ZA200507224B - Velafaxine compositions comprising pellets with double layer coating - Google Patents
Velafaxine compositions comprising pellets with double layer coating Download PDFInfo
- Publication number
- ZA200507224B ZA200507224B ZA200507224A ZA200507224A ZA200507224B ZA 200507224 B ZA200507224 B ZA 200507224B ZA 200507224 A ZA200507224 A ZA 200507224A ZA 200507224 A ZA200507224 A ZA 200507224A ZA 200507224 B ZA200507224 B ZA 200507224B
- Authority
- ZA
- South Africa
- Prior art keywords
- pellet
- coating
- core
- coated
- weight
- Prior art date
Links
- 239000008188 pellet Substances 0.000 title claims description 66
- 238000000576 coating method Methods 0.000 title claims description 53
- 239000011248 coating agent Substances 0.000 title claims description 49
- 239000000203 mixture Substances 0.000 title claims description 26
- 238000000034 method Methods 0.000 claims description 24
- 229920000642 polymer Polymers 0.000 claims description 12
- QYRYFNHXARDNFZ-UHFFFAOYSA-N venlafaxine hydrochloride Chemical compound [H+].[Cl-].C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 QYRYFNHXARDNFZ-UHFFFAOYSA-N 0.000 claims description 11
- 229960002416 venlafaxine hydrochloride Drugs 0.000 claims description 11
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 10
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 10
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 10
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 10
- 239000003960 organic solvent Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 229920003176 water-insoluble polymer Polymers 0.000 claims description 8
- 239000011230 binding agent Substances 0.000 claims description 7
- 229940082500 cetostearyl alcohol Drugs 0.000 claims description 7
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 7
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 claims description 7
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 6
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 claims description 6
- 239000006185 dispersion Substances 0.000 claims description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 5
- 239000008101 lactose Substances 0.000 claims description 5
- 239000000454 talc Substances 0.000 claims description 5
- 229910052623 talc Inorganic materials 0.000 claims description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims description 4
- 239000001856 Ethyl cellulose Substances 0.000 claims description 4
- 239000007900 aqueous suspension Substances 0.000 claims description 4
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 4
- 229920001249 ethyl cellulose Polymers 0.000 claims description 4
- 239000001828 Gelatine Substances 0.000 claims description 3
- 239000007864 aqueous solution Substances 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 229920000159 gelatin Polymers 0.000 claims description 3
- 235000019322 gelatine Nutrition 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 239000004359 castor oil Substances 0.000 claims description 2
- 235000019438 castor oil Nutrition 0.000 claims description 2
- 229920002678 cellulose Polymers 0.000 claims description 2
- 239000001913 cellulose Substances 0.000 claims description 2
- 235000010980 cellulose Nutrition 0.000 claims description 2
- 150000002191 fatty alcohols Chemical class 0.000 claims description 2
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 2
- 239000011118 polyvinyl acetate Substances 0.000 claims description 2
- 229920002689 polyvinyl acetate Polymers 0.000 claims description 2
- 238000007873 sieving Methods 0.000 claims description 2
- -1 hydroxypropyl Chemical group 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 229920002959 polymer blend Polymers 0.000 claims 1
- 229920000193 polymethacrylate Polymers 0.000 claims 1
- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 description 20
- 229960004688 venlafaxine Drugs 0.000 description 18
- 239000010410 layer Substances 0.000 description 10
- 239000011247 coating layer Substances 0.000 description 7
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 7
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 7
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 229920003163 Eudragit® NE 30 D Polymers 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 238000013265 extended release Methods 0.000 description 3
- 239000007903 gelatin capsule Substances 0.000 description 3
- 229920003134 Eudragit® polymer Polymers 0.000 description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 235000014633 carbohydrates Nutrition 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 238000013268 sustained release Methods 0.000 description 2
- 239000012730 sustained-release form Substances 0.000 description 2
- 229920003169 water-soluble polymer Polymers 0.000 description 2
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 229920003161 Eudragit® RS 30 D Polymers 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229940098766 effexor Drugs 0.000 description 1
- 208000019906 panic disease Diseases 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
Description
VENLAFAXINE COMPOSITIONS COMPRISING PELLETS WITH DOUBLE LAYER COATING
This invention relates to pharmaceutical compositions of venlafaxine.
Venlafaxine is the non-proprietary name for 1-[2-(dimethylamino)-1-(4-methoxyphenyl) ethyl]cyclohexanol and is useful in treating a number of disorders including depression, anxiety, panic disorder and pain. Venlafaxine is administered as venlafaxine hydrochloride in treating depression. See The Merck Index, 12th Edition, entry 10079.
Published European patent application EP 797 991 A discloses encapsulated extended release formulations of venlafaxine hydrochloride which comprise a hard gelatin capsule containing spheroids comprised of venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropylmethylcellulose coated with ethyl cellulose and hydroxypropylmethylcellulose.
Solvents used in the coating step include methylene chloride and anhydrous methanol.
The present applicants have sought to overcome the drawbacks of hitherto known formulations of venlafaxine.
In one aspect, therefore, this invention provides coated core pellets comprising venlafaxine for use in a delayed and/or extended release formulation which core pellets undergo at least one - coating step in the absence or substantial absence of organic solvents.
In another aspect, this invention provides a coated pellet comprising a) a pellet core which comprises venlafaxine hydrochloride; b) a first coating which comprises a lipophilic layer or a sparingly water-soluble layer, and ¢) asecond coating which comprises a water-soluble or water-insoluble polymer.
-o.
The pellet core may comprise in addition a carrier, for example microcrystalline cellulose. -
The pellet core may comprise in addition a binder, for example a cellulose derivative, e.g. . hydroxypropylmethylcellulose (HPMC). The present applicants have found that HPMC of e.g. grade K 4 M has an appropriate viscosity for use in this invention. .
The pellet core may be spheroidal in geometry and typically exhibits a diameter, when coated, of between around 0.5 mm to 2 mm, e.g. 0.7 to 1.75mm, for example 0.8 mm to 1.5 mm.
The first coating and second coating may each be complete or substantially complete, e.g. so as to provide a surface coverage of at least 60 %, e.g. 70 % or more, e.g. 80 to 95 % around the core (first coating) or around the first coating (second coating). Complete coatings are preferred. -
The first coating may comprise between 0.5 to 5% by weight, e.g. 1 to 4%, of the first-coated pellet core.
The second coating may comprise 8 to 30% by weight, e.g. 10 to 25%, based on the total weight of the double-coated core. oe
The first coating serves to protect the pellet core from moisture, both in storage and in use.
The lipophilic layer may comprise a fat, fatty alcohol or wax. The lipophilic layer preferably comprises cetostearyl alcohol, castor oil or dibutyl phthalate.
The sparingly water-soluble layer may comprise a carbohydrate or a sugar, e.g. lactose, in the . form of an aqueous suspension wherein the concentration of the carbohydrate or sugar is at least about 0.1 g/ml, e.g. 0.15 to 0.25 g/ml or greater, e.g. 0.28 g/ml to 0.4 g/ml or even : higher, e.g. 0.41 to 0.6 g/ml, for example 0.43 or 0.5 g/ml.
The sparingly water-soluble layer, which may be formed by spray-coating, may comprise : lactose in an’ amount of up to about 30% to 40% by weight.
The first coating may be free of, or substantially free of, ethyl cellulose.
The water-soluble or water-insoluble polymer may be selected from acrylate-based aqueous dispersions, ethylcellulose aqueous dispersions and polyvinyl acetate aqueous dispersions. oo
Thus the second coating is aqueous-based and serves to provide the extended release effect.
Water-insoluble polymers are preferred.and may serve to control release of the venlafaxine.
The water-insoluble polymer may display pH-independent solubility and may comprise a water-insoluble polymer mixture.
The term “water-insoluble”, as used herein is understood to mean a polymer solubility in water at room temperature of less than 100 mg/litre, e.g. 20 mg/litre or less, e.g. 10mg/litre. or less, e.g. Img/litre or less. Co
In a preferred aspect, the pellet core and/or coating(s) of this invention are free of, or substantially free of, polyvinylpyrrolidone.
In another aspect, this invention provides a composition comprising coated pellets as herein ~~ : described. The composition may be in tablet, hard gelatine capsule or sachet form. :
In another aspect, this invention provides a coated pellet consisting of or consisting essentially of a) a core containing venlafaxine hydrochloride in an amount of between 30 and 60 % by weight, microcrystalline cellulose in an amount of between 40 and 65% by weight, and
HPMCK 4 Min an amount of between 0.3 and 0.8% by weight, wherein the respective weights are in relation to the double-coated core; . b) a first coating containing cetostearyl alcohol in an amount of between 1.0 and 4.0 %, e.g." 1.7 and 3.5 %, by weight of the first-coated pellet core; and
*¢) a second coating containing an acrylate-based polymer in an amount of between 9 and - 25%, e.g. 9 and 13 %, by weight based on the total weight of the double-coated core, and talc . in an amount of between 2 and 15%, e.g. 3 and 8 %, by weight based on the total weight of the double-coated pellet core.
Suitable acrylate-based polymers or water-insoluble polymers having pH-independent solubility are available commercially e.g. from the Rohm company, Germany, under the trade marks EUDRAGIT, SURELEASE or AQUACOAT, e.g. EUDRAGIT NE 30 D, EUDRAGIT
RL 30 D, EUDRAGIT RS 30 D or KOLLCOAT SR as dry polymer. :
The second coating may further comprise triethyl citrate or dibutyl phthalate, e. g.1n an amount of 5 to 35%, e.g. 10 to 30 %, by weight of the dry polymer.
In a further aspect, this invention provides a composition consisting of or consisting essentially of coated pellets as herein described. The composition may be in tablet, hard. : gelatine capsule or sachet form.
In a further aspect, this invention provides a process for preparing pellets as herein described which comprises the steps of :
Ai) forming a pellet core mixture comprising venlafaxine hydrochloride with water or an aqueous solution of a binder,
Ail) extruding and spheronising the mixture, and subsequently drying, Co . . Aiii) applying the first coating, . Aiv) applying the second coating, and subsequently sieving so as to obtain coated pellets within the desired size range, wherein the process is carried out in the absence or substantial absence of any organic solvent at least in the second layer.
Coating steps Aiii) and Aiv) may employ conventional fluidised bed processes. Alternatively, the first coating layer may be applied using a spray melt process or by using a tangential coating process.
In another embodiment, the first coating layer may be dissolved in an organic solvent medium, e.g. methylene chloride or methanol, and sprayed onto the pellet cores.
In a further aspect, this invention provides a process for preparing pellets as herein described which comprises the steps of
Bi) forming a pellet core mixture comprising venlafaxine hydrochloride, microcrystalline cellulose and HPMC with water or an aqueous solution of a binder,
Bii) extruding and spheronising the mixture, and subsequently drying, Co
Biii) collecting the core pellets between 0.8 mm to 1.75 mm for further processing,
Biv) applying the first coating, and .
Bv) applying the second coating wherein the process is carried out in the absence or substantial absence of any organic solvent at least in the second layer.
Coating steps Biv) and Bv) may employ conventional fluidised bed processes. Alternatively, the first coating layer may be applied using a spray melt process or by using a tangential coating process. oo.
A preferred embodiment of each of the above processes is such that the process is carried out a in the absence or substantial absence of any organic solvent in both the first coating layer and : in the second coating layer. SE Co _
The venlafaxine hydrochloride is sourced from the Medichem company, Spain. The ] venlafaxine may be used in any polymorphic form, e.g. in the forms known as Form I or Form
I. The compositions of this invention may be administered to adults in doses ranging from 75 mgto 350 mg venlafaxine per day.
Following is a description by way of example only of compositions of this invention.
Example 1
Pellets according to the following composition are prepared and filled into hard gelatin capsules.
I Core pellets Quantity per capsule (mg) . venlafaxine HCI 169.70 microcrystalline cellulose 199.0
HPMCK 4M 1.85 "0 Wax coating cetostearyl alcohol 9.26 <<
II Polymer coating
Eudragit NE30D _ 56.97 talc 28.49
Total weight of coated pellets 476.90
The core pellets are prepared by mixing the above components with a small amount of water, . i.e. enough to form a paste without dissolving the venlafaxine, under I followed by extrusion spheronisation. The wax coating is applied using a fluidised bed process at or close to the melting temperature of the coating layer. The subsequent polymer (sustained release) coat is applied by a fluidised bed process. The resulting coated pellets are sieved so as to obtain a ) desired pellet size range of between 0.85 mm and 1.75 mm. :
Example 2 T
Pellets are prepared in analogous manner to those in Example 1 with replacement of the wax ST coating by an aqueous suspension of lactose at a concentration of 0.15 g/ml. The suspension is sprayed onto the cores using a perforated pan or a fluidised bed process. i
In view of the small amount of water involved in the first coating step, negligible dissolution of venlafaxine takes place and a protective layer is formed between the pellet core and the second coating.
Examples 3a) and 3b)
Pellets according to the following composition are prepared and filled into hard gelatin capsules.
I Core pellets Quantity per capsule (mg) venlafaxine HCI 169.70 microcrystalline cellulose 193.27
HPMC K 4M 1.85
II Wax coating ) cetostearyl alcohol 10.03 )
IH Polymer coating
Eudragit NE 30 D 70.10 talc 35.05
Total weight of coated pellets 480.00
The core pellets are prepared by mixing the above components with a small amount of water, Co 1.e. enough to form a paste without dissolving the venlafaxine, under I followed by extrusion . spheronisation. The pellets with size between 0.8mm and 1.75mm are collected. The wax coating is applied using in Example 3a) a fluidised bed process, and in Example 3b) tangential coater, - at or close to the melting temperature of the coating layer. The subsequent polymer (sustained release) coat is applied by a fluidised bed process. :
Examples 4a) and 4b) . Pellets are prepared in analogous manner to those in Example 1 with replacement of the wax coating by an aqueous suspension of lactose at a concentration of 0.43 g/ml. The suspension ) is sprayed onto the cores using ) Ls 4a) a perforated pan, or 4b) a fluidised bed process.
In view of the small amount of water involved in the first coating step, negligible dissolution of venlafaxine takes place and a protective first layer is formed between the pellet core and the ) second coating.
Example S
A capsule composition is prepared in analogous manner to that in Example 1 with the following component amounts. 1 Core pellets Quantity in % venlafaxine HCl 37.3 % by weight of core pellets microcrystalline cellulose 62.1 % by weight of core pellets . HPMCK4 M 0.5 % by weight of core pellets
II Wax coating cetostearyl alcohol 2.5 % by weight of core pellets :
I Polymer coating a . Eudragit NE 30 D (dry) 15% by weight of pellets with first coating talc 50% by weight of dry polymer
The following dissolution profiles are observed using USP Apparatus 1 at 100 rpm in purified : water at 37°C.
Cumulative amount dissolved (%)
Time EFFEXOR ER ~ Formulation of Dissolution range (hours) Example 3 in % 2 14 8 <30 4 40 32 30 to 55 8 67 68 56 to 80 12 79 85 65 to 90 : 24 93 98 > 80
The principal advantages of the pellets and compositions of the present invention include a release profile of venlafaxine as effective as the commercially available product, however without the use of an organic solvent medium at least for application of the second coating, A further advantage is the absence of any organic solvent residue in the coated pellets.
The process is more cost-effective and less harzardous than hitherto known processes.
The coated pellets of this invention are thus produced using more economically and : environmentally attractive processes than hitherto known processes for venlafaxine. - -
Claims (17)
1. A coated pellet comprising ) a) a pellet core which comprises venlafaxine hydrochloride; b) afirst coating which comprises a lipophilic layer or a sparingly water-soluble layer,and ¢) asecond coating which comprises a water-insoluble polymer or polymer mixture.
2. A pellet as claimed in claim 1 wherein the core additionally comprises a carrier, e.g. - microcrystalline cellulose.
3. A pellet as claimed in claim 1 or claim 2 wherein the core further comprises a binder.
4. A pellet as claimed in claim 3 wherein the binder comprises a cellulose derivative.
5. A pellet as claimed in claim 3 or claim 4 wherein the binder comprises hydroxypropyl 7 methylcellulose (HPMC).
6. A pellet as claimed in claim 1 or claim 2 wherein the lipophilic layer comprises a fat, fatty alcohol or wax.
7. A pellet as claimed in any preceding claim wherein the lipophilic layer comprises cetostearyl alcohol, castor oil or dibutyl phthalate.
8. A pellet as claimed in claim 1 or claim 2 wherein the sparingly water-soluble layer comprises a sugar, e.g. lactose, in the form of an aqueous suspension wherein the concentration of the sugar is at least 0.3 g/ml.
9. Apellet as claimed in any preceding claim wherein the water-insoluble polymer is selected from polymethacrylate dispersions, ethylcellulose dispersions and polyvinyl acetate dispersions.
10. A composition comprising pellets as claimed in any preceding claim. a
11. A composition as claimed in claim 10 in tablet, hard gelatine capsule or sachet form.
12. A process for preparing coated pellet cores which process comprises the steps of ) © 1) forming a pellet core mixture comprising venlafaxine hydrochloride with water or an aqueous solution of a binder, i) extruding and spheronising the mixture, drying and sieving, iii) applying a first coating, and iv) applying a second coating, : wherein the process is carried out in the absence or substantial absence of any organic solvent medium at least in the second coating. C-
13. A process as claimed in claim 12 wherein the pellet core mixture further comprises microcrystalline cellulose and HPMC.
14. A process as claimed in claim 12 or claim 13 wherein the process is carried out in the absence or substantial absence of any organic solvent medium in both the first and second coatings.
15. A coated pellet produced by the process as claimed in any one of claims 12 to 14.
16. A coated pellet consisting of or consisting essentially of a) acore containing venlafaxine hydrochloride in an amount of between 30 and 60 % by weight, microcrystalline cellulose in an amount of between 40 and 65% by weight, and
HPMC K 4 M in an amount of between 0.3 and 0.8% by weight, wherein the respective ) weights are in relation to the double-coated core; b) a first coating containing cetostearyl alcohol in an amount of between 1.7 and 3.5 % by weight of the first-coated pellet core; and ¢) a second coating containing an acrylate-based polymer in an amount of between 9 and 13% by weight based on the total weight of the double-coated core, and talc in an amount of between 3 and 8% by weight based on the total weight of the double-coated pellet core.
17. A composition comprising pellets as claimed in claim 16.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0307277A GB0307277D0 (en) | 2003-03-28 | 2003-03-28 | Organic compounds |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA200507224B true ZA200507224B (en) | 2006-07-26 |
Family
ID=9955789
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA200507224A ZA200507224B (en) | 2003-03-28 | 2005-09-08 | Velafaxine compositions comprising pellets with double layer coating |
Country Status (3)
| Country | Link |
|---|---|
| CN (1) | CN1767814A (en) |
| GB (1) | GB0307277D0 (en) |
| ZA (1) | ZA200507224B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101756934A (en) * | 2008-12-10 | 2010-06-30 | 上海复星普适医药科技有限公司 | Preparation method for venlafaxine sustained-release preparations |
-
2003
- 2003-03-28 GB GB0307277A patent/GB0307277D0/en not_active Ceased
-
2004
- 2004-03-26 CN CN 200480008398 patent/CN1767814A/en active Pending
-
2005
- 2005-09-08 ZA ZA200507224A patent/ZA200507224B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GB0307277D0 (en) | 2003-05-07 |
| CN1767814A (en) | 2006-05-03 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8557282B2 (en) | Extended release compositions comprising as active compound venlafaxine hydrochloride | |
| US6077533A (en) | Powder-layered oral dosage forms | |
| EP0711152B1 (en) | Powder-layered oral dosage forms | |
| JP4790415B2 (en) | Pharmaceutical composition | |
| US20090175935A1 (en) | Pharmaceutical compositions of duloxetine | |
| JP2007511510A (en) | Sustained release venlafaxine formulation | |
| JP2002523443A (en) | Omeprazole preparation | |
| JP2012504582A (en) | Alcohol-resistant sustained-release oral pharmaceutical dosage forms based on fine granules | |
| EP1187599B1 (en) | Stable benzimidazole formulation | |
| KR20090005237A (en) | Duloxetine hydrochloride delayed release formulations | |
| US20030185887A1 (en) | Controlled release oral dosage form of beta-adrenergic blocking agents | |
| JP2002529401A (en) | Controlled release formulation of water-soluble drug | |
| AU2005257977A1 (en) | Stable pharmaceutical formulations of benzimidazole compounds | |
| JP4234427B2 (en) | Microgranules based on active ingredients and process for their production | |
| US20090004284A1 (en) | Controlled release tamsulosin hydrochloride formulation | |
| US20090017111A1 (en) | Tolterodine bead | |
| EP1635795A1 (en) | Controlled release pharmaceutical compositions of tolterodine and processes for their preparation | |
| US20080226711A1 (en) | Pharmaceutical compositions of duloxetine | |
| US8871275B2 (en) | Extended release compositions comprising tolterodine | |
| EP1689373B1 (en) | Sustained-release microgranules containing ginkgo biloba extract and the process for manufacturing these | |
| US20090192228A1 (en) | Controlled-Release Tolterodine Compositions and Methods | |
| US20060115526A1 (en) | Venlafaxine compositions comprising pellets with double layer coating | |
| ZA200507224B (en) | Velafaxine compositions comprising pellets with double layer coating | |
| AU2008200657A1 (en) | Venlafaxine compositions comprising pellets with double layer coating | |
| EP1778193B1 (en) | Sustained release pharmaceutical particulate composition comprising venlafaxine |