Formulation
One effervescent tablet made with weights 1.5 grams (1500 mg).
Formula for 1 piece of Vitamin C effervescent tablets:

  • Vitamin C 500 mg
  • Pyridoxine 20 mg
  • PVP 3% 45 mg
  • Sucrose 15% 225 mg
  • Citric Acid Monohydrate 208 mg
  • Tartaric Acid 222,9 mg
  • Sodium Bicarbonate 249,5 mg
  • PEG 8000 30 mg 
Read more about :Effervescent Tablet Formulation and Manufacture


Calculation

Weight of effervescent tablet = 1500 mg

Inner Phase weight (consist of active ingredient, acid, base, binder and filler) (98%) = 98/100 1500 mg = 1470 mg

Outer Phase (consists of glidant) (2%) = 2/100  1500 mg = 30 mg

Acid and Base weight = Inner phase– (active ingredient + binder +filler)
= 1470 mg – ( 520 + 45 + 225 ) mg = 680 mg

Citric acid monohydrate:
Molecular weight = 210,13
Equivalent number = 3
Equivalent weight = 210,13/3 = 70,04

Tartaric Acid :
Molecular weight = 150,09
Equivalent number = 2
Equivalent weight = 150,09/2 = 75,05

Sodium Bicarbonate:
Molecular weight = 84,01
Equivalent number = 1
Equivalent weight = 84,01/1 = 84,01

70,04 mol Equivalent + 75,05 mol Equivalent + 84,01 mol Equivalent = 680 mg
229,1 mol Equivalent = 680 mg
mol Equivalent = 2,97

Citric acid monohydrate = 70,04 x 2,97 = 208 mg
Tartaric Acid = 75,05 x 2,97 = 222,9 mg
Sodium Bicarbonate = 84,01 x 2,97 = 249,5 mg

Read more about :Effervescent Tablet Formulation and Manufacture

Consideration of Materials in The Formula And Method Of Manufacture Selection
  • The weight of tablet is 1500 mg because the weight is adequate for the weight of effervescent tablets
  • The selected dose of ascorbic acid is 500 mg / day because the dose can be used for the treatment of canker sores due to deficiency of vitamin C.
  • Number of pyridoxine consumed per day should be fulfilled as much as 2.2 mg for men and 2 mg for women. Pyridoxine is used therapeutically to treat anemia sideroblastik and metabolic disorders due to deficiency of pyridoxine, has a dose of 100-400 mg per day. Pyridoxine dose selected in this formula is 20 mg / day because it still includes a range of doses that can be used for prophylaxis and pyridoxine deficiency, also to meet the effervescent tablet weight of 1.5 grams.
  • Binder used is PVP because PVP is a water soluble binder and a selected concentration of 3% for PVP which is used as a binder in pharmaceutical formulations and technology for 0.5 to 5%
  • Fillers used is sucrose, because filler used in the effervescent tablet is sugar. Concentrations of the selected is 15% because sucrose is used as filler in pharmaceutical formulations and technology is 20-20%.
  • The acid used is a combination of citric acid monohydrate and tartaric acid as would be obtained good effervescent tablets. When used citric acid monohydrate only, granules produced would be sticky and soft, so it can not be compressed, whereas when used in single-tartaric acid it will produce effervescent tablets are hard and cracked.
  • Base used is sodium bicarbonate because the base is usually used in combination with tartaric acid.
  • lubricant used should be water soluble so that the selected PEG 8000
  • The method chosen was the manufacture of dry granulation because the active substance is a vitamin that can not stand the heat so that it is not necessary dry granulation drying process that requires heat.
Weighing to Make 1000 Effervescent Tablets

Asam askorbat 500 mg x 1000 = 2500 g
Pyridoxine 20 mg x 1000 = 100 gr
PVP 3% 45 mg x 1000 = 225 gr
Sukrosa 15% 225 mg x 1000 = 1125 gr
Asam sitrat monohidrat 208 mg x 1000 = 1040 gr
Asam tartrat 222,9 mg x 1000 = 1114.5 gr
Natrium bikarbonat 249,5 mg x 1000 = 1247.5 gr
PEG 8000 30 mg x 1000 = 150 gr

Procedures

Dry Granulation Method
  1. Active Ingredient and excipients each were sieved in separated place.
  2. Mixed together and then mixed until homogeneous.
  3. Powder mass was slugged (5 kg/cm2), and then crushed/sieved trough mesh 12 and mesh 20 siever.
  4. Granular flow test obtained. The flow must be obtained at 10 g / sec. If not obtained, the flow of it, should be slugging back up to obtain the desired flow.
  5. Once the granules have a flow of 10 g / sec, the granules added lubricants. Granules ready to be compressed into tablets weighing 1.5 grams.
Read more about :Effervescent Tablet Formulation and Manufacture

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