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof in crystalline form and one or more pharmaceutically acceptable excipients.
In another embodiment, the present invention relates to an immediate release pharmaceutical composition comprising Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent and the composition is prepared by direct compression.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) formulating the blend of step (i) into suitable dosage form.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) optionally, lubricating the blended material of step (i) with a lubricant, and
(iii) preparing the lubricated material of step (ii) into a suitable dosage form.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients, and
(ii) compressing the blend of step (i) into tablet dosage form.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) optionally lubricating the blend of step (i) with a lubricant, and
(iii) compressing the blend of step (ii) into a tablet dosage form.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) granulating the blend of step (i),
(iii) blending the granules of step (ii) with one or more pharmaceutically acceptable excipients, and
(iv) compressing the lubricated blend of step (iii) into tablet dosage form.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients, and
(iii) filling the blend of step (i) into capsules.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) lubricating the blended material of step (i) with a lubricant, and
(iii) filling the lubricated material of step (ii) into capsules.
In another embodiment, the present invention relates to a process for the preparation of an immediate release pharmaceutical composition, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients,
(ii) granulating the blend of step (i),
(iii) blending the granules of step (ii) with one or more pharmaceutically acceptable excipients, and
(iv) filling the lubricated blend of step (iii) into capsules.
In another embodiment, the present invention relates to an immediate release pharmaceutical composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant.
In another embodiment, the present invention relates to an immediate release pharmaceutical composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent.
In another embodiment, the present invention relates to an immediate release pharmaceutical composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent, and
the composition is prepared by wet granulation.
In another embodiment, the present invention relates to an immediate release pharmaceutical composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent, and
the composition is prepared by direct compression.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent, and
the composition is prepared by wet granulation.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent, and
the composition is prepared by dry granulation.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of one or more disintegrants;
(iii) about 0-15% by weight of a binder;
(iv) about 0.1-10% by weight of a glidant and/or lubricant,
wherein the composition is free of diluent, and
the composition is prepared by direct compression.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof; (ii) about 1-20% by weight of a disintegrant selected from low substituted hydroxypropyl cellulose, Croscarmellose sodium and combination thereof;
(iii) about 0.1-10% by weight of colloidal silicon dioxide,
(iv) about 0.1-10% by weight of sodium stearyl fumarate,
wherein the composition is free of diluent, and
the composition is prepared by wet granulation.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof; (ii) about 1-20% by weight of a disintegrant selected from low substituted hydroxypropyl cellulose, Croscarmellose sodium and combination thereof;
(iii) about 0.1-10% by weight of colloidal silicon dioxide,
(iv) about 0.1-10% by weight of sodium stearyl fumarate,
wherein the composition is free of diluent, and
the composition is prepared by dry granulation.
In another embodiment, the present invention relates to an immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof; (ii) about 1-20% by weight of a disintegrant selected from low substituted hydroxypropyl cellulose, Croscarmellose sodium and combination thereof;
(iii) about 0.1-10% by weight of colloidal silicon dioxide,
(iv) about 0.1-10% by weight of sodium stearyl fumarate,
wherein the composition is free of diluent, and
the composition is prepared by direct compression.
In another embodiment, the immediate release pharmaceutical composition according to the present invention is in the form of tablets, capsules, granules, powder, pellets and sachets.
In another embodiment, the blend is formulated into a suitable dosage form like tablets or capsules using different techniques which are well known in the prior art.
In another embodiment, the compositions of the present invention may be prepared using any method known in the art, but are not limited to wet granulation, dry granulation, roller compaction, solid dispersion, encapsulation and direct compression.
In another embodiment, the granulation can be done using one pharmaceutically acceptable excipient, a binder, which can be added to the drug substance in a dissolved state (e.g. in an aqueous/non-aqueous solution) or in a powder form and then granulated by adding a granulation liquid. A combination of more than one binder can be used.
In another embodiment, the solvents used for granulation process may be selected from water, isopropyl alcohol, methanol, ethanol, methylene chloride or combination thereof.
In another embodiment, the granulation can be done using any method known in the art, but are not limited to fluidized bed granulation, high-shear granulation, low shear granulation, spray granulation and melt granulation.
The pharmaceutical composition may be further film coated with functional or non functional layer. The coating may be selected from amongst one or more of those suitable coating materials known in the art. For example, the coating material can be Opadry or Opadry AMB. Coating may be performed by applying one or more film forming polymers, with or without other pharmaceutically inert excipients, as a solution/suspension using any conventional coating technique known in the art, such as spray coating in a conventional coating pan or fluidized bed processor; or dip coating.
Coloring agent may be selected from FDA approved colorants such as Iron Oxide, Lake of Tartrazine, Allura Red, Lake of Quinoline Yellow, Lake of Erythrosine, Titanium Dioxide and the like.
In one preferred embodiment, the pharmaceutical composition according to the present invention is in the form of tablets.
In yet another embodiment, the present invention provides a tablet composition comprising Osimertinib or a pharmaceutically acceptable salt thereof in the range of about 1mg to about 500 mg, preferably 10mg to 100mg.
In another embodiment, the present invention provides a tablet composition comprising Osimertinib or a pharmaceutically acceptable salt thereof for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC).
The invention is further illustrated by the following examples which are provided to be exemplary of the invention and do not limit the scope of the invention. While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.

Example 1: Tablet compositions comprising Osimertinib mesylate
S. No Ingredients Quantity (mg/tab)
1 Osimertinib mesylate 95.400
2 Low substituted hydroxypropyl cellulose 21.350
3 Colloidal silicon dioxide 0.980
4 Magnesium stearate 4.270
Total weight of Core tablet 122.000

The processing steps involved in manufacturing the tablets were given below:
(i) Osimertinib mesylate, low substituted hydroxy propyl cellulose, colloidal silicon dioxide were sifted separately and blended,
(ii) the blend of step (i) was lubricated with magnesium stearate, and
(iii) the lubricated blend of step (ii) was compressed into tablets.
,CLAIMS:We Claim:
1. An immediate release pharmaceutical composition comprising about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients, wherein the composition is free of a diluent.
2. The composition as claimed in claim 1, wherein one or more pharmaceutically acceptable excipients are selected from disintegrants, binders, surfactants, glidants and lubricants.
3. The composition as claimed in claim 2, wherein the disintegrant is selected from starch, modified starches, pregelatinized starch, croscarmellose sodium, carmellose sodium, carmellose calcium, povidone, copovidone, crospovidone, sodium starch glycolate, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, alginic acid and combinations thereof.
4. The composition as claimed in claim 2, wherein the glidant is selected from silica, colloidal silicon dioxide, talc, magnesium silicate and the lubricant is selected from stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, zinc stearate, glyceryl mono fatty acid, glyceryl monostearate, glyceryl dibehenate, glyceyryl palmito stearic ester and hydrogenated castor oil.
5. The composition as claimed in claim 1, wherein the composition is in the form of tablets, capsules, granules, powder, pellets and sachets.

6. A process for the preparation of composition as claimed in claim 1, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with one or
more pharmaceutically acceptable excipients,
(ii) optionally, lubricating the blended material of step (i) with a lubricant, and
(iii) preparing the lubricated material of step (ii) into a suitable dosage form.

7. The composition as claimed in claim 5, wherein the process for preparation of the composition is selected from wet granulation, dry granulation, roller compaction, and direct compression.

8. A process for the preparation of composition as claimed in claim 1, comprising the steps of:
(i) blending Osimertinib or a pharmaceutically acceptable salt thereof with a
disintegrant and optionally one or more pharmaceutically acceptable excipients,
(ii) optionally lubricating the blend of step (i) with a lubricant, and
(iii) compressing the blend of step (ii) into a tablet dosage form.

9. An immediate release pharmaceutical composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt
thereof;
(ii) about 1-20% by weight of a disintegrant selected from low substituted
hydroxypropyl cellulose, Croscarmellose sodium and combination thereof;
(iii) about 0.1-10% by weight of colloidal silicon dioxide,
(iv) about 0.1-10% by weight of sodium stearyl fumarate,
wherein the composition is free of a diluent.

10. An immediate release tablet composition comprising:
(i) about 70-95% w/w of Osimertinib or a pharmaceutically acceptable salt thereof;
(ii) about 1-20% by weight of a disintegrant selected from low substituted
hydroxypropyl cellulose, Croscarmellose sodium and combination thereof;
(iii) about 0.1-10% by weight of colloidal silicon dioxide,
(iv) about 0.1-10% by weight of sodium stearyl fumarate,
wherein the composition is free of a diluent, and
the composition is prepared by direct compression.