DESC:Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carrier.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers, where in the carriers are polymers or pharmaceutically acceptable excipients or combination thereof and process for the preparation.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the polymers are selected from hydrophobic or hydrophilic polymers like PVP, copovidone, HPC, HPMC and combinations thereof.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, process for preparation of pharmaceutical composition comprising solid dispersion of Finerenone.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. where in the composition comprising a solid dispersion of Finerenone and a carrier, wherein the Finerenone is dispersed or dissolved in the carrier.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. where in the pharmaceutical composition is oral solid dosage form.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. where in formulations is prepared into powders, granules and tablets, methods for manufacturing and processing the powders, granules and tablets.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, wherein the Finerenone having 5-70% w/w of the composition.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients having comparable dissolution properties, content uniformity, stability and equivalent bioavailability w.r.t commercialized Finerenone dosage form.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients like diluent, binder, glidant, lubricant, solubilizer, antacid, disintegrant and colorant.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the particle size of Finerenone is less than 250 microns, preferably less than 100 microns, more preferably less than 50 microns.
Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in Finerenone is in the form of crystalline of amorphous form.
Present invention is to provide a method for treatment of a diabetes by administering an immediate release pharmaceutical formulation comprising Finerenone and its pharmaceutically acceptable salts.
The term "composition" or "formulation" or "dosage form" has been employed interchangeably for the purpose of the present invention and mean that it is a pharmaceutical composition which is suitable for administration to a patient or subject.
The subject can be an animal, preferably a mammal, more preferably a human. For the purpose of the present invention terms "immediate release" or "sustained release" or "extended release" or "prolonged release" have been used interchangeably and mean broadly that Finerenone.
The term “pharmaceutically acceptable” as used herein means that which is useful in preparing a pharmaceutical composition that is generally safe and non-toxic.
The term “excipients” as used herein means a component of a pharmaceutical product that is not an active ingredient such as, for example, fillers, diluents, carriers and the like. The excipients that are useful in preparing a pharmaceutical composition are generally safe and non-toxic.
By the term “composition” as used herein refers to a solid dosage form suitable for oral administration, such as a tablet, capsule, spheroids, mini-tablets, pellets, granules, pills and the like; preferably, oral tablets.
Diluents according to the present invention include but not limited to lactose monohydrate, lactose anhydrous, fructose, dextrose, dextrates, dextrins, mannitol, lactitol, sorbitol, starch, sucrose, calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium sulfate, microcrystalline cellulose, silicified microcrystalline cellulose, or combinations thereof.
Binders according to the present invention include but not limited to hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, gelatin, ethyl cellulose, polyvinyl alcohol, pregelatinized starch, carboxymethyl cellulose, Polysorbate 80, sodium alginate, microcrystalline cellulose, Calcium hydrogen phosphate and the like or combinations thereof.
Disintegrants according to the present invention include but not limited to starches or modified starches such as pregelatinized starch, croscarmellose sodium, crospovidone, sodium starch glycolate, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, chitosan and the like or combinations thereof.
Surfactants according to the present invention may be selected from anionic, cationic or non- ionic surface-active agents or surfactants. Suitable anionic surfactants include but not limited to carboxylate, sulfonate, and sulfate ions such as sodium lauryl sulfate (SLS), sodium laurate, dialkyl sodium sulfosuccinates particularly bis- (2-ethylhexyl) sodium sulfosuccinate, sodium stearate, potassium stearate, sodium oleate and the like. Suitable cationic surfactants include but not limited to those containing long chain cations, such as benzalkonium chloride, bis-2- hydroxyethyl oleyl amine or the like.
Lubricants and/or glidants according to the present invention include but not limited to colloidal silicon dioxide, stearic acid, magnesium stearate, Syloid XDP, calcium stearate, sodium stearyl fumarate, talc, hydrogenated castor oil, and mixtures thereof.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carrier.
In one of the embodiments of the present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers, where in the carriers are polymers or pharmaceutically acceptable excipients or combination thereof and process for the preparation.
In one of the embodiments of the present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the polymers are selected from hydrophobic or hydrophilic polymers like PVP, copovidone, HPC, HPMC and combinations thereof.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients and processes for the preparation of the pharmaceutical composition.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the composition comprising a solid dispersion of Finerenone and a carrier, wherein the Finerenone is dispersed or dissolved in the carrier.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. where in the pharmaceutical composition is oral solid dosage form.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. where in formulations is prepared into powders, granules and tablets, methods for manufacturing and processing the powders, granules and tablets.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, wherein the Finerenone having 5-70% w/w of the composition.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients having comparable dissolution properties, content uniformity, stability and equivalent bioavailability w.r.t commercialized Finerenone dosage form.
In one of the embodiments of the Present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients like diluent, binder, glidant, lubricant, solubilizer, antacid, disintegrant and colorant.
In one of the embodiments of the present invention is to provide a method for treatment of a diabetes by administering an immediate release pharmaceutical formulation comprising Finerenone and its pharmaceutically acceptable salts.
In one of the embodiments of the present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the particle size of Finerenone is less than 250 microns, preferably less than 100 microns, more preferably less than 50 microns.
In one of the embodiments of the present invention relates to a pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in Finerenone is in the form of crystalline of amorphous form.
Examples
The following examples are for the purpose of illustration of the invention only and are not intended in any way to limit the scope of the present invention.
Example 1:
S. No Ingredients Qty/ Tablet (mg)
1. Finerenone; HPMC (Premix) 49 Mg
2. Microcrystalline Cellulose 39Mg
3. Pregelatinized starch 29.5 Mg
4. Crospovidone 5 Mg
5. Croscarmellose sodium 5 Mg
6. Povidone K30 6 Mg
7. Sodium Lauryl Sulfate 0.65 Mg
8. Talc 0.85 Mg

Manufacturing process:

The preparation method of the Finerenone containing tablet of the present invention adopts a wet granulation process, comprising the following steps:
1) Micronize Finerenone to a particle size of D50=35µm, D90=82µm;
(2) adding the micronized Finerenone, binder and solubilizer into purified water to prepare a granular solution;
(3) put filler and disintegrating agent into wet granulator, mix well, add granule solution to granulate;
(4) granulating the obtained particles through a 60-mesh sieve and drying;
(5) Put the lubricant and the dried particles into the three-dimensional mixer, and mix them evenly;
(6) compressing the material obtained in step (5) into a tablet and coating with a coating liquid to obtain a tablet containing Finerenone. In step (2), the mass ratio of purified water and Finerenone is 15:1-20:1. In step (6), coating liquid is made up of the raw material of following parts by weight: 5-7 parts of water-soluble coating materials, 30-60 parts of coating solvent; The water-soluble coating material is Opadry; The coating solvent is water, ethanol or a mixture of water and ethanol, preferably a mixture of water and ethanol, and the mixing volume ratio of water and ethanol is 6:1-1:1.
,CLAIMS:1) A pharmaceutical composition comprising a solid dispersion of Finerenone or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients.

2) The pharmaceutical composition as claimed in claim 1, wherein solid dispersion is a mixture of Finerenone and HPMC, wherein the Finerenone is dispersed or dissolved in the HPMC.

3) The pharmaceutical composition as claimed in claim 1, wherein the composition comprising of Finerenone solid dispersion and one or more pharmaceutically acceptable excipients like diluent, binder, glidant, lubricant, solubilizer, antacid, disintegrant and colorant.

4) The pharmaceutical composition as claimed in claim 1, wherein the composition is comprising of Finerenone solid dispersion and one or more pharmaceutically acceptable excipients like microcrystalline cellulose, pregelatinized starch, crospovidone, croscarmellose sodium, povidone, sodium lauryl sulfate, talc.

5) The pharmaceutical composition as claimed in claim 1, where in Finerenone having particle size is less than 250 microns, preferably less than 100 microns, more preferably less than 50 microns.

6) The pharmaceutical composition as claimed in claim 1, wherein Finerenone is in the form of crystalline or amorphous form.

7) The pharmaceutical composition as claimed in claim 1, wherein Finerenone formulations is in the form of powders, granules or tablets.

8) The pharmaceutical composition as claimed in claim 1, wherein Finerenone formulations is prepared by direct compression, wet granulation or dry granulation.

9) The pharmaceutical composition as claimed in claim 1, where in the composition is used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.