FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
[Section 10, and Rule 13]
PHARMACEUTICAL COMPOSITION OF TELMISARTAN AND AMLODIPINE AND PROCESS FOR PREPARATION
THEREOF
Applicant
Name: Torrent Pharmaceuticals Limited
Nationality: Indian
Address: Torrent House, Off Ashram Road, Near Dinesh
Hall, Ahmedabad 380 009, Gujarat, India
The following specification particularly describes the invention and the manner in which
it is to performed

PHARMACEUTICAL COMPOSITION OF TELMISARTAN AND AMLODIPINE AND PROCESS FOR PREPARATION THEREOF
FIELD OF THE INVENTION
The present invention relates to a pharmaceutical composition comprising telmisartan and amlodipine components in dissolving matrix and process for preparation of said composition.
BACKGROUND OF THE INVENTION
Telmisartan, chemically designated as 4'-[2-n-propyl-4-methyl-6-(l-methylbenzimidazol-2-yl)-benzimidazol-l-ylmethyl]-biphenyl-2-carboxylic acid, is disclosed in EP502314 Bl as an angiotensin II receptor antagonist useful for the treatment of hypertension and other medical indications. Telmisartan is generally manufactured and supplied in the free acid form, such as Micardis® marketed by Boehringer Ingelheim. Amlodipine is a well known calcium channel blocker, which is orally administered in the treatment of hypertension alone or in combination with other antihypertensive agents.
Combination therapy of telmisartan with calcium channel blocker such as amlodipine is marketed by Boehringer Ingelheim under the brand name Twynsta®, for the treatment of hypertension. However, formulating an oral fixed dose combination composition which may have the features of pharmacologic efficacy, adequate stability and a robust method of manufacture involves overcoming numerous technical problems and difficulties. For example, telmisartan is characterized by its very poor solubility in aqueous systems at the physiological pH range of the gastro-intestinal tract of between pH 1 to 7 and hence for in vivo performance telmisartan part must comprise basic components like for example sodium hydroxide or meglumine, on the other end amlodipine is surprisingly not stable enough when it gets in direct contact with excipients to be used in a telmisartan composition as the ester bonds in the amlodipine molecule appear to be subject to hydrolysis when exposed to an alkaline environment. Therefore, the direct mixing the

active components with the necessary excipients cannot be applied to a fixed dose combination of telrnisartan and amlodipine and more sophisticated techniques are needed to separate the basic telrnisartan composition from the amlodipine drug substance. Under these circumstances coated, bilayer, inlayed tablet technology could be used.
WO2004028505 describes that the solubility of telrnisartan can be increased several hundred fold in a pharmaceutical composition comprising telrnisartan dispersed in a dissolving matrix comprising a basic agent, a surfactant or emulsifier, water soluble diluent in an amount of 25 to 70 wt %, and optionally further excipients.
WO2006048208 application discloses a bilayer pharmaceutical tablet comprising a first layer containing telrnisartan in substantially amorphous form in a dissolving tablet matrix and a second layer containing a calcium channel blocker such as amlodipine besylate in a disintegrating tablet matrix. The dissolving matrix of the telrnisartan layer comprises a basic agent, a water-soluble diluent, and, optionally, other excipients. WO2007001065 discloses wet granulation method for the preparation of a solid dosage form comprising an angiotensin II receptor antagonist and a calcium channel blocker. WO2007001067 discloses a solid dosage form comprising an angiotensin II receptor antagonist and a calcium channel blocker wherein both active ingredients are not intimately mixed, WO2008146178 discloses inlayed tablet of the active ingredients.
Preparation of fixed dose combination of telrnisartan and amlodipine due to its incompatibility with each other, poses challenges to the formulators to formulate stable composition. Inventors of the present invention have surprisingly found easy to manufacture and stable pharmaceutical compositions comprising telrnisartan and amlodipine by dispersing both in dissolving matrix as disclosed in the present invention.
SUMMARY OF THE INVENTION
The present invention relates to pharmaceutical compositions comprising telrnisartan and amlodipine and process for preparing such compositions.

In one aspect, the specification discloses a stable pharmaceutical composition comprising;
(i) a first component comprising telmisartan in a dissolving matrix comprises basic agent, and
(ii) a second component comprising amlodipine in a dissolving matrix.
In another aspect, the specification discloses pharmaceutical composition comprising telmisartan and amlodipine, wherein the composition may be in the forms of monolithic, bilayered, multilayered, inlayered or multiparticulate system.
In another aspect, the specification discloses pharmaceutical composition comprising telmisartan and amlodipine, wherein telmisartan is present in a dissolving tablet matrix, which is in the form of a core, with a dissolving coat of amlodipine applied onto the core.
In another aspect, the specification discloses a process for preparing telmisartan component, wherein the process comprises:
(a) dissolving telmisartan, basic agent, at least one pharmaceutically acceptable excipient in a solvent,
(b) spray-drying a the solution of step (a) and drying the obtained wet granules,
(c) lubricating the granules of step (b),
(d) optionally coating the granules of step (b) and lubricating it;
In another aspect, the specification discloses a process for preparing telmisartan component, wherein the process comprises:
(a) dissolving telmisartan, basic agent, at least one pharmaceutically acceptable excipient in a solvent,
(b) spraying the solution of step (a) on to a pharmaceutically acceptable excipient to obtain the granules and drying the granules,
(c) lubricating the granules of step (b);
(d) optionally coating the granules of step (b) and lubricating it.

In another aspect, the specification discloses a process for preparation telmisartan component, wherein the process comprises:
(a) granulating telmisartan, basic agent and at least one pharmaceutically acceptable excipient with suitable solvent or binder solution,
(b) drying the granules step (a)
(c) lubricating the granules of step (b);
(d) optionally coating the granules of step (b) and lubricating it;
In another aspect, the specification discloses a process for preparing amlodipine component, wherein the process comprises:
(a) mixing amlodipine and at least one pharmaceutically acceptable excipient which is soluble in water,
(b) granulating the mixture of step (a) with suitable solvent or binder solution and drying the granules;
(c) sizing and lubricating the granules of step (b);
(d) optionally coating the granules of step (b) and lubricating it;
In another aspect, the specification discloses a process for preparing amlodipine component, wherein the process comprises:
(a) mixing amlodipine and at least one pharmaceutically acceptable excipient which is soluble in water,
(b) granulating the mixture of step (a) by dry granulation using suitable technique to obtain the granules;
(c) sizing and lubricating the granules of step (b);
(d) optionally coating the granules of step (b) and lubricating it;
In another aspect, the specification discloses a process for preparing a stable pharmaceutical composition comprising,"
(i) compressing the mixture of the telmisartan component and the amlodipine component into tablet, or

(ii) filling the mixture of the telmisartan component and the amlodipine
component into capsules, or (iii)compressing the blend of the telmisartan component and the amlodipine
component into a bilayer tablet, or (iv)coating the telmisartan component with amlodipine and a film-forming
polymer; mixing with suitable pharmaceutical excipients compressing into
tablet, or (v) compressing the telmisartan component into tablet and coating it with
amlodipine and a film-forming polymer, or (vi)compressing the amlodipine component into tablet or mini-tablet and inlayed
tablet prepared by compressing the telmisartan component along with
prepared tablet or mini-tablet of amlodipine.
DETAILED DESCRIPTION OF THE INVENTION
The term "pharmaceutical composition" as described herein includes oral solid dosage form such as tablet, capsule, mini tablet and the like.
The term "telmisartan" as described herein is defined to include telmisartan free acid or pharmaceutically acceptable salts, hydrates, solvates, polymorphs, enantiomers thereof. Telmisartan may be in a crystalline or amorphous form, or mixtures thereof. Telmisartan as described herein may be of varying particle size, for example it may be in micronized or non-micronized form. The particle size of telmisartan as described herein may vary from 1 µm to 200 µm. Telmisartan may be present in an amount ranging from 10 mg to 160 mg in the composition or in amount ranging from 1 % to 80 % by weight of the composition.
The term "amlodipine" as described herein is defined to include amlodipine free base or pharmaceutically acceptable salt, polymorphs, hydrates and solvates thereof. Amlodipine may be present in an amount ranging from 2,5 mg to 25 mg in the composition or in amount ranging from 0.1 % to 30 % by weight of the composition.

In one embodiment, present invention provides a stable pharmaceutical composition
comprising;
(i) a telmisartan component comprising telmisartan in a dissolving matrix comprises a
basic agent, and
(ii) an amlodipine component comprising amlodipine in a dissolving matrix.
The term "Dissolving matrix" as described herein means a matrix comprises at least 50% of water soluble excipients and is devoid of disintegrant.
The term "component" as described herein means a portion or a part of the pharmaceutical composition. The "component" is in the form of a powder, granule, bead, pellet, spheroid, mini-tablet or micro-tablet. The pharmaceutical compositions as described herein comprise one component comprising telmisartan, basic agent and optionally pharmaceutically acceptable excipients and another component comprising amlodipine and optionally pharmaceutically acceptable excipients.
A basic agent as described herein may be selected from metal hydroxides such as sodium hydroxide, potassium hydroxide; metal carbonates such as sodium carbonate, potassium carbonate; metal phosphates such as disodium hydrogen phosphate, dipotassium hydrogen phosphate; metal bicarbonates such as sodium bicarbonate, potassium bicarbonate; basic amino acids such as arginine; meglumine (N-methyl-D-glucamine) or tromethamine; and the like. The basic agent may be present in an amount ranging from 0.1 % to 20 % by weight of the composition.
The pharmaceutical compositions as described herein may comprise at least one pharmaceutically acceptable excipient selected from diluent, binder, glidant, lubricant, surfactant, film forming polymer, plasticizer or complexing agent.
A diluent may be selected from powdered cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, starch, dibasic calcium phosphate, dibasic sodium phosphate,

tribasic sodium phosphate; sugars such as dextrose, lactose or sucrose; sugar alcohols such as mannitol, sorbitol, xylitol or erythritol; or mixtures thereof. The diluent may be present in an amount ranging from 1 % to 90 % by weight of the composition.
A binder may be selected from starches such as maize starch, corn starch, pregelatinised starch; cellulose derivatives such as cellulose powder, microcrystalline cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, gelatin, zein, polymethacrylates, sodium alginate, gums, synthetic resins or mixtures thereof. The binder may be present in an amount ranging from 0.1% to 20% by weight of the composition.
-A lubricant or glidant may be selected from talc, metallic stearate such as magnesium stearate, calcium stearate, zinc stearate; colloidal silicon dioxide, finely divided silicon dioxide, stearic acid, hydrogenated vegetable oil, glyceryl palmitostearate, glyceryl monostearate, glyceryl behenate, sodium stearyl fumarate, magnesium trisilicate; or mixtures thereof. The lubricant or glidant may be present in an amount ranging from 0.1 %to 10 % by weight of the composition.
A surfactant may be selected from one or more non-ionic or ionic (i. e., cationic, anionic and Zwitterionic) surfactants suitable for use in pharmaceutical compositions. Suitable surfactants include mono fatty acid esters of polyoxyethylene sorbitan such as those sold under the brand name Tween®; sodium lauryl sulfate, polyoxyethylene castor oil derivatives such as those sold under the brand name Cremophor®, polyethoxylated fatty acids and their derivatives, propylene glycol fatty acid esters, sterol and sterol derivatives; sorbitan fatty acid esters and their derivatives, sugar esters, polyoxyethylene-polyoxypropylene block copolymers such as those sold under the brand name Poloxamer®, soy lecithin, or mixtures thereof. The surfactant may be present in an amount ranging from 0.1 % to 10 % by weight of the composition.
A complexing agent may be selected from cyclodextrin class of molecules, such as cyclodextrins containing from six to twelve glucose units, especially, alpha- cyclodextrin,

beta-cyclodextrin, gamma-cyclodextrin, or their derivatives, such as hydroxypropyl beta cyclodextrins, or mixtures thereof.
Film forming polymers may be selected from hydroxpropyl methylcellulose, methylcellulose, ethylcellulose, hydroxypropyl cellulose, povidone, polydextrose, lactose, maltodextrin, acrylic polymer, or mixtures thereof.
The coating may also comprise of a plasticizer such as glyceryl triacetate, dibutyl sebacate, diethylphthalate, polyethylene glycol, propylene glycol, glycerol, castor oil, copolymers of propylene oxide and ethylene oxide, or mixtures thereof. Such compositions are also available under the brand name of Opadry® or Lustreclear®, sold by Colorcon.
The pharmaceutical compositions may additionally contain excipients such as colorants selected from known F.D. & C. and D. & C. dyes, and the like.
The pharmaceutical composition as described herein may be obtained in the form of a tablet or a capsule. The composition may comprise a first component comprising telmisartan and basic agent to prepare dissolving matrix, a second component of amlodipine also in the dissolving matrix. Each component may be prepared using wet granulation, dry granulation or direct compression.
For example, the telmisartan component may be prepared by dissolving or dispersing telmisartan, basic agent and at least one pharmaceutically acceptable excipient in the solvent and spraying the dispersion on the excipient like mannitol, drying the obtained granules, optionally coated and finally lubricated.
Alternatively, the telmisartan component may be prepared by spray drying process in which dissolving or dispersing telmisartan, basic agent and at least one pharmaceutically acceptable excipient in the solvent and spray drying the solution to obtain the granules, optionally coated and finally lubricated.

Alternatively, telmisartan component may be prepared by wet granulation process in which telmisartan and basic agent may be mixed with at least one pharmaceutically acceptable excipient and granulated by a solvent or converted into compacts or slugs to form a telmisartan component, optionally coated and finally lubricated.
Similarly amlodipine component may be prepared by wet granulation process in which amlodipine and suitable pharmaceutical excipients granulated using suitable solvent or binder solution, sizing the granules, coated and finally lubricated.
Alternatively, telmisartan component and/or amlodipine component may be obtained as granules of desired size prepared by dry granulation using specific techniques such as roller compactor. For example, amlodipine component may be prepared by dry granulation wherein a mixture of amlodipine, water soluble excipients and other excipients compacted using roller compactor and performing slugging, deslugging and sifting cycles to obtain the granules of desired size and mixing it with pharmaceutical excipients, the obtained granules optionally coated and finally lubricated.
A pharmaceutical composition may be prepared by person skilled in the art by using telmisartan component and amlodipine component prepared by any of the process mentioned above and compressing both the components into bilayer tablet or mixing both the component and compressing into a tablet or filling the mixture of both the components into a capsule.
Alternatively, the telmisartan component may be prepared comprising telmisartan, basic agent and pharmaceutically acceptable excipients and the said component may be coated by amlodipine and film forming polymer. Alternatively, the telmisartan component comprising telmisartan and basic agent may be obtained as a bead or a pellet which may be coated with the amlodipine component comprising amlodipine. The said composition may optionally contain a separating coat comprising film-forming polymer between telmisartan component and amlodipine.

In one of the preferred embodiment, a pharmaceutical composition may be prepared by preparing telmisartan component by dissolving or dispersing a mixture of telmisartan, a basic agent, a binder and optionally a diluent in a solvent, spraying the solution or dispersion on the pharmaceutical excipient like mannitol to obtain granules, drying and optionally coating the granules and lubricating it; preparing amlodipine component by wet granulation process in which granulating a mixture of amlodipine, water soluble excipients, and a binder, with a solvent or binder solution; drying and optionally coating the granules and lubricating it; followed by compressing the blends of both the components into a bilayer tablet. Alternatively compressing the mixture of both the components into a tablet or filling the mixture of both the components into a capsule.
In another preferred embodiment, a pharmaceutical composition may be prepared by preparing telmisartan component by dissolving or dispersing a mixture of telmisartan, basic agent, a binder and optionally a diluent in a solvent, spraying the solution or dispersion on the pharmaceutical excipient like mannitol to obtain granules, drying and optionally coating the granules and lubricating it; preparing amlodipine component by dry granulation process in which granulating a mixture of amlodipine, water soluble excipients and other excipients by dry granulation using roller compactor and performing slugging, deslugging and sifting cycles to obtain the granules of desired size and mixing it with pharmaceutical excipients; followed by compressing the blends of both the components into a bilayer tablet. Alternatively compressing the mixture of both the components into a tablet or filling the mixture of both the components into a capsule.
In another embodiment, a pharmaceutical composition may be prepared by using telmisartan component as described earlier and coating the granules of telmisartan with a dispersion of amlodipine and a film-forming polymer, mixing granules with at least one pharmaceutically acceptable excipient and compressing the mixture into a tablet or filling the mixture into a capsule. Alternatively granules of telmisartan lubricated and can be compressed in to a tablet and coated with a dispersion of amlodipine and a film-forming polymer. The final composition may optionally be coated with film forming polymer.

In another embodiment, a pharmaceutical composition may be prepared by preparing telmisartan component as described earlier; preparing amlodipine component by granulating a mixture of amlodipine, water soluble excipients and other excipients by dry granulation using roller compactor and performing slugging, deslugging and sifting cycles to obtain the granules of desired size and mixing it with pharmaceutical excipients; compressing the granules of the amlodipine component into tablet or mini-tablet; the blend of telmisartan component compressed along with the tablet or mini-tablet of the amlodipine component in such way that it remains inlayed at any position in the blend of telmisartan component.
The pharmaceutical compositions as described herein may be illustrated by the following examples which are not to be construed as limiting the scope of the invention:
EXAMPLE 1
Telmisartan component:

Sr.
No Ingredient Qty./Tablet (mg)
Intragranular
1 Telmisartan 40.00
2
3 Mannitol (Pearlitol SD 200) 132.64

Meglumine 12.00
4 Sodium hydroxide 3.36
5 Polyvinylpyrrolidone K-30 12.00
6 Purified Water q.s.
Blending
7 Mannitol (Pearlitol SD 200) | 34.00
Lubrication
8 Sodium Stearyl Fumarate 6.00
Total 240.00
Amlodipine component:
Sr. Ingredient Qty./Tablet (mg)

* 6.93mg of Amlodipir Bilayer compression:
No
Intragranular
1 Amlodipine Besylate* 6.93*
2 Mannitol 200.52
3 Lake o f Ponceau 4 R 0.05
4 Polyvinylpyrrolidone K.-30 6.50
5 Purified Water q.s.
Lubrication
6 Talc 4.00
7 Magnesium stearate 2.00
Total 220.00
fAml odipine Besylate is equivalent to 5.000 m g Amlodipine.

Sr.
No Ingredient Qty./Tablet (mg)
1 Telmisartan component 240.00
2 | Amlodipine component 220.00
Total (Core tablet) 460.00
Procedure:
Manufacturing Process for the Telmisartan component:
1. Mannitol was sifted through appropriate sieve.
2. Material of step-1 was loaded in Fluid Bed Processor and aqueous solution of telmisartan, polyvinylpyrrolidone, meglumine and sodium hydroxide was sprayed to obtain granules of telmisartan.
3. The granules obtained from step-2 were dried and sifted through appropriate sieve.
4. The granules obtained from step-3 were blended.
5. Mannitol and magnesium stearate were sifted through appropriate sieve separately.
6. The granules obtained from step-4 were blended with the mannitol obtained from step- 5.
7. The granules obtained from step-6 were lubricated with the magnesium stearate obtained from step-5.
Manufacturing Process for the Amlodipine component:

1. Amlodipine besylate and mannitol were co-sifted and granulated with aqueous solution of Polyvinylpyrrolidone (PVP) to obtain granules of amlodipine.
2. The granules obtained from step-1 were dried and sized using appropriate sieve.
3. Talc and magnesium stearate were sifted through appropriate sieve.
4. The granules obtained from step-2 were lubricated with the ingredients of step-3.
The blends of telmisartan component and amlodipine component obtained from above processes were compressed into bilayer tablets using appropriate tooling.
EXAMPLE 2
Telmisartan component:

Sr. J Ingredient
No | Qty./Tablet (mg)
Intragranular
1 Telmisartan 40.00
2 Mannitol (Pearlitol SD 200) 132.64
3 Meglumine 12.00
4 Sodium hydroxide 3.36
5 Polyvinylpyrrolidone K-30 12.00
6 Purified Water q.s.
Blending
7 Mannitol (Pearlitol SD 200) 34.00
Lubrication
8 Sodium Stearyl Fumarate 2.25
9 Magnesium stearate 3.75
Total 240.00
Amlodipine component:

Sr.
No Ingredient Qty./Tablet (mg)
Intragranular
1 Amlodipine Besylate* 6.935*
2 Mannitol (Pearlitol SD 200) 80.440
3 Mannitol (Mannitol 25) 12.500
4 Ferric Oxide Red 0.125
Sr.
No Ingredient Qty ./Tablet (mg)
5 Sodium Stearyl Fumarate 2.000
Lubrication

6 Mannitol (Pearlitol SD 200) 45.000
7 Magnesium stearate 3.000
Total 150.00
* 6.935 mg Amlodipine Besylate is equivalent to 5.000 mg Amlodipine. Bilayer compression:

Sr.
No Ingredient j Qty./Tablet (mg)
1 Telmisartan component 240.00
2 Amlodipine component 150.00
Total (Core tablet) 390.00
Procedure:
Manufacturing Process for the Telmisartan component:
1. Mannitol was sifted through appropriate sieve.
2. Material of step-1 was loaded in Fluid Bed Processor and aqueous solution of telmisartan, polyvinylpyrrolidone, meglumine and sodium hydroxide was sprayed to obtain granules of telmisartan.
3. The granules obtained from step-2 were dried and sifted through appropriate sieve.
4. The granules obtained from step-3 were blended.
5. Mannitol, magnesium stearate and sodium stearyl fumarate were sifted through appropriate sieve separately.
6. The granules obtained from step-4 were blended with the mannitol obtained from step- 5.
7. The granules obtained from step-6 were lubricated with the magnesium stearate and sodium stearyl fumarate obtained from step-5.
Manufacturing Process for the Amlodipine component:
1. Mannitol (Pearlitol SD 200) was sifted through 100 # sieve and oversized and undersized materials were kept separate.
2. Ferric oxide red was co-sifted through appropriate sieve with the undersized material of step-1.
3. Amlodipine besylate and mannitol 25 were co-sifted through appropriate sieve.
4. Sodium stearyl fumarate was sifted through appropriate sieve.

5. The materials of the step 2, 3, 4 and the oversized material of step-1 were co-sifted through appropriate sieve and blended in a suitable container.
6. The blend of step-5 was compacted in a roller compactor at optimum parameter.
7. The compacted mass of step-6 was deslugged in oscillating granulator through suitable screen and sifted through appropriate sieve on a sifter.
8. The undersized mass obtained from step-7 was recompacted and the cycle of slugging, deslugging and sifting was repeated until ratio of granules to fines (80:20) was achieved.
9. Mannitol (Pearlitol SD 200) was sifted through appropriate sieve.
10. The granules obtained from of step-8 and the material obtained from step-9 was blended.
11. Magnesium stearate was sifted through appropriate sieve.
12. The blend of step-10 was lubricated with the material of step-11.
The blends of telmisartan component and amlodipine component obtained from above processes were compressed into bilayer tablets using appropriate tooling.
Example-3 & 4
The blends of telmisartan component and amlodipine component obtained from processes mentioned in the example-1 & 2 were used alternatively and compressed into bilayer tablets using appropriate tooling.
Example 5
Telmisartan 80 mg and amlodipine besylate 6.935 mg (equivalent to 5mg amlodipine) were prepared according to example 2. The blends obtained were compressed into bilayer tablets using appropriate tooling.
Example 6
Tablets obtained according to example 2 were packed in 40 micron thick aluminium strip and subjected to stability study at 30 °C and 40 °C with 75% relative humidity. Results are summarized in Table 1.

Table 1

Temp/Time 0 months 1 months 2 months 3 months
30 °C Assay % Telmisartan 102.3 NA NA 103.9

Amlodipinc 101.9 NA NA 100.6
40 °C Assay % Telmisartan 102.3 102.3 102.4 104.2

Amlodipinc 101.9 101.3 99.4 99.1
NA- Not available
Example 7
Tablets obtained according to example 5 were packed in 40 micron thick aluminium strip and subjected to stability study at 30 °C and 40 °C with 75% relative humidity. Results are summarized in Table 2.
Table 2

Temp/Time 0 months 1 months 2 months 3 months
30 °C Assay % Telmisartan 103.0 NA NA 100.7

Amlodipinc 103.0 NA NA 101.4
40 °C Assay % Telmisartan 103.0 103.2 101.3 101.8

Amlodipine 103.0 101.4 101.7 100.6
NA-Not Available

We Claim
1. A pharmaceutical composition comprising:
a) a first component comprising telmisartan in a dissolving matrix comprises basic agent, and
b) a second component comprising amlodipine in a dissolving matrix

2. A pharmaceutical composition according to claim 1, wherein the composition is in the form of monolithic, bilayered, inlayered, multilayered or multiparticulate system.
3. A pharmaceutical composition according to claim 2 wherein composition is in the form of bilayered tablet.
4. A pharmaceutical composition according to claim 1 wherein basic agents is selected from metal hydroxide, metal carbonates, metal phosphates, metal bicarbonates and basic amino acids.
5. A pharmaceutical composition according to claim 1, wherein telmisartan and/or amlodipine components are prepared by wet granulation, dry granulation or direct compression process.
6. A process of preparing first component comprising telmisartan according to claim 1 comprises,

a) dissolving telmisartan, basic agent, at least one pharmaceutically acceptable excipient in solvent
b) spray-drying the solution of step (a) and drying the obtained wet granules
c) lubricating the granules of step (b)
d) optionally coating the granules of step (b) and lubricating it
7. A process of preparing first component comprising telmisartan according to claim
1 comprises,
a) dissolving telmisartan, basic agent, at least one pharmaceutically acceptable excipient in solvent,

b) spraying the solution of step (a) on to pharmaceutically acceptable excipient to obtain the granules and drying the granules,
c) lubricating the granules of step (b);
d) optionally coating the granules of step (b) and lubricating it.
8. A process of preparing second component comprising amlodipine according to
claim 1 comprises,
a) mixing amlodipine and at least one pharmaceutically acceptable excipient which is soluble in water,
b) granulating the mixture of step (a) with solvent or binder solution and drying the granules;
c) sizing and lubricating the granules of step (b);
d) optionally coating the granules of step (b) and lubricating it.
9. A process of preparing second component comprising amlodipine according to
claim I comprises,
a) mixing amlodipine and at least one pharmaceutically acceptable excipient which is soluble in water,
b) granulating the mixture of step (a) by dry granulation to obtain the granules;
c) sizing and lubricating the granules of step (b);
d) optionally coating the granules of step (b) and lubricating it.
10. A pharmaceutical composition of telmisartan and amlodipine as substantially
described and exemplified herein.