generic drug formulations s

Generic Drug Formulations

with

Kollicoat SR 30 D

and

Kollidon SR

Generic Drug Formulations with Kollicoat SR 30 D and Kollidon SR

Page2/51 MEF/EP076 Contents

Contents

I. Kollicoat SR 30 D

Coating

1.1 Theophylline sustained-release pellets

1.2 Theophylline sustained-release pellets(drug-layering process)

2. Caffeine sustained-release pellets(extrusion process)

3.1 Propranolol HCl sustained-release pellets(extrusion process)

3.2 Propranolol HCl sustained-release pellets(drug-layering process)

3.2.1 Propranolol HCl pellet-releasing tablet

4. Acetaminophen taste masked

5. Ibuprofen sustained-release pellets(drug-layering process)

6. Ambroxol HCl sustained-release pellets(drug-layering process)

6.1 Ambroxol HCl pellet-releasing tablet

7. Tramadol HCl sustained-release pellets(drug-layering process)

8. Acetylsalicylic acid crystals



Granulation

9. Propranolol HCl sustained-release tablet

10. Theophylline sustained-release tablet

11. Carbamazepine sustained-release tablet



II. Kollidon SR

12. Metoprolol tartrate sustained-release tablet


14. Caffeine sustained-release tablet

15. Diclofenac Na sustained-release tablet

16. Ascorbic acid sustained-release tablet

17. Indometacin sustained-release tablet


19. Nifedipine sustained-release tablet

20. Tramadol HCl sustained-release tablet

21. Diltiazem HCl sustained-release tablet

22. Naphtidrofuryl oxalate sustained-releasetablet



Page5/51 Caffeine sustained-release pellets



1.1 Theophylline sustained-release pellets

a) Formulation

The formulation is designed for 500g of pure theophylline pellets (Spherofillin [1];diameter 0.8-1.3mm)

Polymer suspension Kollicoat SR 30 D [1] 223.67gPropylene glycol [1] 6.71gWater 149.86g

Pigment suspension Kollidon 30 [1] 2.24gTitanium dioxide [2] 2.24gSicovit Red 30 [1] 2.24gTalc [3] 15.66gWater 44.73g

b) Preparation of the spray suspension

Polymer suspension Add propylene glycol followed by Kollicoat SR30 D to the given quantity of water with stirring.

Pigment suspension Dissolve Kollidon 30 in the given quantity ofwater. Add Sicovit Red 30, titanium dioxide andtalc with vigorous stirring and homogenize themixture in a corundum disk mill.

Spray suspension Incorporate the pigment suspension into thepolymer suspension with stirring. The suspensionmust be stirred during the spraying process toprevent settling.



c) Coating

The pellets were coated in an Aeromatic Strea-1 (Aeromatic AG). The suspensionwas sprayed continuously onto the fluidized, pre-heated pellets from the top.

Process parameters Inlet air temperature 60COutlet air temperature 37CProduct temperature 38CAir flow 80m/hNozzle diameter 0.8mmSpraying rate approx. 11.5g/minSpraying time 39 minAtomizing pressure 1.0barDrying 45C/ 5minCoating weight 2mg film former/cm

The coating weight of 2mg film former / cm given here was determined from thesurface area of the pellets. Since the particle size distribution and surface structureinfluence the polymer quantity required, calculating the surface area is recommendedas a means of estimating the required coating weight in each specific case.

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0.5 mg Kollicoat SR 30 D/cm 1.0 mg Kollicoat SR 30 D/cm 2.0 mg Kollicoat SR 30 D/cm

method: paddle 50 rpm; 37C0-2h: 0.08 M HCl2-24h: phosphate buffer pH 6.8



1.2 Theophylline sustained-release pellets(drug-layering process)

a) Formulation

The formulation is designed for 800g of pellets manufactured by drug layering ofnonpareilles.

Polymer suspension Kollicoat SR 30 D [1] 533.0gTriethyl citrate (TEC) [4] 16.0gWater 433.0g

Pigment suspension Talc [3] 56.0gWater 100.0g


Polymer suspension Add TEC followed by Kollicoat SR 30 D to thegiven quantity of water with stirring.

Pigment suspension Add talc to the given quantity of water withvigorous stirring.




c) Coating

The pellets were coated in an GPCG1 (Glatt). The suspension was sprayedcontinuously onto the fluidized, pre-heated pellets by the Wurster method.

Process parameters Machine Glatt GPCG1Method Bottom-spray (Wurster)Inlet air temperature 50-55COutlet air temperature 29-32CProduct temperature 35-40CAir flow 90m/hNozzle diameter 1.2mmSpraying time 260 minSpraying rate approx. 4.5 g/minAtomizing pressure 1.2barDrying 40C/ 15minCoating weight 20%

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method: paddle 100 rpm; 37C0-20h: pH 7.4



2. Caffeine sustained-release pellets

a) Formulation

The formulation is designed for 500g of pellets (composition of pellets: 10% caffeine[1], 43.75% Avicel PH 101 [5], 43.75% lactose [6], 2.5% Kollidon VA 64 [1];diameter 0.7-1.4mm; made by wet extrusion).


Pigment suspension Kollidon 30 [1] 2.7gTitanium dioxide [2] 2.7gSicovit Red 30 [1] 2.7gTalc [3] 18.87gWater 53.89g


Polymer suspension Add propylene glycol followed by Kollicoat SR 30 Dto the given quantity of water with stirring.

Pigment suspension Dissolve Kollidon 30 in the given quantity of water.Add Sicovit Red 30, titanium dioxide and talc withvigorous stirring and homogenize the mixture in acorundum disk mill.

Spray suspension Incorporate the pigment suspension into the polymersuspension with stirring. The suspension must bestirred during the spraying process to prevent settling.



c) Coating


Process parameters Inlet air temperature 60COutlet air temperature 36CProduct temperature 37CAir flow 80m/hNozzle diameter 0.8mmSpraying rate approx. 12g/minSpraying time 45 minAtomizing pressure 1.0barDrying 45C/ 5minCoating weight 3mg film former/cm

The coating weight of 3mg film former / cm given here was established for thepellets by surface area determination. Since the particle size distribution and surfacestructure influence the required polymer quantity, calculating the surface area isrecommended as a means of estimating the required coating weight in each specificcase.

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Page12/51 Acetminophen taste masked

3.1 Propranolol HCl sustained-release pellets(extrusion process)

a) Formulation

The formulation is designed for 500g of pellets (composition of pellets: 20%propranolol HCl [1], 51.66% Avicel PH 101 [5], 25.84% lactose [6], 2.5% KollidonVA 64 [1]; diameter 0.4-1.5mm; made by wet extrusion).)


Talc suspension Talc [3] 29.94gWater 44.91g


Polymer suspension Add propylene glycol followed by Kollicoat SR30 D to the given quantity of water with stirring.

Talc suspension Add talc with vigorous stirring and homogenizethe mixture in a corundum disk mill.

Spray suspension Incorporate the talc suspension into the polymersuspension with stirring. The suspension must bestirred during the spraying process to preventsettling.



c) Coating


Process parameters Inlet air temperature 60COutlet air temperature 35CProduct temperature 36CAir flow 80m/hNozzle diameter 0.8mmSpraying rate approx. 13g/minSpraying time 39 minAtomizing pressure 1.0barDrying 45C/ 5minCoating weight 3mg film former/cm

The coating weight of 3mg film former / cm given here was established for thepellets by surface area determination. Since the particle size distribution and surfacestructure influence the required polymer quantity, calculating the surface area isrecommended as a means of estimating the required coating weight in each specificcase.

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3.2 Propranolol HCl sustained-release pellets(drug-layering process)

a) Formulation










c) Coating

The pellets were coated in a Glatt GPCG1 coater. The suspension was sprayedcontinuously onto the fluidized, pre-heated pellets from the bottom by the Wurstermethod. Weight gains of 5, 10, 15 and 20% were tested.


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5% Kollicoat SR 30 D10% Kollicoat SR 30 D15% Kollicoat SR 30 D20% Kollicoat SR 30 D

method: paddle 50 rpm; 37C0-20h: 0.1M HCl



3.2.1 Propranolol HCl pellet-releasing tablet

a) Formulation

The formulation is designed for 500g of tablets:

Propranolol HCl/ Kollicoat SR pellets 250.0gMicrocrystalline cellulose (Vivapur 200) [7] 250.0gMagnesium stearate [8] 2.5g

b) Procedure

Mix the ingredients together, pass through a 0.8mm sieve and compress into tabletswith a force of about 15kN.

Tablet press Korsch EK0, 30 tablets/ minCompression force 15kN

c) Tablet properties

Weight 400mgDiameter 10mmForm biplanarHardness 82-112N

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Tablets 850 - 1000 mTablets 710 - 850 mPellets 850 - 1000 mPellets 710 - 850 m

method: paddle 100 rpm; 37Ccoating level: 20%0-20h: 0.1M HCl



4. Acetaminophen - taste masked

a) Formulation

The formulation is designed for 500g of acetaminophen granules [1].

Polymer suspension Kollicoat SR 30 D [1] 73.33g


The dispersion is used directly without any additives.

c) Coating

The crystals were coated in an Aeromatic Strea-1 (Aeromatic AG). The dispersionwas sprayed continuously onto the fluidized, pre-heated crystals from the top.

Process parameters Inlet air temperature 60COutlet air temperature 40CProduct temperature 41CAir flow 80m/hNozzle diameter 0.8mmSpraying rate approx. 9g/minSpraying time 9 minAtomizing pressure 1.0barDrying 45C/ 5minCoating weight 4%

Crystalline acetaminophen is coated with 4% Kollicoat SR 30 D.



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0.1N HClphosphate buffer pH 6.8


Page19/51 Ibuprofen sustained-release pellets

5. Ibuprofen sustained-release pellets(drug-layering process)


a) Subcoating

The polymer spray solution for a weight gain of 5%:

Spray solution Mowiol 4-88 (PVA) [9] 48.0gWater 432.0g

b) Preparation of the spray solution (subcoating)

Dissolve Mowiol in hot water and cool with stirring.

Process parameters Machine Glatt GPCG1Method Bottom-spray (Wurster)Inlet air temperature 50COutlet air temperature 35CProduct temperature 40CAir flow 80m/hNozzle diameter 1.2mmSpraying time 56 minSpraying rate approx. 3.1g/minAtomizing pressure 1.2barDrying 40C/ 15minSubcoating weight 5%

c) Polymer coating

The formulation is designed for 800g of subcoated pellets.




Page20/51 Ibuprofen sustained-release pellets

d) Preparation of the spray suspension (polymer coating):




Process parameters Machine Glatt GPCG1Method Bottom-spray (Wurster)Inlet air temperature 50-55COutlet air temperature 29-32CProduct temperature 35-40CAir flow 90m/hNozzle diameter 1.2mmSpraying time 230 minSpraying rate approx. 4.5 g/minAtomizing pressure 1.2barDrying 40C/ 15min

Spray the suspension continuously onto fluidized pre-heated pellets by the wursterspray method. Weight gains 5, 10, 15 and 20%.

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5% Kollicoat SR 30D10% Kollicoat SR 30D15% Kollicoat SR 30D20% Kollicoat SR 30D



Page21/51 Ambroxol HCl sustained-release pellets

6. Ambroxol HCl sustained-release pellets(drug-layering process)


a) Formulation







c) Coating




Process parameters Machine Glatt GPCG1Method Bottom-spray (Wurster)Inlet air temperature 50-55COutlet air temperature 29-32CProduct temperature 35-40CAir flow 90m/hNozzle diameter 1.2mmSpraying time 220 minSpraying rate approx. 4.5 g/minAtomizing pressure 1.2barDrying 40C/ 15minWeight gain 20%

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6.1 Ambroxol HCl pellet-releasing tablet

d) Formulation

The formulation is designed for 500g of tablets:

Ambroxol HCl/ Kollicoat SR pellets 250.0gMicrocrystalline cellulose (Vivapur 200) [7] 250.0gMagnesium stearate [8] 2.5g

e) Procedure


Tablet press Korsch EK0, 30 tablets/ minCompression force 15kN

f) Tablet properties

Weight 400mgDiameter 10mmForm biplanarHardness 92-116N

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Page24/51 Tramadol HCl sustained-release pellets

7. Tramadol HCl sustained-release pellets(drug-layering process)

a) Polymer coating








c) Coating



Page25/51 Tramadol HCl sustained-release pellets

Process parameters Machine Glatt GPCG1Method Bottom-spray (Wurster)Inlet air temperature 50-55COutlet air temperature 29-32CProduct temperature 35-40CAir flow 90m/hNozzle diameter 1.2mmSpraying time 225 minSpraying rate approx. 4.5 g/minAtomizing pressure 1.2barDrying 40C/ 15minWeight gain 20%

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tablets, 15% Kollicoat SR 30 Dtablets, 20% Kollicoat SR 30 Dpellets, 15% Kollicoat SR 30 Dpellets, 20% Kollicoat SR 30 D



Page26/51 Acetylsalicylic acid crystals

8. Acetylsalicylic acid crystals

a) Formulation

The formulation is designed for 800g of acetylicsalicylic acid crystals [12].

Spray suspension Kollicoat SR 30 D [1] 666.25gTalc [3] 70.00gWater 666.25g


Add talk to the given amount of water with vigorous stirring.Then add Kollicoat SR 30 D with slow stirring.

c) Coating

The crystals were coated in a Glatt GPCG1 coater. The suspension was sprayedcontinously onto the fluidized, pre-heated crystals by the Wurster method. Weightgains of 5, 10, 15 and 20% were tested.



Page27/51 Acetylsalicylic acid crystals

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crystals10% Kollicoat SR 30D15% Kollicoat SR 30D20% Kollicoat SR 30D25% Kollicoat SR 30D

method: paddle 100 rpm; 37C0-20h: pH 7.4no plasticizer


Page28/51 Kollicoat SR 30 D - Granulation


Page29/51 Propranolol HCl sustained-release tablet


a) Formulation of the granules

Propranolol HCl Powder 80 [1] 250.0gGranulac 140 (lactose) [6] 100.0g

Kollicoat SR 30 D [1] 525.0g

b) Manufacture of the granules

The active ingredient and excipient were granulated in an Aeromatic Strea-1(Aeromatic AG). The polymer dispersion was sprayed into the fluid bed from the top.

Process parameters Inlet air temperature 55COutlet air temperature 22 27CNozzle diameter 1.2mmSpraying rate approx. 10g/minAtomizing pressure 2.0bar

c) Formulation of the tablets

Propranolol HCl powder 80 [1] 160.0mgKollicoat SR 30 D [1] 96.0mgGranulac 140 [6] 64.0mgAerosil 200 [13] 1.6mgMagnesium stearate [8] 1.6mg

d) Tableting

The granules were passed together with magnesium stearate (0.5%) and Aerosil200 (0.5%) through an 800m sieve, blended for 10 min in a Turbula mixer andcompressed into tablets with a force of about 18kN.

Tablet press Korsch EK0, 30 tablets/ minCompression force 17.7kN



e) Tablet properties

Weight 323.0mgDiameter 10mmForm biplanarHardness 260N

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Page31/51 Theophylline sustained-release tablet



Theophylline powder [1] 250.0gGranulac 140 [6] 212.5g



The active ingredient and excipient was granulated in an Aeromatic Strea-1(Aeromatic AG). The polymer dispersion was sprayed into the fluid bed from the top.



Theophylline pdr [1] 400.0mgKollicoat SR 30 D [1] 60.0mgGranulac 140 [6] 340.0mgAerosil 200 [13] 4.0mgMagnesium stearate [8] 4.0mg

d) Tableting


Tablet press Korsch PH 106, 30 rpmCompression force 18.7kN




Weight 808.0mgDiameter football shape 19.0x8.5mmHardness 276N

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Page33/51 Carbamazepine sustained-release tablet



Carbamazepine [14] 250.0gGranulac 140 [6] 185.3gKollidon CL-M [1] 25.3g



The active ingredient and excipients were granulated in an Aeromatic Strea-1(Aeromatic AG). The polymer dispersion was sprayed into the fluid bed from the top.



Carbamazepine [14] 200.0mgKollicoat SR 30 D [1] 30.0mgKollidon CL-M [1] 20.2mgGranulac 140 [6] 149.8mgAerosil 200 [13] 2.0mgMagnesium stearate [8] 2.0mg

d) Tableting






Weight 404.0mgDiameter 11mmForm biconvexHardness 136N

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method: paddle 50 rpm; 37C0-16h: SDS-solution (1%; water)


Page35/51 Kollidon SR


Page36/51 Metoprolol tartrate sustained-release tablet

12. Metoprolol tartrate sustained-release tablet


Metoprolol tartrate [15] 454.5gKollicoat SR 30 D [1] 45.5g


The active ingredient was granulated in an Aeromatic Strea-1 (Aeromatic AG). Thepolymer dispersion was sprayed into the fluid bed from the top.



Metoprolol tartrate [15] 200.0mgKollicoat SR 30 D solid polymer 6.0mgKollidon SR [1] 250.0mgMagnesium stearate [8] 2.5mg

d) Tableting

The granules were passed together with magnesium stearate (0.5%) and KollidonSR (54.5%) through an 800m sieve, blended for 10 min in a Turbula mixer andcompressed into tablets with a force of about 10kN.

Tablet press Korsch EK0, 30 tablets/ minCompression force 9,3kN


Page37/51 Metoprolol tartrate sustained-release tablet



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a) Formulation

Propranolol HCl [1] 160.0mgKollidon SR [1] 160.0mgAerosil 200 [13] 3.4mgMagnesium stearate [8] 1.6mg

b) Procedure

Mix the ingredients together, pass through a 0.8mm sieve and compress intotablets with a force of about 10kN.

Tablet press Korsch PH 100/6 30 rpmCompression force 9,9kN



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Page39/51 Caffeine sustained-release tablet

14. Caffeine sustained-release tablet

a) Formulation

Caffeine gran. 0,2/0,5 [1] 160.0mg 160.0mg 160.0mgKollidon SR [1] 160.0mg 120.0mg 80.0mgAvicel PH 102 [5] -- 40.0mg 80.0mgMagnesium stearate [8] 1.6mg 1.6mg 1.6mg

b) Procedure


Tablet press Korsch PH100/6, 30 rpmCompression force 9.6kN 9.8kN 10.1kN


Weight 322.0mg 322.0mg 322.0mgDiameter 10mm 10mm 10mmForm biplanarHardness 213N 201N 193NFriability


Page40/51 Caffeine sustained-release tablet

15. Diclofenac Na sustained-release tablet

a) Formulation

Diclofenac Na [16] 100.0mg 100.0mgKollidon SR [1] 100.0mg 150.0mgAerosil 200 [13] 3.4mg 3.4mgMagnesium stearate [8] 3.0mg 3.0mg

b) Procedure


Tablet press Korsch EK0, 30 tablets/ minCompression force 7.9kN 7.0kN


Weight 206.0mg 256.0mgDiameter 8mmForm biplanarHardness 195N 229NFriability



16. Ascorbic acid sustained-release tablet

a) Formulation

Ascorbic acid cryst. [1] -- 200.0mg 200.0mgAscorbic acid pdr. [1] 200.0mg -- --Kollidon SR [1] 200.0mg 200.0mg 280.0mgLudipress LCE [1] 75.0mg 80.0mg --Aerosil 200 [13] 5.0mg -- --Magnesium stearate [8] 9.0mg 9.0mg 9.0mg

b) Procedure


Tablet press Korsch EK0, 30 tablets/ minCompression force 17.1kN 20.0kN 18.6kN


Weight 489.0mg 489.0mg 489.0mgDiameter 12mmForm biplanarHardness 164N 140N 151NFriability 0.1% 0.1% 0.2%

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ascorbic acid plv./ K.SR/ L.LCE (200mg/ 200mg/ 75mg)

ascorbic acid cryst./ K.SR/ L.LCE (200mg/ 200mg/ 80mg)

ascorbic acid cryst./ K.SR/ L.LCE (200mg/ 200mg/ 80mg)

method: paddle 50 rpm; 37C0-24h: phosphate buffer pH 4.0(1% cysteine HCl-solution)



17. Indometacin sustained-release tablet

a) Formulation

Indometacin [12] 75.0mg 75.0mgKollidon SR [1] 125.0mg 125.0mgLudipress LCE [1] 100.0mg --Aerosil 200 [13] 1.5mg 4.0mgMagnesium stearate [8] 1.5mg 2.0mg

b) Procedure




Weight 303.0mg 203.0mgDiameter 10mmForm biplanarHardness 163N 133NFriability




a) Formulation

Carbamazepine [14] 200.0mg 200.0mgKollidon SR [1] 100.0mg 100.0mgLudipress LCE [1] 200.0mg 150.0mgKollidon CL-M [13] -- 20.0mgMagnesium stearate [8] 2.5mg 2.5mg

b) Procedure




Weight 503.0mg 473.0mgDiameter 12mmForm biplanarHardness 146N 164NFriability 0.1%


Page44/51 Nifedipine sustained-release tablet

19. Nifedipine sustained-release tablet

a) Formulation

Nifedipine [17] 20.0mgKollidon SR [1] 100.0mgLudipress LCE [1] 100.0mgMagnesium stearate [8] 1.0mg

b) Procedure




Weight 221.0mgDiameter 8mmForm biplanarHardness 193NFriability


Page45/51 Tramadol HCl sustained-release tablet

20. Tramadol HCl sustained-release tablet

a) Formulation

Tramadol HCl [11] 100.0mgKollidon SR [1] 150.0mgAerosil 200 [13] 2.5mgMagnesium stearate [8] 1.5mg

b) Procedure






Page46/51 Diltiazem HCl sustained-release tablet

21. Diltiazem HCl sustained-release tablet

a) Formulation

Diltiazem HCl [18] 120.0mgKollidon SR [1] 180.0mgAerosil 200 [13] 3.0mgMagnesium stearate [8] 1.5mg

b) Procedure






Page47/51 Naphtidrofuryl oxalate sustained-release tablet

22. Naphtidrofuryl oxalate sustained-release tablet

a) Formulation

Naphtidrofuryl oxalate [18] 100.0mgKollidon SR [1] 150.0mgTalc [3] 25.0mgAerosil 200 [13] 5.4mgMagnesium stearate [8] 2.5mg

b) Procedure


Tablet press Korsch PH106, 30 rpmCompression force 17.0kN






a) Formulation

Theophylline pdr. [1] 500.0mgKollidon SR [1] 200.0mgLudipress LCE [1] 225.0mgMagnesium stearate [8] 3.0mg

b) Procedure


Tablet press Korsch PH 106, 30 rpmCompression force 10.8kN


Weight 928.0mgDiameter 19.0x8.5mmForm football shapeHardness 172NFriability


Page49/51 Substances

Substances[1] BASF Aktiengesellschaft Excipients

Carl-Bosch Str. 38 Kollicoat SR 30 D67056 Ludwigshafen, Germany Kollidon 30

Kollidon CLKollidon CL-MKollidon SRKollidon VA 64Ludipress LCEPropylene glycolSicovit Red 30

ActivesAcetaminophen gran.Ascorbic acid cryst.Ascorbic acid powderCaffeine gran. 0.2/0.5IbuprofenPropranolol HCl powder 80Theophylline powderSpherofillin

[2] Kronos Titan GmbH Titanium dioxidePostfach 10072051307 Leverkusen, Germany

[3] Riedel-de-Han AG TalcWunstdorferstr. 4030926 Seelze, Germany

[4] Merck-Schuchardt Triethyl citrate85662 Hohenbrunn, Germany

[5] FMC Corp. Food + Pharmaceutical Avicel PH 101Products Avicel PH 102735 Market StreetPhiladelphia, PA 19103, USA

[6] Meggle Milchindustrie Granulac 140Postfach 40 Granulac 23083512 Wasserburg, Germany

[7] J. Rettenmaier & Shne Vivapur 200Holzmhle 173494 Rosenberg, Germany

[8] Brlocher GmbH Magnesium stearate80992 Munich, Germany


Page50/51 Substances

[9] Clariant GmbH Mowiol 4-88 PVADivision CP/TQM-QP65926 Frankfurt am Main, Germany

[10] Heumann Pharma GmbH Ambroxol HClPostfach 226090008 Nuremberg, Germany

[11] Chemagis Ltd. Tramadol HClP.O. Box 9091Tel Aviv 61090, Israel

[12] Synopharm GmbH Acetylicsalicylic acid crystalsPostfach 1205 Indometacin22882 Barsbttel, Germany

[13] Degussa-Hls AG Aerosil 200Weissfrauenstr. 960287 Frankfurt, Germany

[14] Fabbrica Italiana Sintetici S.p.A. CarbamazepineViale Milano, 2636041 Alte di Montecclio Maggiore,Italy

[15] Moehs S.A. Metoprolol tartrateApartado 5908191 Rubi, Spain

[16] Irotec Laboratories Diclofenac NaLittle Island, Cork, Ireland

[17] Prosintex Industrie ChimicheItaliano

Nifedipine

Via E. Ferm, 20/2620019 Seltimo Milanese (Mi), Italy

[18] Farmak a.s. Diltiazem HClNa Vlcinci 3 Naphtidrofuryl oxalate77117 Olomouc, Czech Republic


Page51/51

Note

The data submitted in this publication are based on our current knowledge andexperience. They do not constitute a guarantee in the legal sense of the term and, inview of the mainfold factors that may effect processing and application, do not relieveprocessors from the responsibility of carrying out their own tests and experiments.Any relevant patent rights and existing legislation and regulations must be observed.

BASF AktiengesellschaftUnternehmensbereich Fine Chemicals67056 Ludwigshafen, Germany

generic drug formulations s

Documents

release pellets1

release tablet13

release tablet16

release tablet17

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release tablet21

release tablet10

release tablet14