Professional Documents
Culture Documents
Formula Sirup Kering
Formula Sirup Kering
1. Formulation (granules)
I. Aceclofenac .............................................1.3 g
Orange flavour .........................................4.3 g
Sorbitol ..................................................85.6 g
II. Lutrol F 68 [1]...........................................4.4 g
Cremophor RH 40 [1] ...............................4.4 g
Water ..............................................about 50 g
2. Manufacturing
1. Formulation
I. Albendazole ................................................4 g
Citric acid ...................................................3 g
Sodium citrate.............................................3 g
Sorbitol, crystalline [10]..............................88 g
II. Ethanol 96 % ............................................22 g
Lutrol F 68 [1] .............................................2 g
2. Manufacturing
Granulate mixture I with solution II, pass through a 0.8 mm screen, dry
and sieve again.
3. Administration forms
1. Formulation
2. Manufacturing
Granulate mixture I with solution II, pass through a sieve and dry.
80
60
40
20
0
0 4 8 12
Kollidon CL-M in the administration form [%]
1. Formulation
Amoxicillin trihydrate.................................5.0 g
Sodium citrate..........................................5.0 g
Citric acid, crystalline ................................2.1 g
Sodium gluconate ....................................5.0 g
Sorbitol crystalline [10] ............................40.0 g
Kollidon CL-M [1] .....................................6.0 g
Orange flavour .........................................1.5 g
Lemon flavour ..........................................0.5 g
Saccharin sodium.....................................0.4 g
2. Manufacturing
90
80
70
60
50
0
0 2 4 6 8
Kollidon CL-M in the administration form [%]
1. Formulation
2. Manufacturing
3. Administration
1. Formulation
2. Manufacturing
Viscosity [mPa·s] 80
60
40
20
0
0 2 4 6 8
Kollidon CL-M in the suspension [g/100 ml]
1. Formulation
2. Manufacturing
The mixture I is granulated with the solution II. The obtained granules are
passed through a 1.0 mm sieve and dried at room temperature. Fill 83 g
of the granules in a 100 ml flask.
3. Remark
1. Formulation
2. Manufacturing
Granulate the mixture (I) in a Diosna granulator with water (II) and press
the humid granules through a sieve of 1.5 mm. Form pellets in a sphero-
nizer during 10 min with the rotation speed of 380-420 rpm. Dry the pel-
lets in a fluidizedd bed at 70°C.
1. Formulation
Indomethacin ..........................................160 g
Kollidon CL [1].........................................320 g
Aerosil 200 [4] ............................................q.s.
2. Manufacturing
Mix the components for about 10 min and fill in hard gelatin capsules to
obtain 160 mg indomethacin in each capsule.
3. Dissolution
Indomethacin dissolved [%]
100
80 with Kollidon CL
60
40
20 without Kollidon CL
0
0 15 30 45 60 75 90 105 120
Minutes
1. Formulation
2. Manufacturing
3. Administration
• Dry syrup:
Fill the flask with drinking water until the mark of 100 ml and shake
well. 10 ml of the suspension correspond to 800 mg Magaldrate.
1. Formulation
2. Manufacturing
Granulate mixture I with solution II, pass through a 0.8 mm sieve, dry
well and mix with III.
Fill 3 – 4 g in sachets.
4. Administration
1. Formulation
2. Manufacturing
Pass mixture through a 0.8 mm sieve and granulate with solution II in the
fluidized bed. Fill 6 –12 g of the granules in sachets.
3. Administration
Vitamin C..................................................91%
Calcium pantothenate .......................not tested
All other vitamins ....................................> 95 %
Paracetamol (= Acetaminophen) +
Doxylamine + Caffeine Effervescent
Granules (500 mg + 5 mg + 33 mg/2.1 g)
1. Formulation
I. Paracetamol, powder...............................500 g
Doxylamine succinate ..................................5 g
Caffeine (BASF) .........................................33 g
Tartaric acid ............................................391 g
Sodium hydrogen carbonate ....................417 g
II. Kollidon 30 [1] .............................................6 g
Isopropanol (or Ethanol) ..............................q.s.
III. Sodium citrate...........................................30 g
Sugar .....................................................707 g
2. Manufacturing
Granulate mixture I with solution II, dry at 60°C under vacuum conditi-
ons, sieve and mix with III.
Fill 2.1 g in sachets at maximum 30 % of relative atmospheric humidity.
3. Properties
4. Remark
1. Formulations
No. 1 No. 2
Granulate mixture I with solution II, and pass through a 0.8 mm sieve.
Formulation No. 1: Fill 1.5 g or 3.0 g in sachets.
Formulation No. 2: Fill 1.3 g or 2.6 g in sachets.
The free flowing granules are very well dispersible in cold water.
4. Administration
1. Formulation
2. Manufacturing
1. Formulations
2. Manufacturing
Granulate the mixture (I) in a Diosna granulator with water (II) and press
the humid granules through a sieve of 1.5 mm. Form pellets in a sphero-
nizer with the rotation speed of 200-400 rpm. Dry the pellets in a fluizid
bed and sieve through a 0.7 mm sieve to eliminate the fine particles.
3. Remark
1. Formulation
2. Manufacturing
Introduce solution II into the mixture I. Granulate the powder mixture III
with the well stirred mixture I/II, dry and pass through a 1 mm sieve.
Fill 1 or 2 g in sachets.
4. Administration
1. Formulation
Sulfamethoxazol .......................................4.0 g
Trimethoprim ............................................0.8 g
Sorbitol, crystalline [10] ...........................30.0 g
Sodium citrate..........................................5.0 g
Sodium gluconate ....................................5.0 g
Kollidon CL-M [1]....................................10.0 g
Vanillin .....................................................0.1 g
Saccharin sodium .....................................0.1 g
Chocolate flavour .....................................0.1 g
Sodium benzoate .....................................0.1 g
2. Manufacturing
Mix all components and sieve for administration. Fill 55 g of the mixture
in a 100 ml flask.
II Water......................................................400 g
2. Manufacturing
Granulate the mixture (I) in a Diosna granulator with water (II) and pass
the humid granules through a sieve of 1.5 mm. Form pellets in a sphero-
nizer with the rotation speed of 300-400 rpm. Dry the pellets in a fluidi-
zed bed and sieve through a 0.7 mm sieve to eliminate the fine particles.
3. Remark
1. Formulation
2. Manufacturing
Mix the components I, add the mixture II, granulate mixture I+II with the
liquid III, pass through a 0.8 mm sieve, dry well and mix with III.
Fill 2.1 g of the granules in sachets.
4. Administration
2. Manufacturing
Mix the components I, granulate with soluiton II, dry and pass through a
0.8 mm sieve.
4. Administration
B1 100 % 100 % 93 %
B2 100 % 93 % 80 %
B3 100 % 100 % 98 %
B6 100 % 100 % 97 %
B 12 100 % 100 % 100 %
C 100 % 100 % 97 %
6. Remark