FIELD OF INVENTION
The present invention relates to stable pharmaceutical compositions comprising active cores of proton pump inhibitor drugs such as benzimidazole derivatives, and with a direct enteric coating on the core, without any intermediate sub-coat layer, which is directly and simultaneously coated with two polymer solutions, to have a de/ayed release or modified release effect. However, it will be appreciated that the invention is not limited to this particular field of use and can be easily adapted to drugs of other classes that require a delayed release or modified release effect.
BACKGROUND Of THE J7MVENT10N AND RELATED PRIOR AR7^
Any discussion of the "prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of the common general knowledge in the field.
Various benzimidazole compounds have a proton pump inhibitory (PPl) action, and are widely employed as therapeutic drugs for gastric ulcers, reflux esophagitis, duodenal ulcers, anastomotic ulcers, Zollinger-Ellison syndrome and the like. Some benzimidazole compounds are unstable against acid or water and are susceptible to decomposing. Accordingly, a pharmaceutical composition which contains such a benzimidazole compound may decompose during storage from the action of an acidic substance in the drug product compositions or may decompose when comes in acidic/ neutral media in the human body.
Hence enteric coatings are needed over the composition so that the drug remains intact and can reach the small intestine without degradation by acidic pH of stomach. But these PPJ compositions are prone ro degradation when they come in contact with enteric polymer coatings. The matter has been subject of much

patenting such as those listed below. To solve this problem, a tested technique in the prior art is use of an intermediate/ sub-coating layer to separate the core comprising benzimidazole derivative and the enteric coating.
US4786505 and US4853230 disclose stable pharmaceuticaf preparations
comprising I
(a) a core region comprising an effective amount of a material selected from the
group consisting of omeprazole;
(b) an inert sub-coating which is soluble or rapidly disintegrating in water
disposed on the core region; and
(c) an enteric coating/ outer layer disposed on the sub-coating.
■~ - US5997903 discloses a Pantoprazole formulation resistant to gastric juice, comprising of pellets or tablet made up of a drug core in admixture with tablet auxiliaries and a basic physiologically-tolerated inorganic compound having an inert water-soluble intermediate layer surrounding the core and an outer enteric layer.
US6569453 claims an oral administration form for an acid-labiie active compound comprising an acid-labile active compound in the form of a plurality of individual compound units, the units having a particle size less than 200 microns and a pharmaceutical auxiliary such that the auxiliary is not suitable for formation of an enteric layer.
US70413I3 claims a Pantoprazole formulation which comprises the active compound in a capsule in two different administration forms, which release the active compound at two different points of time, wherein one administration form comprises the active compound together with a tablet disintegrant and bears a sustained-release coating film comprising a water-insoluble and physiologically

tolerable plastic membrane having low swelling power in water and in which small soluble particles arejembedded, and wherein the other administration form comprises the active compound and bears an enteric coating film.
The focus of above patents is to have proton pump inhibitor compositions having a separating layer in between the drug and the enteric coat to prevent the drug from degradation that would arise from contact of drug and enteric coating. During our research, we have now surprisingly found that compositions containing benzimidazole derivative can be prepared without any intermediate/ sub-coating, wherein the functional enteric coating layer is designed such that it limits the enteric polymer hiediated degradation of benzimidazole derivative.
.The functional enteric coating layer of the instant invention-is composed of combination of two polymers, formed over the core by spraying two polymer solutions simultaneously, both solutions comprise a mixture of water soluble polymer and water insoluble enteric polymer in differing ratio and wherein the drug can still withstand contact with enteric coat.
OBJECTS OF THE INVENTION
It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.
In another object of the invention, there is provided a stable solid pharmaceutical composition comprising an effective amount of a benzimidazole derivative or a proton pump inhibitor (PPl), wherein the core comprises:
a) at least one water soluble binder
b) optionally a surface active agent and/ or an alkaline agent,
and where the core is coated directly with a functional coat, formed by spraying with two polymeric solutions simultaneously.

In yet another object of the invention is to provide a process of layering a functional enteric coat around the core, formed by spraying with two polymeric solutions simultaneously.
SUMMARY OF THE INVENTION
According to the [invention there is provided a stable pharmaceutical compositions comprising an effective amount of a benzimidazole derivative such as a proton pump inhibitor (PPI), wherein a core is directly coated with functional enteric coating layer, without any intermediate/ sub-coating, which is further processed to make tablets or capsules.
Another aspect of the invention provides a process for making a pharmaceutical formulation disclosed above.
DETAILED DESCRIPTTON INCLUDING PREFERRED EMBODIMENTS OF THE INVENTION:
In the present invention the benzimidazole compound is not especially limited, and a preferable example may include a proton pump inhibitor. Examples of such a proton pump linhibitor include rabeprazole, omeprazole, hydroxy omeprazole, esomeprazole, pantoprazole, lansoprazole, nepaprazole, leminoprazole etc.
The compositions of the subject invention preferably includes, a tablet core . comprising an acid-labiie compound as an active ingredient and pharmaceutically acceptable excipients, e.g., a substituted benzimidazole, a water soluble binder, optionally [an alkaline agent and/ or a surface-active agent and pharmaceutically acceptable excipients, applying an enteric coating directly over the core by simultaneously spraying two polymeric solutions. The cores may be compressed to form tablets or may be filled in capsules.

The invention also covers a process for the preparation of a stable pharmaceutical composition for oral administration of proton pump inhibitor comprising preparing a core of the drug and pharmaceutical excipients, and then directly applying an enteric coat by simultaneous spraying of two polymer solutions over the core.
The drug containing cores can be made using any of the known techniques. Cores can be prepared by granulating the blend comprising proton pump inhibitor and other pharmaceutically acceptable excipients, using an aqueous or non-aqueous solution of binding agent in suitable equipment, to get the granules of desired particle sizes, which can then be compressed into unit core tablet or the granules itself can be used as multiple cores particles in capsules.
Alternatively the cores can be prepared by subjecting the blend containing proton pump inhibitor and other pharmaceutically acceptable excipients to roll compaction, milling the compacted material to get the granules of desired particle size and compressing them using suitable punches and dies on the tablet compression machine after lubricating with lubricant.
The core can also be prepared by mixing the proton pump inhibitor along with an alkaline agent, pharmaceutically acceptable diluents, disintegrating agent, binding agent and one or more lubricants. This blend can then be compressed into tablets using suitable punches and dies.
Drug layered non-parei/ seed can also be used as cores for the instant invention. Commercially available seeds include Nonpareil 101, "Nonpareil 103, Nonpareil 105, Nonpareil 108 (all from Freund Corporation), and Celphere (Asahi Kasei Corporation). The drug is layered over these inactive seed to make active cores.

The solid oral dosage form may further comprise pharmaceuticaiiy acceptable excipient known in the art. Pharmaceuticaiiy acceptable excipients such as fillers or diluents, binding agent, disintegrants, alkaline agent, surface active agents, lubricants, glidants, and the like
The diluent may be. for example, any pharmaceuticaiiy acceptable, non¬toxic diluent. The preferred diluent can be any one or more selected from the following group; mannitol, sorbitol, maltose, lactose, microcrystalline cellulose, starch, dextrose, fructose, sucrose starch, calcium hydrogen phosphate, and the like.
The binder can be any pharmaceuticaiiy acceptable, non-toxic binder such as a water-soluble polymer,». e.g.. polyvinyl alcohol, polyvinylpyrrolidone, methylceliulose, hydroxypropyl cellulose, hydroxypropyl methy! cellulose, and ■ the like
Disintegrants or disintegrating agent in the composition can be" one or more from the following group of crospovidone, sodium starch glycolate, starch, croscarmellose sodium, croscarmellose calcium, polacrillin potassium, bentonite. sodium alginate, hydroxypropylmethyicellulose or the like.
The alkaline agent in the composition can be one or more agents selected from pharmacologically tolerated alkali metal, alkaline earth metal or earth metal salts of weak acids and the pharmacologically tolerated hydroxides and oxides of alkaline earth and earth metals. vSodium carbonate is the preferred alkalizing agent. Other agents like , magnesium carbonate, magnesium oxide, calcium carbonate, sodium bicarbonate, sodium citrate, sodium phosphates, dipotassium hydrogen phosphate, suiccinic acid, tartaric acid, tris buffer, meglumine, L-arginine, lysine and organic agents like Tricine.

The surface-active agent can be any pharmaceutically acceptable, non¬toxic surfactant, e.g. sodium lauryl sulfate, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80 (Tween 80) and the like.'
Lubricants may begone or more from the following group Magnesium Stearate, Calcium StearateJStearic acid, Cutina, Stear-0-vvet-M, Talc, etc.
Instead of the water soluble intermediate layer, the present invention employs coating of functional enteric coat directly over the core, formed by spraying two polymeric solutions [solution A and solution B] simultaneously. Both solutions contain a dispersion formed by mixing a water soluble polymer and water insoluble enteric polymer in a complementary ratio. -
Polymeric solution A can be prepared by dispersing v»'ater soluble polymer from about 1 to 10% w/w;and water insoluble enteric polymer from about 90 to
99% w/w in suitable solvent. Polymeric solution B can be prepared by dispersing
I
water soluble polymer from about 90 to 99% w/w and water insoluble enteric polymer from about 1 to \0% w/w in suitable solvent. Further, the amount of solid matter dissolved or dispersed in the coating solution to make the built up weight is usually 5 to 20%) by weight, and preferably 14 to 16%o by weight.
The water soluble polymer is selected from hydroxypropyl methyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, methylcellulose, hydroxymethyl cellulose, hydroxypropyl cellulose, and the like; preferably hydroxypropyl methylcellulose.
The water insolubib enteric polymers include Cellulose acetate phthalate,
HPMC Phthalate (Trade names: HP-55, HP-55S and HP-50, Shin-Etsu Chemical
■I
Co., Ltd.), hydroxypropyl'methyl cellulose acetate succinate (Trade name: Shin-Etsu AQOAT, Shin-Etsu Chemical Co., Ltd.). methacrylic acid methacrylic acid

methyl copolymer (Trade name: Eudragit LiOO, Eudragit L500-55, Eudragit SIOO. Rohm Pharma). melhacrvlic acid acrvlic acid ethyl copolymer (Trade name: Eudragit L-30 D55; Rohm Pharma), carboxymethylethyl cellulose (Trade name: CM EC, Freund Corporation), polyvinyl alcohol acetate phthalate (Trade name: Opa-dry Enteric, Colorcon, inc.) and cellulose acetate phthalate (Trade name: CAP, Wako Pure Chemical industries, Ltd.); preferably a poiymethyl methacrylate copolymer. The enteric polymer solution optionally may include a plasticizer, for example triethyl acetate.
The enteric coating polymer can be coated over tablets either by using the solution in the organic solvent or water or by using an aqueous dispersion. The solvent used when producing the coating,solution include, for example, water, ethanol, hydrous ethanoi, isopropyl alcohol, water/ isopropyl alcohol, acetone or the like. Preferably, the solvent is water/ isopropyl alcohol, ethanol or hydrous ethanol.The solid pharmaceutical composition comprises a core which contains:
a) a proton pump inhibitor,
b) at least one water soluble binder,
c) optionally an alkaline agent and/ or a surface active agent, and
d) an enteric coating layer applied onto said core,
wherein the enteric coating layer is formed by simultaneously spraying two different polymeric solutions over the core without an intermediate separating layer.
The pharmaceutical composition has two polymeric solutions containing a mixture of polymers selected from
a) a water soluble polymer and
b) a water insoluble enteric polymer and
c) other excipients. I

The pharmaceutical composition's two polymeric solutions are preferably as follows:
a) a first polymeric solution [Solution A] is prepared by dispersing the water soluble polymer from about \ to 10% w/w and the water insoluble enteric polymer from about 90 to 99% w/w in a suitable solvent.
b) a second polymeric solution [Solution B] is prepared by dispersing the water
soluble polymer from about 90 to 99% w/w and the water insoluble enteric
polymer from about 1 to iO% w/w in a suitable solvent-it
In one embodiment, the core is prepared by using one of the techniques as disclosed above. The cores are then coated with an outer coating formed by ; simultaneously spraying two polymeric, solutions on the core. The pharmaceutical tablet composition in one of its preferred forms comprises of an orally administrable medicament in solid dosage form and which is resistant to gastric juice, wherein each tablet consists of:
a) cores containing an active ingredient, in admixture with Povidone, mannltol, anhydrous sodium carbonate, crospovidone and a calcium stearate,
b) a functional enteric coat over the cores formed by spraying two polymeric solutions A and B, which is resistant to gastric juice, and provides a delayed release or modified release, consisting of
i) a first polymeric solution [solution A] contains hydroxypropyl methylcelluiose and polymethyl methacrylate copolymer solution comprising 5%
w/w and 95% w/w,
I
ii) a second polymeric solution [solution B] contains hydroxypropyl methylcelluiose and polymethyl methacrylate copolymer solution comprising
95% w/w and 5% w/w.

The process for making solid pharmaceutical composition comprises the following steps:
a) forming a core which contains a proton pump inhibitor; at least one water soluble binder; optionally an alkaline agent and a surface active agent:
b) preparing a first polymeric soiution [solution A] by dispersing a water soluble polymer from about 1 to 10% w/w and a water insoluble enteric polymer from about 90 to 99% w/w in suitable solvent and
c) preparing second polymeric solution [solution B] by dispersing a water soluble
polymer from about 90 to 99% w/w and a water insoluble enteric polymer from
ii about 1 to 10% w/w in suitable solvent, and
d) coating the cores by simultaneously spraying polymeric solution A and B to
form an enteric coat around the core, without an intermediate separating layer in
between the coat and the core.
The present invention is explained by way of below, non-limiting examples.

Example 3

Ingredients Qty in mg
Intragranular
Proton pump inhibitor 45.10
Sodium Carbonate 5.00
Mannitol 42.70
Crospovidone 25.00
Binder
Povidone(PVP 90) :: . 4.00
Sodium Carbonate :, 5.00
Purified Water ^ q.s
Extragranular
Crospovidone 25.00
Calcium Stearate 3.20
Core Tablet weight 155.00
Enteric Coating
Purifiedwater -- ~— — --„_^. .„ . :. ..._ q-s. .,
Eudragit Solution A* 10.00%
Eudragit Solution B* 14.00%
Weight of enteric coated tablet 194.38
* Eudragit Solution A
HPMC 5cps 14.73
Eudragit L 30:55 0.78
Purified water/ Isopropyl Alcohol q.s
* Eudragit Solution B
HPMC5cps 1.19
Eudragit L 100:55 20.64
Triethyl citrate 2.04
Purified water/ Isopropyl Alcohol q^s
Core Tablet: i
1. Proton pump inhibitor, Sodium Carbonate, Crospovidone and Mannitol are sifted together and rn'iKed thoroiighjy in Rapid Mixer Cranu)ator.
2. Binder solution of sodium bicarbonate in water and Povidone (PVP 90) water is prepared separately.
3. The binder solutions are added to the dry mix in Rapid Mixer granulator until suitable granules are obtained.
4. The wet mass is dried, sifted and milled to obtain desired granules.
5. The blend js lubricated with crospovidone and calcium slearale.
6. Compress the lubricated blend with suitable punches Into tablets.

Enteric Coating: Eudragit solution A:
7. The solution is prepared by taking 95% w/w of HPMC and 5%) w/w of Eudragit in water/1 so propyl alcohol calculated for a tablet, weight build up of 10 %w/w.
8. The core tablet is coat with solution A upto the weight build up of 10% w/w. Eudragit solution B:
9. The solution is prepared by taking 5% w/w of HPMC; 95% w/w" of Eudragit and in
water/Jsopropyl alcohol calculated for a weight build up 14% w/w.
I
10. The core tablet is coated with solution B upto the weight build up of 14% w/w.
Example 2

Ingredients Qty in mg
Intra granular
Proton pump inhibitor 45.10
Sodium Carbonate 5.00
"Mannito! I ' ' ' ' ., - 42.70 ■.-:■ -
Crospovidone 25.00
Binder
Povidone(PVP 90) 4.00
Sodium Carbonate 5.00
Purified Water q.s
Extragranular
Crospovidone ;; 25.00
Calcium Stearate ^ 3.20
Core Tablet weight '. 155.00
Enteric Coating L
Purified water ■ q.s
Eudragit Solution A* 10.00%
Eudraait Solution B* 14.00%
Weight of enteric coated tablet 194.38
* Eudragit Solution A
HPMC 5cps 13.95
Eudragit L 30:55 .1.55
Purified water/ Isopropyl Alcohol q.s
* Eudragit Solution B
HPMC 5 cps 2.39
Eudragit L 100:55 19.55
Triethy] citrate 1.93
Purified water / Isopropyl Alcohol q.s

Core Tablet:
1. Proton pump inhibitor. Sodium Carbonate, Crospovidone and Mannito! are sifted together and mixed thoroughly in Rapid Mixer Granulator.
2. Binder solution of sodium bicarbonate in water and Povidone (PVP 90) water is prepared separately.
3. The binder solutions are added to the dry mix in Rapid Mixer granulator until suitable granules are obtained. '
4. The wet mass is dried, sifted and milled to obtain desired granules.
5. The blend is lubricated with crospovidone and calcium slearate.
6. Compress the lubricated blend with suitable punches into tablets. Enteric Coating:
Eudragit solution A:
7. The solution is prepared by taking 90% w/vv of HPMC and 10%w/w of Eudragit in water/ Isopropyl alcohol calculated for a tablet, weight build up of 10%w/w.
8. The core tablet is coated with solution A upto the weight build up of 10%w/w. Eudragit solution B:
9. The solution is prepared by taking 10%w/w of HPMC; 90% w/\v of Eudragit in water/
Isopropyl alcohol calculated for a weight build up 14% w/w.
10. The core tablet is coated With solution B upto the weight builds up of 14%w/w.
i!
Examples i;

Ingredients i[ Qty in nig
Intragranular f
Proton pump inhibitor ? 45.10
Meglumine 5.00
Mannitol 42.70
Crospovidone 25.00
Binder
Povidone(PVP 90) 4.00
Meglumine 5.00
Purifted Water q.s
Extragranular
Crospovidone 25.00
Calcium Stearate 3.20
Core Tablet weight 155.00
Enteric Coating
Purified water q.s

Eudragit Solution A* 10.00%
Eudragit Solution B* 14.00%
Weight of enteric coated tablet 194.38
* Eudragit Solution A |-
HPMC 5cps : 13.95
Eudragit L 30:55 i 1.55
Purified water/ Isopropyl Alcohol q.s
* Eudragit Solution B
HPMC 5 ops 2.39
Eudragit L 100:55 19.55
Triethyl citrate 1.93
Purified water/Jsopropyl Alcohol q.s
Core Tablet:
1. Proton pump inhibitor, Meglumine , Crospovidone and Mannitol are sifted together and mixed thoroughly in rapid mixer granulator.
2. Binder solution of Meglurnine in water and Povidone (PVP 90) water is prepared Separately. ' .'^ j ' - :j-^ ^ V' ■""'~'■■"" ' "
3. The binder solutions are added to the dry mix in Rapid Mixer granulator until suitable granules are obtained.
4. The wet mass is dried, sifted and milled to obtain desired granules.
5. The blend is lubricated with crospovidone and calcium stearate.
6. Compress the lubricated blend with suitable punches into tablets. Enteric Coating:
Eudragit solution A:
7. The solution is prepared by taking 90%w/w of HPMC and 10%vv/w of Eudragit in water/ Isopropyl alcohol calculated for a tablet, weight build up of 10% w/w.
8. The core tablet is coated with solution A upto the weight build up of 10% w/w. Eudragit solution B:
9. The solution is prepared by taking 10% w/w of HPMC; 90% w/w of Eudragit in water/
Isopropyl alcohol calculated for a weight build up 14% w/w.
10. The core tablet is coated with solution B upio the weight build up of 14%w/w.

Example 4

Ingredients Qty in mg
Intragranular
Proton pump inhibitor 45.10
Sodium Carbonate 5.00
Mannitol 42.70
Crospovidone 25.00
Binder
Klucel LF 4.00
Sodium carbonate 5.00
Purified Water q.s
Extragranular
Crospovidone 25.00
Calcium Stearate 3.20
Core Tablet weight 155.00
Enteric Coating
-Purified water ;= . _./, ~. - - - -q.s
Eudragit Solution A* ' 10.00%
Eudragit Solution B* i| 14.00%
Weight of enteric coated tablet 194.38
* Eudragit Solution A !
HPMC 5cps 13.95
Eudragit L 30:55 1.55
Purified water/ Isopropyl,Alcohol q.s
* Eudragit Solution B
KPMC 5 cps 2.39
Eudragit L 100:55 19.55
Triethvl citrate 1.93
Purified water/ Isopropyl Alcohol q.s
Core Tablet:
1. Pantoprazole sodium. Sodium carbonate, Crospovidone and Mannitol are sifted together and mixed thoroughly in rapid mixer granuiator.
2. Binder solution of Sodium carbonate in water and Klucel LF in water Is prepared separately.
3. The binder solutions are added lo the dry mix in Rapid Mixer granuiator until suitable granules are obtained.
4. The wet mass is dried, sifted and milled to obtain desired granules.
5. The blend is lubricated with crospovidone and calcium stearate.

6. Compress the lubricated blend with suitable punches into tablets.
Enteric Coating:
Eudragit solution A:
7. The solution is prepared by taking 90%vv/w of HPMC and 10%w/w of Eudragit in water/ Isopropyj alcohol calculated for a tablet, weight build Xip of 10% w/w.
8. The core tablet is coated with solution A upto the weight build up of 10% w/w. Eudragit solution B:
9. The solution is prepared by taking 10%w/w of HPMC; 90% w/w of Eudragit in water/
Isopropyl alcohol calculated for a weight build up 14% w/w.
10. The core tablet is coated with solution 8 upto the weight build up of 14%w/w.
Example 5

Ingredients Qty in mg
-Core i ,
Proton pump inhibitor if ■ ■ 45.10. -^
Kollidon CLM :, 12.94
Klucel LF 12.64
Mannitol 228.42
Talc 3.00
Aerosil 1.50
SSF 12.40
Purified Water q.s
Core pellets weight 316
Enteric Coating
Purified water q.s
Eudragit Solution A* 10.00%
Eudragit Solution .8* 14.00%
Weight of enteric coated pellets 396.25
* Eudragit Solution A
HPMC 5cps 30.02
Eudragit L 30:55 i.58
Purified water/ isopropyl Alcohol q.s
* Eudragit Solution B [
HPMGScps ■ !f 2.43
Eudragit L 100:55 42.06
Triethyl citrate 4.16
Purified water / jsopropyl Alcohol q.s

Core pellet:
I
1. Proton pump inhibitor, Kollidon CLM, Mannitol and aerosil are sifted together and
mixed thoroughly in rapid mixer granulator.
2. Binder solution is prepared by dissolving Klucel LF in water.
3. The binder solution is added to the dry mix in Rapid Mi.xer granulator until suitable granular mass is obtained.
4. The wet mass is passed through extruder followed by spheronizer and dried.
5. The spheronized pellets are sifted through a suitable mesh.
6. The spheronized pellets is lubricated with sodium stearyl fumarate and talc. Enteric Coating:
Eudragit solution A:
7. The solution is prepared by taking 90%w/w of HPMC and 10% w/w of Eudragit in
water/Isopropyl alcohol. '[
I
8. The core pellet is coated in a fluidized bed (wurster process) with solution A upto
weight build up of 10%w/w. I , „ ' '
Eudragit solution B:
9. The solution is prepared by taking 10% w/w of HPMC; 90%w/w of Eudragit in water
/Isopropyl alcohol.
10. The core pellet is coated in a fluidized bed (wurster process) with solution B upto
weight build up of 14%w/w.
Example 6

Ingredients Qty in mg
Core
Proton pump inhibitor 45.10
Sugar spheres(#20-25) 100.00
Kollidon CLM 51.90
Klucel LF 19.50
Talc i 3.00
Purified Water 'i q.s
Core pellets weight [ 316
Enteric Coating
Purified water q.s
Eudragit Solution A* 10.00%
Eudragit Solution B* 14.00%
Weight of enteric coated pellets 396.26
" Eudragit Solution A


Core pellet:
1. Proton pump inhibitor, Rollidon CLM. Klucel LF and talc is dispersed in water.
2. The dispersion is sprayed in a fluidized bed (wurster process) onto the sugar spheres
(#2025). Enteric Coating:
Eudragit solution A:
-3. The solution is prepared by taking 90%w/w of HPJVlC and 10%w/w of Eudragit in ^ water / Isopropyi alcohol.
4. The core pellet is coated in a fluidized bed (Wurster process) with solution A upto
weight build up of 10%w/w.
Eudragit solution B:
5. The solution is prepared by taking ] 0%w/w of HPMC; 90% w/w of Eudragit in water /
Isopropyi alcohol calculated for a weight build up 14% w/w.
6- The core pellet is coated in a fluidized bed (wurster process) with solution B upto weight build up of 14%w/w.

We claim:
1. A solid pharmaceutical composition comprising a core which contains:
a) a proton pump inhibitor,
b) at least one water soluble binder,
c) optionally an alkaline agent and/ or a surface active agent, and
d) an enteric coating layer applied onto said core,
wherein said enteric coating layer is formed by simultaneously spraying two
different polymeric solutio'ns over said core without an intermediate separating
layer. '
2. A composition according to claim }, wherein said water soluble binder is
selected from hydroxypropyl methylcellulose, hydroxypropyl celiuiose, polyvinyl
pyroiidone. i! *
3. A pharmaceutical composition according to claim 1, wherein said two
polymeric solutions contain a mixture of polymers selected from
a) a water soluble polymer and
b) a water insoluble enteric polymer and
c) other excipients.
4. A pharmaceutical composition according to claim 3, wherein
a) a first polymeric solution [Solution A] is prepared by dispersing said water soluble polymer from about, 1 to 10% w/w and said wati^r insoluble enteric polymer from about 90 to 99% w/w in a suitable solvent.
b) a second polymeric solution [Solution B] is prepared by dispersing said water soluble polymer from about 90 to 99% w/w and said water insoluble enteric polymer from about 1 to 10% w/w in a suitable solvent.

5. A pharmaceutical composition according to claim 4, wherein said water soluble polymer is hydroxypropyl methyiceUulose and said water insoluble enteric polymer is apolymethyl methacrylate copolymer.
6. A pharmaceutical composition according to claim I, wherein said proton pump inhibitor is selected from omeprazole, esomeprazole, hydroxy omeprazole, rabeprazole lansoprazole, tenatoprazolC; perprazole, leminoprazole, nepaprazole or pantoprazole and their pharmaceutically acceptable salts.
7. A pharmaceutical composition according to claim 1, wherein said alkaline
f agent is selected from meglumine, sodium bicarbonate, sodium citrate, suiccinic
acid, tartaric acid, tris buffer, magnesium oxide, or organic agents like Tricine.
8. A pharmaceutical composition according to claim 1, wherein said surface active agents is selected from sodium lauryl sulphate, Polyoxyethylene-sorbitan-20-monooleate [poiysorbate 80], cetyl trimethyl ammonium bromide, sorbitan mono-oliate and the like.
9. A pharmaceutical tablet composition comprising of an orally administrable medicament in solid dosage form and which is resistant to gastric juice, wherein each tablet consists of:

a) cores containing an active ingredient, in admi.xture with Povidone, mannitoi, anhydrous sodium carbonate, crospovidone and a calcium stearate,
b) a functional enteric coat over the cores formed by spraying two polymeric solutions A and B, which is resistant to gastric juice, and provides a delayed release or modified release, consisting of
i) a first polymeric solution [solution A] contains hydroxypropyl methyiceUulose and polymethyl methacrylate copolymer solution comprising 5% w/vv and 95% w/w.

ii) a second polymeric solution [solution B] contains hydroxypropyl methyicellulose and polymethyl methacrylate copolymer solution comprising
95% w/w and 5% w/w.
10. A process for making solid pharmaceutical composition which comprises the
steps of: .
a) forming a core which contains a proton pump inhibitor; at least one water
soluble binder; optionally ^n alkaline agent and a surface active agent;
b) preparing a first polymeric solution [solution A] by dispersing a water soluble
polymer from about 1 to l6% w/w and a water insoluble enteric polymer from
about 90 to 99% w/w in suitable solvent and
c) preparing second polymeric solution [solution B] by dispersing a water soluble ■ polymer from about 90 to 99%) w/w and a water insoluble^enteric polymer from '^'*"" about 1 to 10%) w/w in suitable solvent, and
d) coating said cores by simultaneously spraying said polymeric solution A and B to form an enteric coat around said core, without an intermediate separating layer.